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Cochlear Implantation in Cases of Single-Sided Deafness

Cochlear Implantation in Cases of Single-Sided Deafness

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02203305
Acronym
CI in SSD
Enrollment
43
Registered
2014-07-29
Start date
2014-10-31
Completion date
2021-09-16
Last updated
2022-07-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asymmetric Hearing Loss, Single-Sided Deafness (SSD), Unilateral Moderate to Profound Hearing Loss

Keywords

Unilateral hearing loss, Single Sided Deafness, Asymmetric hearing loss

Brief summary

The primary goal of this project is to determine whether subjects with Single-Sided Deafness (SSD) experience an improvement in speech perception, localization, and quality of life with a cochlear implant as compared to an unaided listening condition.

Detailed description

Single-sided deafness (SSD) can be defined as moderate-to-profound sensorineural hearing loss with limited speech perception benefit in one ear and normal hearing in the contralateral ear. Though one ear is within the normal hearing limits, SSD may result in reduced speech perception in noise, variable abilities on localization tasks, increased subjective report of hearing handicap, and reduced quality of life. This patient population cannot utilize conventional amplification due to the severity of the hearing loss and poor speech discrimination abilities in the affected ear. Current treatment options include: contralateral routing of the signal (CROS) hearing aids, and bone-conduction devices. A CROS hearing aid is a two-part system that includes a microphone/transmitter on the affected ear and a receiver on the normal hearing ear. The microphone/transmitter sends the acoustic signal from the affected ear to the receiver, which is presented to the normal hearing ear. Bone-conduction devices utilize a percutaneous, implanted titanium abutment to send the acoustic signal from the affected side to the normal hearing ear via vibrations. The goal of both of these technologies is to send the signal from the affected side to the normal hearing side, thereby leaving the patient in a unilateral listening condition. Though CROS hearing aids and bone-conduction devices provide the patient with auditory information from both sides to the better hearing ear, the ability to use binaural cues for speech perception in noise is variable. It is of interest whether cochlear implantation of the affected ear would benefit the SSD population. A cochlear implant is a two-part system, including the internal electrode array and external speech processor. The internal electrode array is surgically implanted into the affected cochlea. The external speech processor receives sounds and transmits this signal to the internal portion. The electrode array presents the acoustic signal via electrical pulses within the cochlea, which is interpreted by the brain as sound. Presumably, cochlear implantation may provide the SSD population improvements in speech perception in the affected ear, which cannot benefit from appropriately fit hearing aids. Cochlear implantation may provide a benefit over current treatment options in the SSD population, as it stimulates the auditory pathway on the affected side, thus allowing for ipsilateral representation of acoustic signals arriving to each ear independently. The primary goal of this project is to determine whether subjects with SSD experience an improvement in speech perception, localization, and quality of life with a cochlear implant as compared to an unaided listening condition. Secondary aims include: 1) a comparison of speech perception, localization, and quality of life outcomes in the study population to a SSD control group with long-term listening experience with a current treatment option (i.e. bone-conduction device), and 2) a within-subject comparison of speech perception and localization abilities with cochlear implantation versus the bone-conduction test device.

Interventions

DEVICECochlear Implant

cochlear implantation used a treatment for single-sided deafness and/or asymmetric hearing loss

OTHERControl Group

Subjects in the control group will have had listening experience with a bone-conduction device, which is an approved treatment for SSD.

Sponsors

Med-El Corporation
CollaboratorINDUSTRY
University of North Carolina, Chapel Hill
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

(SSD): * Unilateral moderate-to-profound sensorineural hearing loss \[Unaided residual hearing thresholds measured from 250-8000 Hertz (Hz) (Pure Tone Average (PTA) ≥70 decibel (dB) Hearing Level (HL) in the ear to be implanted\] * Normal to mild residual hearing thresholds from 250-8000 Hz in the contralateral ear (≤35 dB HL at each frequency, 250-8000 Hz) * Greater than or equal to 18 years of age at implantation * Duration of moderate-to-profound sensorineural hearing loss less than or equal to 5 years \[Either reported by subject or documented in previous audiograms\] \[Can be less than or equal to 10 years if the subject consistently utilized hearing technology (such as a bone conduction device or conventional hearing aid) within the past 5 years\] * Previous experience with a current treatment option for SSD, including a conventional hearing aid, bone-conduction device, or CROS/BICROS (Bilateral Contralateral Routing Of the Signal) technology. \[At least one month of listening experience with device\] \[Dissatisfaction with and/or discontinued use of current treatment option due to: insufficient gain, poor sound quality, and/or lack of perceived benefit\] * Aided word recognition in the ear to be implanted of 60% or less as measured with Consonant-Nucleus-Consonant (CNC) words (50-word list) \[When listening with an appropriately fit hearing aid and masking applied to the contralateral ear\] \[Aided testing will be conducted in a sound-proof booth with the subject seated 1 meter from the sound source, facing 0° azimuth. Recorded materials will be presented at 60 dB Sound Pressure Level (SPL).\] \[The hearing aid output will be measured using National Acoustic Laboratory-NonLinear (NAL-NL1) targets.\] * Realistic expectations * Willing to obtain recommended meningitis vaccinations per Center for Disease Control (CDC) recommendations * No reported cognitive issues \[Pass the Mini Mental State Examination (MMSE) screener\] * Able and willing to comply with study requirements, including travel to investigational site and study-related activities

Exclusion criteria

(SSD): * Non-native English speaker \[Speech perception materials are presented in English\] * Conductive hearing loss in either ear * Compromised auditory nerve, including those with a history of vestibular schwannoma * Ossification * Inability to participate in follow-up procedures (i.e., unwillingness, geographic location) * History of meningitis, autoimmune disease, or any medical condition that contraindicate middle or inner ear surgery or anesthesia * Meniere's disease with intractable vertigo * Trauma that precludes inner ear surgery * Case of sudden sensorineural hearing loss that has not been first evaluated by a physician * Pregnancy \[Subjects who are pregnant or become pregnant prior to surgery are excluded due to the potential risk of anesthesia to an unborn child.\] \[Subjects who become pregnant after surgery may continue to participate in study procedures\] * Tinnitus as the primary purpose for seeking cochlear implantation * Subject obtains a severe or catastrophic score on the Tinnitus Handicap Inventory (Newman, Jacobson & Spitzer, 1996). Inclusion Criteria (asymmetric hearing loss): a. Ear to be implanted i. Moderate-to-profound sensorineural hearing loss ii. PTA ≥70 dB HL iii. Aided word recognition of 60% or less as measured with CNC words (50-word list). b. Contralateral ear i. PTA ≥35 and ≤55 dB HL ii. Aided word recognition of 80% or more as measured with CNC words (50-word list). iii. Use of conventional amplification c. Greater than or equal to 18 years of age at implantation d. Duration of moderate-to-profound sensorineural hearing loss in the ear to be implanted is less than or equal to 5 years \[Either reported by subject or documented in previous audiograms. Can be up to 10 years if the subject consistently utilized hearing technology in the ear to be implanted (such as a bone conduction device or conventional hearing aid) within the past 5 years\] e. Previous experience with a current treatment option for asymmetric hearing loss, including a conventional hearing aid, bone-conduction device, or CROS/BiCROS technology. \[At least one month of listening experience with device. Dissatisfaction with and/or discontinued use of current treatment option due to: insufficient gain, poor sound quality, and/or lack of perceived benefit.\] f. Realistic expectations g. Willing to obtain recommended meningitis vaccinations per CDC recommendations h. No reported cognitive issues \[Pass the Mini Mental State Examination (MMSE) screener\] i. Able and willing to comply with study requirements, including travel to investigational site and study-related activities

Design outcomes

Primary

MeasureTime frameDescription
Change in Sentence Recognition in Noise Over Time, Measured With Bamford-Kowal-Bamford (BKB) Sentences With Speech Presented From the Front and Noise Towards the Poorer Hearing Ear (Implanted Ear)Intervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation)Results on recorded speech perception materials: sentence recognition in noise with the target (speaker) from the front and the 4-talker masker 90 degrees towards the poorer hearing ear (implanted ear). Scored as dB signal-to-noise ratio that the listener gets 50% speech understanding. Lower values indicate better performance (range -7.5 to 23.5 dB SNR).
Change in Word Recognition in Quiet Over TimeIntervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation)Results on recorded speech perception materials: monosyllabic (Consonant-Nucleus-Consonant) words in quiet during the first year of device use.
Change in Localization Results (Measured in Root-mean-squared (RMS) Error) Over TimeIntervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation)Subjects were asked to identify the noise source from an 11-speaker array with the cochlear implant on versus off. The intensity level of the stimulus was randomly varied (10 dB around 70 dB SPL) to limit the listener relying on level effects. Responses at each intensity level (i.e., 60, 70, and 80 dB SPL) for a given sound source (speaker) were combined (averaged). Results are reported in root-mean-squared (RMS) error. A lower value indicates better performance. Results are compared during the first year of cochlear implant use.
Change in Subjective Benefit (Measured With the Speech, Spatial, and Qualities (SSQ) of Hearing Questionnaire) Over TimeIntervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation)Subjects completed subjective questionnaires in order to evaluate the perceived benefits of cochlear implantation. For the Speech, Spatial, and Qualities of hearing questionnaire, participants rank their perceived abilities on a scale of 0-10. Higher values indicate more perceived abilities. Results are reported as the total score at each interval, which is the average of the responses from all questions for the questionnaire.
Change in Sentence Recognition in Noise Over Time, Measured With the AzBio Sentences With Speech Presented From the Front and Noise Towards the Better Hearing EarIntervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation)Results on recorded speech perception materials: sentence recognition in noise with the target (speaker) from the front and the 10-talker masker 90 degrees towards the normal/better hearing ear. Scored as the percent correctly repeated.
Change in Localization Results (Measured in Variable Error) Over TimeIntervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation)Subjects were asked to identify the noise source from an 11-speaker array with the cochlear implant on versus off. The intensity level of the stimulus was randomly varied (10 dB around 70 dB SPL) to limit the listener relying on level effects. Responses at each intensity level (i.e., 60, 70, and 80 dB SPL) for a given sound source (speaker) were combined (averaged). Results are reported in variable error. A lower value indicates better performance. Results are compared during the first year of cochlear implant use.
Change in Localization Results (Measured in Constant Error) Over TimeIntervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation)Subjects were asked to identify the noise source from an 11-speaker array with the cochlear implant on versus off. The intensity level of the stimulus was randomly varied (10 dB around 70 dB SPL) to limit the listener relying on level effects. Responses at each intensity level (i.e., 60, 70, and 80 dB SPL) for a given sound source (speaker) were combined (averaged). Results are reported in constant error. A lower value indicates better performance. Results are compared during the first year of cochlear implant use.
Change in Localization Results (Measured in Adjusted Constant Error) Over TimeIntervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation)Subjects were asked to identify the noise source from an 11-speaker array with the cochlear implant on versus off. The intensity level of the stimulus was randomly varied (10 dB around 70 dB SPL) to limit the listener relying on level effects. Responses at each intensity level (i.e., 60, 70, and 80 dB SPL) for a given sound source (speaker) were combined (averaged). Results are reported in adjusted constant error. A lower value indicates better performance. Results are compared during the first year of cochlear implant use.
Change in Subjective Benefit (Measured With the Abbreviated Profile of Hearing Aid Benefit (APHAB) Questionnaire) Over TimeIntervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation)Subjects completed subjective questionnaires in order to evaluate the perceived benefits of cochlear implantation. For the Abbreviated Profile of Hearing Aid Benefit, participants rank their perceived difficulty on a scale of 1-99, with lower values indicate less perceived difficulty. The global score is average response across questions for the ease of communication, reverberation, and effectiveness in background noise subscales.
Change in Subjective Benefit (Measured With the Tinnitus Handicap Inventory (THI) of Hearing Questionnaire) Over TimeIntervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation)Subjects completed subjective questionnaires to order to evaluate the perceived benefits of cochlear implantation. For the Tinnitus Handicap Inventory, participants rank their perceived tinnitus severity on a scale of 0-100, with lower values indicate less tinnitus severity. Responses across all questions are summed to derive the total score.
Change in Sentence Recognition in Noise Over Time, Measured With AzBio Sentences With Speech Presented From the Front and Noise Towards the Poorer Hearing Ear (Implanted Ear)Intervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation)Results on recorded speech perception materials: sentence recognition in noise with the target (speaker) from the front and the 10-talker masker 90 degrees towards the poorer hearing ear (implanted ear). Scored as the percent correctly repeated.
Change in Sentence Recognition in Noise Over Time, Measured With AzBio Sentences With Speech and Noise Presented From the FrontIntervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation)Results on recorded speech perception materials: sentence recognition in noise with the target (speaker) and the 10-talker masker from the front speaker. Scored as the percent correctly repeated.
Change in Sentence Recognition in Noise Over Time, Measured With Bamford-Kowal-Bamford (BKB) Sentences With Speech and Noise Presented From the FrontIntervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation)Results on recorded speech perception materials: sentence recognition in noise with the target (speaker) and the 4-talker masker from the front speaker. Scored as dB signal-to-noise ratio that the listener gets 50% speech understanding. Lower numbers indicate better performance (range -7.5 to 23.5 dB SNR).
Change in Sentence Recognition in Noise Over Time, Measured With Bamford-Kowal-Bamford (BKB) Sentences With Speech Presented From the Front and Noise Towards the Better Hearing EarIntervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation)Results on recorded speech perception materials: sentence recognition in noise with the target (speaker) from the front and the 4-talker masker 90 degrees towards the normal/better hearing ear. Scored as dB signal-to-noise ratio that the listener gets 50% speech understanding. A lower value indicates better performance (range -7.5 to 23.5 dB SNR).

Secondary

MeasureTime frameDescription
Localization for a Control GroupAssessment completed after 12 months of implantable bone-conduction listening experienceSubjects were asked to identify the noise source from an 11-speaker array with the bone-conduction device on versus off. The intensity level of the stimulus was randomly varied (10 dB around 70 dB SPL) to limit the listener relying on level effects. Responses at each intensity level (i.e., 60, 70, and 80 dB SPL) for a given sound source (speaker) were combined (averaged). Results are reported in root-mean-squared (RMS) error. A lower value indicates better performance. Subjects in the control group were implantable bone-conduction device recipients (alternative treatment option) with at least 12 months of listening experience with their implanted bone-conduction device. Participants completed the task with their device on and off.
Subjective Benefit for a Control Group: Abbreviated Profile of Hearing Aid Benefit (APHAB)Assessment completed after 12 months of implantable bone-conduction listening experienceSubjects completed subjective questionnaires. For the Abbreviated Profile of Hearing Aid Benefit, participants rank their perceived difficulty on a scale of 1-99, with lower values indicate less perceived difficulty. Results are reported as the average responses for each of the four subscales: ease of communication, reverberation, effectiveness in background noise, and reverberation. The global score is the average response across questions for the ease of communication, reverberation, and effectiveness in background noise subscales. Participants in the control group had at least 12 months of listening experience with their implanted bone-conduction device prior to study participation.
Subjective Benefit for a Control Group: Speech, Spatial, and Qualities of Hearing Scale (SSQ)Assessment completed after 12 months of implantable bone-conduction listening experienceSubjects completed subjective questionnaires. For the Speech, Spatial, and Qualities of hearing questionnaire, participants rank their perceived abilities on a scale of 0-10. Higher values indicate more perceived abilities. Results are reported as the average responses across questions for each subscale (Speech Hearing, Spatial Hearing, and Qualities of Hearing). Results are also reported as the total score at each interval, which is the average of the responses from all questions for the questionnaire. Participants in the control group had at least 12 months of listening experience with their implanted bone-conduction device prior to study participation.
Aided Word Recognition With a Cochlear Implant Versus a Current Treatment Option (i.e., Hearing Aid)preoperative interval and 12 month post-activation intervalResults on recorded speech perception materials: aided word recognition. Recorded 50-word CNC words were evaluated preoperatively with a conventional hearing aid. Performance was compared to the CI alone at the 12 month interval. A paired samples t-test compared the performance with the two devices. Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis to control for potential floor or ceiling effects (e.g., scores \<20%).
Localization Abilities With a Cochlear Implant Versus a Current Treatment Option (i.e., Bone-conduction Device)Intervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation)Subjects were asked to identify the noise source from an 11-speaker array with the cochlear implant on versus with a bone-conduction device. The intensity level of the stimulus was randomly varied (10 dB around 70 dB SPL) to limit the listener relying on level effects. Responses at each intensity level (i.e., 60, 70, and 80 dB SPL) for a given sound source (speaker) were combined (averaged). Results are reported in root-mean-squared (RMS) error. A lower value indicates better performance.
Subjective Benefit (Measured With the Abbreviated Profile of Hearing Aid Benefit Questionnaire) With Cochlear Implant Versus Preoperative Perceptions With Alternative Treatment Options (e.g., Hearing Aid, Bone-conduction Device)preoperative interval, and post-activation intervals (1, 3, 6, 9, and 12 months)Subjects completed subjective questionnaires. For the Abbreviated Profile of Hearing Aid Benefit, participants rank their perceived difficulty on a scale of 1-99, with lower values indicate less perceived difficulty. The global score is the average response across questions for the ease of communication, reverberation, and effectiveness in background noise subscales.
Subjective Benefit (Measured With the Tinnitus Handicap Inventory (THI) Questionnaire) With Cochlear Implant Versus Preoperative Perceptions With Alternative Treatment Options (e.g., Hearing Aid, Bone-conduction Device)Intervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation)Subjects completed subjective questionnaires. For the Tinnitus Handicap Inventory, participants rank their perceived tinnitus severity on a scale of 0-100, with lower values indicate less tinnitus severity. Responses across all questions are summed to derive the total score.
Subjective Benefit (Measured With the Speech, Spatial, and Qualities of Hearing (SSQ) Questionnaire) With Cochlear Implant Versus Preoperative Perceptions With Alternative Treatment Options (e.g., Hearing Aid, Bone-conduction Device)preoperative interval, and post-activation intervals (1, 3, 6, 9, and 12 months)Subjects completed subjective questionnaires. For the Speech, Spatial, and Qualities of hearing questionnaire, participants rank their perceived abilities on a scale of 0-10. Higher values indicate more perceived abilities. Results are reported as the total score at each interval, which is the average of the responses from all questions for the questionnaire.
Speech Perception Outcomes With a Cochlear Implant Versus a Bone-conduction Device: Sentence Recognition in Noise (AzBio, Speech Front and Noise Front)preoperative interval and 12 month post-activation intervalRecorded AzBio sentences in a 10-talker masker were evaluated in 2 conditions: 1) bone-conduction device at the preoperative interval and 2) with the cochlear implant (CI) at the 12-month post-activation period. A paired samples t-test compared the performance with the two devices. Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.
Speech Perception Outcomes With a Cochlear Implant Versus a Bone-conduction Device: Sentence Recognition in Noise (AzBio, Speech Front and Noise to the Poorer Hearing Ear)preoperative interval and 12 month post-activation intervalRecorded AzBio sentences in a 10-talker masker were evaluated in 2 conditions: 1) bone-conduction device at the preoperative interval and 2) with the cochlear implant (CI) at the 12-month post-activation period. A paired samples t-test compared the performance with the two devices. Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.
Speech Perception Outcomes With a Cochlear Implant Versus a Bone-conduction Device: Sentence Recognition in Noise (AzBio, Speech Front and Noise to the Better Hearing Ear)preoperative interval and 12 month post-activation intervalRecorded AzBio sentences in a 10-talker masker were evaluated in 2 conditions: 1) bone-conduction device at the preoperative interval and 2) with the cochlear implant (CI) at the 12-month post-activation period. A paired samples t-test compared the performance with the two devices. Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.
Speech Perception Outcomes With a Cochlear Implant Versus a Bone-conduction Device: Sentence Recognition in Noise (BKB-Speech In Noise (SIN), Speech Front and Noise Front)preoperative interval and 12 month post-activation intervalRecorded BKB sentences in a 4-talker masker were evaluated in 2 conditions: 1) bone-conduction device at the preoperative interval and 2) with the cochlear implant (CI) at the 12-month post-activation period. A paired samples t-test compared the performance with the two devices. Results are reported in dB SNR, where a lower value indicates better performance (range -7.5 to 23.5 dB SNR).
Speech Perception Outcomes With a Cochlear Implant Versus a Bone-conduction Device: Sentence Recognition in Noise (BKB-SIN, Speech Front and Noise to the Poorer Hearing Ear)preoperative interval and 12 month post-activation intervalRecorded BKB sentences in a 4-talker masker were evaluated in 2 conditions: 1) bone-conduction device at the preoperative interval and 2) with the cochlear implant (CI) at the 12-month post-activation period. A paired samples t-test compared the performance with the two devices. Results are reported in dB SNR, where a lower value indicates better performance (range -7.5 to 23.5 dB SNR).
Speech Perception Outcomes With a Cochlear Implant Versus a Bone-conduction Device: Sentence Recognition in Noise (BKB-SIN, Speech Front and Noise to the Better Hearing Ear)preoperative interval and 12 month post-activation intervalRecorded BKB sentences in a 4-talker masker were evaluated in 2 conditions: 1) bone-conduction device at the preoperative interval and 2) with the cochlear implant (CI) at the 12-month post-activation period. A paired samples t-test compared the performance with the two devices. Results are reported in dB SNR, where a lower value indicates better performance (range -7.5 to 23.5 dB SNR).
Speech Recognition in Noise for a Control Group: AzBio Sentences (0 dB SNR)Assessment completed after 12 months of implantable bone-conduction listening experienceThe speech perception (cochlear implant recipients with UHL/SSD) to a control group of implantable bone-conduction device recipients (alternative treatment option). Participants in the control group had at least 12 months of listening experience with their implanted bone-conduction device prior to study participation. Sentence recognition was assessed in a 10-talker masker at 0 dB SNR with the target speech presented from the front and the masker (1) presented from the front (SoNo), (2) presented towards the implanted ear (SoNbc), and (3) presented towards the acoustic ear (SoNnh). Performance was scored as the percent of words correctly repeated, with higher values indicating better performance. The task was completed with the participants listening with their bone-conduction device on versus off.
Speech Recognition in Noise for a Control Group: BKB-SIN TestAssessment completed after 12 months of implantable bone-conduction listening experienceThe speech perception outcomes in the study population (cochlear implant recipients with UHL/SSD) to a control group of implantable bone-conduction device recipients (alternative treatment option). Participants in the control group had at least 12 months of listening experience with their implanted bone-conduction device prior to study participation. Sentence recognition was assessed in a 4-talker masker with the target speech presented from the front and the masker (1) presented from the front, (2) presented towards the implanted ear, and (3) presented towards the acoustic ear. Performance was scored as the dB SNR when the participant understood 50% correct, with lower values indicating better performance. Participants completed the task with the device on and off.

Other

MeasureTime frameDescription
Change in Pitch Perception With the Cochlear Implant Over the Post-activation Periodpost-activation period (1, 3, 6, and 12 months post-activation)Participants completed an adaptive pitch matching task that compared the pitch of acoustic stimulation presented to their normal hearing ear with the perception of stimulation from the cochlear implant. Two stimuli were used: clicks & tones. Pitch perception was evaluated for the 5 most apical electrodes. A normalized score was obtained (normalized score = geometric mean of the responses / electric center frequency of the evaluated electrode); that is, the normalized score = perceived frequency / frequency information presented by the electrode. Results are reported as the averaged normalized score for clicks & tones for each electrode (electrodes 1-5) at each interval (1, 3, 6, and 12 months post-activation). A value of 1.0 indicates the participant perceived the same frequency as the center frequency presented by the electrode. A value \< 1.0 indicates a lower perceived pitch and a value \> 1.0 indicates a higher perceived pitch than the electric frequency information.

Countries

United States

Participant flow

Participants by arm

ArmCount
Cochlear Implant: Unilateral Hearing Loss/Single-sided Deafness Group
Cochlear implantation of the affected ear Cochlear Implant: cochlear implantation used as a treatment for single-sided deafness/unilateral hearing loss and/or asymmetric hearing loss
20
Control Group
A control group without the study intervention (cochlear implantation) will complete the test battery. Control Group: Subjects in the control group will have had listening experience with a bone-conduction device, which is an approved treatment for SSD.
3
Cochlear Implant: Asymmetric Hearing Loss Group
Cochlear implantation of the poorer hearing ear Cochlear Implant: cochlear implantation used as a treatment for single-sided deafness/unilateral hearing loss and/or asymmetric hearing loss
20
Total43

Baseline characteristics

CharacteristicCochlear Implant: Unilateral Hearing Loss/Single-sided Deafness GroupControl GroupCochlear Implant: Asymmetric Hearing Loss GroupTotal
Age, Continuous50 years
STANDARD_DEVIATION 12
45 years
STANDARD_DEVIATION 3
70 years
STANDARD_DEVIATION 7
58 years
STANDARD_DEVIATION 16
Duration of Hearing Loss3 years
STANDARD_DEVIATION 2
4 years
STANDARD_DEVIATION 2
3 years
STANDARD_DEVIATION 3
3 years
STANDARD_DEVIATION 2
Race and Ethnicity Not Collected0 Participants
Region of Enrollment
United States
20 Participants3 Participants20 Participants43 Participants
Sex: Female, Male
Female
12 Participants2 Participants11 Participants25 Participants
Sex: Female, Male
Male
8 Participants1 Participants9 Participants18 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 200 / 200 / 3
other
Total, other adverse events
8 / 205 / 200 / 3
serious
Total, serious adverse events
0 / 200 / 200 / 3

Outcome results

Primary

Change in Localization Results (Measured in Adjusted Constant Error) Over Time

Subjects were asked to identify the noise source from an 11-speaker array with the cochlear implant on versus off. The intensity level of the stimulus was randomly varied (10 dB around 70 dB SPL) to limit the listener relying on level effects. Responses at each intensity level (i.e., 60, 70, and 80 dB SPL) for a given sound source (speaker) were combined (averaged). Results are reported in adjusted constant error. A lower value indicates better performance. Results are compared during the first year of cochlear implant use.

Time frame: Intervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation)

Population: Three participants in the asymmetric hearing loss group did not complete the 9-month interval. One participant in the asymmetric hearing loss group withdrew from the study prior to the 12-month interval.

ArmMeasureGroupValue (MEAN)Dispersion
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupChange in Localization Results (Measured in Adjusted Constant Error) Over Time3 months after surgery, unaided46 degreesStandard Deviation 12
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupChange in Localization Results (Measured in Adjusted Constant Error) Over Time6 months after surgery, aided (cochlear implant)16 degreesStandard Deviation 5
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupChange in Localization Results (Measured in Adjusted Constant Error) Over Time1 month after surgery, aided (cochlear implant)23 degreesStandard Deviation 10
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupChange in Localization Results (Measured in Adjusted Constant Error) Over Time9 months after surgery, unaided47 degreesStandard Deviation 12
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupChange in Localization Results (Measured in Adjusted Constant Error) Over Time3 months after surgery, aided (cochlear implant)18 degreesStandard Deviation 5
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupChange in Localization Results (Measured in Adjusted Constant Error) Over Time9 months after surgery, aided (cochlear implant)16 degreesStandard Deviation 5
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupChange in Localization Results (Measured in Adjusted Constant Error) Over Time1 month after surgery, unaided47 degreesStandard Deviation 11
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupChange in Localization Results (Measured in Adjusted Constant Error) Over Time12 months after surgery, unaided46 degreesStandard Deviation 12
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupChange in Localization Results (Measured in Adjusted Constant Error) Over Time6 months after surgery, unaided47 degreesStandard Deviation 12
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupChange in Localization Results (Measured in Adjusted Constant Error) Over Time12 months after surgery, aided (cochlear implant)16 degreesStandard Deviation 5
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupChange in Localization Results (Measured in Adjusted Constant Error) Over TimeBefore surgery, unaided48 degreesStandard Deviation 9
Cochlear Implant: Asymmetric Hearing Loss GroupChange in Localization Results (Measured in Adjusted Constant Error) Over Time12 months after surgery, aided (cochlear implant)25 degreesStandard Deviation 6
Cochlear Implant: Asymmetric Hearing Loss GroupChange in Localization Results (Measured in Adjusted Constant Error) Over TimeBefore surgery, unaided48 degreesStandard Deviation 10
Cochlear Implant: Asymmetric Hearing Loss GroupChange in Localization Results (Measured in Adjusted Constant Error) Over Time1 month after surgery, unaided53 degreesStandard Deviation 6
Cochlear Implant: Asymmetric Hearing Loss GroupChange in Localization Results (Measured in Adjusted Constant Error) Over Time1 month after surgery, aided (cochlear implant)30 degreesStandard Deviation 8
Cochlear Implant: Asymmetric Hearing Loss GroupChange in Localization Results (Measured in Adjusted Constant Error) Over Time3 months after surgery, unaided52 degreesStandard Deviation 5
Cochlear Implant: Asymmetric Hearing Loss GroupChange in Localization Results (Measured in Adjusted Constant Error) Over Time3 months after surgery, aided (cochlear implant)29 degreesStandard Deviation 6
Cochlear Implant: Asymmetric Hearing Loss GroupChange in Localization Results (Measured in Adjusted Constant Error) Over Time6 months after surgery, unaided52 degreesStandard Deviation 5
Cochlear Implant: Asymmetric Hearing Loss GroupChange in Localization Results (Measured in Adjusted Constant Error) Over Time6 months after surgery, aided (cochlear implant)27 degreesStandard Deviation 7
Cochlear Implant: Asymmetric Hearing Loss GroupChange in Localization Results (Measured in Adjusted Constant Error) Over Time9 months after surgery, unaided53 degreesStandard Deviation 5
Cochlear Implant: Asymmetric Hearing Loss GroupChange in Localization Results (Measured in Adjusted Constant Error) Over Time9 months after surgery, aided (cochlear implant)26 degreesStandard Deviation 6
Cochlear Implant: Asymmetric Hearing Loss GroupChange in Localization Results (Measured in Adjusted Constant Error) Over Time12 months after surgery, unaided53 degreesStandard Deviation 4
Comparison: Soundfield localization of 200-ms speech-shaped noise, presented from 11 speakers at 60, 70, or 80 decibel (dB) sound pressure level (SPL) in a sound treated room. Adjusted constant error is a measure of reliability in the response taking side bias into account, and a lower score indicates a more reliable response. A repeated-measures ANOVA evaluated the effects of interval, condition (unaided or with the cochlear implant), and their interaction.p-value: <0.024Mixed Models Analysis
Comparison: Soundfield localization of 200-ms speech-shaped noise, presented from 11 speakers at 60, 70, or 80 decibel (dB) sound pressure level (SPL) in a sound treated room. Adjusted constant error is a measure of reliability in the response taking side bias into account, and a lower score indicates a more reliable response. A repeated-measures ANOVA evaluated the effects of interval, condition (unaided or with the cochlear implant), and their interaction.p-value: <0.219Mixed Models Analysis
Comparison: Soundfield localization of 200-ms speech-shaped noise, presented from 11 speakers at 60, 70, or 80 decibel (dB) sound pressure level (SPL) in a sound treated room. Adjusted constant error is a measure of reliability in the response taking side bias into account, and a lower score indicates a more reliable response. A repeated-measures ANOVA evaluated the effect of interval (pre-operatively, 1, 3, 6, 9, and 12 months post). Pre-op: unaided, Post: bilateral.p-value: <0.001ANOVA
Comparison: Soundfield localization of 200-ms speech-shaped noise, presented from 11 speakers at 60, 70, or 80 decibel (dB) sound pressure level (SPL) in a sound treated room. Adjusted constant error is a measure of reliability in the response taking side bias into account, and a lower score indicates a more reliable response. A repeated-measures ANOVA evaluated the effects of interval (pre-operatively, 1, 3, 6, 9, and 12 months post). Pre-op: unaided, Post: bilateral.p-value: <0.001ANOVA
Primary

Change in Localization Results (Measured in Constant Error) Over Time

Subjects were asked to identify the noise source from an 11-speaker array with the cochlear implant on versus off. The intensity level of the stimulus was randomly varied (10 dB around 70 dB SPL) to limit the listener relying on level effects. Responses at each intensity level (i.e., 60, 70, and 80 dB SPL) for a given sound source (speaker) were combined (averaged). Results are reported in constant error. A lower value indicates better performance. Results are compared during the first year of cochlear implant use.

Time frame: Intervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation)

Population: Three participants in the asymmetric hearing loss group did not complete the 9-month interval. One participant in the asymmetric hearing loss group withdrew from the study prior to the 12-month interval.

ArmMeasureGroupValue (MEAN)Dispersion
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupChange in Localization Results (Measured in Constant Error) Over Time3 months after surgery, unaided58 degreesStandard Deviation 21
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupChange in Localization Results (Measured in Constant Error) Over Time6 months after surgery, aided (cochlear implant)19 degreesStandard Deviation 7
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupChange in Localization Results (Measured in Constant Error) Over Time1 month after surgery, aided (cochlear implant)29 degreesStandard Deviation 18
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupChange in Localization Results (Measured in Constant Error) Over Time9 months after surgery, unaided62 degreesStandard Deviation 23
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupChange in Localization Results (Measured in Constant Error) Over Time3 months after surgery, aided (cochlear implant)20 degreesStandard Deviation 6
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupChange in Localization Results (Measured in Constant Error) Over Time9 months after surgery, aided (cochlear implant)18 degreesStandard Deviation 5
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupChange in Localization Results (Measured in Constant Error) Over Time1 month after surgery, unaided60 degreesStandard Deviation 24
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupChange in Localization Results (Measured in Constant Error) Over Time12 months after surgery, unaided58 degreesStandard Deviation 22
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupChange in Localization Results (Measured in Constant Error) Over Time6 months after surgery, unaided60 degreesStandard Deviation 23
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupChange in Localization Results (Measured in Constant Error) Over Time12 months after surgery, aided (cochlear implant)19 degreesStandard Deviation 5
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupChange in Localization Results (Measured in Constant Error) Over TimeBefore surgery, unaided59 degreesStandard Deviation 23
Cochlear Implant: Asymmetric Hearing Loss GroupChange in Localization Results (Measured in Constant Error) Over Time12 months after surgery, aided (cochlear implant)28 degreesStandard Deviation 8
Cochlear Implant: Asymmetric Hearing Loss GroupChange in Localization Results (Measured in Constant Error) Over TimeBefore surgery, unaided67 degreesStandard Deviation 24
Cochlear Implant: Asymmetric Hearing Loss GroupChange in Localization Results (Measured in Constant Error) Over Time1 month after surgery, unaided73 degreesStandard Deviation 19
Cochlear Implant: Asymmetric Hearing Loss GroupChange in Localization Results (Measured in Constant Error) Over Time1 month after surgery, aided (cochlear implant)37 degreesStandard Deviation 12
Cochlear Implant: Asymmetric Hearing Loss GroupChange in Localization Results (Measured in Constant Error) Over Time3 months after surgery, unaided71 degreesStandard Deviation 18
Cochlear Implant: Asymmetric Hearing Loss GroupChange in Localization Results (Measured in Constant Error) Over Time3 months after surgery, aided (cochlear implant)33 degreesStandard Deviation 9
Cochlear Implant: Asymmetric Hearing Loss GroupChange in Localization Results (Measured in Constant Error) Over Time6 months after surgery, unaided74 degreesStandard Deviation 19
Cochlear Implant: Asymmetric Hearing Loss GroupChange in Localization Results (Measured in Constant Error) Over Time6 months after surgery, aided (cochlear implant)31 degreesStandard Deviation 8
Cochlear Implant: Asymmetric Hearing Loss GroupChange in Localization Results (Measured in Constant Error) Over Time9 months after surgery, unaided72 degreesStandard Deviation 20
Cochlear Implant: Asymmetric Hearing Loss GroupChange in Localization Results (Measured in Constant Error) Over Time9 months after surgery, aided (cochlear implant)29 degreesStandard Deviation 7
Cochlear Implant: Asymmetric Hearing Loss GroupChange in Localization Results (Measured in Constant Error) Over Time12 months after surgery, unaided73 degreesStandard Deviation 21
Comparison: Soundfield localization of 200-ms speech-shaped noise, presented from 11 speakers at 60, 70, or 80 decibel (dB) sound pressure level (SPL) in a sound treated room. Constant error is a measure of side bias, and a lower score indicates less response bias to either side. A repeated-measures ANOVA evaluated the effects of interval, condition (unaided or with the cochlear implant), and their interaction.p-value: <0.071Mixed Models Analysis
Comparison: Soundfield localization of 200-ms speech-shaped noise, presented from 11 speakers at 60, 70, or 80 decibel (dB) sound pressure level (SPL) in a sound treated room. Constant error is a measure of side bias, and a lower score indicates less response bias to either side. A repeated-measures ANOVA evaluated the effects of interval, condition (unaided or with the cochlear implant), and their interaction.p-value: <0.109Mixed Models Analysis
Comparison: Soundfield localization of 200-ms speech-shaped noise, presented from 11 speakers at 60, 70, or 80 decibel (dB) sound pressure level (SPL) in a sound treated room. Constant error is a measure of side bias, and a lower score indicates less response bias to either side. A repeated-measures ANOVA evaluated the effect of interval (pre-operatively, 1, 3, 6, 9, and 12 months post). Pre-op: unaided, Post: bilateral.p-value: <0.001ANOVA
Comparison: Soundfield localization of 200-ms speech-shaped noise, presented from 11 speakers at 60, 70, or 80 decibel (dB) sound pressure level (SPL) in a sound treated room. Constant error is a measure of side bias, and a lower score indicates less response bias to either side. A repeated-measures ANOVA evaluated the effects of interval (pre-operatively, 1, 3, 6, 9, and 12 months post). Pre-op: unaided, Post: bilateral.p-value: <0.001ANOVA
Primary

Change in Localization Results (Measured in Root-mean-squared (RMS) Error) Over Time

Subjects were asked to identify the noise source from an 11-speaker array with the cochlear implant on versus off. The intensity level of the stimulus was randomly varied (10 dB around 70 dB SPL) to limit the listener relying on level effects. Responses at each intensity level (i.e., 60, 70, and 80 dB SPL) for a given sound source (speaker) were combined (averaged). Results are reported in root-mean-squared (RMS) error. A lower value indicates better performance. Results are compared during the first year of cochlear implant use.

Time frame: Intervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation)

Population: Three participants in the asymmetric hearing loss group did not complete the 9-month interval. One participant in the asymmetric hearing loss group withdrew from the study prior to the 12-month interval.

ArmMeasureGroupValue (MEAN)Dispersion
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupChange in Localization Results (Measured in Root-mean-squared (RMS) Error) Over Time1 month after surgery, unaided70 degreesStandard Deviation 19
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupChange in Localization Results (Measured in Root-mean-squared (RMS) Error) Over Time6 months after surgery, aided (cochlear implant)27 degreesStandard Deviation 7
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupChange in Localization Results (Measured in Root-mean-squared (RMS) Error) Over Time3 months after surgery, unaided68 degreesStandard Deviation 18
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupChange in Localization Results (Measured in Root-mean-squared (RMS) Error) Over Time9 months after surgery, unaided69 degreesStandard Deviation 19
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupChange in Localization Results (Measured in Root-mean-squared (RMS) Error) Over TimeBefore surgery, unaided67 degreesStandard Deviation 19
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupChange in Localization Results (Measured in Root-mean-squared (RMS) Error) Over Time9 months after surgery, aided (cochlear implant)26 degreesStandard Deviation 6
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupChange in Localization Results (Measured in Root-mean-squared (RMS) Error) Over Time3 months after surgery, aided (cochlear implant)28 degreesStandard Deviation 8
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupChange in Localization Results (Measured in Root-mean-squared (RMS) Error) Over Time12 months after surgery, unaided67 degreesStandard Deviation 18
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupChange in Localization Results (Measured in Root-mean-squared (RMS) Error) Over Time1 month after surgery, aided (cochlear implant)37 degreesStandard Deviation 19
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupChange in Localization Results (Measured in Root-mean-squared (RMS) Error) Over Time12 months after surgery, aided (cochlear implant)27 degreesStandard Deviation 6
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupChange in Localization Results (Measured in Root-mean-squared (RMS) Error) Over Time6 months after surgery, unaided68 degreesStandard Deviation 18
Cochlear Implant: Asymmetric Hearing Loss GroupChange in Localization Results (Measured in Root-mean-squared (RMS) Error) Over Time12 months after surgery, aided (cochlear implant)40 degreesStandard Deviation 11
Cochlear Implant: Asymmetric Hearing Loss GroupChange in Localization Results (Measured in Root-mean-squared (RMS) Error) Over Time1 month after surgery, unaided79 degreesStandard Deviation 14
Cochlear Implant: Asymmetric Hearing Loss GroupChange in Localization Results (Measured in Root-mean-squared (RMS) Error) Over Time1 month after surgery, aided (cochlear implant)52 degreesStandard Deviation 13
Cochlear Implant: Asymmetric Hearing Loss GroupChange in Localization Results (Measured in Root-mean-squared (RMS) Error) Over Time3 months after surgery, unaided77 degreesStandard Deviation 15
Cochlear Implant: Asymmetric Hearing Loss GroupChange in Localization Results (Measured in Root-mean-squared (RMS) Error) Over Time3 months after surgery, aided (cochlear implant)48 degreesStandard Deviation 10
Cochlear Implant: Asymmetric Hearing Loss GroupChange in Localization Results (Measured in Root-mean-squared (RMS) Error) Over Time6 months after surgery, unaided79 degreesStandard Deviation 15
Cochlear Implant: Asymmetric Hearing Loss GroupChange in Localization Results (Measured in Root-mean-squared (RMS) Error) Over Time6 months after surgery, aided (cochlear implant)43 degreesStandard Deviation 9
Cochlear Implant: Asymmetric Hearing Loss GroupChange in Localization Results (Measured in Root-mean-squared (RMS) Error) Over Time9 months after surgery, unaided78 degreesStandard Deviation 16
Cochlear Implant: Asymmetric Hearing Loss GroupChange in Localization Results (Measured in Root-mean-squared (RMS) Error) Over Time9 months after surgery, aided (cochlear implant)41 degreesStandard Deviation 9
Cochlear Implant: Asymmetric Hearing Loss GroupChange in Localization Results (Measured in Root-mean-squared (RMS) Error) Over Time12 months after surgery, unaided79 degreesStandard Deviation 17
Cochlear Implant: Asymmetric Hearing Loss GroupChange in Localization Results (Measured in Root-mean-squared (RMS) Error) Over TimeBefore surgery, unaided76 degreesStandard Deviation 19
Comparison: Soundfield localization of 200-ms speech-shaped noise, presented from 11 speakers at 60, 70, or 80 decibel (dB) sound pressure level (SPL) in a sound treated room. Overall root-mean-square (RMS) error is the difference between the sound source azimuth and the response azimuth and a lower score indicates more accurate localization of the sound source. A repeated-measures ANOVA evaluated the effects of interval, condition (unaided or with the cochlear implant), and their interaction.p-value: <0.019Mixed Models Analysis
Comparison: Soundfield localization of 200-ms speech-shaped noise, presented from 11 speakers at 60, 70, or 80 decibel (dB) sound pressure level (SPL) in a sound treated room. Overall root-mean-square (RMS) error is the difference between the sound source azimuth and the response azimuth and a lower score indicates more accurate localization of the sound source. A repeated-measures ANOVA evaluated the effects of interval, condition (unaided or with the cochlear implant), and their interaction.p-value: <0.012Mixed Models Analysis
Comparison: Soundfield localization of 200-ms speech-shaped noise, presented from 11 speakers at 60, 70, or 80 decibel (dB) sound pressure level (SPL) in a sound treated room. Overall root-mean-square (RMS) error is the difference between the sound source azimuth and the response azimuth and a lower score indicates more accurate localization of the sound source. A repeated-measures ANOVA evaluated the effect of interval (pre-operatively, 1, 3, 6, 9, and 12 months post). Pre-op: unaided, Post: bilateral.p-value: <0.001ANOVA
Comparison: Soundfield localization of 200-ms speech-shaped noise, presented from 11 speakers at 60, 70, or 80 decibel (dB) sound pressure level (SPL) in a sound treated room. Overall root-mean-square (RMS) error is the difference between the sound source azimuth and the response azimuth and a lower score indicates more accurate localization of the sound source. A repeated-measures ANOVA evaluated the effects of interval (pre-operatively, 1, 3, 6, 9, and 12 months post). Pre-op: unaided, Post: bilateral.p-value: <0.001ANOVA
Comparison: Association of age at implantation and sound source localization (RMS) at the 12-month interval with the cochlear implant, analyzed with a Bivariate Pearson correlation (one-tailed).p-value: =0.033bivariate pearson correlation
Comparison: Comparison of sound source localization between groups (UHL/SSD and AHL) over the post-activation intervals (1, 3, 6, 9, and 12 months).p-value: <0.249Mixed Models Analysis
Primary

Change in Localization Results (Measured in Variable Error) Over Time

Subjects were asked to identify the noise source from an 11-speaker array with the cochlear implant on versus off. The intensity level of the stimulus was randomly varied (10 dB around 70 dB SPL) to limit the listener relying on level effects. Responses at each intensity level (i.e., 60, 70, and 80 dB SPL) for a given sound source (speaker) were combined (averaged). Results are reported in variable error. A lower value indicates better performance. Results are compared during the first year of cochlear implant use.

Time frame: Intervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation)

Population: Three participants in the asymmetric hearing loss group did not complete the 9-month interval. One participant in the asymmetric hearing loss group withdrew from the study prior to the 12-month interval.

ArmMeasureGroupValue (MEAN)Dispersion
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupChange in Localization Results (Measured in Variable Error) Over Time1 month after surgery, unaided26 degreesStandard Deviation 18
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupChange in Localization Results (Measured in Variable Error) Over Time6 months after surgery, unaided23 degreesStandard Deviation 14
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupChange in Localization Results (Measured in Variable Error) Over Time1 month after surgery, aided (cochlear implant)23 degreesStandard Deviation 10
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupChange in Localization Results (Measured in Variable Error) Over Time6 months after surgery, aided (cochlear implant)19 degreesStandard Deviation 7
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupChange in Localization Results (Measured in Variable Error) Over TimeBefore surgery, unaided24 degreesStandard Deviation 16
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupChange in Localization Results (Measured in Variable Error) Over Time9 months after surgery, unaided25 degreesStandard Deviation 14
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupChange in Localization Results (Measured in Variable Error) Over Time3 months after surgery, unaided28 degreesStandard Deviation 16
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupChange in Localization Results (Measured in Variable Error) Over Time9 months after surgery, aided (cochlear implant)18 degreesStandard Deviation 7
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupChange in Localization Results (Measured in Variable Error) Over Time12 months after surgery, unaided28 degreesStandard Deviation 15
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupChange in Localization Results (Measured in Variable Error) Over Time12 months after surgery, aided (cochlear implant)18 degreesStandard Deviation 7
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupChange in Localization Results (Measured in Variable Error) Over Time3 months after surgery, aided (cochlear implant)19 degreesStandard Deviation 7
Cochlear Implant: Asymmetric Hearing Loss GroupChange in Localization Results (Measured in Variable Error) Over Time12 months after surgery, aided (cochlear implant)27 degreesStandard Deviation 10
Cochlear Implant: Asymmetric Hearing Loss GroupChange in Localization Results (Measured in Variable Error) Over Time12 months after surgery, unaided24 degreesStandard Deviation 17
Cochlear Implant: Asymmetric Hearing Loss GroupChange in Localization Results (Measured in Variable Error) Over TimeBefore surgery, unaided29 degreesStandard Deviation 18
Cochlear Implant: Asymmetric Hearing Loss GroupChange in Localization Results (Measured in Variable Error) Over Time1 month after surgery, aided (cochlear implant)35 degreesStandard Deviation 13
Cochlear Implant: Asymmetric Hearing Loss GroupChange in Localization Results (Measured in Variable Error) Over Time3 months after surgery, unaided23 degreesStandard Deviation 12
Cochlear Implant: Asymmetric Hearing Loss GroupChange in Localization Results (Measured in Variable Error) Over Time3 months after surgery, aided (cochlear implant)33 degreesStandard Deviation 12
Cochlear Implant: Asymmetric Hearing Loss GroupChange in Localization Results (Measured in Variable Error) Over Time6 months after surgery, unaided23 degreesStandard Deviation 13
Cochlear Implant: Asymmetric Hearing Loss GroupChange in Localization Results (Measured in Variable Error) Over Time6 months after surgery, aided (cochlear implant)28 degreesStandard Deviation 9
Cochlear Implant: Asymmetric Hearing Loss GroupChange in Localization Results (Measured in Variable Error) Over Time9 months after surgery, unaided23 degreesStandard Deviation 14
Cochlear Implant: Asymmetric Hearing Loss GroupChange in Localization Results (Measured in Variable Error) Over Time9 months after surgery, aided (cochlear implant)29 degreesStandard Deviation 11
Cochlear Implant: Asymmetric Hearing Loss GroupChange in Localization Results (Measured in Variable Error) Over Time1 month after surgery, unaided25 degreesStandard Deviation 14
Comparison: Soundfield localization of 200-ms speech-shaped noise, presented from 11 speakers at 60, 70, or 80 decibel (dB) sound pressure level (SPL) in a sound treated room. Variable error is the average of the standard deviation of the responses for each source and a lower score reflects a more consistently accurate response. A repeated-measures ANOVA evaluated the effects of interval, condition (unaided or with the cochlear implant), and their interaction.p-value: <0.183Mixed Models Analysis
Comparison: Soundfield localization of 200-ms speech-shaped noise, presented from 11 speakers at 60, 70, or 80 decibel (dB) sound pressure level (SPL) in a sound treated room. Variable error is the average of the standard deviation of the responses for each source and a lower score reflects a more consistently accurate response. A repeated-measures ANOVA evaluated the effects of interval, condition (unaided or with the cochlear implant), and their interaction.p-value: <0.196Mixed Models Analysis
Comparison: Soundfield localization of 200-ms speech-shaped noise, presented from 11 speakers at 60, 70, or 80 decibel (dB) sound pressure level (SPL) in a sound treated room. Variable error is the average of the standard deviation of the responses for each source and a lower score reflects a more consistently accurate response. A repeated-measures ANOVA evaluated the effect of interval (pre-operatively, 1, 3, 6, 9, and 12 months post). Pre-op: unaided, Post: bilateral.p-value: 0.056ANOVA
Comparison: Soundfield localization of 200-ms speech-shaped noise, presented from 11 speakers at 60, 70, or 80 decibel (dB) sound pressure level (SPL) in a sound treated room. Variable error is the average of the standard deviation of the responses for each source and a lower score reflects a more consistently accurate response. A repeated-measures ANOVA evaluated the effects of interval (pre-operatively, 1, 3, 6, 9, and 12 months post). Pre-op: unaided, Post: bilateral.p-value: =0.21ANOVA
Primary

Change in Sentence Recognition in Noise Over Time, Measured With AzBio Sentences With Speech and Noise Presented From the Front

Results on recorded speech perception materials: sentence recognition in noise with the target (speaker) and the 10-talker masker from the front speaker. Scored as the percent correctly repeated.

Time frame: Intervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation)

Population: Three participants with asymmetric hearing loss did not complete the 9-month interval. One participant with asymmetric hearing loss withdrew from the study prior to the 12-month interval. Four participants were tested at a different signal-to-noise ratio.

ArmMeasureGroupValue (MEAN)Dispersion
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupChange in Sentence Recognition in Noise Over Time, Measured With AzBio Sentences With Speech and Noise Presented From the Front12 months after surgery, unaided42 percentage of words correctly repeatedStandard Deviation 12
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupChange in Sentence Recognition in Noise Over Time, Measured With AzBio Sentences With Speech and Noise Presented From the FrontBefore surgery, unaided37 percentage of words correctly repeatedStandard Deviation 11
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupChange in Sentence Recognition in Noise Over Time, Measured With AzBio Sentences With Speech and Noise Presented From the Front1 month after surgery, unaided39 percentage of words correctly repeatedStandard Deviation 8
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupChange in Sentence Recognition in Noise Over Time, Measured With AzBio Sentences With Speech and Noise Presented From the Front1 month after surgery, aided (cochlear implant)41 percentage of words correctly repeatedStandard Deviation 8
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupChange in Sentence Recognition in Noise Over Time, Measured With AzBio Sentences With Speech and Noise Presented From the Front3 months after surgery, unaided43 percentage of words correctly repeatedStandard Deviation 10
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupChange in Sentence Recognition in Noise Over Time, Measured With AzBio Sentences With Speech and Noise Presented From the Front3 months after surgery, aided (cochlear implant)45 percentage of words correctly repeatedStandard Deviation 15
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupChange in Sentence Recognition in Noise Over Time, Measured With AzBio Sentences With Speech and Noise Presented From the Front6 months after surgery, unaided38 percentage of words correctly repeatedStandard Deviation 13
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupChange in Sentence Recognition in Noise Over Time, Measured With AzBio Sentences With Speech and Noise Presented From the Front6 months after surgery, aided (cochlear implant)45 percentage of words correctly repeatedStandard Deviation 10
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupChange in Sentence Recognition in Noise Over Time, Measured With AzBio Sentences With Speech and Noise Presented From the Front9 months after surgery, unaided45 percentage of words correctly repeatedStandard Deviation 15
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupChange in Sentence Recognition in Noise Over Time, Measured With AzBio Sentences With Speech and Noise Presented From the Front9 months after surgery, aided (cochlear implant)49 percentage of words correctly repeatedStandard Deviation 12
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupChange in Sentence Recognition in Noise Over Time, Measured With AzBio Sentences With Speech and Noise Presented From the Front12 months after surgery, aided (cochlear implant)47 percentage of words correctly repeatedStandard Deviation 11
Cochlear Implant: Asymmetric Hearing Loss GroupChange in Sentence Recognition in Noise Over Time, Measured With AzBio Sentences With Speech and Noise Presented From the Front12 months after surgery, aided (cochlear implant)24 percentage of words correctly repeatedStandard Deviation 14
Cochlear Implant: Asymmetric Hearing Loss GroupChange in Sentence Recognition in Noise Over Time, Measured With AzBio Sentences With Speech and Noise Presented From the Front6 months after surgery, unaided21 percentage of words correctly repeatedStandard Deviation 14
Cochlear Implant: Asymmetric Hearing Loss GroupChange in Sentence Recognition in Noise Over Time, Measured With AzBio Sentences With Speech and Noise Presented From the FrontBefore surgery, unaided18 percentage of words correctly repeatedStandard Deviation 12
Cochlear Implant: Asymmetric Hearing Loss GroupChange in Sentence Recognition in Noise Over Time, Measured With AzBio Sentences With Speech and Noise Presented From the Front9 months after surgery, aided (cochlear implant)25 percentage of words correctly repeatedStandard Deviation 14
Cochlear Implant: Asymmetric Hearing Loss GroupChange in Sentence Recognition in Noise Over Time, Measured With AzBio Sentences With Speech and Noise Presented From the Front1 month after surgery, unaided23 percentage of words correctly repeatedStandard Deviation 14
Cochlear Implant: Asymmetric Hearing Loss GroupChange in Sentence Recognition in Noise Over Time, Measured With AzBio Sentences With Speech and Noise Presented From the Front6 months after surgery, aided (cochlear implant)26 percentage of words correctly repeatedStandard Deviation 10
Cochlear Implant: Asymmetric Hearing Loss GroupChange in Sentence Recognition in Noise Over Time, Measured With AzBio Sentences With Speech and Noise Presented From the Front1 month after surgery, aided (cochlear implant)28 percentage of words correctly repeatedStandard Deviation 14
Cochlear Implant: Asymmetric Hearing Loss GroupChange in Sentence Recognition in Noise Over Time, Measured With AzBio Sentences With Speech and Noise Presented From the Front12 months after surgery, unaided22 percentage of words correctly repeatedStandard Deviation 15
Cochlear Implant: Asymmetric Hearing Loss GroupChange in Sentence Recognition in Noise Over Time, Measured With AzBio Sentences With Speech and Noise Presented From the Front3 months after surgery, unaided17 percentage of words correctly repeatedStandard Deviation 10
Cochlear Implant: Asymmetric Hearing Loss GroupChange in Sentence Recognition in Noise Over Time, Measured With AzBio Sentences With Speech and Noise Presented From the Front9 months after surgery, unaided20 percentage of words correctly repeatedStandard Deviation 15
Cochlear Implant: Asymmetric Hearing Loss GroupChange in Sentence Recognition in Noise Over Time, Measured With AzBio Sentences With Speech and Noise Presented From the Front3 months after surgery, aided (cochlear implant)23 percentage of words correctly repeatedStandard Deviation 10
Comparison: Recorded AzBio sentences in a 10-talker masker were evaluated in 2 conditions: 1) unaided and 2) with the cochlear implant (CI) over the post-activation study period. A repeated-measures ANOVA evaluated the main effects of interval (1, 3, 6, 9, and 12 months post-activation), condition (unaided or with the CI), and their interaction.p-value: <0.581Mixed Models Analysis
Comparison: Recorded AzBio sentences in a 10-talker masker were evaluated in 2 conditions: 1) unaided and 2) with the cochlear implant (CI) over the post-activation study period. A repeated-measures ANOVA evaluated the main effects of interval (1, 3, 6, 9, and 12 months post-activation), condition (unaided or with the CI), and their interaction.p-value: <0.817Mixed Models Analysis
Comparison: Recorded AzBio sentences in a 10-talker masker were evaluated in an unaided condition for the poorer hearing ear pre-operatively and with the cochlear implant (CI) over the study period. A repeated-measures ANOVA evaluated the main effect of interval (before surgery, and 1, 3, 6, 9, and 12 months post-activation). Percent correct converted to RAU.p-value: =0.008ANOVA
Comparison: Recorded AzBio sentences in a 10-talker masker were evaluated in an unaided condition for the poorer hearing ear pre-operatively and with the cochlear implant (CI) over the study period. A repeated-measures ANOVA evaluated the main effect of interval (before surgery, and 1, 3, 6, 9, and 12 months post-activation). Percent correct converted to RAU.p-value: =0.009ANOVA
Comparison: Association of age at implantation and performance at the 12-month interval with the cochlear implant, analyzed with a Bivariate Pearson correlation (one-tailed).p-value: =0.049bivariate pearson correlation
Comparison: Association of word recognition and speech recognition in noise, analyzed with a Bivariate Pearson correlation. Scores were averaged between 3 and 12 months post-activation as an estimate of asymptotic performance.p-value: >0.185bivariate pearson correlation
Primary

Change in Sentence Recognition in Noise Over Time, Measured With AzBio Sentences With Speech Presented From the Front and Noise Towards the Poorer Hearing Ear (Implanted Ear)

Results on recorded speech perception materials: sentence recognition in noise with the target (speaker) from the front and the 10-talker masker 90 degrees towards the poorer hearing ear (implanted ear). Scored as the percent correctly repeated.

Time frame: Intervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation)

Population: Three participants with asymmetric hearing loss did not complete the 9-month interval. One participant with asymmetric hearing loss withdrew from the study prior to the 12-month interval. Four participants were tested at a different signal-to-noise ratio.

ArmMeasureGroupValue (MEAN)Dispersion
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupChange in Sentence Recognition in Noise Over Time, Measured With AzBio Sentences With Speech Presented From the Front and Noise Towards the Poorer Hearing Ear (Implanted Ear)3 months after surgery, unaided85 percentage of words correctly repeatedStandard Deviation 9
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupChange in Sentence Recognition in Noise Over Time, Measured With AzBio Sentences With Speech Presented From the Front and Noise Towards the Poorer Hearing Ear (Implanted Ear)6 months after surgery, aided (cochlear implant)88 percentage of words correctly repeatedStandard Deviation 7
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupChange in Sentence Recognition in Noise Over Time, Measured With AzBio Sentences With Speech Presented From the Front and Noise Towards the Poorer Hearing Ear (Implanted Ear)1 month after surgery, aided (cochlear implant)87 percentage of words correctly repeatedStandard Deviation 7
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupChange in Sentence Recognition in Noise Over Time, Measured With AzBio Sentences With Speech Presented From the Front and Noise Towards the Poorer Hearing Ear (Implanted Ear)9 months after surgery, unaided84 percentage of words correctly repeatedStandard Deviation 15
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupChange in Sentence Recognition in Noise Over Time, Measured With AzBio Sentences With Speech Presented From the Front and Noise Towards the Poorer Hearing Ear (Implanted Ear)3 months after surgery, aided (cochlear implant)87 percentage of words correctly repeatedStandard Deviation 8
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupChange in Sentence Recognition in Noise Over Time, Measured With AzBio Sentences With Speech Presented From the Front and Noise Towards the Poorer Hearing Ear (Implanted Ear)9 months after surgery, aided (cochlear implant)89 percentage of words correctly repeatedStandard Deviation 9
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupChange in Sentence Recognition in Noise Over Time, Measured With AzBio Sentences With Speech Presented From the Front and Noise Towards the Poorer Hearing Ear (Implanted Ear)1 month after surgery, unaided88 percentage of words correctly repeatedStandard Deviation 9
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupChange in Sentence Recognition in Noise Over Time, Measured With AzBio Sentences With Speech Presented From the Front and Noise Towards the Poorer Hearing Ear (Implanted Ear)12 months after surgery, unaided84 percentage of words correctly repeatedStandard Deviation 11
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupChange in Sentence Recognition in Noise Over Time, Measured With AzBio Sentences With Speech Presented From the Front and Noise Towards the Poorer Hearing Ear (Implanted Ear)6 months after surgery, unaided89 percentage of words correctly repeatedStandard Deviation 9
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupChange in Sentence Recognition in Noise Over Time, Measured With AzBio Sentences With Speech Presented From the Front and Noise Towards the Poorer Hearing Ear (Implanted Ear)12 months after surgery, aided (cochlear implant)85 percentage of words correctly repeatedStandard Deviation 11
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupChange in Sentence Recognition in Noise Over Time, Measured With AzBio Sentences With Speech Presented From the Front and Noise Towards the Poorer Hearing Ear (Implanted Ear)Before surgery, unaided83 percentage of words correctly repeatedStandard Deviation 10
Cochlear Implant: Asymmetric Hearing Loss GroupChange in Sentence Recognition in Noise Over Time, Measured With AzBio Sentences With Speech Presented From the Front and Noise Towards the Poorer Hearing Ear (Implanted Ear)12 months after surgery, aided (cochlear implant)42 percentage of words correctly repeatedStandard Deviation 22
Cochlear Implant: Asymmetric Hearing Loss GroupChange in Sentence Recognition in Noise Over Time, Measured With AzBio Sentences With Speech Presented From the Front and Noise Towards the Poorer Hearing Ear (Implanted Ear)Before surgery, unaided40 percentage of words correctly repeatedStandard Deviation 18
Cochlear Implant: Asymmetric Hearing Loss GroupChange in Sentence Recognition in Noise Over Time, Measured With AzBio Sentences With Speech Presented From the Front and Noise Towards the Poorer Hearing Ear (Implanted Ear)1 month after surgery, unaided53 percentage of words correctly repeatedStandard Deviation 17
Cochlear Implant: Asymmetric Hearing Loss GroupChange in Sentence Recognition in Noise Over Time, Measured With AzBio Sentences With Speech Presented From the Front and Noise Towards the Poorer Hearing Ear (Implanted Ear)1 month after surgery, aided (cochlear implant)49 percentage of words correctly repeatedStandard Deviation 15
Cochlear Implant: Asymmetric Hearing Loss GroupChange in Sentence Recognition in Noise Over Time, Measured With AzBio Sentences With Speech Presented From the Front and Noise Towards the Poorer Hearing Ear (Implanted Ear)3 months after surgery, unaided39 percentage of words correctly repeatedStandard Deviation 16
Cochlear Implant: Asymmetric Hearing Loss GroupChange in Sentence Recognition in Noise Over Time, Measured With AzBio Sentences With Speech Presented From the Front and Noise Towards the Poorer Hearing Ear (Implanted Ear)3 months after surgery, aided (cochlear implant)41 percentage of words correctly repeatedStandard Deviation 18
Cochlear Implant: Asymmetric Hearing Loss GroupChange in Sentence Recognition in Noise Over Time, Measured With AzBio Sentences With Speech Presented From the Front and Noise Towards the Poorer Hearing Ear (Implanted Ear)6 months after surgery, unaided29 percentage of words correctly repeatedStandard Deviation 19
Cochlear Implant: Asymmetric Hearing Loss GroupChange in Sentence Recognition in Noise Over Time, Measured With AzBio Sentences With Speech Presented From the Front and Noise Towards the Poorer Hearing Ear (Implanted Ear)6 months after surgery, aided (cochlear implant)38 percentage of words correctly repeatedStandard Deviation 22
Cochlear Implant: Asymmetric Hearing Loss GroupChange in Sentence Recognition in Noise Over Time, Measured With AzBio Sentences With Speech Presented From the Front and Noise Towards the Poorer Hearing Ear (Implanted Ear)9 months after surgery, unaided38 percentage of words correctly repeatedStandard Deviation 17
Cochlear Implant: Asymmetric Hearing Loss GroupChange in Sentence Recognition in Noise Over Time, Measured With AzBio Sentences With Speech Presented From the Front and Noise Towards the Poorer Hearing Ear (Implanted Ear)9 months after surgery, aided (cochlear implant)42 percentage of words correctly repeatedStandard Deviation 21
Cochlear Implant: Asymmetric Hearing Loss GroupChange in Sentence Recognition in Noise Over Time, Measured With AzBio Sentences With Speech Presented From the Front and Noise Towards the Poorer Hearing Ear (Implanted Ear)12 months after surgery, unaided38 percentage of words correctly repeatedStandard Deviation 24
Comparison: Recorded AzBio sentences in a 10-talker masker were evaluated in 2 conditions: 1) unaided and 2) with the cochlear implant (CI) over the post-activation study period. A repeated-measures ANOVA evaluated the main effects of interval (1, 3, 6, 9, and 12 months post-activation), condition (unaided or with the CI), and their interaction.p-value: <0.322Mixed Models Analysis
Comparison: Recorded AzBio sentences in a 10-talker masker were evaluated in 2 conditions: 1) unaided and 2) with the cochlear implant (CI) over the post-activation study period. A repeated-measures ANOVA evaluated the main effects of interval (1, 3, 6, 9, and 12 months post-activation), condition (unaided or with the CI), and their interaction.p-value: <0.317Mixed Models Analysis
Comparison: Recorded AzBio sentences in a 10-talker masker were evaluated in an unaided condition for the poorer hearing ear pre-operatively and with the cochlear implant (CI) over the study period. A repeated-measures ANOVA evaluated the main effect of interval (before surgery, and 1, 3, 6, 9, and 12 months post-activation). Percent correct converted to RAU.p-value: =0.017ANOVA
Comparison: Recorded AzBio sentences in a 10-talker masker were evaluated in an unaided condition for the poorer hearing ear pre-operatively and with the cochlear implant (CI) over the study period. A repeated-measures ANOVA evaluated the main effect of interval (before surgery, and 1, 3, 6, 9, and 12 months post-activation). Percent correct converted to RAU.p-value: =0.292ANOVA
Comparison: Association of word recognition and speech recognition in noise, analyzed with a Bivariate Pearson correlation. Scores were averaged between 3 and 12 months post-activation as an estimate of asymptotic performance.p-value: >0.185bivariate pearson correlation
Primary

Change in Sentence Recognition in Noise Over Time, Measured With Bamford-Kowal-Bamford (BKB) Sentences With Speech and Noise Presented From the Front

Results on recorded speech perception materials: sentence recognition in noise with the target (speaker) and the 4-talker masker from the front speaker. Scored as dB signal-to-noise ratio that the listener gets 50% speech understanding. Lower numbers indicate better performance (range -7.5 to 23.5 dB SNR).

Time frame: Intervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation)

Population: Three participants with asymmetric hearing loss did not complete the 9-month interval. One participant with asymmetric hearing loss withdrew from the study prior to the 12-month interval. Four participants were tested at a different signal-to-noise ratio.

ArmMeasureGroupValue (MEAN)Dispersion
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupChange in Sentence Recognition in Noise Over Time, Measured With Bamford-Kowal-Bamford (BKB) Sentences With Speech and Noise Presented From the Front3 months after surgery, unaided-0.2 signal-to-noise ratioStandard Deviation 1.3
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupChange in Sentence Recognition in Noise Over Time, Measured With Bamford-Kowal-Bamford (BKB) Sentences With Speech and Noise Presented From the Front6 months after surgery, aided (cochlear implant)-0.9 signal-to-noise ratioStandard Deviation 1.4
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupChange in Sentence Recognition in Noise Over Time, Measured With Bamford-Kowal-Bamford (BKB) Sentences With Speech and Noise Presented From the Front1 month after surgery, aided (cochlear implant)-0.6 signal-to-noise ratioStandard Deviation 1.5
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupChange in Sentence Recognition in Noise Over Time, Measured With Bamford-Kowal-Bamford (BKB) Sentences With Speech and Noise Presented From the Front9 months after surgery, unaided-0.7 signal-to-noise ratioStandard Deviation 1.4
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupChange in Sentence Recognition in Noise Over Time, Measured With Bamford-Kowal-Bamford (BKB) Sentences With Speech and Noise Presented From the Front3 months after surgery, aided (cochlear implant)-0.9 signal-to-noise ratioStandard Deviation 1.7
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupChange in Sentence Recognition in Noise Over Time, Measured With Bamford-Kowal-Bamford (BKB) Sentences With Speech and Noise Presented From the Front9 months after surgery, aided (cochlear implant)-1.4 signal-to-noise ratioStandard Deviation 1.4
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupChange in Sentence Recognition in Noise Over Time, Measured With Bamford-Kowal-Bamford (BKB) Sentences With Speech and Noise Presented From the Front1 month after surgery, unaided-0.2 signal-to-noise ratioStandard Deviation 1.2
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupChange in Sentence Recognition in Noise Over Time, Measured With Bamford-Kowal-Bamford (BKB) Sentences With Speech and Noise Presented From the Front12 months after surgery, unaided-0.9 signal-to-noise ratioStandard Deviation 1.2
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupChange in Sentence Recognition in Noise Over Time, Measured With Bamford-Kowal-Bamford (BKB) Sentences With Speech and Noise Presented From the Front6 months after surgery, unaided-0.1 signal-to-noise ratioStandard Deviation 2.4
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupChange in Sentence Recognition in Noise Over Time, Measured With Bamford-Kowal-Bamford (BKB) Sentences With Speech and Noise Presented From the Front12 months after surgery, aided (cochlear implant)-0.8 signal-to-noise ratioStandard Deviation 1.7
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupChange in Sentence Recognition in Noise Over Time, Measured With Bamford-Kowal-Bamford (BKB) Sentences With Speech and Noise Presented From the FrontBefore surgery, unaided0.2 signal-to-noise ratioStandard Deviation 1.4
Cochlear Implant: Asymmetric Hearing Loss GroupChange in Sentence Recognition in Noise Over Time, Measured With Bamford-Kowal-Bamford (BKB) Sentences With Speech and Noise Presented From the Front12 months after surgery, aided (cochlear implant)3.4 signal-to-noise ratioStandard Deviation 3.4
Cochlear Implant: Asymmetric Hearing Loss GroupChange in Sentence Recognition in Noise Over Time, Measured With Bamford-Kowal-Bamford (BKB) Sentences With Speech and Noise Presented From the FrontBefore surgery, unaided4.2 signal-to-noise ratioStandard Deviation 3.5
Cochlear Implant: Asymmetric Hearing Loss GroupChange in Sentence Recognition in Noise Over Time, Measured With Bamford-Kowal-Bamford (BKB) Sentences With Speech and Noise Presented From the Front1 month after surgery, unaided3.3 signal-to-noise ratioStandard Deviation 4.1
Cochlear Implant: Asymmetric Hearing Loss GroupChange in Sentence Recognition in Noise Over Time, Measured With Bamford-Kowal-Bamford (BKB) Sentences With Speech and Noise Presented From the Front1 month after surgery, aided (cochlear implant)2.6 signal-to-noise ratioStandard Deviation 3.1
Cochlear Implant: Asymmetric Hearing Loss GroupChange in Sentence Recognition in Noise Over Time, Measured With Bamford-Kowal-Bamford (BKB) Sentences With Speech and Noise Presented From the Front3 months after surgery, unaided3.6 signal-to-noise ratioStandard Deviation 3.8
Cochlear Implant: Asymmetric Hearing Loss GroupChange in Sentence Recognition in Noise Over Time, Measured With Bamford-Kowal-Bamford (BKB) Sentences With Speech and Noise Presented From the Front3 months after surgery, aided (cochlear implant)2.6 signal-to-noise ratioStandard Deviation 3.1
Cochlear Implant: Asymmetric Hearing Loss GroupChange in Sentence Recognition in Noise Over Time, Measured With Bamford-Kowal-Bamford (BKB) Sentences With Speech and Noise Presented From the Front6 months after surgery, unaided3.1 signal-to-noise ratioStandard Deviation 3.8
Cochlear Implant: Asymmetric Hearing Loss GroupChange in Sentence Recognition in Noise Over Time, Measured With Bamford-Kowal-Bamford (BKB) Sentences With Speech and Noise Presented From the Front6 months after surgery, aided (cochlear implant)1.8 signal-to-noise ratioStandard Deviation 3.6
Cochlear Implant: Asymmetric Hearing Loss GroupChange in Sentence Recognition in Noise Over Time, Measured With Bamford-Kowal-Bamford (BKB) Sentences With Speech and Noise Presented From the Front9 months after surgery, unaided2.7 signal-to-noise ratioStandard Deviation 2.7
Cochlear Implant: Asymmetric Hearing Loss GroupChange in Sentence Recognition in Noise Over Time, Measured With Bamford-Kowal-Bamford (BKB) Sentences With Speech and Noise Presented From the Front9 months after surgery, aided (cochlear implant)1.4 signal-to-noise ratioStandard Deviation 2.5
Cochlear Implant: Asymmetric Hearing Loss GroupChange in Sentence Recognition in Noise Over Time, Measured With Bamford-Kowal-Bamford (BKB) Sentences With Speech and Noise Presented From the Front12 months after surgery, unaided3.9 signal-to-noise ratioStandard Deviation 3.7
Comparison: Recorded BKB sentences in a 4-talker masker were evaluated in 2 conditions: 1) unaided and 2) with the cochlear implant (CI) over the post-activation study period. Results are reported in dB SNR, where a lower value indicates better performance. A repeated-measures ANOVA evaluated the main effects of interval (1, 3, 6, 9, and 12 months post-activation), condition (unaided or with the CI), and their interaction.p-value: <0.44Mixed Models Analysis
Comparison: Recorded BKB sentences in a 4-talker masker were evaluated in 2 conditions: 1) unaided and 2) with the cochlear implant (CI) over the post-activation study period. Results are reported in dB SNR, where a lower value indicates better performance. A repeated-measures ANOVA evaluated the main effects of interval (1, 3, 6, 9, and 12 months post-activation), condition (unaided or with the CI), and their interaction.p-value: <0.379Mixed Models Analysis
Comparison: Recorded BKB sentences in a 4-talker masker were evaluated in an unaided condition for the poorer hearing ear pre-operatively and with the cochlear implant (CI) over the study period. A repeated-measures ANOVA evaluated the main effect of interval (before surgery, and 1, 3, 6, 9, and 12 months post-activation).p-value: =0.021ANOVA
Comparison: Recorded BKB sentences in a 4-talker masker were evaluated in an unaided condition for the poorer hearing ear pre-operatively and with the cochlear implant (CI) over the study period. A repeated-measures ANOVA evaluated the main effect of interval (before surgery, and 1, 3, 6, 9, and 12 months post-activation).p-value: <0.001ANOVA
Primary

Change in Sentence Recognition in Noise Over Time, Measured With Bamford-Kowal-Bamford (BKB) Sentences With Speech Presented From the Front and Noise Towards the Better Hearing Ear

Results on recorded speech perception materials: sentence recognition in noise with the target (speaker) from the front and the 4-talker masker 90 degrees towards the normal/better hearing ear. Scored as dB signal-to-noise ratio that the listener gets 50% speech understanding. A lower value indicates better performance (range -7.5 to 23.5 dB SNR).

Time frame: Intervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation)

Population: Three participants with asymmetric hearing loss did not complete the 9-month interval. One participant with asymmetric hearing loss withdrew from the study prior to the 12-month interval. Four participants were tested at a different signal-to-noise ratio.

ArmMeasureGroupValue (MEAN)Dispersion
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupChange in Sentence Recognition in Noise Over Time, Measured With Bamford-Kowal-Bamford (BKB) Sentences With Speech Presented From the Front and Noise Towards the Better Hearing Ear3 months after surgery, unaided0.6 signal-to-noise ratioStandard Deviation 1.9
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupChange in Sentence Recognition in Noise Over Time, Measured With Bamford-Kowal-Bamford (BKB) Sentences With Speech Presented From the Front and Noise Towards the Better Hearing Ear6 months after surgery, aided (cochlear implant)-0.7 signal-to-noise ratioStandard Deviation 1.1
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupChange in Sentence Recognition in Noise Over Time, Measured With Bamford-Kowal-Bamford (BKB) Sentences With Speech Presented From the Front and Noise Towards the Better Hearing Ear1 month after surgery, aided (cochlear implant)-0.2 signal-to-noise ratioStandard Deviation 2.2
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupChange in Sentence Recognition in Noise Over Time, Measured With Bamford-Kowal-Bamford (BKB) Sentences With Speech Presented From the Front and Noise Towards the Better Hearing Ear9 months after surgery, unaided0.7 signal-to-noise ratioStandard Deviation 2
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupChange in Sentence Recognition in Noise Over Time, Measured With Bamford-Kowal-Bamford (BKB) Sentences With Speech Presented From the Front and Noise Towards the Better Hearing Ear3 months after surgery, aided (cochlear implant)-1.0 signal-to-noise ratioStandard Deviation 2.5
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupChange in Sentence Recognition in Noise Over Time, Measured With Bamford-Kowal-Bamford (BKB) Sentences With Speech Presented From the Front and Noise Towards the Better Hearing Ear9 months after surgery, aided (cochlear implant)-1.2 signal-to-noise ratioStandard Deviation 1.7
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupChange in Sentence Recognition in Noise Over Time, Measured With Bamford-Kowal-Bamford (BKB) Sentences With Speech Presented From the Front and Noise Towards the Better Hearing Ear1 month after surgery, unaided0.7 signal-to-noise ratioStandard Deviation 1.8
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupChange in Sentence Recognition in Noise Over Time, Measured With Bamford-Kowal-Bamford (BKB) Sentences With Speech Presented From the Front and Noise Towards the Better Hearing Ear12 months after surgery, unaided0.8 signal-to-noise ratioStandard Deviation 1.4
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupChange in Sentence Recognition in Noise Over Time, Measured With Bamford-Kowal-Bamford (BKB) Sentences With Speech Presented From the Front and Noise Towards the Better Hearing Ear6 months after surgery, unaided0.6 signal-to-noise ratioStandard Deviation 1.7
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupChange in Sentence Recognition in Noise Over Time, Measured With Bamford-Kowal-Bamford (BKB) Sentences With Speech Presented From the Front and Noise Towards the Better Hearing Ear12 months after surgery, aided (cochlear implant)-1.0 signal-to-noise ratioStandard Deviation 2.2
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupChange in Sentence Recognition in Noise Over Time, Measured With Bamford-Kowal-Bamford (BKB) Sentences With Speech Presented From the Front and Noise Towards the Better Hearing EarBefore surgery, unaided1.8 signal-to-noise ratioStandard Deviation 1.3
Cochlear Implant: Asymmetric Hearing Loss GroupChange in Sentence Recognition in Noise Over Time, Measured With Bamford-Kowal-Bamford (BKB) Sentences With Speech Presented From the Front and Noise Towards the Better Hearing Ear12 months after surgery, aided (cochlear implant)4.4 signal-to-noise ratioStandard Deviation 4.3
Cochlear Implant: Asymmetric Hearing Loss GroupChange in Sentence Recognition in Noise Over Time, Measured With Bamford-Kowal-Bamford (BKB) Sentences With Speech Presented From the Front and Noise Towards the Better Hearing EarBefore surgery, unaided7.1 signal-to-noise ratioStandard Deviation 4
Cochlear Implant: Asymmetric Hearing Loss GroupChange in Sentence Recognition in Noise Over Time, Measured With Bamford-Kowal-Bamford (BKB) Sentences With Speech Presented From the Front and Noise Towards the Better Hearing Ear1 month after surgery, unaided6.8 signal-to-noise ratioStandard Deviation 4.1
Cochlear Implant: Asymmetric Hearing Loss GroupChange in Sentence Recognition in Noise Over Time, Measured With Bamford-Kowal-Bamford (BKB) Sentences With Speech Presented From the Front and Noise Towards the Better Hearing Ear1 month after surgery, aided (cochlear implant)5.2 signal-to-noise ratioStandard Deviation 3.4
Cochlear Implant: Asymmetric Hearing Loss GroupChange in Sentence Recognition in Noise Over Time, Measured With Bamford-Kowal-Bamford (BKB) Sentences With Speech Presented From the Front and Noise Towards the Better Hearing Ear3 months after surgery, unaided6.9 signal-to-noise ratioStandard Deviation 3.5
Cochlear Implant: Asymmetric Hearing Loss GroupChange in Sentence Recognition in Noise Over Time, Measured With Bamford-Kowal-Bamford (BKB) Sentences With Speech Presented From the Front and Noise Towards the Better Hearing Ear3 months after surgery, aided (cochlear implant)4.6 signal-to-noise ratioStandard Deviation 3.3
Cochlear Implant: Asymmetric Hearing Loss GroupChange in Sentence Recognition in Noise Over Time, Measured With Bamford-Kowal-Bamford (BKB) Sentences With Speech Presented From the Front and Noise Towards the Better Hearing Ear6 months after surgery, unaided6.9 signal-to-noise ratioStandard Deviation 3.4
Cochlear Implant: Asymmetric Hearing Loss GroupChange in Sentence Recognition in Noise Over Time, Measured With Bamford-Kowal-Bamford (BKB) Sentences With Speech Presented From the Front and Noise Towards the Better Hearing Ear6 months after surgery, aided (cochlear implant)3.9 signal-to-noise ratioStandard Deviation 3.3
Cochlear Implant: Asymmetric Hearing Loss GroupChange in Sentence Recognition in Noise Over Time, Measured With Bamford-Kowal-Bamford (BKB) Sentences With Speech Presented From the Front and Noise Towards the Better Hearing Ear9 months after surgery, unaided6.2 signal-to-noise ratioStandard Deviation 3.4
Cochlear Implant: Asymmetric Hearing Loss GroupChange in Sentence Recognition in Noise Over Time, Measured With Bamford-Kowal-Bamford (BKB) Sentences With Speech Presented From the Front and Noise Towards the Better Hearing Ear9 months after surgery, aided (cochlear implant)4.2 signal-to-noise ratioStandard Deviation 3
Cochlear Implant: Asymmetric Hearing Loss GroupChange in Sentence Recognition in Noise Over Time, Measured With Bamford-Kowal-Bamford (BKB) Sentences With Speech Presented From the Front and Noise Towards the Better Hearing Ear12 months after surgery, unaided6.9 signal-to-noise ratioStandard Deviation 4.2
Comparison: Recorded BKB sentences in a 4-talker masker were evaluated in 2 conditions: 1) unaided and 2) with the cochlear implant (CI) over the post-activation study period. Results are reported in dB SNR, where a lower value indicates better performance. A repeated-measures ANOVA evaluated the main effects of interval (1, 3, 6, 9, and 12 months post-activation), condition (unaided or with the CI), and their interaction.p-value: <0.639Mixed Models Analysis
Comparison: Recorded BKB sentences in a 4-talker masker were evaluated in 2 conditions: 1) unaided and 2) with the cochlear implant (CI) over the post-activation study period. Results are reported in dB SNR, where a lower value indicates better performance. A repeated-measures ANOVA evaluated the main effects of interval (1, 3, 6, 9, and 12 months post-activation), condition (unaided or with the CI), and their interaction.p-value: <0.637Mixed Models Analysis
Comparison: Recorded BKB sentences in a 4-talker masker were evaluated in an unaided condition for the poorer hearing ear pre-operatively and with the cochlear implant (CI) over the study period. A repeated-measures ANOVA evaluated the main effect of interval (before surgery, and 1, 3, 6, 9, and 12 months post-activation).p-value: <0.001ANOVA
Comparison: Recorded BKB sentences in a 4-talker masker were evaluated in an unaided condition for the poorer hearing ear pre-operatively and with the cochlear implant (CI) over the study period. A repeated-measures ANOVA evaluated the main effect of interval (before surgery, and 1, 3, 6, 9, and 12 months post-activation).p-value: =0.002ANOVA
Primary

Change in Sentence Recognition in Noise Over Time, Measured With Bamford-Kowal-Bamford (BKB) Sentences With Speech Presented From the Front and Noise Towards the Poorer Hearing Ear (Implanted Ear)

Results on recorded speech perception materials: sentence recognition in noise with the target (speaker) from the front and the 4-talker masker 90 degrees towards the poorer hearing ear (implanted ear). Scored as dB signal-to-noise ratio that the listener gets 50% speech understanding. Lower values indicate better performance (range -7.5 to 23.5 dB SNR).

Time frame: Intervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation)

Population: Three participants with asymmetric hearing loss did not complete the 9-month interval. One participant with asymmetric hearing loss withdrew from the study prior to the 12-month interval. Four participants were tested at a different signal-to-noise ratio.

ArmMeasureGroupValue (MEAN)Dispersion
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupChange in Sentence Recognition in Noise Over Time, Measured With Bamford-Kowal-Bamford (BKB) Sentences With Speech Presented From the Front and Noise Towards the Poorer Hearing Ear (Implanted Ear)3 months after surgery, unaided-5.2 signal-to-noise ratioStandard Deviation 1.6
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupChange in Sentence Recognition in Noise Over Time, Measured With Bamford-Kowal-Bamford (BKB) Sentences With Speech Presented From the Front and Noise Towards the Poorer Hearing Ear (Implanted Ear)6 months after surgery, aided (cochlear implant)-5.3 signal-to-noise ratioStandard Deviation 1.5
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupChange in Sentence Recognition in Noise Over Time, Measured With Bamford-Kowal-Bamford (BKB) Sentences With Speech Presented From the Front and Noise Towards the Poorer Hearing Ear (Implanted Ear)1 month after surgery, aided (cochlear implant)-5.3 signal-to-noise ratioStandard Deviation 1.5
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupChange in Sentence Recognition in Noise Over Time, Measured With Bamford-Kowal-Bamford (BKB) Sentences With Speech Presented From the Front and Noise Towards the Poorer Hearing Ear (Implanted Ear)9 months after surgery, unaided-5.5 signal-to-noise ratioStandard Deviation 1.2
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupChange in Sentence Recognition in Noise Over Time, Measured With Bamford-Kowal-Bamford (BKB) Sentences With Speech Presented From the Front and Noise Towards the Poorer Hearing Ear (Implanted Ear)3 months after surgery, aided (cochlear implant)-5.0 signal-to-noise ratioStandard Deviation 1.5
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupChange in Sentence Recognition in Noise Over Time, Measured With Bamford-Kowal-Bamford (BKB) Sentences With Speech Presented From the Front and Noise Towards the Poorer Hearing Ear (Implanted Ear)9 months after surgery, aided (cochlear implant)-5.9 signal-to-noise ratioStandard Deviation 1.1
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupChange in Sentence Recognition in Noise Over Time, Measured With Bamford-Kowal-Bamford (BKB) Sentences With Speech Presented From the Front and Noise Towards the Poorer Hearing Ear (Implanted Ear)1 month after surgery, unaided-5.1 signal-to-noise ratioStandard Deviation 1
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupChange in Sentence Recognition in Noise Over Time, Measured With Bamford-Kowal-Bamford (BKB) Sentences With Speech Presented From the Front and Noise Towards the Poorer Hearing Ear (Implanted Ear)12 months after surgery, unaided-4.7 signal-to-noise ratioStandard Deviation 1.8
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupChange in Sentence Recognition in Noise Over Time, Measured With Bamford-Kowal-Bamford (BKB) Sentences With Speech Presented From the Front and Noise Towards the Poorer Hearing Ear (Implanted Ear)6 months after surgery, unaided-4.9 signal-to-noise ratioStandard Deviation 1.3
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupChange in Sentence Recognition in Noise Over Time, Measured With Bamford-Kowal-Bamford (BKB) Sentences With Speech Presented From the Front and Noise Towards the Poorer Hearing Ear (Implanted Ear)12 months after surgery, aided (cochlear implant)-4.8 signal-to-noise ratioStandard Deviation 1.7
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupChange in Sentence Recognition in Noise Over Time, Measured With Bamford-Kowal-Bamford (BKB) Sentences With Speech Presented From the Front and Noise Towards the Poorer Hearing Ear (Implanted Ear)Before surgery, unaided-4.8 signal-to-noise ratioStandard Deviation 1.6
Cochlear Implant: Asymmetric Hearing Loss GroupChange in Sentence Recognition in Noise Over Time, Measured With Bamford-Kowal-Bamford (BKB) Sentences With Speech Presented From the Front and Noise Towards the Poorer Hearing Ear (Implanted Ear)12 months after surgery, aided (cochlear implant)2.4 signal-to-noise ratioStandard Deviation 3.8
Cochlear Implant: Asymmetric Hearing Loss GroupChange in Sentence Recognition in Noise Over Time, Measured With Bamford-Kowal-Bamford (BKB) Sentences With Speech Presented From the Front and Noise Towards the Poorer Hearing Ear (Implanted Ear)Before surgery, unaided1.4 signal-to-noise ratioStandard Deviation 3.8
Cochlear Implant: Asymmetric Hearing Loss GroupChange in Sentence Recognition in Noise Over Time, Measured With Bamford-Kowal-Bamford (BKB) Sentences With Speech Presented From the Front and Noise Towards the Poorer Hearing Ear (Implanted Ear)1 month after surgery, unaided0.4 signal-to-noise ratioStandard Deviation 4.6
Cochlear Implant: Asymmetric Hearing Loss GroupChange in Sentence Recognition in Noise Over Time, Measured With Bamford-Kowal-Bamford (BKB) Sentences With Speech Presented From the Front and Noise Towards the Poorer Hearing Ear (Implanted Ear)1 month after surgery, aided (cochlear implant)0.5 signal-to-noise ratioStandard Deviation 4.6
Cochlear Implant: Asymmetric Hearing Loss GroupChange in Sentence Recognition in Noise Over Time, Measured With Bamford-Kowal-Bamford (BKB) Sentences With Speech Presented From the Front and Noise Towards the Poorer Hearing Ear (Implanted Ear)3 months after surgery, unaided1.4 signal-to-noise ratioStandard Deviation 4.2
Cochlear Implant: Asymmetric Hearing Loss GroupChange in Sentence Recognition in Noise Over Time, Measured With Bamford-Kowal-Bamford (BKB) Sentences With Speech Presented From the Front and Noise Towards the Poorer Hearing Ear (Implanted Ear)3 months after surgery, aided (cochlear implant)1.7 signal-to-noise ratioStandard Deviation 3.6
Cochlear Implant: Asymmetric Hearing Loss GroupChange in Sentence Recognition in Noise Over Time, Measured With Bamford-Kowal-Bamford (BKB) Sentences With Speech Presented From the Front and Noise Towards the Poorer Hearing Ear (Implanted Ear)6 months after surgery, unaided1.4 signal-to-noise ratioStandard Deviation 4
Cochlear Implant: Asymmetric Hearing Loss GroupChange in Sentence Recognition in Noise Over Time, Measured With Bamford-Kowal-Bamford (BKB) Sentences With Speech Presented From the Front and Noise Towards the Poorer Hearing Ear (Implanted Ear)6 months after surgery, aided (cochlear implant)1.3 signal-to-noise ratioStandard Deviation 4.1
Cochlear Implant: Asymmetric Hearing Loss GroupChange in Sentence Recognition in Noise Over Time, Measured With Bamford-Kowal-Bamford (BKB) Sentences With Speech Presented From the Front and Noise Towards the Poorer Hearing Ear (Implanted Ear)9 months after surgery, unaided0.5 signal-to-noise ratioStandard Deviation 3.8
Cochlear Implant: Asymmetric Hearing Loss GroupChange in Sentence Recognition in Noise Over Time, Measured With Bamford-Kowal-Bamford (BKB) Sentences With Speech Presented From the Front and Noise Towards the Poorer Hearing Ear (Implanted Ear)9 months after surgery, aided (cochlear implant)0.8 signal-to-noise ratioStandard Deviation 3.6
Cochlear Implant: Asymmetric Hearing Loss GroupChange in Sentence Recognition in Noise Over Time, Measured With Bamford-Kowal-Bamford (BKB) Sentences With Speech Presented From the Front and Noise Towards the Poorer Hearing Ear (Implanted Ear)12 months after surgery, unaided2.3 signal-to-noise ratioStandard Deviation 4.9
Comparison: Recorded BKB sentences in a 4-talker masker were evaluated in 2 conditions: 1) unaided and 2) with the cochlear implant (CI) over the post-activation study period. Results are reported in dB SNR, where a lower value indicates better performance. A repeated-measures ANOVA evaluated the main effects of interval (1, 3, 6, 9, and 12 months post-activation), condition (unaided or with the CI), and their interaction.p-value: <0.671Mixed Models Analysis
Comparison: Recorded BKB sentences in a 4-talker masker were evaluated in 2 conditions: 1) unaided and 2) with the cochlear implant (CI) over the post-activation study period. Results are reported in dB SNR, where a lower value indicates better performance. A repeated-measures ANOVA evaluated the main effects of interval (1, 3, 6, 9, and 12 months post-activation), condition (unaided or with the CI), and their interaction.p-value: >0.124Mixed Models Analysis
Comparison: Recorded BKB sentences in a 4-talker masker were evaluated in an unaided condition for the poorer hearing ear pre-operatively and with the cochlear implant (CI) over the study period. A repeated-measures ANOVA evaluated the main effect of interval (before surgery, and 1, 3, 6, 9, and 12 months post-activation).p-value: =0.025ANOVA
Comparison: Recorded BKB sentences in a 4-talker masker were evaluated in an unaided condition for the poorer hearing ear pre-operatively and with the cochlear implant (CI) over the study period. A repeated-measures ANOVA evaluated the main effect of interval (before surgery, and 1, 3, 6, 9, and 12 months post-activation).p-value: =0.442ANOVA
Primary

Change in Sentence Recognition in Noise Over Time, Measured With the AzBio Sentences With Speech Presented From the Front and Noise Towards the Better Hearing Ear

Results on recorded speech perception materials: sentence recognition in noise with the target (speaker) from the front and the 10-talker masker 90 degrees towards the normal/better hearing ear. Scored as the percent correctly repeated.

Time frame: Intervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation)

Population: Three participants with asymmetric hearing loss did not complete the 9-month interval. One participant with asymmetric hearing loss withdrew from the study prior to the 12-month interval. Four participants were tested at a different signal-to-noise ratio.

ArmMeasureGroupValue (MEAN)Dispersion
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupChange in Sentence Recognition in Noise Over Time, Measured With the AzBio Sentences With Speech Presented From the Front and Noise Towards the Better Hearing Ear6 months after surgery, unaided23 percentage of words correctly repeatedStandard Deviation 18
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupChange in Sentence Recognition in Noise Over Time, Measured With the AzBio Sentences With Speech Presented From the Front and Noise Towards the Better Hearing Ear3 months after surgery, aided (cochlear implant)49 percentage of words correctly repeatedStandard Deviation 19
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupChange in Sentence Recognition in Noise Over Time, Measured With the AzBio Sentences With Speech Presented From the Front and Noise Towards the Better Hearing Ear6 months after surgery, aided (cochlear implant)49 percentage of words correctly repeatedStandard Deviation 16
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupChange in Sentence Recognition in Noise Over Time, Measured With the AzBio Sentences With Speech Presented From the Front and Noise Towards the Better Hearing Ear1 month after surgery, unaided21 percentage of words correctly repeatedStandard Deviation 14
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupChange in Sentence Recognition in Noise Over Time, Measured With the AzBio Sentences With Speech Presented From the Front and Noise Towards the Better Hearing Ear9 months after surgery, unaided25 percentage of words correctly repeatedStandard Deviation 17
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupChange in Sentence Recognition in Noise Over Time, Measured With the AzBio Sentences With Speech Presented From the Front and Noise Towards the Better Hearing Ear9 months after surgery, aided (cochlear implant)52 percentage of words correctly repeatedStandard Deviation 18
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupChange in Sentence Recognition in Noise Over Time, Measured With the AzBio Sentences With Speech Presented From the Front and Noise Towards the Better Hearing Ear1 month after surgery, aided (cochlear implant)40 percentage of words correctly repeatedStandard Deviation 16
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupChange in Sentence Recognition in Noise Over Time, Measured With the AzBio Sentences With Speech Presented From the Front and Noise Towards the Better Hearing Ear12 months after surgery, unaided21 percentage of words correctly repeatedStandard Deviation 19
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupChange in Sentence Recognition in Noise Over Time, Measured With the AzBio Sentences With Speech Presented From the Front and Noise Towards the Better Hearing EarBefore surgery, unaided16 percentage of words correctly repeatedStandard Deviation 13
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupChange in Sentence Recognition in Noise Over Time, Measured With the AzBio Sentences With Speech Presented From the Front and Noise Towards the Better Hearing Ear12 months after surgery, aided (cochlear implant)53 percentage of words correctly repeatedStandard Deviation 21
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupChange in Sentence Recognition in Noise Over Time, Measured With the AzBio Sentences With Speech Presented From the Front and Noise Towards the Better Hearing Ear3 months after surgery, unaided25 percentage of words correctly repeatedStandard Deviation 16
Cochlear Implant: Asymmetric Hearing Loss GroupChange in Sentence Recognition in Noise Over Time, Measured With the AzBio Sentences With Speech Presented From the Front and Noise Towards the Better Hearing Ear12 months after surgery, aided (cochlear implant)22 percentage of words correctly repeatedStandard Deviation 18
Cochlear Implant: Asymmetric Hearing Loss GroupChange in Sentence Recognition in Noise Over Time, Measured With the AzBio Sentences With Speech Presented From the Front and Noise Towards the Better Hearing Ear3 months after surgery, aided (cochlear implant)10 percentage of words correctly repeatedStandard Deviation 10
Cochlear Implant: Asymmetric Hearing Loss GroupChange in Sentence Recognition in Noise Over Time, Measured With the AzBio Sentences With Speech Presented From the Front and Noise Towards the Better Hearing EarBefore surgery, unaided3 percentage of words correctly repeatedStandard Deviation 3
Cochlear Implant: Asymmetric Hearing Loss GroupChange in Sentence Recognition in Noise Over Time, Measured With the AzBio Sentences With Speech Presented From the Front and Noise Towards the Better Hearing Ear1 month after surgery, unaided5 percentage of words correctly repeatedStandard Deviation 5
Cochlear Implant: Asymmetric Hearing Loss GroupChange in Sentence Recognition in Noise Over Time, Measured With the AzBio Sentences With Speech Presented From the Front and Noise Towards the Better Hearing Ear1 month after surgery, aided (cochlear implant)8 percentage of words correctly repeatedStandard Deviation 8
Cochlear Implant: Asymmetric Hearing Loss GroupChange in Sentence Recognition in Noise Over Time, Measured With the AzBio Sentences With Speech Presented From the Front and Noise Towards the Better Hearing Ear6 months after surgery, unaided2 percentage of words correctly repeatedStandard Deviation 4
Cochlear Implant: Asymmetric Hearing Loss GroupChange in Sentence Recognition in Noise Over Time, Measured With the AzBio Sentences With Speech Presented From the Front and Noise Towards the Better Hearing Ear6 months after surgery, aided (cochlear implant)15 percentage of words correctly repeatedStandard Deviation 10
Cochlear Implant: Asymmetric Hearing Loss GroupChange in Sentence Recognition in Noise Over Time, Measured With the AzBio Sentences With Speech Presented From the Front and Noise Towards the Better Hearing Ear9 months after surgery, unaided2 percentage of words correctly repeatedStandard Deviation 4
Cochlear Implant: Asymmetric Hearing Loss GroupChange in Sentence Recognition in Noise Over Time, Measured With the AzBio Sentences With Speech Presented From the Front and Noise Towards the Better Hearing Ear9 months after surgery, aided (cochlear implant)15 percentage of words correctly repeatedStandard Deviation 12
Cochlear Implant: Asymmetric Hearing Loss GroupChange in Sentence Recognition in Noise Over Time, Measured With the AzBio Sentences With Speech Presented From the Front and Noise Towards the Better Hearing Ear12 months after surgery, unaided4 percentage of words correctly repeatedStandard Deviation 8
Cochlear Implant: Asymmetric Hearing Loss GroupChange in Sentence Recognition in Noise Over Time, Measured With the AzBio Sentences With Speech Presented From the Front and Noise Towards the Better Hearing Ear3 months after surgery, unaided3 percentage of words correctly repeatedStandard Deviation 6
Comparison: Recorded AzBio sentences in a 10-talker masker were evaluated in 2 conditions: 1) unaided and 2) with the cochlear implant (CI) over the post-activation study period. A repeated-measures ANOVA evaluated the main effects of interval (1, 3, 6, 9, and 12 months post-activation), condition (unaided or with the CI), and their interaction.p-value: <0.161Mixed Models Analysis
Comparison: Recorded AzBio sentences in a 10-talker masker were evaluated in 2 conditions: 1) unaided and 2) with the cochlear implant (CI) over the post-activation study period. A repeated-measures ANOVA evaluated the main effects of interval (1, 3, 6, 9, and 12 months post-activation), condition (unaided or with the CI), and their interaction.p-value: >0.107Mixed Models Analysis
Comparison: Recorded AzBio sentences in a 10-talker masker were evaluated in an unaided condition for the poorer hearing ear pre-operatively and with the cochlear implant (CI) over the study period. A repeated-measures ANOVA evaluated the main effect of interval (before surgery, and 1, 3, 6, 9, and 12 months post-activation). Percent correct converted to RAU.p-value: <0.001ANOVA
Comparison: Recorded AzBio sentences in a 10-talker masker were evaluated in an unaided condition for the poorer hearing ear pre-operatively and with the cochlear implant (CI) over the study period. A repeated-measures ANOVA evaluated the main effect of interval (before surgery, and 1, 3, 6, 9, and 12 months post-activation). Percent correct converted to RAU.p-value: <0.001ANOVA
Comparison: Association of age at implantation and speech recognition in noise at the 12-month interval with the cochlear implant, analyzed with a Bivariate Pearson correlation.p-value: =0.58bivariate pearson correlation
Comparison: Comparison of speech recognition between groups (UHL/SSD and AHL) for the three masker configurations (noise towards the better hearing ear, noise towards the poorer hearing ear, and noise from the front) and signal-to-noise ratio (SNR; 0, 5, or 10 dB SNR) over the post-activation intervals (1, 3, 6, 9, and 12 months).p-value: <0.743Mixed Models Analysis
Comparison: Association of word recognition and speech recognition in noise, analyzed with a Bivariate Pearson correlation. Scores were averaged between 3 and 12 months post-activation as an estimate of asymptotic performance.p-value: =0.036bivariate pearson correlation
Primary

Change in Subjective Benefit (Measured With the Abbreviated Profile of Hearing Aid Benefit (APHAB) Questionnaire) Over Time

Subjects completed subjective questionnaires in order to evaluate the perceived benefits of cochlear implantation. For the Abbreviated Profile of Hearing Aid Benefit, participants rank their perceived difficulty on a scale of 1-99, with lower values indicate less perceived difficulty. The global score is average response across questions for the ease of communication, reverberation, and effectiveness in background noise subscales.

Time frame: Intervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation)

Population: Three participants in the asymmetric hearing loss group did not complete the 9 month interval. One participant in the asymmetric hearing loss group withdrew from the study prior to the 12-month interval.

ArmMeasureGroupValue (MEAN)Dispersion
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupChange in Subjective Benefit (Measured With the Abbreviated Profile of Hearing Aid Benefit (APHAB) Questionnaire) Over Timebefore surgery50 score on a scaleStandard Deviation 19
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupChange in Subjective Benefit (Measured With the Abbreviated Profile of Hearing Aid Benefit (APHAB) Questionnaire) Over Time1 month after surgery26 score on a scaleStandard Deviation 13
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupChange in Subjective Benefit (Measured With the Abbreviated Profile of Hearing Aid Benefit (APHAB) Questionnaire) Over Time3 months after surgery21 score on a scaleStandard Deviation 9
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupChange in Subjective Benefit (Measured With the Abbreviated Profile of Hearing Aid Benefit (APHAB) Questionnaire) Over Time6 months after surgery20 score on a scaleStandard Deviation 8
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupChange in Subjective Benefit (Measured With the Abbreviated Profile of Hearing Aid Benefit (APHAB) Questionnaire) Over Time9 months after surgery17 score on a scaleStandard Deviation 8
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupChange in Subjective Benefit (Measured With the Abbreviated Profile of Hearing Aid Benefit (APHAB) Questionnaire) Over Time12 months after surgery18 score on a scaleStandard Deviation 9
Cochlear Implant: Asymmetric Hearing Loss GroupChange in Subjective Benefit (Measured With the Abbreviated Profile of Hearing Aid Benefit (APHAB) Questionnaire) Over Time9 months after surgery29 score on a scaleStandard Deviation 15
Cochlear Implant: Asymmetric Hearing Loss GroupChange in Subjective Benefit (Measured With the Abbreviated Profile of Hearing Aid Benefit (APHAB) Questionnaire) Over Timebefore surgery52 score on a scaleStandard Deviation 17
Cochlear Implant: Asymmetric Hearing Loss GroupChange in Subjective Benefit (Measured With the Abbreviated Profile of Hearing Aid Benefit (APHAB) Questionnaire) Over Time6 months after surgery31 score on a scaleStandard Deviation 14
Cochlear Implant: Asymmetric Hearing Loss GroupChange in Subjective Benefit (Measured With the Abbreviated Profile of Hearing Aid Benefit (APHAB) Questionnaire) Over Time1 month after surgery32 score on a scaleStandard Deviation 10
Cochlear Implant: Asymmetric Hearing Loss GroupChange in Subjective Benefit (Measured With the Abbreviated Profile of Hearing Aid Benefit (APHAB) Questionnaire) Over Time12 months after surgery28 score on a scaleStandard Deviation 10
Cochlear Implant: Asymmetric Hearing Loss GroupChange in Subjective Benefit (Measured With the Abbreviated Profile of Hearing Aid Benefit (APHAB) Questionnaire) Over Time3 months after surgery28 score on a scaleStandard Deviation 10
Comparison: Responses on the Abbreviated Profile of Hearing Aid Benefit (APHAB) as measured with the global score were compared over the post-activation period (i.e., 1, 3, 6, 9, and 12 months).p-value: =0.011ANOVA
Comparison: The Abbreviated Profile of Hearing Aid Benefit, participants rank their perceived difficulty on a scale of 1-99, with lower values indicate less perceived difficulty. The global score is calculated from the responses on the ease of communication, reverberation, and effectiveness in background noise subscales. Responses were compared to responses over the post-activation period (1, 3, 6, 9, and 12 months) with the cochlear implant using a repeated-measures ANOVA.p-value: =0.264ANOVA
Comparison: The Abbreviated Profile of Hearing Aid Benefit, participants rank their perceived difficulty on a scale of 1-99, with lower values indicate less perceived difficulty. Subscales include: ease of communication, reverberation, effectiveness in background noise, and reverberation. A repeated-measures ANOVA compared the main effects of interval and subscale and their interaction over time with the cochlear implant (1, 3, 6, 9, and 12 months post-activation).p-value: <0.023Mixed Models Analysis
Comparison: The Abbreviated Profile of Hearing Aid Benefit, participants rank their perceived difficulty on a scale of 1-99, with lower values indicate less perceived difficulty. Subscales include: ease of communication, reverberation, effectiveness in background noise, and reverberation. A repeated-measures ANOVA compared the main effects of interval and subscale and their interaction over time with the cochlear implant (1, 3, 6, 9, and 12 months post-activation).p-value: <0.643Mixed Models Analysis
Comparison: Association of subjective benefit (Noise Subscale) at the preoperative interval and speech recognition with AzBio sentences when the target is from the front and the masker is towards the acoustic ear.p-value: =0.947bivariate pearson correlation
Comparison: Association of subjective benefit (Noise Subscale) at the preoperative interval and speech recognition with AzBio sentences when the target is from the front and the masker is towards the acoustic ear.p-value: =0.5bivariate pearson correlation
Comparison: Association of subjective benefit (Noise Subscale) at the 12-month interval and speech recognition with AzBio sentences when the target is from the front and the masker is towards the acoustic ear.p-value: =0.023bivariate pearson correlation
Comparison: Association of subjective benefit (Noise Subscale) at the 12-month interval and speech recognition with AzBio sentences when the target is from the front and the masker is towards the acoustic ear.p-value: =0.033bivariate pearson correlation
Comparison: Comparison of subjective benefit between groups (UHL/SSD and AHL) on the ease of communication, background noise, and reverberation subscales over the post-activation intervals (1, 3, 6, 9, and 12 months).p-value: >0.208Mixed Models Analysis
Primary

Change in Subjective Benefit (Measured With the Speech, Spatial, and Qualities (SSQ) of Hearing Questionnaire) Over Time

Subjects completed subjective questionnaires in order to evaluate the perceived benefits of cochlear implantation. For the Speech, Spatial, and Qualities of hearing questionnaire, participants rank their perceived abilities on a scale of 0-10. Higher values indicate more perceived abilities. Results are reported as the total score at each interval, which is the average of the responses from all questions for the questionnaire.

Time frame: Intervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation)

Population: Three participants in the asymmetric hearing loss group did not complete the 9 month interval. One participant in the asymmetric hearing loss group withdrew from the study prior to the 12-month interval.

ArmMeasureGroupValue (MEAN)Dispersion
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupChange in Subjective Benefit (Measured With the Speech, Spatial, and Qualities (SSQ) of Hearing Questionnaire) Over Timebefore surgery4 score on a scaleStandard Deviation 1
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupChange in Subjective Benefit (Measured With the Speech, Spatial, and Qualities (SSQ) of Hearing Questionnaire) Over Time1 month after surgery6 score on a scaleStandard Deviation 2
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupChange in Subjective Benefit (Measured With the Speech, Spatial, and Qualities (SSQ) of Hearing Questionnaire) Over Time3 months after surgery6 score on a scaleStandard Deviation 2
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupChange in Subjective Benefit (Measured With the Speech, Spatial, and Qualities (SSQ) of Hearing Questionnaire) Over Time6 months after surgery7 score on a scaleStandard Deviation 1
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupChange in Subjective Benefit (Measured With the Speech, Spatial, and Qualities (SSQ) of Hearing Questionnaire) Over Time9 months after surgery7 score on a scaleStandard Deviation 1
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupChange in Subjective Benefit (Measured With the Speech, Spatial, and Qualities (SSQ) of Hearing Questionnaire) Over Time12 months after surgery7 score on a scaleStandard Deviation 1
Cochlear Implant: Asymmetric Hearing Loss GroupChange in Subjective Benefit (Measured With the Speech, Spatial, and Qualities (SSQ) of Hearing Questionnaire) Over Time9 months after surgery6 score on a scaleStandard Deviation 1
Cochlear Implant: Asymmetric Hearing Loss GroupChange in Subjective Benefit (Measured With the Speech, Spatial, and Qualities (SSQ) of Hearing Questionnaire) Over Timebefore surgery4 score on a scaleStandard Deviation 1
Cochlear Implant: Asymmetric Hearing Loss GroupChange in Subjective Benefit (Measured With the Speech, Spatial, and Qualities (SSQ) of Hearing Questionnaire) Over Time6 months after surgery6 score on a scaleStandard Deviation 1
Cochlear Implant: Asymmetric Hearing Loss GroupChange in Subjective Benefit (Measured With the Speech, Spatial, and Qualities (SSQ) of Hearing Questionnaire) Over Time1 month after surgery5 score on a scaleStandard Deviation 1
Cochlear Implant: Asymmetric Hearing Loss GroupChange in Subjective Benefit (Measured With the Speech, Spatial, and Qualities (SSQ) of Hearing Questionnaire) Over Time12 months after surgery6 score on a scaleStandard Deviation 1
Cochlear Implant: Asymmetric Hearing Loss GroupChange in Subjective Benefit (Measured With the Speech, Spatial, and Qualities (SSQ) of Hearing Questionnaire) Over Time3 months after surgery6 score on a scaleStandard Deviation 2
Comparison: Responses on the Speech, Spatial, \& Qualities of hearing scale (SSQ) as measured with the total score were compared over the post-activation period (i.e., 1, 3, 6, 9, and 12 months).p-value: <0.001ANOVA
Comparison: Responses on the SSQ as measured with the total score were compared over the post-activation period (i.e., 1, 3, 6, 9, and 12 months).p-value: =0.056ANOVA
Comparison: Responses on the SSQ over the post-activation period (i.e., 1, 3, 6, 9, and 12 months). Subscales include: speech, spatial, and qualities of hearing. A repeated-measures ANOVA compared the main effects of interval and subscale and their interaction over time with the cochlear implant (1, 3, 6, 9, and 12 months post-activation).p-value: <0.448Mixed Models Analysis
Comparison: Responses on the SSQ over the post-activation period (i.e., 1, 3, 6, 9, and 12 months). Subscales include: speech, spatial, and qualities of hearing. A repeated-measures ANOVA compared the main effects of interval and subscale and their interaction over time with the cochlear implant (1, 3, 6, 9, and 12 months post-activation).p-value: <0.299Mixed Models Analysis
Comparison: Responses on the SSQ Speech pragmatic subscale over the post-activation period (i.e., 1, 3, 6, 9, and 12 months). A repeated-measures ANOVA compared the main effects of interval and pragmatic subscale and their interaction over time with the cochlear implant (1, 3, 6, 9, and 12 months post-activation).p-value: <0.018Mixed Models Analysis
Comparison: Responses on the SSQ Spatial pragmatic subscale over the post-activation period (i.e., 1, 3, 6, 9, and 12 months). A repeated-measures ANOVA compared the main effects of interval and pragmatic subscale and their interaction over time with the cochlear implant (1, 3, 6, 9, and 12 months post-activation).p-value: <0.767Mixed Models Analysis
Comparison: Responses on the SSQ Qualities of Hearing pragmatic subscale over the post-activation period (i.e., 1, 3, 6, 9, and 12 months). A repeated-measures ANOVA compared the main effects of interval and pragmatic subscale and their interaction over time with the cochlear implant (1, 3, 6, 9, and 12 months post-activation).p-value: <0.242Mixed Models Analysis
Comparison: Association of subjective benefit (Speech Subscale) at the preoperative interval and speech recognition with AzBio sentences when the target is from the front and the masker is towards the acoustic ear.p-value: 0.37bivariate pearson correlation
Comparison: Association of subjective benefit (Speech Subscale) at the preoperative interval and speech recognition with AzBio sentences when the target is from the front and the masker is towards the acoustic ear.p-value: =0.865bivariate pearson correlation
Comparison: Association of subjective benefit (Speech Subscale) at the 12-month interval and speech recognition with AzBio sentences when the target is from the front and the masker is towards the acoustic ear.p-value: =0.005bivariate pearson correlation
Comparison: Association of subjective benefit (Speech Subscale) at the 12-month interval and speech recognition with AzBio sentences when the target is from the front and the masker is towards the acoustic ear.p-value: =0.006bivariate pearson correlation
Comparison: Association of subjective benefit (Spatial Subscale) at the preoperative interval and sound source localization (RMS error).p-value: =0.152bivariate pearson correlation
Comparison: Association of subjective benefit (Spatial Subscale) at the preoperative interval and sound source localization (RMS error).p-value: =0.761bivariate pearson correlation
Comparison: Association of subjective benefit (Spatial Subscale) at the 12-month interval and sound source localization (RMS error).p-value: =0.315bivariate pearson correlation
Comparison: Association of subjective benefit (Spatial Subscale) at the 12-month interval and sound source localization (RMS error).p-value: =0.666bivariate pearson correlation
Comparison: Comparison of subjective benefit between groups (UHL/SSD and AHL) on the speech, spatial, and qualities of hearing subscales during the post-activation intervals (1, 3, 6, 9, and 12 months).p-value: >0.175Mixed Models Analysis
Primary

Change in Subjective Benefit (Measured With the Tinnitus Handicap Inventory (THI) of Hearing Questionnaire) Over Time

Subjects completed subjective questionnaires to order to evaluate the perceived benefits of cochlear implantation. For the Tinnitus Handicap Inventory, participants rank their perceived tinnitus severity on a scale of 0-100, with lower values indicate less tinnitus severity. Responses across all questions are summed to derive the total score.

Time frame: Intervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation)

Population: Three participants in the asymmetric hearing loss group did not complete the 9 month interval. One participant in the asymmetric hearing loss group withdrew from the study prior to the 12-month interval.

ArmMeasureGroupValue (MEAN)Dispersion
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupChange in Subjective Benefit (Measured With the Tinnitus Handicap Inventory (THI) of Hearing Questionnaire) Over Timebefore surgery25 score on a scaleStandard Deviation 17
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupChange in Subjective Benefit (Measured With the Tinnitus Handicap Inventory (THI) of Hearing Questionnaire) Over Time1 month after surgery6 score on a scaleStandard Deviation 10
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupChange in Subjective Benefit (Measured With the Tinnitus Handicap Inventory (THI) of Hearing Questionnaire) Over Time3 months after surgery4 score on a scaleStandard Deviation 7
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupChange in Subjective Benefit (Measured With the Tinnitus Handicap Inventory (THI) of Hearing Questionnaire) Over Time6 months after surgery2 score on a scaleStandard Deviation 5
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupChange in Subjective Benefit (Measured With the Tinnitus Handicap Inventory (THI) of Hearing Questionnaire) Over Time9 months after surgery4 score on a scaleStandard Deviation 6
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupChange in Subjective Benefit (Measured With the Tinnitus Handicap Inventory (THI) of Hearing Questionnaire) Over Time12 months after surgery3 score on a scaleStandard Deviation 5
Cochlear Implant: Asymmetric Hearing Loss GroupChange in Subjective Benefit (Measured With the Tinnitus Handicap Inventory (THI) of Hearing Questionnaire) Over Time9 months after surgery2 score on a scaleStandard Deviation 7
Cochlear Implant: Asymmetric Hearing Loss GroupChange in Subjective Benefit (Measured With the Tinnitus Handicap Inventory (THI) of Hearing Questionnaire) Over Timebefore surgery18 score on a scaleStandard Deviation 20
Cochlear Implant: Asymmetric Hearing Loss GroupChange in Subjective Benefit (Measured With the Tinnitus Handicap Inventory (THI) of Hearing Questionnaire) Over Time6 months after surgery4 score on a scaleStandard Deviation 12
Cochlear Implant: Asymmetric Hearing Loss GroupChange in Subjective Benefit (Measured With the Tinnitus Handicap Inventory (THI) of Hearing Questionnaire) Over Time1 month after surgery4 score on a scaleStandard Deviation 6
Cochlear Implant: Asymmetric Hearing Loss GroupChange in Subjective Benefit (Measured With the Tinnitus Handicap Inventory (THI) of Hearing Questionnaire) Over Time12 months after surgery4 score on a scaleStandard Deviation 13
Cochlear Implant: Asymmetric Hearing Loss GroupChange in Subjective Benefit (Measured With the Tinnitus Handicap Inventory (THI) of Hearing Questionnaire) Over Time3 months after surgery2 score on a scaleStandard Deviation 7
Comparison: The Tinnitus Handicap Inventory is a 25-item questionnaire. The subject answers yes (4 points), sometimes (2 points), or no (0 points) to each question. Responses are added to quantify tinnitus severity: none/slight (0-16), mild (18-36), moderate (38-56), severe (58-76), and catastrophic (78-100). Responses were compared over the post-activation time period (1, 3, 6, 9, and 12 months).p-value: =0.221ANOVA
Comparison: The Tinnitus Handicap Inventory is a 25-item questionnaire. The subject answers yes (4 points), sometimes (2 points), or no (0 points) to each question. Responses are added to quantify tinnitus severity: none/slight (0-16), mild (18-36), moderate (38-56), severe (58-76), and catastrophic (78-100). Responses were compared over the post-activation time period (1, 3, 6, 9, and 12 months).p-value: =0.538ANOVA
Comparison: Comparison of subjective benefit between groups (UHL/SSD and AHL) on the Tinnitus Handicap Inventory over the post-activation intervals (1, 3, 6, 9, and 12 months).p-value: >0.218Mixed Models Analysis
Primary

Change in Word Recognition in Quiet Over Time

Results on recorded speech perception materials: monosyllabic (Consonant-Nucleus-Consonant) words in quiet during the first year of device use.

Time frame: Intervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation)

Population: Three participants with asymmetric hearing loss did not complete the 9-month interval. One participant with asymmetric hearing loss withdrew from the study prior to the 12-month interval.

ArmMeasureGroupValue (MEAN)Dispersion
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupChange in Word Recognition in Quiet Over Time3 months after surgery, unaided0 percentage of words correctly repeatedStandard Deviation 0
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupChange in Word Recognition in Quiet Over Time6 months after surgery, aided (cochlear implant)51 percentage of words correctly repeatedStandard Deviation 15
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupChange in Word Recognition in Quiet Over Time1 month after surgery, aided (cochlear implant)36 percentage of words correctly repeatedStandard Deviation 18
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupChange in Word Recognition in Quiet Over Time9 months after surgery, unaided0 percentage of words correctly repeatedStandard Deviation 0
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupChange in Word Recognition in Quiet Over Time3 months after surgery, aided (cochlear implant)47 percentage of words correctly repeatedStandard Deviation 19
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupChange in Word Recognition in Quiet Over Time9 months after surgery, aided (cochlear implant)55 percentage of words correctly repeatedStandard Deviation 19
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupChange in Word Recognition in Quiet Over Time1 month after surgery, unaided0 percentage of words correctly repeatedStandard Deviation 1
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupChange in Word Recognition in Quiet Over Time12 months after surgery, unaided0 percentage of words correctly repeatedStandard Deviation 0
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupChange in Word Recognition in Quiet Over Time6 months after surgery, unaided0 percentage of words correctly repeatedStandard Deviation 1
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupChange in Word Recognition in Quiet Over Time12 months after surgery, aided (cochlear implant)55 percentage of words correctly repeatedStandard Deviation 18
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupChange in Word Recognition in Quiet Over TimeBefore surgery, unaided4 percentage of words correctly repeatedStandard Deviation 7
Cochlear Implant: Asymmetric Hearing Loss GroupChange in Word Recognition in Quiet Over Time12 months after surgery, aided (cochlear implant)55 percentage of words correctly repeatedStandard Deviation 18
Cochlear Implant: Asymmetric Hearing Loss GroupChange in Word Recognition in Quiet Over TimeBefore surgery, unaided8 percentage of words correctly repeatedStandard Deviation 11
Cochlear Implant: Asymmetric Hearing Loss GroupChange in Word Recognition in Quiet Over Time1 month after surgery, unaided0 percentage of words correctly repeatedStandard Deviation 0
Cochlear Implant: Asymmetric Hearing Loss GroupChange in Word Recognition in Quiet Over Time1 month after surgery, aided (cochlear implant)32 percentage of words correctly repeatedStandard Deviation 19
Cochlear Implant: Asymmetric Hearing Loss GroupChange in Word Recognition in Quiet Over Time3 months after surgery, unaided0 percentage of words correctly repeatedStandard Deviation 0
Cochlear Implant: Asymmetric Hearing Loss GroupChange in Word Recognition in Quiet Over Time3 months after surgery, aided (cochlear implant)40 percentage of words correctly repeatedStandard Deviation 17
Cochlear Implant: Asymmetric Hearing Loss GroupChange in Word Recognition in Quiet Over Time6 months after surgery, unaided0 percentage of words correctly repeatedStandard Deviation 1
Cochlear Implant: Asymmetric Hearing Loss GroupChange in Word Recognition in Quiet Over Time6 months after surgery, aided (cochlear implant)47 percentage of words correctly repeatedStandard Deviation 17
Cochlear Implant: Asymmetric Hearing Loss GroupChange in Word Recognition in Quiet Over Time9 months after surgery, unaided0 percentage of words correctly repeatedStandard Deviation 1
Cochlear Implant: Asymmetric Hearing Loss GroupChange in Word Recognition in Quiet Over Time9 months after surgery, aided (cochlear implant)49 percentage of words correctly repeatedStandard Deviation 22
Cochlear Implant: Asymmetric Hearing Loss GroupChange in Word Recognition in Quiet Over Time12 months after surgery, unaided0 percentage of words correctly repeatedStandard Deviation 0
Comparison: Recorded 50-word consonant-nucleus-consonant (CNC) words were evaluated for the poorer hearing ear 1) unaided and 2) with the cochlear implant (CI) over the post-activation study period. A repeated-measures ANOVA evaluated the main effects of interval (1, 3, 6, 9, and 12 months post-activation), condition (unaided or with the CI), and their interaction. Percent correct converted to RAU.p-value: <0.001Mixed Models Analysis
Comparison: Recorded 50-word CNC words were evaluated for the poorer hearing ear 1) unaided and 2) with the cochlear implant (CI) over the post-activation study period. A repeated-measures ANOVA evaluated the main effects of interval (1, 3, 6, 9, and 12 months post-activation), condition (unaided or with the CI), and their interaction. Percent correct converted to RAU.p-value: <0.001Mixed Models Analysis
Comparison: Recorded 50-word CNC words were evaluated in an unaided condition for the poorer hearing ear pre-operatively and with the cochlear implant (CI) over the study period. A repeated-measures ANOVA evaluated the main effect of interval (before surgery, and 1, 3, 6, 9, and 12 months post-activation). Percent correct converted to RAU.p-value: <0.001ANOVA
Comparison: Recorded 50-word CNC words were evaluated in an unaided condition for the poorer hearing ear pre-operatively and with the cochlear implant (CI) over the study period. A repeated-measures ANOVA evaluated the main effect of interval (before surgery, and 1, 3, 6, 9, and 12 months post-activation). Percent correct converted to RAU.p-value: <0.001ANOVA
Comparison: Comparison of word recognition between groups (UHL/SSD and AHL) over the post-activation intervals (1, 3, 6, 9, and 12 months).p-value: <0.429Mixed Models Analysis
Secondary

Aided Word Recognition With a Cochlear Implant Versus a Current Treatment Option (i.e., Hearing Aid)

Results on recorded speech perception materials: aided word recognition. Recorded 50-word CNC words were evaluated preoperatively with a conventional hearing aid. Performance was compared to the CI alone at the 12 month interval. A paired samples t-test compared the performance with the two devices. Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis to control for potential floor or ceiling effects (e.g., scores \<20%).

Time frame: preoperative interval and 12 month post-activation interval

Population: One asymmetric hearing loss participant withdrew prior to the 12-month interval.

ArmMeasureGroupValue (MEAN)Dispersion
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupAided Word Recognition With a Cochlear Implant Versus a Current Treatment Option (i.e., Hearing Aid)preop, hearing aid4 percentage of words correctStandard Deviation 7
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupAided Word Recognition With a Cochlear Implant Versus a Current Treatment Option (i.e., Hearing Aid)12-month post-activation, cochlear implant55 percentage of words correctStandard Deviation 18
Cochlear Implant: Asymmetric Hearing Loss GroupAided Word Recognition With a Cochlear Implant Versus a Current Treatment Option (i.e., Hearing Aid)preop, hearing aid8 percentage of words correctStandard Deviation 9
Cochlear Implant: Asymmetric Hearing Loss GroupAided Word Recognition With a Cochlear Implant Versus a Current Treatment Option (i.e., Hearing Aid)12-month post-activation, cochlear implant55 percentage of words correctStandard Deviation 18
Comparison: Paired samples t-test comparing word recognition (percent correct for CNC words) with a hearing aid at the pre-operative interval and the cochlear implant at the 12-month interval for the affected ear (masking presented to the contralateral ear).p-value: <0.001t-test, 2 sided
Comparison: Paired samples t-test comparing word recognition (percent correct for CNC words) with a hearing aid at the pre-operative interval and the cochlear implant at the 12-month interval for the affected ear (masking presented to the contralateral ear).p-value: <0.001t-test, 2 sided
Secondary

Localization Abilities With a Cochlear Implant Versus a Current Treatment Option (i.e., Bone-conduction Device)

Subjects were asked to identify the noise source from an 11-speaker array with the cochlear implant on versus with a bone-conduction device. The intensity level of the stimulus was randomly varied (10 dB around 70 dB SPL) to limit the listener relying on level effects. Responses at each intensity level (i.e., 60, 70, and 80 dB SPL) for a given sound source (speaker) were combined (averaged). Results are reported in root-mean-squared (RMS) error. A lower value indicates better performance.

Time frame: Intervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation)

Population: Three participants in the asymmetric group did not complete testing at the 9-month interval. One participant did not complete testing with the CI on at the 12-month interval. Three participants did not complete testing in the with the bone conduction device at the 12-month interval.

ArmMeasureGroupValue (MEAN)Dispersion
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupLocalization Abilities With a Cochlear Implant Versus a Current Treatment Option (i.e., Bone-conduction Device)3-month, cochlear implant28 degreesStandard Deviation 8
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupLocalization Abilities With a Cochlear Implant Versus a Current Treatment Option (i.e., Bone-conduction Device)9-month, cochlear implant26 degreesStandard Deviation 6
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupLocalization Abilities With a Cochlear Implant Versus a Current Treatment Option (i.e., Bone-conduction Device)1-month, cochlear implant37 degreesStandard Deviation 19
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupLocalization Abilities With a Cochlear Implant Versus a Current Treatment Option (i.e., Bone-conduction Device)12-month, cochlear implant27 degreesStandard Deviation 6
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupLocalization Abilities With a Cochlear Implant Versus a Current Treatment Option (i.e., Bone-conduction Device)6-month, cochlear implant27 degreesStandard Deviation 7
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupLocalization Abilities With a Cochlear Implant Versus a Current Treatment Option (i.e., Bone-conduction Device)12-month, bone conduction device69 degreesStandard Deviation 19
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupLocalization Abilities With a Cochlear Implant Versus a Current Treatment Option (i.e., Bone-conduction Device)preoperative, bone-conduction device70 degreesStandard Deviation 19
Cochlear Implant: Asymmetric Hearing Loss GroupLocalization Abilities With a Cochlear Implant Versus a Current Treatment Option (i.e., Bone-conduction Device)12-month, bone conduction device80 degreesStandard Deviation 14
Cochlear Implant: Asymmetric Hearing Loss GroupLocalization Abilities With a Cochlear Implant Versus a Current Treatment Option (i.e., Bone-conduction Device)preoperative, bone-conduction device76 degreesStandard Deviation 18
Cochlear Implant: Asymmetric Hearing Loss GroupLocalization Abilities With a Cochlear Implant Versus a Current Treatment Option (i.e., Bone-conduction Device)1-month, cochlear implant52 degreesStandard Deviation 13
Cochlear Implant: Asymmetric Hearing Loss GroupLocalization Abilities With a Cochlear Implant Versus a Current Treatment Option (i.e., Bone-conduction Device)3-month, cochlear implant48 degreesStandard Deviation 10
Cochlear Implant: Asymmetric Hearing Loss GroupLocalization Abilities With a Cochlear Implant Versus a Current Treatment Option (i.e., Bone-conduction Device)6-month, cochlear implant43 degreesStandard Deviation 9
Cochlear Implant: Asymmetric Hearing Loss GroupLocalization Abilities With a Cochlear Implant Versus a Current Treatment Option (i.e., Bone-conduction Device)9-month, cochlear implant41 degreesStandard Deviation 9
Cochlear Implant: Asymmetric Hearing Loss GroupLocalization Abilities With a Cochlear Implant Versus a Current Treatment Option (i.e., Bone-conduction Device)12-month, cochlear implant40 degreesStandard Deviation 11
Comparison: Participants listened with a bone conduction device preoperatively and with the cochlear implant at 1, 3, 6, 9, and 12 months post-activation. Overall root-mean-square (RMS) error is the difference between the sound source azimuth and the response azimuth and a lower score indicates more accurate localization of the sound source. Repeated-measures ANOVA compared performance over time.p-value: <0.001ANOVA
Comparison: Participants listening with a bone conduction device preoperatively and with the cochlear implant at 1, 3, 6, 9, and 12 months post-activation. Overall root-mean-square (RMS) error is the difference between the sound source azimuth and the response azimuth and a lower score indicates more accurate localization of the sound source. Repeated-measures ANOVA compared performance over time.p-value: <0.001ANOVA
Comparison: Compare localization performance with the cochlear implant to a bone-conduction device at the 12-month interval using a paired samples t-test.p-value: <0.001t-test, 2 sided
Comparison: Compare localization performance with the cochlear implant to a bone-conduction device at the 12-month interval using a paired samples t-test.p-value: <0.001t-test, 2 sided
Secondary

Localization for a Control Group

Subjects were asked to identify the noise source from an 11-speaker array with the bone-conduction device on versus off. The intensity level of the stimulus was randomly varied (10 dB around 70 dB SPL) to limit the listener relying on level effects. Responses at each intensity level (i.e., 60, 70, and 80 dB SPL) for a given sound source (speaker) were combined (averaged). Results are reported in root-mean-squared (RMS) error. A lower value indicates better performance. Subjects in the control group were implantable bone-conduction device recipients (alternative treatment option) with at least 12 months of listening experience with their implanted bone-conduction device. Participants completed the task with their device on and off.

Time frame: Assessment completed after 12 months of implantable bone-conduction listening experience

ArmMeasureGroupValue (MEDIAN)
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupLocalization for a Control Groupdevice on63 degrees
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupLocalization for a Control Groupdevice off60 degrees
Secondary

Speech Perception Outcomes With a Cochlear Implant Versus a Bone-conduction Device: Sentence Recognition in Noise (AzBio, Speech Front and Noise Front)

Recorded AzBio sentences in a 10-talker masker were evaluated in 2 conditions: 1) bone-conduction device at the preoperative interval and 2) with the cochlear implant (CI) at the 12-month post-activation period. A paired samples t-test compared the performance with the two devices. Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.

Time frame: preoperative interval and 12 month post-activation interval

Population: One participant with asymmetric hearing loss withdrew from the study prior to the 12-month interval. Seven participants were tested at a different signal-to-noise ratio at the preoperative interval. Four participants were tested at a different signal-to-noise ratio.

ArmMeasureGroupValue (MEAN)Dispersion
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupSpeech Perception Outcomes With a Cochlear Implant Versus a Bone-conduction Device: Sentence Recognition in Noise (AzBio, Speech Front and Noise Front)pre-op, bone-conduction device32 percent correctStandard Deviation 17
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupSpeech Perception Outcomes With a Cochlear Implant Versus a Bone-conduction Device: Sentence Recognition in Noise (AzBio, Speech Front and Noise Front)12-month post-activation, cochlear implant47 percent correctStandard Deviation 11
Cochlear Implant: Asymmetric Hearing Loss GroupSpeech Perception Outcomes With a Cochlear Implant Versus a Bone-conduction Device: Sentence Recognition in Noise (AzBio, Speech Front and Noise Front)pre-op, bone-conduction device17 percent correctStandard Deviation 12
Cochlear Implant: Asymmetric Hearing Loss GroupSpeech Perception Outcomes With a Cochlear Implant Versus a Bone-conduction Device: Sentence Recognition in Noise (AzBio, Speech Front and Noise Front)12-month post-activation, cochlear implant24 percent correctStandard Deviation 14
Comparison: Recorded AzBio sentences in a 10-talker masker were evaluated in 2 conditions: 1) bone-conduction device at the preoperative interval and 2) with the cochlear implant (CI) at the 12-month post-activation period. A paired samples t-test compared the performance with the two devices. Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.p-value: =0.001t-test, 2 sided
Comparison: Recorded AzBio sentences in a 10-talker masker were evaluated in 2 conditions: 1) bone-conduction device at the preoperative interval and 2) with the cochlear implant (CI) at the 12-month post-activation period. A paired samples t-test compared the performance with the two devices. Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.p-value: =0.034t-test, 2 sided
Secondary

Speech Perception Outcomes With a Cochlear Implant Versus a Bone-conduction Device: Sentence Recognition in Noise (AzBio, Speech Front and Noise to the Better Hearing Ear)

Recorded AzBio sentences in a 10-talker masker were evaluated in 2 conditions: 1) bone-conduction device at the preoperative interval and 2) with the cochlear implant (CI) at the 12-month post-activation period. A paired samples t-test compared the performance with the two devices. Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.

Time frame: preoperative interval and 12 month post-activation interval

Population: One participant with asymmetric hearing loss withdrew from the study prior to the 12-month interval. Seven participants were tested at a different signal-to-noise ratio at the preoperative interval. Four participants were tested at a different signal-to-noise ratio.

ArmMeasureGroupValue (MEAN)Dispersion
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupSpeech Perception Outcomes With a Cochlear Implant Versus a Bone-conduction Device: Sentence Recognition in Noise (AzBio, Speech Front and Noise to the Better Hearing Ear)pre-op, bone-conduction device18 percent correctStandard Deviation 18
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupSpeech Perception Outcomes With a Cochlear Implant Versus a Bone-conduction Device: Sentence Recognition in Noise (AzBio, Speech Front and Noise to the Better Hearing Ear)12-month post-activation, cochlear implant53 percent correctStandard Deviation 21
Cochlear Implant: Asymmetric Hearing Loss GroupSpeech Perception Outcomes With a Cochlear Implant Versus a Bone-conduction Device: Sentence Recognition in Noise (AzBio, Speech Front and Noise to the Better Hearing Ear)pre-op, bone-conduction device6 percent correctStandard Deviation 8
Cochlear Implant: Asymmetric Hearing Loss GroupSpeech Perception Outcomes With a Cochlear Implant Versus a Bone-conduction Device: Sentence Recognition in Noise (AzBio, Speech Front and Noise to the Better Hearing Ear)12-month post-activation, cochlear implant22 percent correctStandard Deviation 18
Comparison: Recorded AzBio sentences in a 10-talker masker were evaluated in 2 conditions: 1) bone-conduction device at the preoperative interval and 2) with the cochlear implant (CI) at the 12-month post-activation period. A paired samples t-test compared the performance with the two devices. Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.p-value: <0.001t-test, 2 sided
Comparison: Recorded AzBio sentences in a 10-talker masker were evaluated in 2 conditions: 1) bone-conduction device at the preoperative interval and 2) with the cochlear implant (CI) at the 12-month post-activation period. A paired samples t-test compared the performance with the two devices. Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.p-value: =0.001t-test, 2 sided
Secondary

Speech Perception Outcomes With a Cochlear Implant Versus a Bone-conduction Device: Sentence Recognition in Noise (AzBio, Speech Front and Noise to the Poorer Hearing Ear)

Recorded AzBio sentences in a 10-talker masker were evaluated in 2 conditions: 1) bone-conduction device at the preoperative interval and 2) with the cochlear implant (CI) at the 12-month post-activation period. A paired samples t-test compared the performance with the two devices. Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.

Time frame: preoperative interval and 12 month post-activation interval

Population: One participant with asymmetric hearing loss withdrew from the study prior to the 12-month interval. Seven participants were tested at a different signal-to-noise ratio at the preoperative interval. Four participants were tested at a different signal-to-noise ratio.

ArmMeasureGroupValue (MEAN)Dispersion
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupSpeech Perception Outcomes With a Cochlear Implant Versus a Bone-conduction Device: Sentence Recognition in Noise (AzBio, Speech Front and Noise to the Poorer Hearing Ear)pre-op, bone-conduction device61 percent correctStandard Deviation 28
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupSpeech Perception Outcomes With a Cochlear Implant Versus a Bone-conduction Device: Sentence Recognition in Noise (AzBio, Speech Front and Noise to the Poorer Hearing Ear)12-month post-activation, cochlear implant85 percent correctStandard Deviation 11
Cochlear Implant: Asymmetric Hearing Loss GroupSpeech Perception Outcomes With a Cochlear Implant Versus a Bone-conduction Device: Sentence Recognition in Noise (AzBio, Speech Front and Noise to the Poorer Hearing Ear)pre-op, bone-conduction device24 percent correctStandard Deviation 18
Cochlear Implant: Asymmetric Hearing Loss GroupSpeech Perception Outcomes With a Cochlear Implant Versus a Bone-conduction Device: Sentence Recognition in Noise (AzBio, Speech Front and Noise to the Poorer Hearing Ear)12-month post-activation, cochlear implant42 percent correctStandard Deviation 22
Comparison: Recorded AzBio sentences in a 10-talker masker were evaluated in 2 conditions: 1) bone-conduction device at the preoperative interval and 2) with the cochlear implant (CI) at the 12-month post-activation period. A paired samples t-test compared the performance with the two devices. Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.p-value: =0.001t-test, 2 sided
Comparison: Recorded AzBio sentences in a 10-talker masker were evaluated in 2 conditions: 1) bone-conduction device at the preoperative interval and 2) with the cochlear implant (CI) at the 12-month post-activation period. A paired samples t-test compared the performance with the two devices. Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.p-value: =0.037t-test, 2 sided
Secondary

Speech Perception Outcomes With a Cochlear Implant Versus a Bone-conduction Device: Sentence Recognition in Noise (BKB-SIN, Speech Front and Noise to the Better Hearing Ear)

Recorded BKB sentences in a 4-talker masker were evaluated in 2 conditions: 1) bone-conduction device at the preoperative interval and 2) with the cochlear implant (CI) at the 12-month post-activation period. A paired samples t-test compared the performance with the two devices. Results are reported in dB SNR, where a lower value indicates better performance (range -7.5 to 23.5 dB SNR).

Time frame: preoperative interval and 12 month post-activation interval

Population: One asymmetric hearing loss participant withdrew prior to the 12-month interval.

ArmMeasureGroupValue (MEAN)Dispersion
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupSpeech Perception Outcomes With a Cochlear Implant Versus a Bone-conduction Device: Sentence Recognition in Noise (BKB-SIN, Speech Front and Noise to the Better Hearing Ear)pre-op, bone-conduction device1.8 signal-to-noise ratioStandard Deviation 2.3
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupSpeech Perception Outcomes With a Cochlear Implant Versus a Bone-conduction Device: Sentence Recognition in Noise (BKB-SIN, Speech Front and Noise to the Better Hearing Ear)12-month post-activation, cochlear implant-1.0 signal-to-noise ratioStandard Deviation 2.2
Cochlear Implant: Asymmetric Hearing Loss GroupSpeech Perception Outcomes With a Cochlear Implant Versus a Bone-conduction Device: Sentence Recognition in Noise (BKB-SIN, Speech Front and Noise to the Better Hearing Ear)pre-op, bone-conduction device6.1 signal-to-noise ratioStandard Deviation 4.4
Cochlear Implant: Asymmetric Hearing Loss GroupSpeech Perception Outcomes With a Cochlear Implant Versus a Bone-conduction Device: Sentence Recognition in Noise (BKB-SIN, Speech Front and Noise to the Better Hearing Ear)12-month post-activation, cochlear implant4.4 signal-to-noise ratioStandard Deviation 4.3
Comparison: Recorded BKB sentences in a 4-talker masker were evaluated in 2 conditions: 1) bone-conduction device at the preoperative interval and 2) with the cochlear implant (CI) at the 12-month post-activation period. A paired samples t-test compared the performance with the two devices. Results are reported in dB SNR, where a lower value indicates better performance.p-value: =0.001t-test, 2 sided
Comparison: Recorded BKB sentences in a 4-talker masker were evaluated in 2 conditions: 1) bone-conduction device at the preoperative interval and 2) with the cochlear implant (CI) at the 12-month post-activation period. A paired samples t-test compared the performance with the two devices. Results are reported in dB SNR, where a lower value indicates better performance.p-value: =0.09t-test, 2 sided
Secondary

Speech Perception Outcomes With a Cochlear Implant Versus a Bone-conduction Device: Sentence Recognition in Noise (BKB-SIN, Speech Front and Noise to the Poorer Hearing Ear)

Recorded BKB sentences in a 4-talker masker were evaluated in 2 conditions: 1) bone-conduction device at the preoperative interval and 2) with the cochlear implant (CI) at the 12-month post-activation period. A paired samples t-test compared the performance with the two devices. Results are reported in dB SNR, where a lower value indicates better performance (range -7.5 to 23.5 dB SNR).

Time frame: preoperative interval and 12 month post-activation interval

Population: One asymmetric hearing loss participant withdrew prior to the 12-month interval.

ArmMeasureGroupValue (MEAN)Dispersion
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupSpeech Perception Outcomes With a Cochlear Implant Versus a Bone-conduction Device: Sentence Recognition in Noise (BKB-SIN, Speech Front and Noise to the Poorer Hearing Ear)pre-op, bone-conduction device-2.6 signal-to-noise ratioStandard Deviation 2.4
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupSpeech Perception Outcomes With a Cochlear Implant Versus a Bone-conduction Device: Sentence Recognition in Noise (BKB-SIN, Speech Front and Noise to the Poorer Hearing Ear)12-month post-activation, cochlear implant-4.8 signal-to-noise ratioStandard Deviation 1.7
Cochlear Implant: Asymmetric Hearing Loss GroupSpeech Perception Outcomes With a Cochlear Implant Versus a Bone-conduction Device: Sentence Recognition in Noise (BKB-SIN, Speech Front and Noise to the Poorer Hearing Ear)pre-op, bone-conduction device2.7 signal-to-noise ratioStandard Deviation 3.7
Cochlear Implant: Asymmetric Hearing Loss GroupSpeech Perception Outcomes With a Cochlear Implant Versus a Bone-conduction Device: Sentence Recognition in Noise (BKB-SIN, Speech Front and Noise to the Poorer Hearing Ear)12-month post-activation, cochlear implant2.4 signal-to-noise ratioStandard Deviation 3.8
Comparison: Recorded BKB sentences in a 4-talker masker were evaluated in 2 conditions: 1) bone-conduction device at the preoperative interval and 2) with the cochlear implant (CI) at the 12-month post-activation period. A paired samples t-test compared the performance with the two devices. Results are reported in dB SNR, where a lower value indicates better performance.p-value: <0.001t-test, 2 sided
Comparison: Recorded BKB sentences in a 4-talker masker were evaluated in 2 conditions: 1) bone-conduction device at the preoperative interval and 2) with the cochlear implant (CI) at the 12-month post-activation period. A paired samples t-test compared the performance with the two devices. Results are reported in dB SNR, where a lower value indicates better performance.p-value: =0.727t-test, 2 sided
Secondary

Speech Perception Outcomes With a Cochlear Implant Versus a Bone-conduction Device: Sentence Recognition in Noise (BKB-Speech In Noise (SIN), Speech Front and Noise Front)

Recorded BKB sentences in a 4-talker masker were evaluated in 2 conditions: 1) bone-conduction device at the preoperative interval and 2) with the cochlear implant (CI) at the 12-month post-activation period. A paired samples t-test compared the performance with the two devices. Results are reported in dB SNR, where a lower value indicates better performance (range -7.5 to 23.5 dB SNR).

Time frame: preoperative interval and 12 month post-activation interval

Population: One asymmetric hearing loss participant withdrew prior to the 12-month interval.

ArmMeasureGroupValue (MEAN)Dispersion
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupSpeech Perception Outcomes With a Cochlear Implant Versus a Bone-conduction Device: Sentence Recognition in Noise (BKB-Speech In Noise (SIN), Speech Front and Noise Front)pre-op, bone-conduction device0.8 signal-to-noise ratioStandard Deviation 2
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupSpeech Perception Outcomes With a Cochlear Implant Versus a Bone-conduction Device: Sentence Recognition in Noise (BKB-Speech In Noise (SIN), Speech Front and Noise Front)12-month post-activation, cochlear implant-0.8 signal-to-noise ratioStandard Deviation 1.7
Cochlear Implant: Asymmetric Hearing Loss GroupSpeech Perception Outcomes With a Cochlear Implant Versus a Bone-conduction Device: Sentence Recognition in Noise (BKB-Speech In Noise (SIN), Speech Front and Noise Front)pre-op, bone-conduction device4.9 signal-to-noise ratioStandard Deviation 3
Cochlear Implant: Asymmetric Hearing Loss GroupSpeech Perception Outcomes With a Cochlear Implant Versus a Bone-conduction Device: Sentence Recognition in Noise (BKB-Speech In Noise (SIN), Speech Front and Noise Front)12-month post-activation, cochlear implant3.4 signal-to-noise ratioStandard Deviation 3.4
Comparison: Recorded BKB sentences in a 4-talker masker were evaluated in 2 conditions: 1) with a bone-conduction device (preoperative interval) and 2) with the cochlear implant (CI) at the 12-month post-activation interval. Results are reported in dB SNR, where a lower value indicates better performance. A paired samples t-test compared the performance with the two devices.p-value: =0.004t-test, 2 sided
Comparison: Recorded BKB sentences in a 4-talker masker were evaluated in 2 conditions: 1) bone-conduction device at the preoperative interval and 2) with the cochlear implant (CI) at the 12-month post-activation period. A paired samples t-test compared the performance with the two devices. Results are reported in dB SNR, where a lower value indicates better performance.p-value: =0.004t-test, 2 sided
Secondary

Speech Recognition in Noise for a Control Group: AzBio Sentences (0 dB SNR)

The speech perception (cochlear implant recipients with UHL/SSD) to a control group of implantable bone-conduction device recipients (alternative treatment option). Participants in the control group had at least 12 months of listening experience with their implanted bone-conduction device prior to study participation. Sentence recognition was assessed in a 10-talker masker at 0 dB SNR with the target speech presented from the front and the masker (1) presented from the front (SoNo), (2) presented towards the implanted ear (SoNbc), and (3) presented towards the acoustic ear (SoNnh). Performance was scored as the percent of words correctly repeated, with higher values indicating better performance. The task was completed with the participants listening with their bone-conduction device on versus off.

Time frame: Assessment completed after 12 months of implantable bone-conduction listening experience

Population: Performance on measures of speech perception

ArmMeasureGroupValue (MEDIAN)
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupSpeech Recognition in Noise for a Control Group: AzBio Sentences (0 dB SNR)SoNo, device on32 percentage of words correctly repeated
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupSpeech Recognition in Noise for a Control Group: AzBio Sentences (0 dB SNR)SoNbc, device on69 percentage of words correctly repeated
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupSpeech Recognition in Noise for a Control Group: AzBio Sentences (0 dB SNR)SoNnh, device on10 percentage of words correctly repeated
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupSpeech Recognition in Noise for a Control Group: AzBio Sentences (0 dB SNR)SoNo, device off19 percentage of words correctly repeated
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupSpeech Recognition in Noise for a Control Group: AzBio Sentences (0 dB SNR)SoNbc, device off80 percentage of words correctly repeated
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupSpeech Recognition in Noise for a Control Group: AzBio Sentences (0 dB SNR)SoNnh, device off7 percentage of words correctly repeated
Secondary

Speech Recognition in Noise for a Control Group: BKB-SIN Test

The speech perception outcomes in the study population (cochlear implant recipients with UHL/SSD) to a control group of implantable bone-conduction device recipients (alternative treatment option). Participants in the control group had at least 12 months of listening experience with their implanted bone-conduction device prior to study participation. Sentence recognition was assessed in a 4-talker masker with the target speech presented from the front and the masker (1) presented from the front, (2) presented towards the implanted ear, and (3) presented towards the acoustic ear. Performance was scored as the dB SNR when the participant understood 50% correct, with lower values indicating better performance. Participants completed the task with the device on and off.

Time frame: Assessment completed after 12 months of implantable bone-conduction listening experience

ArmMeasureGroupValue (MEDIAN)
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupSpeech Recognition in Noise for a Control Group: BKB-SIN TestSoNo, device on-1 signal-to-noise ratio
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupSpeech Recognition in Noise for a Control Group: BKB-SIN TestSoNbc, device on-2.5 signal-to-noise ratio
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupSpeech Recognition in Noise for a Control Group: BKB-SIN TestSoNnh, device on2 signal-to-noise ratio
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupSpeech Recognition in Noise for a Control Group: BKB-SIN TestSoNo, device off-1 signal-to-noise ratio
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupSpeech Recognition in Noise for a Control Group: BKB-SIN TestSoNbc, device off-4.5 signal-to-noise ratio
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupSpeech Recognition in Noise for a Control Group: BKB-SIN TestSoNnh, device off3 signal-to-noise ratio
Secondary

Subjective Benefit for a Control Group: Abbreviated Profile of Hearing Aid Benefit (APHAB)

Subjects completed subjective questionnaires. For the Abbreviated Profile of Hearing Aid Benefit, participants rank their perceived difficulty on a scale of 1-99, with lower values indicate less perceived difficulty. Results are reported as the average responses for each of the four subscales: ease of communication, reverberation, effectiveness in background noise, and reverberation. The global score is the average response across questions for the ease of communication, reverberation, and effectiveness in background noise subscales. Participants in the control group had at least 12 months of listening experience with their implanted bone-conduction device prior to study participation.

Time frame: Assessment completed after 12 months of implantable bone-conduction listening experience

ArmMeasureGroupValue (MEDIAN)
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupSubjective Benefit for a Control Group: Abbreviated Profile of Hearing Aid Benefit (APHAB)global score26.3 score on a scale
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupSubjective Benefit for a Control Group: Abbreviated Profile of Hearing Aid Benefit (APHAB)ease of communication19.2 score on a scale
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupSubjective Benefit for a Control Group: Abbreviated Profile of Hearing Aid Benefit (APHAB)reverberation39.5 score on a scale
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupSubjective Benefit for a Control Group: Abbreviated Profile of Hearing Aid Benefit (APHAB)effectiveness in background noise41.7 score on a scale
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupSubjective Benefit for a Control Group: Abbreviated Profile of Hearing Aid Benefit (APHAB)aversiveness to sounds4.7 score on a scale
Secondary

Subjective Benefit for a Control Group: Speech, Spatial, and Qualities of Hearing Scale (SSQ)

Subjects completed subjective questionnaires. For the Speech, Spatial, and Qualities of hearing questionnaire, participants rank their perceived abilities on a scale of 0-10. Higher values indicate more perceived abilities. Results are reported as the average responses across questions for each subscale (Speech Hearing, Spatial Hearing, and Qualities of Hearing). Results are also reported as the total score at each interval, which is the average of the responses from all questions for the questionnaire. Participants in the control group had at least 12 months of listening experience with their implanted bone-conduction device prior to study participation.

Time frame: Assessment completed after 12 months of implantable bone-conduction listening experience

ArmMeasureGroupValue (MEDIAN)
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupSubjective Benefit for a Control Group: Speech, Spatial, and Qualities of Hearing Scale (SSQ)speech hearing subscale4.5 score on a scale
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupSubjective Benefit for a Control Group: Speech, Spatial, and Qualities of Hearing Scale (SSQ)spatial hearing subscale1.7 score on a scale
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupSubjective Benefit for a Control Group: Speech, Spatial, and Qualities of Hearing Scale (SSQ)qualities of hearing subscale5.2 score on a scale
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupSubjective Benefit for a Control Group: Speech, Spatial, and Qualities of Hearing Scale (SSQ)Total score3.6 score on a scale
Secondary

Subjective Benefit (Measured With the Abbreviated Profile of Hearing Aid Benefit Questionnaire) With Cochlear Implant Versus Preoperative Perceptions With Alternative Treatment Options (e.g., Hearing Aid, Bone-conduction Device)

Subjects completed subjective questionnaires. For the Abbreviated Profile of Hearing Aid Benefit, participants rank their perceived difficulty on a scale of 1-99, with lower values indicate less perceived difficulty. The global score is the average response across questions for the ease of communication, reverberation, and effectiveness in background noise subscales.

Time frame: preoperative interval, and post-activation intervals (1, 3, 6, 9, and 12 months)

Population: Three participants in the asymmetric hearing loss group did not complete the 9 month interval. One participant in the asymmetric hearing loss group withdrew from the study prior to the 12-month interval.

ArmMeasureGroupValue (MEAN)Dispersion
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupSubjective Benefit (Measured With the Abbreviated Profile of Hearing Aid Benefit Questionnaire) With Cochlear Implant Versus Preoperative Perceptions With Alternative Treatment Options (e.g., Hearing Aid, Bone-conduction Device)before surgery50 score on a scaleStandard Deviation 19
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupSubjective Benefit (Measured With the Abbreviated Profile of Hearing Aid Benefit Questionnaire) With Cochlear Implant Versus Preoperative Perceptions With Alternative Treatment Options (e.g., Hearing Aid, Bone-conduction Device)1 month after surgery26 score on a scaleStandard Deviation 13
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupSubjective Benefit (Measured With the Abbreviated Profile of Hearing Aid Benefit Questionnaire) With Cochlear Implant Versus Preoperative Perceptions With Alternative Treatment Options (e.g., Hearing Aid, Bone-conduction Device)3 months after surgery21 score on a scaleStandard Deviation 9
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupSubjective Benefit (Measured With the Abbreviated Profile of Hearing Aid Benefit Questionnaire) With Cochlear Implant Versus Preoperative Perceptions With Alternative Treatment Options (e.g., Hearing Aid, Bone-conduction Device)6 months after surgery20 score on a scaleStandard Deviation 8
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupSubjective Benefit (Measured With the Abbreviated Profile of Hearing Aid Benefit Questionnaire) With Cochlear Implant Versus Preoperative Perceptions With Alternative Treatment Options (e.g., Hearing Aid, Bone-conduction Device)9 months after surgery17 score on a scaleStandard Deviation 8
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupSubjective Benefit (Measured With the Abbreviated Profile of Hearing Aid Benefit Questionnaire) With Cochlear Implant Versus Preoperative Perceptions With Alternative Treatment Options (e.g., Hearing Aid, Bone-conduction Device)12 months after surgery18 score on a scaleStandard Deviation 9
Cochlear Implant: Asymmetric Hearing Loss GroupSubjective Benefit (Measured With the Abbreviated Profile of Hearing Aid Benefit Questionnaire) With Cochlear Implant Versus Preoperative Perceptions With Alternative Treatment Options (e.g., Hearing Aid, Bone-conduction Device)9 months after surgery29 score on a scaleStandard Deviation 15
Cochlear Implant: Asymmetric Hearing Loss GroupSubjective Benefit (Measured With the Abbreviated Profile of Hearing Aid Benefit Questionnaire) With Cochlear Implant Versus Preoperative Perceptions With Alternative Treatment Options (e.g., Hearing Aid, Bone-conduction Device)before surgery52 score on a scaleStandard Deviation 17
Cochlear Implant: Asymmetric Hearing Loss GroupSubjective Benefit (Measured With the Abbreviated Profile of Hearing Aid Benefit Questionnaire) With Cochlear Implant Versus Preoperative Perceptions With Alternative Treatment Options (e.g., Hearing Aid, Bone-conduction Device)6 months after surgery31 score on a scaleStandard Deviation 14
Cochlear Implant: Asymmetric Hearing Loss GroupSubjective Benefit (Measured With the Abbreviated Profile of Hearing Aid Benefit Questionnaire) With Cochlear Implant Versus Preoperative Perceptions With Alternative Treatment Options (e.g., Hearing Aid, Bone-conduction Device)1 month after surgery32 score on a scaleStandard Deviation 10
Cochlear Implant: Asymmetric Hearing Loss GroupSubjective Benefit (Measured With the Abbreviated Profile of Hearing Aid Benefit Questionnaire) With Cochlear Implant Versus Preoperative Perceptions With Alternative Treatment Options (e.g., Hearing Aid, Bone-conduction Device)12 months after surgery28 score on a scaleStandard Deviation 10
Cochlear Implant: Asymmetric Hearing Loss GroupSubjective Benefit (Measured With the Abbreviated Profile of Hearing Aid Benefit Questionnaire) With Cochlear Implant Versus Preoperative Perceptions With Alternative Treatment Options (e.g., Hearing Aid, Bone-conduction Device)3 months after surgery28 score on a scaleStandard Deviation 10
Comparison: The Abbreviated Profile of Hearing Aid Benefit, participants rank their perceived difficulty on a scale of 1-99, with lower values indicate less perceived difficulty. The global score is calculated from the responses on the ease of communication, reverberation, and effectiveness in background noise subscales. Responses at the preoperative interval (alternative treatments for unilateral hearing loss) were compared to responses over time with the cochlear implant using a repeated-measures ANOVA.p-value: <0.001ANOVA
Comparison: The Abbreviated Profile of Hearing Aid Benefit, participants rank their perceived difficulty on a scale of 1-99, with lower values indicate less perceived difficulty. The global score is calculated from the responses on the ease of communication, reverberation, and effectiveness in background noise subscales. Responses at the preoperative interval (alternative treatments for unilateral hearing loss) were compared to responses over time with the cochlear implant using a repeated-measures ANOVA.p-value: <0.001ANOVA
Comparison: The Abbreviated Profile of Hearing Aid Benefit, participants rank their perceived difficulty on a scale of 1-99, with lower values indicate less perceived difficulty. Subscales include: ease of communication, reverberation, effectiveness in background noise, and reverberation. A repeated-measures ANOVA compared the main effects of interval and subscale and their interaction from the preoperative interval (alternative treatments) and over time with the cochlear implant.p-value: <0.001Mixed Models Analysis
Comparison: The Abbreviated Profile of Hearing Aid Benefit, participants rank their perceived difficulty on a scale of 1-99, with lower values indicate less perceived difficulty. Subscales include: ease of communication, reverberation, effectiveness in background noise, and reverberation. A repeated-measures ANOVA compared the main effects of interval and subscale and their interaction from the preoperative interval (alternative treatments) and over time with the cochlear implant.p-value: <0.01Mixed Models Analysis
Secondary

Subjective Benefit (Measured With the Speech, Spatial, and Qualities of Hearing (SSQ) Questionnaire) With Cochlear Implant Versus Preoperative Perceptions With Alternative Treatment Options (e.g., Hearing Aid, Bone-conduction Device)

Subjects completed subjective questionnaires. For the Speech, Spatial, and Qualities of hearing questionnaire, participants rank their perceived abilities on a scale of 0-10. Higher values indicate more perceived abilities. Results are reported as the total score at each interval, which is the average of the responses from all questions for the questionnaire.

Time frame: preoperative interval, and post-activation intervals (1, 3, 6, 9, and 12 months)

Population: Three participants in the asymmetric hearing loss group did not complete the 9 month interval. One participant in the asymmetric hearing loss group withdrew from the study prior to the 12-month interval.

ArmMeasureGroupValue (MEAN)Dispersion
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupSubjective Benefit (Measured With the Speech, Spatial, and Qualities of Hearing (SSQ) Questionnaire) With Cochlear Implant Versus Preoperative Perceptions With Alternative Treatment Options (e.g., Hearing Aid, Bone-conduction Device)before surgery4 score on a scaleStandard Deviation 1
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupSubjective Benefit (Measured With the Speech, Spatial, and Qualities of Hearing (SSQ) Questionnaire) With Cochlear Implant Versus Preoperative Perceptions With Alternative Treatment Options (e.g., Hearing Aid, Bone-conduction Device)1 month after surgery6 score on a scaleStandard Deviation 2
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupSubjective Benefit (Measured With the Speech, Spatial, and Qualities of Hearing (SSQ) Questionnaire) With Cochlear Implant Versus Preoperative Perceptions With Alternative Treatment Options (e.g., Hearing Aid, Bone-conduction Device)3 months after surgery6 score on a scaleStandard Deviation 2
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupSubjective Benefit (Measured With the Speech, Spatial, and Qualities of Hearing (SSQ) Questionnaire) With Cochlear Implant Versus Preoperative Perceptions With Alternative Treatment Options (e.g., Hearing Aid, Bone-conduction Device)6 months after surgery7 score on a scaleStandard Deviation 1
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupSubjective Benefit (Measured With the Speech, Spatial, and Qualities of Hearing (SSQ) Questionnaire) With Cochlear Implant Versus Preoperative Perceptions With Alternative Treatment Options (e.g., Hearing Aid, Bone-conduction Device)9 months after surgery7 score on a scaleStandard Deviation 1
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupSubjective Benefit (Measured With the Speech, Spatial, and Qualities of Hearing (SSQ) Questionnaire) With Cochlear Implant Versus Preoperative Perceptions With Alternative Treatment Options (e.g., Hearing Aid, Bone-conduction Device)12 months after surgery7 score on a scaleStandard Deviation 1
Cochlear Implant: Asymmetric Hearing Loss GroupSubjective Benefit (Measured With the Speech, Spatial, and Qualities of Hearing (SSQ) Questionnaire) With Cochlear Implant Versus Preoperative Perceptions With Alternative Treatment Options (e.g., Hearing Aid, Bone-conduction Device)9 months after surgery6 score on a scaleStandard Deviation 1
Cochlear Implant: Asymmetric Hearing Loss GroupSubjective Benefit (Measured With the Speech, Spatial, and Qualities of Hearing (SSQ) Questionnaire) With Cochlear Implant Versus Preoperative Perceptions With Alternative Treatment Options (e.g., Hearing Aid, Bone-conduction Device)before surgery4 score on a scaleStandard Deviation 1
Cochlear Implant: Asymmetric Hearing Loss GroupSubjective Benefit (Measured With the Speech, Spatial, and Qualities of Hearing (SSQ) Questionnaire) With Cochlear Implant Versus Preoperative Perceptions With Alternative Treatment Options (e.g., Hearing Aid, Bone-conduction Device)6 months after surgery6 score on a scaleStandard Deviation 1
Cochlear Implant: Asymmetric Hearing Loss GroupSubjective Benefit (Measured With the Speech, Spatial, and Qualities of Hearing (SSQ) Questionnaire) With Cochlear Implant Versus Preoperative Perceptions With Alternative Treatment Options (e.g., Hearing Aid, Bone-conduction Device)1 month after surgery5 score on a scaleStandard Deviation 1
Cochlear Implant: Asymmetric Hearing Loss GroupSubjective Benefit (Measured With the Speech, Spatial, and Qualities of Hearing (SSQ) Questionnaire) With Cochlear Implant Versus Preoperative Perceptions With Alternative Treatment Options (e.g., Hearing Aid, Bone-conduction Device)12 months after surgery6 score on a scaleStandard Deviation 1
Cochlear Implant: Asymmetric Hearing Loss GroupSubjective Benefit (Measured With the Speech, Spatial, and Qualities of Hearing (SSQ) Questionnaire) With Cochlear Implant Versus Preoperative Perceptions With Alternative Treatment Options (e.g., Hearing Aid, Bone-conduction Device)3 months after surgery6 score on a scaleStandard Deviation 2
Comparison: Responses on the SSQ as measured with the total score were compared at the preoperative interval (alternative treatments for SSD) and over the post-activation period (i.e., 1, 3, 6, 9, and 12 months).p-value: <0.001ANOVA
Comparison: Responses on the SSQ as measured with the total score were compared at the preoperative interval (alternative treatments for asymmetric hearing loss) and over the post-activation period (i.e., 1, 3, 6, 9, and 12 months).p-value: <0.001ANOVA
Comparison: Responses on the SSQ as measured with the subscales (speech, spatial, \& qualities) were compared at the preoperative interval (alternative treatments for SSD) and over the post-activation period (i.e., 1, 3, 6, 9, and 12 months). A repeated-measures ANOVA assessed the main effects of interval and subscale, and their interaction.p-value: <0.001Mixed Models Analysis
Comparison: Responses on the SSQ as measured with the subscales (speech, spatial, \& qualities) were compared at the preoperative interval (alternative treatments for asymmetric hearing loss) and over the post-activation period (i.e., 1, 3, 6, 9, and 12 months). A repeated-measures ANOVA assessed the main effects of interval and subscale, and their interaction.p-value: <0.034Mixed Models Analysis
Comparison: Responses on the SSQ Speech pragmatic subscale over the study period (i.e., preoperative, and 1, 3, 6, 9, and 12 months post-activation). A repeated-measures ANOVA compared the main effects of interval and pragmatic subscale and their interaction over time.p-value: <0.001Mixed Models Analysis
Comparison: Responses on the SSQ Spatial pragmatic subscale over the study period (i.e., preoperative, and 1, 3, 6, 9, and 12 months post-activation). A repeated-measures ANOVA compared the main effects of interval and pragmatic subscale and their interaction over time.p-value: <0.192Mixed Models Analysis
Comparison: Responses on the SSQ Qualities of Hearing pragmatic subscale over the study period (i.e., preoperative, and 1, 3, 6, 9, and 12 months post-activation). A repeated-measures ANOVA compared the main effects of interval and pragmatic subscale and their interaction over time.p-value: <0.001Mixed Models Analysis
Comparison: Responses on the SSQ Speech pragmatic subscale over the study period (i.e., preoperative, and 1, 3, 6, 9, and 12 months post-activation). A repeated-measures ANOVA compared the main effects of interval and pragmatic subscale and their interaction over time.p-value: <0.479Mixed Models Analysis
Comparison: Responses on the SSQ Spatial pragmatic subscale over the study period (i.e., preoperative, and 1, 3, 6, 9, and 12 months post-activation). A repeated-measures ANOVA compared the main effects of interval and pragmatic subscale and their interaction over time.p-value: <0.804Mixed Models Analysis
Comparison: Responses on the SSQ Qualities of Hearing pragmatic subscale over the study period (i.e., preoperative, and 1, 3, 6, 9, and 12 months post-activation). A repeated-measures ANOVA compared the main effects of interval and pragmatic subscale and their interaction over time.p-value: <0.005Mixed Models Analysis
Secondary

Subjective Benefit (Measured With the Tinnitus Handicap Inventory (THI) Questionnaire) With Cochlear Implant Versus Preoperative Perceptions With Alternative Treatment Options (e.g., Hearing Aid, Bone-conduction Device)

Subjects completed subjective questionnaires. For the Tinnitus Handicap Inventory, participants rank their perceived tinnitus severity on a scale of 0-100, with lower values indicate less tinnitus severity. Responses across all questions are summed to derive the total score.

Time frame: Intervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation)

Population: Three participants in the asymmetric hearing loss group did not complete the 9 month interval. One participant in the asymmetric hearing loss group withdrew from the study prior to the 12-month interval.

ArmMeasureGroupValue (MEAN)Dispersion
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupSubjective Benefit (Measured With the Tinnitus Handicap Inventory (THI) Questionnaire) With Cochlear Implant Versus Preoperative Perceptions With Alternative Treatment Options (e.g., Hearing Aid, Bone-conduction Device)before surgery25 score on a scaleStandard Deviation 17
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupSubjective Benefit (Measured With the Tinnitus Handicap Inventory (THI) Questionnaire) With Cochlear Implant Versus Preoperative Perceptions With Alternative Treatment Options (e.g., Hearing Aid, Bone-conduction Device)1 month after surgery6 score on a scaleStandard Deviation 10
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupSubjective Benefit (Measured With the Tinnitus Handicap Inventory (THI) Questionnaire) With Cochlear Implant Versus Preoperative Perceptions With Alternative Treatment Options (e.g., Hearing Aid, Bone-conduction Device)3 months after surgery4 score on a scaleStandard Deviation 7
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupSubjective Benefit (Measured With the Tinnitus Handicap Inventory (THI) Questionnaire) With Cochlear Implant Versus Preoperative Perceptions With Alternative Treatment Options (e.g., Hearing Aid, Bone-conduction Device)6 months after surgery2 score on a scaleStandard Deviation 5
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupSubjective Benefit (Measured With the Tinnitus Handicap Inventory (THI) Questionnaire) With Cochlear Implant Versus Preoperative Perceptions With Alternative Treatment Options (e.g., Hearing Aid, Bone-conduction Device)9 months after surgery4 score on a scaleStandard Deviation 6
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupSubjective Benefit (Measured With the Tinnitus Handicap Inventory (THI) Questionnaire) With Cochlear Implant Versus Preoperative Perceptions With Alternative Treatment Options (e.g., Hearing Aid, Bone-conduction Device)12 months after surgery3 score on a scaleStandard Deviation 5
Cochlear Implant: Asymmetric Hearing Loss GroupSubjective Benefit (Measured With the Tinnitus Handicap Inventory (THI) Questionnaire) With Cochlear Implant Versus Preoperative Perceptions With Alternative Treatment Options (e.g., Hearing Aid, Bone-conduction Device)9 months after surgery2 score on a scaleStandard Deviation 7
Cochlear Implant: Asymmetric Hearing Loss GroupSubjective Benefit (Measured With the Tinnitus Handicap Inventory (THI) Questionnaire) With Cochlear Implant Versus Preoperative Perceptions With Alternative Treatment Options (e.g., Hearing Aid, Bone-conduction Device)before surgery18 score on a scaleStandard Deviation 20
Cochlear Implant: Asymmetric Hearing Loss GroupSubjective Benefit (Measured With the Tinnitus Handicap Inventory (THI) Questionnaire) With Cochlear Implant Versus Preoperative Perceptions With Alternative Treatment Options (e.g., Hearing Aid, Bone-conduction Device)6 months after surgery4 score on a scaleStandard Deviation 12
Cochlear Implant: Asymmetric Hearing Loss GroupSubjective Benefit (Measured With the Tinnitus Handicap Inventory (THI) Questionnaire) With Cochlear Implant Versus Preoperative Perceptions With Alternative Treatment Options (e.g., Hearing Aid, Bone-conduction Device)1 month after surgery4 score on a scaleStandard Deviation 6
Cochlear Implant: Asymmetric Hearing Loss GroupSubjective Benefit (Measured With the Tinnitus Handicap Inventory (THI) Questionnaire) With Cochlear Implant Versus Preoperative Perceptions With Alternative Treatment Options (e.g., Hearing Aid, Bone-conduction Device)12 months after surgery4 score on a scaleStandard Deviation 13
Cochlear Implant: Asymmetric Hearing Loss GroupSubjective Benefit (Measured With the Tinnitus Handicap Inventory (THI) Questionnaire) With Cochlear Implant Versus Preoperative Perceptions With Alternative Treatment Options (e.g., Hearing Aid, Bone-conduction Device)3 months after surgery2 score on a scaleStandard Deviation 7
Comparison: The Tinnitus Handicap Inventory is a 25-item questionnaire. The subject answers yes (4 points), sometimes (2 points), or no (0 points) to each question. Responses are added to quantify tinnitus severity: none/slight (0-16), mild (18-36), moderate (38-56), severe (58-76), and catastrophic (78-100). Responses were compared at the preoperative interval (alternative treatments) and over the post-activation time period (1, 3, 6, 9, and 12 months) with the cochlear implant.p-value: <0.001ANOVA
Comparison: The Tinnitus Handicap Inventory is a 25-item questionnaire. The subject answers yes (4 points), sometimes (2 points), or no (0 points) to each question. Responses are added to quantify tinnitus severity: none/slight (0-16), mild (18-36), moderate (38-56), severe (58-76), and catastrophic (78-100). Responses were compared at the preoperative interval (alternative treatments) and over the post-activation time period (1, 3, 6, 9, and 12 months) with the cochlear implant.p-value: =0.003ANOVA
Other Pre-specified

Change in Pitch Perception With the Cochlear Implant Over the Post-activation Period

Participants completed an adaptive pitch matching task that compared the pitch of acoustic stimulation presented to their normal hearing ear with the perception of stimulation from the cochlear implant. Two stimuli were used: clicks & tones. Pitch perception was evaluated for the 5 most apical electrodes. A normalized score was obtained (normalized score = geometric mean of the responses / electric center frequency of the evaluated electrode); that is, the normalized score = perceived frequency / frequency information presented by the electrode. Results are reported as the averaged normalized score for clicks & tones for each electrode (electrodes 1-5) at each interval (1, 3, 6, and 12 months post-activation). A value of 1.0 indicates the participant perceived the same frequency as the center frequency presented by the electrode. A value \< 1.0 indicates a lower perceived pitch and a value \> 1.0 indicates a higher perceived pitch than the electric frequency information.

Time frame: post-activation period (1, 3, 6, and 12 months post-activation)

Population: 19 of the 20 participants in the single-sided deafness/unilateral hearing loss group elected to complete the pitch matching task on the five most apical electrodes. One participant missed the 1-month and 3-month intervals. Another participant missed the 6-month interval.

ArmMeasureGroupValue (MEAN)Dispersion
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupChange in Pitch Perception With the Cochlear Implant Over the Post-activation Period1-month: electrode 2, tone1.0 normalized scoreStandard Deviation 0.2
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupChange in Pitch Perception With the Cochlear Implant Over the Post-activation Period1-month: electrode 1, click1.2 normalized scoreStandard Deviation 0.4
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupChange in Pitch Perception With the Cochlear Implant Over the Post-activation Period1-month: electrode 1, tone1.3 normalized scoreStandard Deviation 0.4
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupChange in Pitch Perception With the Cochlear Implant Over the Post-activation Period1-month: electrode 2, click1.0 normalized scoreStandard Deviation 0.4
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupChange in Pitch Perception With the Cochlear Implant Over the Post-activation Period1-month: electrode 3, click0.9 normalized scoreStandard Deviation 0.2
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupChange in Pitch Perception With the Cochlear Implant Over the Post-activation Period1-month: electrode 3, tone1.0 normalized scoreStandard Deviation 0.4
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupChange in Pitch Perception With the Cochlear Implant Over the Post-activation Period1-month: electrode 4, click0.8 normalized scoreStandard Deviation 0.2
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupChange in Pitch Perception With the Cochlear Implant Over the Post-activation Period1-month: electrode 4, tone0.9 normalized scoreStandard Deviation 0.2
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupChange in Pitch Perception With the Cochlear Implant Over the Post-activation Period1-month: electrode 5, click0.9 normalized scoreStandard Deviation 0.4
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupChange in Pitch Perception With the Cochlear Implant Over the Post-activation Period1-month: electrode 5, tone0.9 normalized scoreStandard Deviation 0.2
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupChange in Pitch Perception With the Cochlear Implant Over the Post-activation Period3-month: electrode 1, click1.1 normalized scoreStandard Deviation 0.5
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupChange in Pitch Perception With the Cochlear Implant Over the Post-activation Period3-month: electrode 1, tone1.2 normalized scoreStandard Deviation 0.3
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupChange in Pitch Perception With the Cochlear Implant Over the Post-activation Period3-month: electrode 2, click1.0 normalized scoreStandard Deviation 0.4
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupChange in Pitch Perception With the Cochlear Implant Over the Post-activation Period3-month: electrode 2, tone0.9 normalized scoreStandard Deviation 0.2
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupChange in Pitch Perception With the Cochlear Implant Over the Post-activation Period3-month: electrode 3, click0.8 normalized scoreStandard Deviation 0.2
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupChange in Pitch Perception With the Cochlear Implant Over the Post-activation Period3-month: electrode 3, tone0.8 normalized scoreStandard Deviation 0.2
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupChange in Pitch Perception With the Cochlear Implant Over the Post-activation Period3-month: electrode 4, click0.8 normalized scoreStandard Deviation 0.2
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupChange in Pitch Perception With the Cochlear Implant Over the Post-activation Period3-month: electrode 4, tone0.7 normalized scoreStandard Deviation 0.2
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupChange in Pitch Perception With the Cochlear Implant Over the Post-activation Period3-month: electrode 5, click0.8 normalized scoreStandard Deviation 0.3
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupChange in Pitch Perception With the Cochlear Implant Over the Post-activation Period3-month: electrode 5, tone0.7 normalized scoreStandard Deviation 0.2
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupChange in Pitch Perception With the Cochlear Implant Over the Post-activation Period6-month: electrode 1, click1.2 normalized scoreStandard Deviation 0.4
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupChange in Pitch Perception With the Cochlear Implant Over the Post-activation Period6-month: electrode 1, tone1.2 normalized scoreStandard Deviation 0.4
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupChange in Pitch Perception With the Cochlear Implant Over the Post-activation Period6-month: electrode 2, click1.2 normalized scoreStandard Deviation 0.3
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupChange in Pitch Perception With the Cochlear Implant Over the Post-activation Period6-month: electrode 2, tone1.0 normalized scoreStandard Deviation 0.3
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupChange in Pitch Perception With the Cochlear Implant Over the Post-activation Period6-month: electrode 3, click1.0 normalized scoreStandard Deviation 0.4
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupChange in Pitch Perception With the Cochlear Implant Over the Post-activation Period6-month: electrode 3, tone0.9 normalized scoreStandard Deviation 0.3
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupChange in Pitch Perception With the Cochlear Implant Over the Post-activation Period6-month: electrode 4, click0.9 normalized scoreStandard Deviation 0.3
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupChange in Pitch Perception With the Cochlear Implant Over the Post-activation Period6-month: electrode 4, tone0.8 normalized scoreStandard Deviation 0.2
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupChange in Pitch Perception With the Cochlear Implant Over the Post-activation Period6-month: electrode 5, click0.8 normalized scoreStandard Deviation 0.3
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupChange in Pitch Perception With the Cochlear Implant Over the Post-activation Period6-month: electrode 5, tone0.8 normalized scoreStandard Deviation 0.2
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupChange in Pitch Perception With the Cochlear Implant Over the Post-activation Period12-month: electrode 1, click1.2 normalized scoreStandard Deviation 0.4
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupChange in Pitch Perception With the Cochlear Implant Over the Post-activation Period12-month: electrode 1, tone1.3 normalized scoreStandard Deviation 0.3
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupChange in Pitch Perception With the Cochlear Implant Over the Post-activation Period12-month: electrode 2, click1.1 normalized scoreStandard Deviation 0.4
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupChange in Pitch Perception With the Cochlear Implant Over the Post-activation Period12-month: electrode 2, tone1.1 normalized scoreStandard Deviation 0.3
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupChange in Pitch Perception With the Cochlear Implant Over the Post-activation Period12-month: electrode 3, click0.9 normalized scoreStandard Deviation 0.3
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupChange in Pitch Perception With the Cochlear Implant Over the Post-activation Period12-month: electrode 3, tone1.0 normalized scoreStandard Deviation 0.3
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupChange in Pitch Perception With the Cochlear Implant Over the Post-activation Period12-month: electrode 4, click0.8 normalized scoreStandard Deviation 0.2
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupChange in Pitch Perception With the Cochlear Implant Over the Post-activation Period12-month: electrode 4, tone0.9 normalized scoreStandard Deviation 0.2
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupChange in Pitch Perception With the Cochlear Implant Over the Post-activation Period12-month: electrode 5, click0.9 normalized scoreStandard Deviation 0.2
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupChange in Pitch Perception With the Cochlear Implant Over the Post-activation Period12-month: electrode 5, tone0.9 normalized scoreStandard Deviation 0.3
Comparison: A linear mixed effects model compared the main effects of target stimulus (click, tone), electrode (1-5), and interval (1, 3, 6, and 12 months) on the normalized pitch match.p-value: <0.923Mixed Models Analysis
Comparison: Correlation between pitch perception (normalized mean pitch match) and word recognition with the CI alone.p-value: >0.164bivariate pearson correlation
Comparison: Correlation between pitch perception (normalized mean pitch match) and speech recognition in noise (masker from the front, masker towards the better hearing ear, and masker towards the poorer hearing ear).p-value: >0.367bivariate pearson correlation
Comparison: Correlation between pitch perception (normalized mean pitch match) and sound source localization (RMS error).p-value: >0.349bivariate pearson correlation
Post Hoc

Localization in the Unaided Condition and With a Bone-conduction Device, Measured in Root-mean-squared Error.

Subjects were asked to identify the noise source from an 11-speaker array with a bone-conductive device on versus off. The intensity level of the stimulus was randomly varied (10 dB around 70 dB SPL) to limit the listener relying on level effects. Responses at each intensity level (i.e., 60, 70, and 80 dB SPL) for a given sound source (speaker) were combined. Results are reported in root-mean-squared (RMS) error. A lower value indicates better performance. Results are compared at the preoperative and 12-month post-activation intervals.

Time frame: preoperative and 12-month post-activation intervals.

Population: One participant in the asymmetric group withdrew before the 12-month interval. Two additional participants in the asymmetric hearing loss group did not complete the procedure with the bone-conduction device at the 12-month interval.

ArmMeasureGroupValue (MEAN)Dispersion
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupLocalization in the Unaided Condition and With a Bone-conduction Device, Measured in Root-mean-squared Error.before surgery, unaided66 degreesStandard Deviation 20
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupLocalization in the Unaided Condition and With a Bone-conduction Device, Measured in Root-mean-squared Error.before surgery, bone conduction device70 degreesStandard Deviation 19
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupLocalization in the Unaided Condition and With a Bone-conduction Device, Measured in Root-mean-squared Error.12-month, unaided68 degreesStandard Deviation 18
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupLocalization in the Unaided Condition and With a Bone-conduction Device, Measured in Root-mean-squared Error.12-month, bone conduction device69 degreesStandard Deviation 19
Cochlear Implant: Asymmetric Hearing Loss GroupLocalization in the Unaided Condition and With a Bone-conduction Device, Measured in Root-mean-squared Error.12-month, bone conduction device80 degreesStandard Deviation 14
Cochlear Implant: Asymmetric Hearing Loss GroupLocalization in the Unaided Condition and With a Bone-conduction Device, Measured in Root-mean-squared Error.before surgery, unaided76 degreesStandard Deviation 19
Cochlear Implant: Asymmetric Hearing Loss GroupLocalization in the Unaided Condition and With a Bone-conduction Device, Measured in Root-mean-squared Error.12-month, unaided79 degreesStandard Deviation 17
Cochlear Implant: Asymmetric Hearing Loss GroupLocalization in the Unaided Condition and With a Bone-conduction Device, Measured in Root-mean-squared Error.before surgery, bone conduction device76 degreesStandard Deviation 18
Comparison: A repeated-measures ANOVA assessed the effects of condition (unaided, bone-conduction device) and interval (preoperative, 12-month) and their interaction on sound source localization.p-value: >0.084ANOVA
Comparison: A repeated-measures ANOVA assessed the effects of condition (unaided, bone-conduction device) and interval (preoperative, 12-month) and their interaction on sound source localization.p-value: >0.434ANOVA
Post Hoc

Localization With a Bone-conduction Device Over Time, Measured in Root-mean-squared (RMS) Error

Subjects were asked to identify the noise source from an 11-speaker array. The intensity level of the stimulus was randomly varied (10 dB around 70 dB SPL) to limit the listener relying on level effects. Responses at each intensity level (i.e., 60, 70, and 80 dB SPL) for a given sound source (speaker) were combined. Performance was measured with a bone conduction device preoperatively and 12 months post-activation. Overall root-mean-square (RMS) error is the difference between the sound source azimuth and the response azimuth and a lower score indicates more accurate localization of the sound source.

Time frame: preoperative and 12-month intervals

Population: Three participants in the asymmetric hearing loss group did not complete the task at the 12-month interval.

ArmMeasureGroupValue (MEAN)Dispersion
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupLocalization With a Bone-conduction Device Over Time, Measured in Root-mean-squared (RMS) Errorpreoperative70 degreesStandard Deviation 19
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupLocalization With a Bone-conduction Device Over Time, Measured in Root-mean-squared (RMS) Error12-month69 degreesStandard Deviation 19
Cochlear Implant: Asymmetric Hearing Loss GroupLocalization With a Bone-conduction Device Over Time, Measured in Root-mean-squared (RMS) Errorpreoperative76 degreesStandard Deviation 18
Cochlear Implant: Asymmetric Hearing Loss GroupLocalization With a Bone-conduction Device Over Time, Measured in Root-mean-squared (RMS) Error12-month80 degreesStandard Deviation 14
Comparison: A paired samples t-test compared the performance with the bone-conduction device at the preoperative and 12-month intervals.p-value: =0.739t-test, 2 sided
Comparison: A paired samples t-test compared the performance with the bone-conduction device at the preoperative and 12-month intervals.p-value: =0.553t-test, 2 sided
Post Hoc

Pitch Perception on 5 Most Apical Electrodes With the Fine Structure Coding Strategy (FS4) Versus the Continuous Interleaved Sampling (CIS) Coding Strategy

9 participants repeated the pitch perception task at the 12-month interval while listening to the CIS strategy. FS4 & CIS strategies differ in whether or not fine structure cues are provided on the 4 most apical electrodes; there is no difference in the cues provided by electrode 5. An adaptive task compared the pitch of acoustic stimulation presented to the normal hearing ear with the stimulation from the cochlear implant. A normalized score was obtained (normalized score = geometric mean of the responses / electric center frequency of the evaluated electrode); that is, the normalized score = perceived frequency / presented frequency information. Results are reported as the averaged normalized score for clicks & tones for each electrode. A value of 1.0 indicates the perceived frequency was the same as the electric frequency information. A value \< 1.0 indicates a lower perceived pitch and a value \> 1.0 indicates a higher perceived pitch than the electric frequency information.

Time frame: 12-month interval

Population: One participant did not complete testing for electrode 5

ArmMeasureGroupValue (MEAN)Dispersion
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupPitch Perception on 5 Most Apical Electrodes With the Fine Structure Coding Strategy (FS4) Versus the Continuous Interleaved Sampling (CIS) Coding Strategyelectrode 1, FS41.2 normalized scoreStandard Deviation 0.3
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupPitch Perception on 5 Most Apical Electrodes With the Fine Structure Coding Strategy (FS4) Versus the Continuous Interleaved Sampling (CIS) Coding Strategyelectrode 1, CIS1.5 normalized scoreStandard Deviation 0.3
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupPitch Perception on 5 Most Apical Electrodes With the Fine Structure Coding Strategy (FS4) Versus the Continuous Interleaved Sampling (CIS) Coding Strategyelectrode 2, FS41.0 normalized scoreStandard Deviation 0.2
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupPitch Perception on 5 Most Apical Electrodes With the Fine Structure Coding Strategy (FS4) Versus the Continuous Interleaved Sampling (CIS) Coding Strategyelectrode 2, CIS1.1 normalized scoreStandard Deviation 0.3
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupPitch Perception on 5 Most Apical Electrodes With the Fine Structure Coding Strategy (FS4) Versus the Continuous Interleaved Sampling (CIS) Coding Strategyelectrode 3, FS40.9 normalized scoreStandard Deviation 0.2
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupPitch Perception on 5 Most Apical Electrodes With the Fine Structure Coding Strategy (FS4) Versus the Continuous Interleaved Sampling (CIS) Coding Strategyelectrode 3, CIS0.9 normalized scoreStandard Deviation 0.2
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupPitch Perception on 5 Most Apical Electrodes With the Fine Structure Coding Strategy (FS4) Versus the Continuous Interleaved Sampling (CIS) Coding Strategyelectrode 4, FS40.9 normalized scoreStandard Deviation 0.3
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupPitch Perception on 5 Most Apical Electrodes With the Fine Structure Coding Strategy (FS4) Versus the Continuous Interleaved Sampling (CIS) Coding Strategyelectrode 4, CIS0.8 normalized scoreStandard Deviation 0.3
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupPitch Perception on 5 Most Apical Electrodes With the Fine Structure Coding Strategy (FS4) Versus the Continuous Interleaved Sampling (CIS) Coding Strategyelectrode 5, FS40.9 normalized scoreStandard Deviation 0.2
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupPitch Perception on 5 Most Apical Electrodes With the Fine Structure Coding Strategy (FS4) Versus the Continuous Interleaved Sampling (CIS) Coding Strategyelectrode 5, CIS0.9 normalized scoreStandard Deviation 0.2
Comparison: A linear mixed effect model assessed the main effects of stimulus, electrode, and coding strategy, and their interactions.p-value: >0.023Mixed Models Analysis
Comparison: Paired samples t-tests evaluated whether pitch perception (mean normalized pitch) differed between coding strategy for each electrode.p-value: >0.035t-test, 2 sided
Post Hoc

Speech Recognition in Noise in the Unaided Condition and With a Bone-conduction Device, Measured With AzBio Sentences

Speech recognition in noise with the AzBio sentences in 3 masker conditions (masker from the front, masker towards the better hearing ear, and masker towards the poorer hearing ear) at the preoperative and 12-month intervals in the unaided condition and with a bone-conduction device. Percent correct results were converted to rationalized arcsine units (RAUs) which helps to control for floor and ceiling effects in the perception correct data (e.g., \<20% correct).

Time frame: preoperative interval and 12-month post-activation interval.

Population: All participants in the UHL/SSD group completed the task at 0 dB SNR. Not all participants in the AHL group completed the task at 0 dB SNR.

ArmMeasureGroupValue (MEAN)Dispersion
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupSpeech Recognition in Noise in the Unaided Condition and With a Bone-conduction Device, Measured With AzBio Sentencespreop, unaided, masker towards better ear11 rationalized arcsine unitsStandard Deviation 21
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupSpeech Recognition in Noise in the Unaided Condition and With a Bone-conduction Device, Measured With AzBio Sentencespreop, bone-conduction, masker towards better ear11 rationalized arcsine unitsStandard Deviation 26
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupSpeech Recognition in Noise in the Unaided Condition and With a Bone-conduction Device, Measured With AzBio Sentences12-month, unaided, masker towards better ear18 rationalized arcsine unitsStandard Deviation 23
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupSpeech Recognition in Noise in the Unaided Condition and With a Bone-conduction Device, Measured With AzBio Sentences12-month, bone-conduction, masker towards better ear28 rationalized arcsine unitsStandard Deviation 20
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupSpeech Recognition in Noise in the Unaided Condition and With a Bone-conduction Device, Measured With AzBio Sentencespreop, unaided, masker from front38 rationalized arcsine unitsStandard Deviation 11
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupSpeech Recognition in Noise in the Unaided Condition and With a Bone-conduction Device, Measured With AzBio Sentencespreop, bone-conduction, masker from front29 rationalized arcsine unitsStandard Deviation 22
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupSpeech Recognition in Noise in the Unaided Condition and With a Bone-conduction Device, Measured With AzBio Sentences12-month, unaided, masker from front42 rationalized arcsine unitsStandard Deviation 11
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupSpeech Recognition in Noise in the Unaided Condition and With a Bone-conduction Device, Measured With AzBio Sentences12-month, bone-conduction, masker from front42 rationalized arcsine unitsStandard Deviation 17
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupSpeech Recognition in Noise in the Unaided Condition and With a Bone-conduction Device, Measured With AzBio Sentencespreop, unaided, masker towards poorer ear85 rationalized arcsine unitsStandard Deviation 12
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupSpeech Recognition in Noise in the Unaided Condition and With a Bone-conduction Device, Measured With AzBio Sentencespreop, bone-conduction, masker towards poorer ear61 rationalized arcsine unitsStandard Deviation 33
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupSpeech Recognition in Noise in the Unaided Condition and With a Bone-conduction Device, Measured With AzBio Sentences12-month, unaided, masker towards poorerear86 rationalized arcsine unitsStandard Deviation 15
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupSpeech Recognition in Noise in the Unaided Condition and With a Bone-conduction Device, Measured With AzBio Sentences12-month, bone-conduction, masker from towards poorer ear70 rationalized arcsine unitsStandard Deviation 10
Cochlear Implant: Asymmetric Hearing Loss GroupSpeech Recognition in Noise in the Unaided Condition and With a Bone-conduction Device, Measured With AzBio Sentences12-month, unaided, masker towards poorerear37 rationalized arcsine unitsStandard Deviation 26
Cochlear Implant: Asymmetric Hearing Loss GroupSpeech Recognition in Noise in the Unaided Condition and With a Bone-conduction Device, Measured With AzBio Sentencespreop, unaided, masker towards better ear-13 rationalized arcsine unitsStandard Deviation 12
Cochlear Implant: Asymmetric Hearing Loss GroupSpeech Recognition in Noise in the Unaided Condition and With a Bone-conduction Device, Measured With AzBio Sentences12-month, unaided, masker from front20 rationalized arcsine unitsStandard Deviation 18
Cochlear Implant: Asymmetric Hearing Loss GroupSpeech Recognition in Noise in the Unaided Condition and With a Bone-conduction Device, Measured With AzBio Sentencespreop, bone-conduction, masker towards better ear-5 rationalized arcsine unitsStandard Deviation 16
Cochlear Implant: Asymmetric Hearing Loss GroupSpeech Recognition in Noise in the Unaided Condition and With a Bone-conduction Device, Measured With AzBio Sentencespreop, bone-conduction, masker towards poorer ear22 rationalized arcsine unitsStandard Deviation 22
Cochlear Implant: Asymmetric Hearing Loss GroupSpeech Recognition in Noise in the Unaided Condition and With a Bone-conduction Device, Measured With AzBio Sentences12-month, unaided, masker towards better ear-14 rationalized arcsine unitsStandard Deviation 16
Cochlear Implant: Asymmetric Hearing Loss GroupSpeech Recognition in Noise in the Unaided Condition and With a Bone-conduction Device, Measured With AzBio Sentences12-month, bone-conduction, masker from front12 rationalized arcsine unitsStandard Deviation 20
Cochlear Implant: Asymmetric Hearing Loss GroupSpeech Recognition in Noise in the Unaided Condition and With a Bone-conduction Device, Measured With AzBio Sentences12-month, bone-conduction, masker towards better ear-18 rationalized arcsine unitsStandard Deviation 9
Cochlear Implant: Asymmetric Hearing Loss GroupSpeech Recognition in Noise in the Unaided Condition and With a Bone-conduction Device, Measured With AzBio Sentences12-month, bone-conduction, masker from towards poorer ear29 rationalized arcsine unitsStandard Deviation 24
Cochlear Implant: Asymmetric Hearing Loss GroupSpeech Recognition in Noise in the Unaided Condition and With a Bone-conduction Device, Measured With AzBio Sentencespreop, unaided, masker from front14 rationalized arcsine unitsStandard Deviation 17
Cochlear Implant: Asymmetric Hearing Loss GroupSpeech Recognition in Noise in the Unaided Condition and With a Bone-conduction Device, Measured With AzBio Sentencespreop, unaided, masker towards poorer ear40 rationalized arcsine unitsStandard Deviation 18
Cochlear Implant: Asymmetric Hearing Loss GroupSpeech Recognition in Noise in the Unaided Condition and With a Bone-conduction Device, Measured With AzBio Sentencespreop, bone-conduction, masker from front13 rationalized arcsine unitsStandard Deviation 18
Comparison: A repeated-measures ANOVA assessed the effects of condition (unaided, bone-conduction device), interval (preoperative, 12-month), and masker condition and their 2-way and 3-way interactions on speech recognition in noise.p-value: <0.935ANOVA
Comparison: A repeated-measures ANOVA assessed the effects of condition (unaided, bone-conduction device), interval (preoperative, 12-month), and masker condition and their 2-way and 3-way interactions on speech recognition in noise.p-value: <0.977ANOVA
Post Hoc

Speech Recognition in Noise With a Bone-conduction Device Over Time, Measured With AzBio Sentences

Speech recognition with a bone-conduction device was compared at the preoperative and 12-month intervals. Performance was evaluated for the AzBio sentences in a 10-talker masker (0 dB SNR) presented with the target and masker from the front, the target from the front and masker to the acoustic hearing, and target from the front and masker towards the affected ear.

Time frame: preoperative and 12-month intervals

Population: Thirteen participants with asymmetric hearing loss completed the task at the preoperative and 12-month intervals at 0 dB SNR.

ArmMeasureGroupValue (MEAN)Dispersion
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupSpeech Recognition in Noise With a Bone-conduction Device Over Time, Measured With AzBio Sentencespreoperative, speech front and noise front32 percent correctStandard Deviation 17
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupSpeech Recognition in Noise With a Bone-conduction Device Over Time, Measured With AzBio Sentencespreoperative, speech front and noise to the acoustic ear18 percent correctStandard Deviation 18
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupSpeech Recognition in Noise With a Bone-conduction Device Over Time, Measured With AzBio Sentencespreoperative, speech front and noise to the affected ear61 percent correctStandard Deviation 28
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupSpeech Recognition in Noise With a Bone-conduction Device Over Time, Measured With AzBio Sentences12-month, speech front and noise front42 percent correctStandard Deviation 16
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupSpeech Recognition in Noise With a Bone-conduction Device Over Time, Measured With AzBio Sentences12-month, speech front and noise to the acoustic ear29 percent correctStandard Deviation 18
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupSpeech Recognition in Noise With a Bone-conduction Device Over Time, Measured With AzBio Sentences12-month, speech front and noise to the affected ear69 percent correctStandard Deviation 18
Cochlear Implant: Asymmetric Hearing Loss GroupSpeech Recognition in Noise With a Bone-conduction Device Over Time, Measured With AzBio Sentences12-month, speech front and noise to the acoustic ear1 percent correctStandard Deviation 3
Cochlear Implant: Asymmetric Hearing Loss GroupSpeech Recognition in Noise With a Bone-conduction Device Over Time, Measured With AzBio Sentencespreoperative, speech front and noise front17 percent correctStandard Deviation 12
Cochlear Implant: Asymmetric Hearing Loss GroupSpeech Recognition in Noise With a Bone-conduction Device Over Time, Measured With AzBio Sentences12-month, speech front and noise front16 percent correctStandard Deviation 12
Cochlear Implant: Asymmetric Hearing Loss GroupSpeech Recognition in Noise With a Bone-conduction Device Over Time, Measured With AzBio Sentencespreoperative, speech front and noise to the acoustic ear6 percent correctStandard Deviation 8
Cochlear Implant: Asymmetric Hearing Loss GroupSpeech Recognition in Noise With a Bone-conduction Device Over Time, Measured With AzBio Sentences12-month, speech front and noise to the affected ear31 percent correctStandard Deviation 20
Cochlear Implant: Asymmetric Hearing Loss GroupSpeech Recognition in Noise With a Bone-conduction Device Over Time, Measured With AzBio Sentencespreoperative, speech front and noise to the affected ear24 percent correctStandard Deviation 18
Comparison: A repeated-measures ANOVA assessed the effects of interval (preoperative and 12-months) and masker condition (front, acoustic ear, or affected ear) on performance with the bone conduction device.p-value: <0.345ANOVA
Comparison: A repeated-measures ANOVA assessed the effects of interval (preoperative and 12-months) and masker condition (front, acoustic ear, or affected ear) on performance with the bone conduction device.p-value: <0.577ANOVA
Post Hoc

Unaided Hearing in the Implanted Ear Over the Study Period.

The unaided hearing thresholds were measured preoperatively and post-operatively/post-activation. Twenty-five participants with SSD or AHL had an unaided threshold at 125 Hz of 80 dB HL or better. Their unaided thresholds were reviewed with respect to hearing preservation. The data from the SSD and AHL group were combined to review hearing preservation with long arrays. The inclusion criteria for the implanted ear were the same for the SSD and AHL groups and all subjects received the same 31.5 mm electrode array.

Time frame: pre-operative, initial activation, and post-activation intervals (1, 3, 6, 9, and 12-months).

Population: Participants in the SSD/UHL and AHL groups that presented with an unaided threshold at 125 Hz of 80 dB HL or better (n=25). A value of 100 dB HL was entered for cases of no response.~Nine participants had a threshold of 95 dB HL or better at initial activation and were reviewed over the post-activation period. Two participants did not complete the 9-month and one participant did not complete the 12-month.

ArmMeasureGroupValue (MEAN)Dispersion
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupUnaided Hearing in the Implanted Ear Over the Study Period.preoperative62 decibel hearing levelStandard Deviation 16
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupUnaided Hearing in the Implanted Ear Over the Study Period.initial activation93 decibel hearing levelStandard Deviation 13
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupUnaided Hearing in the Implanted Ear Over the Study Period.1-month post-activation76 decibel hearing levelStandard Deviation 18
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupUnaided Hearing in the Implanted Ear Over the Study Period.3-month post-activation69 decibel hearing levelStandard Deviation 10
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupUnaided Hearing in the Implanted Ear Over the Study Period.6-month post-activation76 decibel hearing levelStandard Deviation 14
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupUnaided Hearing in the Implanted Ear Over the Study Period.9-month post-activation73 decibel hearing levelStandard Deviation 15
Cochlear Implant: Unilateral Hearing Loss/Single-sided Hearing Loss GroupUnaided Hearing in the Implanted Ear Over the Study Period.12-month post-activation74 decibel hearing levelStandard Deviation 14
Comparison: Comparison of the unaided threshold at 125 Hz at the preoperative and initial activation intervals for the 25 participants with unaided threshold of 80 dB HL or better at the preoperative interval.~The data from the SSD and AHL group were combined to review hearing preservation with long arrays. The inclusion criteria for the implanted ear were the same for the SSD and AHL groups and all subjects received the same 31.5 mm electrode array.p-value: <0.001t-test, 2 sided
Comparison: Comparison of the unaided threshold at 125 Hz from the initial activation to the 12-month post-activation interval for the 9 participants with an unaided threshold of 95 dB HL or better at the initial activation interval.~The data from the SSD and AHL group were combined to review hearing preservation with long arrays. The inclusion criteria for the implanted ear were the same for the SSD and AHL groups and all subjects received the same 31.5 mm electrode array.p-value: =0.47ANOVA

Source: ClinicalTrials.gov · Data processed: Mar 9, 2026