Hearing Loss, Unilateral
Conditions
Keywords
cochlear implant
Brief summary
This feasibility study evaluates whether children with unilateral, moderate to profound sensorineural hearing loss experience an improvement in speech perception, hearing in noise, localization, and quality of life with a cochlear implant as compared to an unaided listening condition.
Detailed description
Unilateral hearing loss (UHL) is a term used to describe a substantial hearing loss in one ear and normal hearing in the contralateral ear. Despite normal hearing in one ear, these individuals experience reduced speech perception in noise, variable abilities on localization tasks, increased reports of hearing handicap, reduced quality of life, and often, they obtain limited or no benefit from conventional amplification. In the United States, the prevalence of UHL in children ranges from 0.03% to 3%, depending on the age of the child. Cochlear implantation performed for children with bilateral, severe to profound deafness has significant impacts on several aspects of child development. The practice of providing cochlear implants to children who have significant hearing loss in one ear is of great interest and is occurring with greater frequency as reported in case studies and small set clinical reports. The primary purpose of this feasibility study is to demonstrate the effectiveness of cochlear implantation in children, age 3 years 6 months to 6 years, 6 months, with moderate to profound UHL. Postoperative results will be evaluated with speech perception measures, localization tasks, hearing in noise tasks, and subjective reports.
Interventions
DEVICECochlear implant
Implantation
Sponsors
Med-El Corporation
University of North Carolina, Chapel Hill
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
42 Months to 78 Months
Healthy volunteers
Yes
Inclusion criteria
i) Inclusion Criteria 1. Unilateral moderate-to-profound sensorineural hearing loss. 1. Unaided residual hearing thresholds that yield a pure tone average (PTA) at frequencies 500 Hz, 1 kHz and 2 kHz of ≥70 dB HL in the ear to be implanted. It is possible that subjects may have hearing at other frequencies not included in this average. 2. Hearing thresholds in the contralateral ear of ≤25 dB HL 2. Between 3 years, 6 mos and 6 years, 6 mos of age at implantation. 3. Anatomically normal cochlear nerve 4. Cochlear anatomy that is amenable to cochlear implantation as evaluated by imaging (modality at the physician's discretion) including: 1. Normal cochlear anatomy or 2. Incomplete Partition Type II (IP2) with or without Enlarged Vestibular Aqueduct (EVA) or 3. EVA with normal partitioning 5. No evidence of progressive hearing loss. 6. Willing to undergo 4 week hearing aid trial as warranted based on achieving desired audibility when fitted via real ear desired sensation level (DSL) method. 7. Aided word recognition in the ear to be implanted of 30% or less as measured with Consonant Nucleus Consonant (CNC) words (50-word list) 1. When listening with an appropriately fit hearing aid and masking applied to the contralateral ear (Turner, 2004). 2. Aided testing will be conducted in a sound-proof booth with the participant seated 1 meter from the sound source, facing 0° azimuth. Recorded materials will be presented at 60 dB SPL. 3. The hearing aid output will be measured using DSL targets. 8. Realistic parental expectations: a verbal acknowledgement of the potential benefits and risks, and postoperative variation in performance. For instance, cochlear implantation will not restore normal hearing. 9. Willing to obtain recommended meningitis vaccinations per CDC recommendations. (9) Development and cognition within the normal range as measured by the Leiter-R test of nonverbal intelligence and cognitive abilities and the Bracken Basic Concept Scale -Revised. (10) Parental commitment to study parameters including being able and willing to participate in evaluation schedule, involvement in prescribed therapy, and travel to investigational site and study-related activities. ii)
Exclusion criteria
1. English is not primary language of the home 1. Speech perception materials are presented in English 2. Parental questionnaires are administered in English 2. Conductive hearing loss in either ear 3. Compromised auditory nerve 4. Ossification of the cochlea 5. Inability to participate in follow-up procedures (i.e., unwillingness, geographic location) 6. History of condition that contraindicates middle or inner ear surgery or anesthesia (i.e. otitis media refractory to treatment) 7. Case of sudden sensorineural hearing loss that has not been first evaluated by a physician
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change Over Time in the Ability to Perceive Single Words as Assessed by Consonant-Nucleus-Consonant (CNC) Word Recognition Testing | up to 24 months post-activation | Recorded, open set word recognition presented pre-operatively in the soundfield when using a traditional hearing aid (contralateral ear masked) and at 3-, 6-, 9-, 12-, 18-, and 24-month post-activation intervals by direct input to the speech processor using the Consonant-Nucleus-Consonant (CNC) words. Scores are reported as percent words correct and a higher score is better. Change is measured from the pre-operative to the 3-month post-activation interval, and from the 3-month post-activation interval to each subsequent interval. |
| Mean Change in the Signal-to-noise Ratio 50 (SNR-50) From Device Off to Device on as Measured With the Bamford-Kowal-Bench Speech in Noise Test (BKB-SIN) at 6 Months Post-activation | 6 months post-activation | Two ½ lists of the BKB-SIN were presented in each condition device off and device on after 6-months of device use: Speech and masker in front, speech in front and masker directed 90 degrees to the normal ear, speech in front and masker directed 90 degrees to the affected ear. The SNR-50 represents the signal-to-noise ratio required to perceive 50% of the sentence. A lower score is better. |
| Mean Change in the SNR-50 From Device Off to Device on as Measured With the BKB-SIN at 12 Months Post-activation | 12 months post-activation | Two ½ lists of the BKB-SIN were presented in each condition device off and device on after 12-months of device use: Speech and masker in front, speech in front and masker directed 90 degrees to the normal ear, speech in front and masker directed 90 degrees to the affected ear. The SNR-50 represents the signal-to-noise ratio required to perceive 50% of the sentence. A lower score is better. |
| Mean Change in the SNR-50 From Device Off to Device on as Measured With the BKB-SIN at 24 Months of Device Use | 24 months post-activation | Two ½ lists of the BKB-SIN were presented in each condition device off and device on after 24-months of device use: Speech and masker in front, speech in front and masker directed 90 degrees to the normal ear, speech in front and masker directed 90 degrees to the affected ear. The SNR-50 represents the signal-to-noise ratio required to perceive 50% of the sentence. A lower score is better. |
| Median Change in Localization Error From Device Off to Device on at 3 Months Post-activation | 3 months post-activation | Soundfield localization of 200-ms speech-shaped noise, presented from 11 speakers at 70 decibel (dB) sound pressure level (SPL) in a sound treated room. Error measures are made device on and device off after 3 months of device use. 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. Random error is the average of the standard deviation of the responses for each source and a lower score reflects a more consistently accurate response. Constant error is a measure of side bias, and a lower score indicates less response bias to either side. 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. |
| Median Change in Localization Error From Device Off to Device on at 9 Months Post-activation | 9 months post-activation | Soundfield localization of 200-ms speech-shaped noise, presented from 11 speakers at 70 decibel (dB) sound pressure level (SPL) in a sound treated room. Error measures are made device on and device off after 9 months of device use. 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. Random error is the average of the standard deviation of the responses for each source and a lower score reflects a more consistently accurate response. Constant error is a measure of side bias, and a lower score indicates less response bias to either side. 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. |
| Median Change in Localization RMS Error From Device Off to Device on at 18 Months Post-activation | 18 months post-activation | Soundfield localization of 200-ms speech-shaped noise, presented from 11 speakers at 70 decibel (dB) sound pressure level (SPL) in a sound treated room. Error measures are made device on and device off after 18 months of device use. 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. Random error is the average of the standard deviation of the responses for each source and a lower score reflects a more consistently accurate response. Constant error is a measure of side bias, and a lower score indicates less response bias to either side. 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. |
| Median Change in Localization Error From Device Off to Device on at 24 Months Post-activation | 24 months post-activation | Soundfield localization of 200-ms speech-shaped noise, presented from 11 speakers at 70 decibel (dB) sound pressure level (SPL) in a sound treated room. Error measures are made device on and device off after 24 months of device use. 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. Random error is the average of the standard deviation of the responses for each source and a lower score reflects a more consistently accurate response. Constant error is a measure of side bias, and a lower score indicates less response bias to either side. 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. |
| Change in Mean Response Scores on the Speech Spatial & Qualities (SSQ) Questionnaire | Pre-operatively through 24 months post-activation | The Speech Spatial Qualities Questionnaire requires participants to rate their perceived hearing ability for 49 scenarios using a 10-point scale, ranging from 0 (Not at all) to 10 (Perfectly). A score higher than 0 for each listening scenario shows some benefit of the device, while a score of 10 indicates the device was extremely beneficial. The SSQ questionnaire assesses performance in 3 domains, hearing speech in quiet and noise environments (9 items), spatial or directional hearing (5 items) and sound qualities (8 items). Domain scores represent an average of item ratings, therefore each domain score ranges from 0 to 10 with a higher score indicating a better outcome. The pediatric version of this test was used and parents reported as proxy pre-operatively and at at 3-, 6-, 9-, 12-, 18-, and 24-month post-activation intervals. Change is measured from the pre-operative to the 3-month post-activation interval and between the 3-month interval to all subsequent intervals. |
| Change in Mean Response Scores as Measured by the Bern Single Sided Deafness (SSD) Questionnaire | Pre-operatively through 24 months post-activation | Bern SSD Questionnaire is a 10-item questionnaire used for rating perceived benefit of a hearing technology designed to be used for persons with Unilateral Hearing Loss (UHL). A positive score indicates greater perceived ability with the device and a negative score indicates greater perceived ability without the device. Scores range from -5 meaning much easier listening without the hearing device to +5 indicating much easier listening with the device. Scores across all 10 items are averaged for a single score. A modified version of this test that can be completed by a parent was used pre-operatively and at 3-, 6-, 9-, 12-, 18-, and 24-month post-activation intervals. Change is measured from the pre-operative to the 3-month post-activation interval and from the 3-month interval to each subsequent interval. |
| Change in Mean Fatigue Scores as Measured by the Pediatric Quality of Life (PedsQL) Multidimensional Fatigue Scale | Pre-operatively through 24 months post-activation | PedsQL Multidimensional fatigue scale is a validated scale for determining fatigue in young children, including general fatigue, sleep/rest fatigue and cognitive fatigue. Scores from this test have been previously demonstrated to be substantially affected by hearing loss in children. A parent report version was used pre-operatively and at 3-, 6-, 9-, 12-, 18-, and 24-month post-activation intervals. Items are scored on a 5-point Likert scale and are then reversed scored and linearly transformed to a 0-100 scale where 100 would indicate no fatigue and 0 would indicate near constant fatigue. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Cochlear Implant Pediatric patients with single sided deafness will receive a cochlear implant in the ear of loss
Cochlear implant: Implantation | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | Cochlear Implant |
|---|---|
| Age, Continuous | 5.5 years STANDARD_DEVIATION 2 |
| Ear Affected Left Ear | 10 Participants |
| Ear Affected Right Ear | 10 Participants |
| Etiology of Hearing Loss Congenital Cytomegalovirus | 3 Participants |
| Etiology of Hearing Loss Infection | 1 Participants |
| Etiology of Hearing Loss Mondini Malformation | 2 Participants |
| Etiology of Hearing Loss Trauma | 1 Participants |
| Etiology of Hearing Loss Unknown | 12 Participants |
| Etiology of Hearing Loss Waardenburg Syndrome | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 14 Participants |
| Region of Enrollment United States | 20 participants |
| Sex: Female, Male Female | 8 Participants |
| Sex: Female, Male Male | 12 Participants |
| Suspected Length of Deafness | 3.3 years STANDARD_DEVIATION 1.7 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 20 |
| other Total, other adverse events | 4 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
Primary
Change in Mean Fatigue Scores as Measured by the Pediatric Quality of Life (PedsQL) Multidimensional Fatigue Scale
PedsQL Multidimensional fatigue scale is a validated scale for determining fatigue in young children, including general fatigue, sleep/rest fatigue and cognitive fatigue. Scores from this test have been previously demonstrated to be substantially affected by hearing loss in children. A parent report version was used pre-operatively and at 3-, 6-, 9-, 12-, 18-, and 24-month post-activation intervals. Items are scored on a 5-point Likert scale and are then reversed scored and linearly transformed to a 0-100 scale where 100 would indicate no fatigue and 0 would indicate near constant fatigue.
Time frame: Pre-operatively through 24 months post-activation
Population: One participant was lost to follow-up after Month 12
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Cochlear Implant | Change in Mean Fatigue Scores as Measured by the Pediatric Quality of Life (PedsQL) Multidimensional Fatigue Scale | General Fatigue: pre-operative to 3-month post-activation | 5.4 score on a scale |
| Cochlear Implant | Change in Mean Fatigue Scores as Measured by the Pediatric Quality of Life (PedsQL) Multidimensional Fatigue Scale | General Fatigue: 3-month to 6-month post-activation | 4.6 score on a scale |
| Cochlear Implant | Change in Mean Fatigue Scores as Measured by the Pediatric Quality of Life (PedsQL) Multidimensional Fatigue Scale | General Fatigue: 3-month to 9-month post-activation | 1.9 score on a scale |
| Cochlear Implant | Change in Mean Fatigue Scores as Measured by the Pediatric Quality of Life (PedsQL) Multidimensional Fatigue Scale | General Fatigue: 3-month to 12-month post-activation | 2.5 score on a scale |
| Cochlear Implant | Change in Mean Fatigue Scores as Measured by the Pediatric Quality of Life (PedsQL) Multidimensional Fatigue Scale | General Fatigue: 3-month to 18-month post-activation | -1.0 score on a scale |
| Cochlear Implant | Change in Mean Fatigue Scores as Measured by the Pediatric Quality of Life (PedsQL) Multidimensional Fatigue Scale | General Fatigue: 3-month to 24-month post-activation | 4.0 score on a scale |
| Cochlear Implant | Change in Mean Fatigue Scores as Measured by the Pediatric Quality of Life (PedsQL) Multidimensional Fatigue Scale | Sleep Fatigue: Pre-operative to 3-month post-activation | 3.5 score on a scale |
| Cochlear Implant | Change in Mean Fatigue Scores as Measured by the Pediatric Quality of Life (PedsQL) Multidimensional Fatigue Scale | Sleep Fatigue: 3-month to 6-month post-activation | 6.5 score on a scale |
| Cochlear Implant | Change in Mean Fatigue Scores as Measured by the Pediatric Quality of Life (PedsQL) Multidimensional Fatigue Scale | Sleep Fatigue: 3-month to 9-month post-activation | 2.7 score on a scale |
| Cochlear Implant | Change in Mean Fatigue Scores as Measured by the Pediatric Quality of Life (PedsQL) Multidimensional Fatigue Scale | Sleep Fatigue: 3-month to 12-month post-activation | 2.7 score on a scale |
| Cochlear Implant | Change in Mean Fatigue Scores as Measured by the Pediatric Quality of Life (PedsQL) Multidimensional Fatigue Scale | Sleep Fatigue: 3-month to 18-month post-activation | 4.2 score on a scale |
| Cochlear Implant | Change in Mean Fatigue Scores as Measured by the Pediatric Quality of Life (PedsQL) Multidimensional Fatigue Scale | Sleep Fatigue: 3-month to 24-month post-activation | 3.5 score on a scale |
| Cochlear Implant | Change in Mean Fatigue Scores as Measured by the Pediatric Quality of Life (PedsQL) Multidimensional Fatigue Scale | Cognitive Fatigue: Pre-operative to 3-month post-activation | 7.5 score on a scale |
| Cochlear Implant | Change in Mean Fatigue Scores as Measured by the Pediatric Quality of Life (PedsQL) Multidimensional Fatigue Scale | Cognitive Fatigue: 3-month to 6-month post-activation | 3.3 score on a scale |
| Cochlear Implant | Change in Mean Fatigue Scores as Measured by the Pediatric Quality of Life (PedsQL) Multidimensional Fatigue Scale | Cognitive Fatigue: 3-month to 9-month post-activation | 0.8 score on a scale |
| Cochlear Implant | Change in Mean Fatigue Scores as Measured by the Pediatric Quality of Life (PedsQL) Multidimensional Fatigue Scale | Cognitive Fatigue: 3-month to 12-month post-activation | -2.3 score on a scale |
| Cochlear Implant | Change in Mean Fatigue Scores as Measured by the Pediatric Quality of Life (PedsQL) Multidimensional Fatigue Scale | Cognitive Fatigue: 3-month to 18-month post-activation | 1.7 score on a scale |
| Cochlear Implant | Change in Mean Fatigue Scores as Measured by the Pediatric Quality of Life (PedsQL) Multidimensional Fatigue Scale | Cognitive Fatigue: 3-month to 24-month post-activation | -2.2 score on a scale |
Comparison: Comparison of scores to evaluation change over time: General Fatigue Subtestp-value: 0.1009Mixed Models Analysis
Comparison: Comparison of scores to evaluation change over time: Sleep Fatigue Subtestp-value: 0.109Mixed Models Analysis
Comparison: Comparison of scores to evaluation change over time: Cognitive Fatigue Subtestp-value: 0.1733Mixed Models Analysis
Primary
Change in Mean Response Scores as Measured by the Bern Single Sided Deafness (SSD) Questionnaire
Bern SSD Questionnaire is a 10-item questionnaire used for rating perceived benefit of a hearing technology designed to be used for persons with Unilateral Hearing Loss (UHL). A positive score indicates greater perceived ability with the device and a negative score indicates greater perceived ability without the device. Scores range from -5 meaning much easier listening without the hearing device to +5 indicating much easier listening with the device. Scores across all 10 items are averaged for a single score. A modified version of this test that can be completed by a parent was used pre-operatively and at 3-, 6-, 9-, 12-, 18-, and 24-month post-activation intervals. Change is measured from the pre-operative to the 3-month post-activation interval and from the 3-month interval to each subsequent interval.
Time frame: Pre-operatively through 24 months post-activation
Population: One participant was lost to follow-up after Month 12
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Cochlear Implant | Change in Mean Response Scores as Measured by the Bern Single Sided Deafness (SSD) Questionnaire | Pre-operative to 3-month post-activation interval | 1.9 score on a scale |
| Cochlear Implant | Change in Mean Response Scores as Measured by the Bern Single Sided Deafness (SSD) Questionnaire | 3-month to the 6-month post-activation interval | 0.7 score on a scale |
| Cochlear Implant | Change in Mean Response Scores as Measured by the Bern Single Sided Deafness (SSD) Questionnaire | 3-month to the 9-month post-activation interval | 0.9 score on a scale |
| Cochlear Implant | Change in Mean Response Scores as Measured by the Bern Single Sided Deafness (SSD) Questionnaire | 3-month to the 12-month post-activation interval | 1.4 score on a scale |
| Cochlear Implant | Change in Mean Response Scores as Measured by the Bern Single Sided Deafness (SSD) Questionnaire | 3-month to the 18-month post-activation interval | 1.5 score on a scale |
| Cochlear Implant | Change in Mean Response Scores as Measured by the Bern Single Sided Deafness (SSD) Questionnaire | 3-month to the 24-month post-activation interval | 1.4 score on a scale |
Comparison: Comparison of scores over time.p-value: <0.001Mixed Models Analysis
Primary
Change in Mean Response Scores on the Speech Spatial & Qualities (SSQ) Questionnaire
The Speech Spatial Qualities Questionnaire requires participants to rate their perceived hearing ability for 49 scenarios using a 10-point scale, ranging from 0 (Not at all) to 10 (Perfectly). A score higher than 0 for each listening scenario shows some benefit of the device, while a score of 10 indicates the device was extremely beneficial. The SSQ questionnaire assesses performance in 3 domains, hearing speech in quiet and noise environments (9 items), spatial or directional hearing (5 items) and sound qualities (8 items). Domain scores represent an average of item ratings, therefore each domain score ranges from 0 to 10 with a higher score indicating a better outcome. The pediatric version of this test was used and parents reported as proxy pre-operatively and at at 3-, 6-, 9-, 12-, 18-, and 24-month post-activation intervals. Change is measured from the pre-operative to the 3-month post-activation interval and between the 3-month interval to all subsequent intervals.
Time frame: Pre-operatively through 24 months post-activation
Population: One participant was lost to follow-up after Month 12
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Cochlear Implant | Change in Mean Response Scores on the Speech Spatial & Qualities (SSQ) Questionnaire | Speech: pre-operative to 3-month post-activation interval | 1.4 score on a scale |
| Cochlear Implant | Change in Mean Response Scores on the Speech Spatial & Qualities (SSQ) Questionnaire | Speech: 3-month to 6-month post-activation interval | 0.7 score on a scale |
| Cochlear Implant | Change in Mean Response Scores on the Speech Spatial & Qualities (SSQ) Questionnaire | Speech: 3-month to 9-month post-activation interval | 0.6 score on a scale |
| Cochlear Implant | Change in Mean Response Scores on the Speech Spatial & Qualities (SSQ) Questionnaire | Speech: 3-month to 12-month post-activation interval | 0.7 score on a scale |
| Cochlear Implant | Change in Mean Response Scores on the Speech Spatial & Qualities (SSQ) Questionnaire | Speech: 3-month to 18-month post-activation interval | 0.8 score on a scale |
| Cochlear Implant | Change in Mean Response Scores on the Speech Spatial & Qualities (SSQ) Questionnaire | Speech: 3-month to 24-month post-activation interval | 0.9 score on a scale |
| Cochlear Implant | Change in Mean Response Scores on the Speech Spatial & Qualities (SSQ) Questionnaire | Spatial: pre-operative to 3-month post-activation interval | 2.6 score on a scale |
| Cochlear Implant | Change in Mean Response Scores on the Speech Spatial & Qualities (SSQ) Questionnaire | Spatial: 3-month to 6-month post-activation interval | 0.8 score on a scale |
| Cochlear Implant | Change in Mean Response Scores on the Speech Spatial & Qualities (SSQ) Questionnaire | Spatial: 3-month to 9-month post-activation interval | 1.0 score on a scale |
| Cochlear Implant | Change in Mean Response Scores on the Speech Spatial & Qualities (SSQ) Questionnaire | Spatial: 3-month to 12-month post-activation interval | 1.3 score on a scale |
| Cochlear Implant | Change in Mean Response Scores on the Speech Spatial & Qualities (SSQ) Questionnaire | Spatial: 3-month to 18-month post-activation interval | 1.7 score on a scale |
| Cochlear Implant | Change in Mean Response Scores on the Speech Spatial & Qualities (SSQ) Questionnaire | Spatial: 3-month to 24-month post-activation interval | 1.1 score on a scale |
| Cochlear Implant | Change in Mean Response Scores on the Speech Spatial & Qualities (SSQ) Questionnaire | Qualities: pre-operative to 3-month post-activation interval | 1.0 score on a scale |
| Cochlear Implant | Change in Mean Response Scores on the Speech Spatial & Qualities (SSQ) Questionnaire | Qualities: 3-month to 6-month post-activation interval | 0.6 score on a scale |
| Cochlear Implant | Change in Mean Response Scores on the Speech Spatial & Qualities (SSQ) Questionnaire | Qualities: 3-month to 9-month post-activation interval | 0.5 score on a scale |
| Cochlear Implant | Change in Mean Response Scores on the Speech Spatial & Qualities (SSQ) Questionnaire | Qualities: 3-month to 12-month post-activation interval | 0.5 score on a scale |
| Cochlear Implant | Change in Mean Response Scores on the Speech Spatial & Qualities (SSQ) Questionnaire | Qualities: 3-month to 18-month post-activation interval | 0.9 score on a scale |
| Cochlear Implant | Change in Mean Response Scores on the Speech Spatial & Qualities (SSQ) Questionnaire | Qualities: 3-month to 24-month post-activation interval | 0.4 score on a scale |
Comparison: Comparison of scores across time to investigate change in scores over time: Speech subtest.p-value: <0.001Mixed Models Analysis
Comparison: Comparison of scores across time to investigate change in scores over time: Spatial subtest.p-value: 0.001Mixed Models Analysis
Comparison: Comparison of scores across time to investigate change in scores over time: Qualities subtest.p-value: <0.001Mixed Models Analysis
Primary
Change Over Time in the Ability to Perceive Single Words as Assessed by Consonant-Nucleus-Consonant (CNC) Word Recognition Testing
Recorded, open set word recognition presented pre-operatively in the soundfield when using a traditional hearing aid (contralateral ear masked) and at 3-, 6-, 9-, 12-, 18-, and 24-month post-activation intervals by direct input to the speech processor using the Consonant-Nucleus-Consonant (CNC) words. Scores are reported as percent words correct and a higher score is better. Change is measured from the pre-operative to the 3-month post-activation interval, and from the 3-month post-activation interval to each subsequent interval.
Time frame: up to 24 months post-activation
Population: One participant was lost to follow-up after Month 12
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cochlear Implant | Change Over Time in the Ability to Perceive Single Words as Assessed by Consonant-Nucleus-Consonant (CNC) Word Recognition Testing | Pre-operatively | 1.4 percentage of words correct | Standard Deviation 6.3 |
| Cochlear Implant | Change Over Time in the Ability to Perceive Single Words as Assessed by Consonant-Nucleus-Consonant (CNC) Word Recognition Testing | Month 3 | 14.4 percentage of words correct | Standard Deviation 14.5 |
| Cochlear Implant | Change Over Time in the Ability to Perceive Single Words as Assessed by Consonant-Nucleus-Consonant (CNC) Word Recognition Testing | Month 6 | 28.2 percentage of words correct | Standard Deviation 18 |
| Cochlear Implant | Change Over Time in the Ability to Perceive Single Words as Assessed by Consonant-Nucleus-Consonant (CNC) Word Recognition Testing | Month 9 | 45.0 percentage of words correct | Standard Deviation 15.2 |
| Cochlear Implant | Change Over Time in the Ability to Perceive Single Words as Assessed by Consonant-Nucleus-Consonant (CNC) Word Recognition Testing | Month 12 | 50.3 percentage of words correct | Standard Deviation 33.1 |
| Cochlear Implant | Change Over Time in the Ability to Perceive Single Words as Assessed by Consonant-Nucleus-Consonant (CNC) Word Recognition Testing | Month 18 | 51.8 percentage of words correct | Standard Deviation 11.3 |
| Cochlear Implant | Change Over Time in the Ability to Perceive Single Words as Assessed by Consonant-Nucleus-Consonant (CNC) Word Recognition Testing | Month 24 | 58.6 percentage of words correct | Standard Deviation 15.4 |
Comparison: Analyzed CNC Word scores from 3 months through 24 months to evaluate change over time with device use. Scores were converted to Rau prior to analysis.p-value: <0.001Mixed Models Analysis
Comparison: Analyzed pre-op to 3 month post activation CNC Word scores to test superiority of cochlear implant use to pre-operative hearing aid use.p-value: <0.001Wilcoxon (Mann-Whitney)
Primary
Mean Change in the Signal-to-noise Ratio 50 (SNR-50) From Device Off to Device on as Measured With the Bamford-Kowal-Bench Speech in Noise Test (BKB-SIN) at 6 Months Post-activation
Two ½ lists of the BKB-SIN were presented in each condition device off and device on after 6-months of device use: Speech and masker in front, speech in front and masker directed 90 degrees to the normal ear, speech in front and masker directed 90 degrees to the affected ear. The SNR-50 represents the signal-to-noise ratio required to perceive 50% of the sentence. A lower score is better.
Time frame: 6 months post-activation
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Cochlear Implant | Mean Change in the Signal-to-noise Ratio 50 (SNR-50) From Device Off to Device on as Measured With the Bamford-Kowal-Bench Speech in Noise Test (BKB-SIN) at 6 Months Post-activation | Device off to device on with speech and noise in front | 1.8 signal-to-noise ratio |
| Cochlear Implant | Mean Change in the Signal-to-noise Ratio 50 (SNR-50) From Device Off to Device on as Measured With the Bamford-Kowal-Bench Speech in Noise Test (BKB-SIN) at 6 Months Post-activation | Device off to device on with speech in front and noise to the implanted side | 0.4 signal-to-noise ratio |
| Cochlear Implant | Mean Change in the Signal-to-noise Ratio 50 (SNR-50) From Device Off to Device on as Measured With the Bamford-Kowal-Bench Speech in Noise Test (BKB-SIN) at 6 Months Post-activation | Device off to device on with speech in front and noise to the normal side | 1.9 signal-to-noise ratio |
Primary
Mean Change in the SNR-50 From Device Off to Device on as Measured With the BKB-SIN at 12 Months Post-activation
Two ½ lists of the BKB-SIN were presented in each condition device off and device on after 12-months of device use: Speech and masker in front, speech in front and masker directed 90 degrees to the normal ear, speech in front and masker directed 90 degrees to the affected ear. The SNR-50 represents the signal-to-noise ratio required to perceive 50% of the sentence. A lower score is better.
Time frame: 12 months post-activation
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Cochlear Implant | Mean Change in the SNR-50 From Device Off to Device on as Measured With the BKB-SIN at 12 Months Post-activation | Device on with speech and noise in front | 1.6 signal-to-noise ratio |
| Cochlear Implant | Mean Change in the SNR-50 From Device Off to Device on as Measured With the BKB-SIN at 12 Months Post-activation | Device off to device on with speech in front and noise to the implanted side | 2.5 signal-to-noise ratio |
| Cochlear Implant | Mean Change in the SNR-50 From Device Off to Device on as Measured With the BKB-SIN at 12 Months Post-activation | Device off to device on with speech in front and noise to the normal side | 3.5 signal-to-noise ratio |
Comparison: Analyzed BKB-SIN SNR-50 scores at 12 months post activation to evaluate the impact of device use (CI off vs on) and masker location (front, to the affected ear, or to the normal hearing ear) on hearing in noise.p-value: <0.001ANOVA
Primary
Mean Change in the SNR-50 From Device Off to Device on as Measured With the BKB-SIN at 24 Months of Device Use
Two ½ lists of the BKB-SIN were presented in each condition device off and device on after 24-months of device use: Speech and masker in front, speech in front and masker directed 90 degrees to the normal ear, speech in front and masker directed 90 degrees to the affected ear. The SNR-50 represents the signal-to-noise ratio required to perceive 50% of the sentence. A lower score is better.
Time frame: 24 months post-activation
Population: One participant was lost to follow-up after Month 12
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Cochlear Implant | Mean Change in the SNR-50 From Device Off to Device on as Measured With the BKB-SIN at 24 Months of Device Use | Device off to device on with speech and noise in front | 1.4 signal-to-noise ratio |
| Cochlear Implant | Mean Change in the SNR-50 From Device Off to Device on as Measured With the BKB-SIN at 24 Months of Device Use | Device off to device on with speech in front and noise to the implanted side | 1.7 signal-to-noise ratio |
| Cochlear Implant | Mean Change in the SNR-50 From Device Off to Device on as Measured With the BKB-SIN at 24 Months of Device Use | Device off to device on with speech in front and noise to the normal side | 4.0 signal-to-noise ratio |
Comparison: Analyzed BKB-SIN SNR-50 scores across all time points (6, 12, and 24 months post activation) to evaluate the impact of time, device use (CI off vs on), and masker location (front, to the affected ear, or to the normal hearing ear) on hearing in noise.p-value: <0.001Mixed Models Analysis
Primary
Median Change in Localization Error From Device Off to Device on at 24 Months Post-activation
Soundfield localization of 200-ms speech-shaped noise, presented from 11 speakers at 70 decibel (dB) sound pressure level (SPL) in a sound treated room. Error measures are made device on and device off after 24 months of device use. 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. Random error is the average of the standard deviation of the responses for each source and a lower score reflects a more consistently accurate response. Constant error is a measure of side bias, and a lower score indicates less response bias to either side. 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.
Time frame: 24 months post-activation
Population: One participant was lost to follow-up after Month 12
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Cochlear Implant | Median Change in Localization Error From Device Off to Device on at 24 Months Post-activation | RMS error from device off to device on | 35.1 degrees |
| Cochlear Implant | Median Change in Localization Error From Device Off to Device on at 24 Months Post-activation | Random error from device off to device on | 17.9 degrees |
| Cochlear Implant | Median Change in Localization Error From Device Off to Device on at 24 Months Post-activation | Constant error from device off to device on | 25.8 degrees |
| Cochlear Implant | Median Change in Localization Error From Device Off to Device on at 24 Months Post-activation | Adjusted constant error from device off to device on | 21.1 degrees |
Comparison: Analyzed overall RMS error at 3, 9, 18, and 24 months post activation to evaluate the impact of device use (CI off vs on) and time on localization.p-value: 0.01911Mixed Models Analysis
Primary
Median Change in Localization Error From Device Off to Device on at 3 Months Post-activation
Soundfield localization of 200-ms speech-shaped noise, presented from 11 speakers at 70 decibel (dB) sound pressure level (SPL) in a sound treated room. Error measures are made device on and device off after 3 months of device use. 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. Random error is the average of the standard deviation of the responses for each source and a lower score reflects a more consistently accurate response. Constant error is a measure of side bias, and a lower score indicates less response bias to either side. 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.
Time frame: 3 months post-activation
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Cochlear Implant | Median Change in Localization Error From Device Off to Device on at 3 Months Post-activation | Overall RMS error from device off to device on | 14.7 degrees |
| Cochlear Implant | Median Change in Localization Error From Device Off to Device on at 3 Months Post-activation | Random error from device off to device on | -0.8 degrees |
| Cochlear Implant | Median Change in Localization Error From Device Off to Device on at 3 Months Post-activation | Constant error from device off to device on | 18.8 degrees |
| Cochlear Implant | Median Change in Localization Error From Device Off to Device on at 3 Months Post-activation | Adjusted constant error from device off to device on | 19.1 degrees |
Primary
Median Change in Localization Error From Device Off to Device on at 9 Months Post-activation
Soundfield localization of 200-ms speech-shaped noise, presented from 11 speakers at 70 decibel (dB) sound pressure level (SPL) in a sound treated room. Error measures are made device on and device off after 9 months of device use. 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. Random error is the average of the standard deviation of the responses for each source and a lower score reflects a more consistently accurate response. Constant error is a measure of side bias, and a lower score indicates less response bias to either side. 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.
Time frame: 9 months post-activation
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Cochlear Implant | Median Change in Localization Error From Device Off to Device on at 9 Months Post-activation | Overall RMS error from device off to device on | 24.6 degrees |
| Cochlear Implant | Median Change in Localization Error From Device Off to Device on at 9 Months Post-activation | Random error from device off to device on | 15.8 degrees |
| Cochlear Implant | Median Change in Localization Error From Device Off to Device on at 9 Months Post-activation | Constant error from device off to device on | 27.9 degrees |
| Cochlear Implant | Median Change in Localization Error From Device Off to Device on at 9 Months Post-activation | Adjusted constant error from device off to device on | 24.9 degrees |
Primary
Median Change in Localization RMS Error From Device Off to Device on at 18 Months Post-activation
Soundfield localization of 200-ms speech-shaped noise, presented from 11 speakers at 70 decibel (dB) sound pressure level (SPL) in a sound treated room. Error measures are made device on and device off after 18 months of device use. 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. Random error is the average of the standard deviation of the responses for each source and a lower score reflects a more consistently accurate response. Constant error is a measure of side bias, and a lower score indicates less response bias to either side. 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.
Time frame: 18 months post-activation
Population: One participant was lost to follow-up after Month 12
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Cochlear Implant | Median Change in Localization RMS Error From Device Off to Device on at 18 Months Post-activation | RMS error from device off to device on | 37.7 degrees |
| Cochlear Implant | Median Change in Localization RMS Error From Device Off to Device on at 18 Months Post-activation | Random error from device off to device on | 20.2 degrees |
| Cochlear Implant | Median Change in Localization RMS Error From Device Off to Device on at 18 Months Post-activation | Constant error from device off to device on | 27.5 degrees |
| Cochlear Implant | Median Change in Localization RMS Error From Device Off to Device on at 18 Months Post-activation | Adjusted constant error from device off to device on | 24.9 degrees |