Hearing Loss
Conditions
Keywords
cochlear implant, asymmetric hearing loss
Brief summary
This longitudinal study evaluates the possible benefit of cochlear implantation in the poor ear of adults with asymmetric hearing loss who continue to use a hearing aid in the better hearing ear.
Detailed description
The study will be conducted as a multicenter, prospective, single-arm clinical trial, evaluating the efficacy and safety of cochlear implantation in patients with asymmetric hearing loss. A repeated-measures analysis will be employed whereby patients will act as their own controls. Participants will be recruited from surgeons and audiologists in Otolaryngology departments at the participating sites. Participants will be evaluated at multiple intervals using a variety of test measures (addressing sound localization, understanding speech in noise, understanding speech in quiet, and quality of life). Prior to receiving a cochlear implant (CI) in the poor hearing ear, participants will be evaluated as follows: * Hearing aid (HA) in the better ear alone * HA in the poor ear alone * Bilateral HAs Participants who have not previously used a poor-ear hearing aid or BiCROS hearing aid will complete a 1-2 week trial and be evaluated at the end of the trial. If performance is better with the alternate therapy (bilateral hearing aids or BiCROS hearing aid) than the better ear alone performance and the participant prefers the alternate therapy, the participant will not continue in the study. Participants who do continue in the study will be evaluated at several post-implant intervals. Post-implant evaluations will occur at 3, 6, 9, and 12 months after initial stimulation of the CI. Participants will be evaluated as follows: * HA in the better ear alone * CI in the poor ear alone * HA and CI together
Interventions
DEVICECochlear implant
Participants who have failed a BiCROS or bilateral hearing aid trial and otherwise meet inclusion criteria will receive a cochlear implant at the poor hearing ear. Post-implant, participants will continue use of a hearing aid at the better ear and the cochlear implant at the poor ear.
Sponsors
Washington University School of Medicine
Midwest Ear Institute
House Clinic, Inc.
NYU Langone Health
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years of age or older * English as the native language * Have a desire for functional binaural hearing * Have failed a previous hearing aid (HA) treatment for asymmetric hearing loss (BiCROS or poor ear HA) or willing to complete a trial if necessary * Willingness to comply with all study requirements * Ability to provide informed consent * Poor ear (ear to be implanted): * Pure-tone average (PTA) at .5, 1 and 2 kilohertz (kHz) \> 70 dB HL (hereafter referred to as severe to profound hearing loss - SPHL) * Aided word recognition score (CNC Word Test) at 60 dB SPL ≤ 30% * Duration of SPHL ≥ 6 months * Onset of hearing loss ≥ 6 years of age * Better ear: * PTA at .5, 1, 2, 4 kHz of 40 to 70 dB HL * Currently using a HA * Aided word recognition score (CNC Word Test) at 60 dB SPL \> 40% * Stable hearing for the previous 1-year period. "Stable" is defined as thresholds that have not changed by more than 10 dB at 2 or more octave interval audiometric frequencies
Exclusion criteria
* Medical condition that contraindicates surgery * Actively using an implantable device in the ear to be implanted * Known cochlear malformation or obstruction that would preclude full insertion of the electrode array in the ear to be implanted * Hearing loss of neural or central origin * Unrealistic expectations related to the benefits and limitations of cochlear implantation * Unwillingness or inability to comply with all investigational requirements
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Poor Ear Alone CNC Monosyllabic Word Understanding in Quiet | Pre-implant and 6 months post-implant | Group mean difference in CNC monosyllabic word understanding score in quiet with the CI alone at 6 months post-implant compared to pre-implant with a hearing aid. (CNC scored on a scale from 0% to 100%; Higher scores are better.) |
| Change in Poor Ear Alone Soundfield Thresholds | Pre-implant and 6 months post-implant | Group mean difference in soundfield thresholds (dB HL average across frequency range) with the CI alone at 6 months post-implant compared to pre-implant with a hearing aid. (Measurable decibels in hearing level (dB HL) generally range from -10 dB to 120 dB; Lower levels are better.) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Sound Localization | Pre-implant and 6 months post-implant | Sound localization in RMS error at 6-months post-implant in the CI+HA (CI at poor ear; HA at better ear) condition compared to the pre-implant best aided condition. (Root Mean Error Scores in degrees of error can range from 0 to approximately 80 degrees. Chance level performance is 64 degrees. Lower scores indicate better performance.) |
| Change in AzBio Sentences at 50 Decibels (dB) Sound Pressure Level (SPL) | Pre-implant and 6 months post-implant | Understanding of sentences at a soft presentation level at 6-months post-implant in the CI+HA (CI at poor ear; HA at better ear) condition compared to the pre-implant best aided condition. (Percent correct ranging from 0 to 100%; Higher scores indicate better performance.) |
| Change in AzBio Sentence Scores at 60 dB SPL and 4-talker Babble at +8 dB Signal-to-noise Ratio (SNR) | Pre-implant and 6 months post-implant | Group mean difference in understanding of sentences in noise at 6-months post-implant in the CI+HA (CI at poor ear; HA at better ear) condition compared to the pre-implant best aided condition. (Percent correct scoring ranging from 0 - 100%; Higher scores indicate better performance.) |
| Change in Bamford-Kowal-Bench Speech-in-Noise (BKB-SIN) Sentence Understanding With Noise to the Better Ear | Pre-implant and 6 months post-implant | Group mean difference in BKB-SIN scores in noise (dB SNR) 6-months post-implant in the CI+HA (CI at poor ear; HA at better ear) condition compared to the pre-implant best aided condition. Speech is from the front and noise to the better ear. (Scores are the signal to noise ration in decibels for approximately 50% understanding and can range from -7.5 dB to 23.5 dB; Lower scores indicate better performance.) |
| Change in AzBio Sentence Scores at 60 dB SPL for the Poor Ear Alone | Pre-implant and 6 months post-implant | Group mean difference in AzBio sentence scores in quiet for the poor ear alone with the CI at 6-months post-implant compared to pre-implant with a hearing aid. (Scores are percent of words correct and can range from 0 to 100%; higher scores indicate better performance.) |
| Change in Hearing Handicap Inventory (HHIE) | Pre-implant and 6 months post-implant | Inventory completed by participant regarding emotional and social consequences of hearing loss. Group mean difference in the total HHIE ratings at 6-months post-implant compared to pre-implant. (Ratings can range from 0 to 100; Lower scores indicate less perceived hearing handicap - lower scores are better.) |
| Change in Health Utility Index (HUI3) Ratings | Pre-implant and 6 months post-implant | Questionnaire completed by participant regarding ability/disability across several health dimensions. Group mean difference in HUI3 ratings (total score) at 6 months post-implant compared to pre-implant. (Scores can range from 0.0 to 1.0; Higher scores indicate greater perceived health/ability.) |
| Change in Speech, Spatial and Sound Qualities (SSQ) by 6-months Post-implant | Pre-implant and 6 months post-implant | Questionnaire completed by participant regarding impact of hearing loss on various listening situations. Group mean difference in SSQ ratings at 6-months post-implant compared to pre-implant. (Ratings can range from 0 to 10; Higher scores indicate greater perceived abilities.) |
| Change in Speech, Spatial and Sound Qualities (SSQ) by 12-months Post-implant | Pre-implant and 12 months post-implant | Questionnaire completed by participant regarding impact of hearing loss on various listening situations. Group mean difference in SSQ ratings at 12-months post-implant compared to pre-implant. (Ratings can range from 0 to 10; Higher scores indicate greater perceived abilities.) |
| Change in Satisfaction With Amplification in Daily Use (SADL) | Pre-implant and 6 months post-implant | Questionnaire completed by participant regarding satisfaction of HA use (pre-implant) and bimodal (HA+CI) device use at 6 months post-implant. (Ratings can range from 1 to 7; Higher scores indicate greater satisifaction.) |
| Change in Scores on the Communication Profile for the Hearing Impaired (CPHI) | Pre-implant and 6 months post-implant | The CPHI was completed by participant's spouse/significant other indicating their perception of how well the participant communicates in various situations. Group mean difference in CPHI ratings at 6 months post-implant compared to pre-implant. (Ratings can range from 1 to 5; Higher scores indicate better communication abilities as perceived by the spouse/significant other.) |
| Change in Hearing Impaired Impact - Significant Other Profile (HII-SOP) by 6 Months Post-implant | Pre-implant and 6 months post-implant | Questionnaire completed by participant's spouse/significant other indicating their perception of the impact of the participant's hearing loss on the spouse/significant other. Group mean difference in HII-SOP scores at 6 months post-implant compared to pre-implant. (Scores can range from 0 - 100; Lower scores are better - less impact of the hearing loss on the spouse/significant other.) |
| Change in Bamford-Kowal-Bench Speech-in-Noise (BKB-SIN) Sentence Understanding With Noise to the Poor Ear | Pre-implant and 6 months post-implant | Group mean difference in BKB-SIN scores in noise (dB SNR) 6-months post-implant in the CI+HA (CI at poor ear; HA at better ear) condition compared to the pre-implant best aided condition. Speech is from the front and noise to the poor ear. (Scores are the signal to noise ration in decibels for approximately 50% understanding and can range from -7.5 dB to 23.5 dB; Lower scores indicate better performance.) |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJill B Firszt, PhD
Washington University School of Medicine
Participant flow
Recruitment details
Recruitment occurred from Summer 2017 through 2019.
Participants by arm
| Arm | Count |
|---|---|
| Cochlear Implantation Cochlear implantation of the poor hearing ear
Cochlear implant: Participants who have failed a BiCROS or bilateral hearing aid trial and otherwise meet inclusion criteria will receive a cochlear implant at the poor hearing ear. Post-implant, participants will continue use of a hearing aid at the better ear and the cochlear implant at the poor ear. | 40 |
| Total | 40 |
Baseline characteristics
| Characteristic | Cochlear Implantation |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 30 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants |
| Age, Continuous | 68.96 years STANDARD_DEVIATION 10.27 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 35 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 4 Participants |
| Length of Deafness - Poor Ear | 10.18 years STANDARD_DEVIATION 12.06 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants |
| Race (NIH/OMB) White | 33 Participants |
| Region of Enrollment United States | 40 Participants |
| Sex: Female, Male Female | 17 Participants |
| Sex: Female, Male Male | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 40 |
| other Total, other adverse events | 11 / 40 |
| serious Total, serious adverse events | 8 / 40 |
Outcome results
Primary
Change in Poor Ear Alone CNC Monosyllabic Word Understanding in Quiet
Group mean difference in CNC monosyllabic word understanding score in quiet with the CI alone at 6 months post-implant compared to pre-implant with a hearing aid. (CNC scored on a scale from 0% to 100%; Higher scores are better.)
Time frame: Pre-implant and 6 months post-implant
Population: 36 participants had both pre-implant and 6-month post-implant CNC scores for the poor ear alone.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cochlear Implantation | Change in Poor Ear Alone CNC Monosyllabic Word Understanding in Quiet | Pre-Implant Mean | 0.09 percentage of words correct | Standard Error 0.016 |
| Cochlear Implantation | Change in Poor Ear Alone CNC Monosyllabic Word Understanding in Quiet | 6 Month Post-Implant Mean | 0.53 percentage of words correct | Standard Error 0.422 |
| Cochlear Implantation | Change in Poor Ear Alone CNC Monosyllabic Word Understanding in Quiet | Group mean difference | 0.44 percentage of words correct | Standard Error 0.039 |
Comparison: Mean difference in percent correct for CNC words at 6 months post-implant and pre-implant is reported.p-value: <0.001t-test, 2 sided
Primary
Change in Poor Ear Alone Soundfield Thresholds
Group mean difference in soundfield thresholds (dB HL average across frequency range) with the CI alone at 6 months post-implant compared to pre-implant with a hearing aid. (Measurable decibels in hearing level (dB HL) generally range from -10 dB to 120 dB; Lower levels are better.)
Time frame: Pre-implant and 6 months post-implant
Population: 36 participants had both pre-implant and 6-month post-implant Soundfield thresholds for the poor ear alone.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cochlear Implantation | Change in Poor Ear Alone Soundfield Thresholds | Pre-Implant Mean | 54.95 Decibels | Standard Error 1.72 |
| Cochlear Implantation | Change in Poor Ear Alone Soundfield Thresholds | 6 Month Post-Implant Mean | 26.54 Decibels | Standard Error 1.03 |
| Cochlear Implantation | Change in Poor Ear Alone Soundfield Thresholds | Group mean difference | 28.41 Decibels | Standard Error 1.68 |
Comparison: Mean difference in Soundfield thresholds (averaged across the frequency range in dB HL) at 6 months post-implant and pre-implant is reported.p-value: <0.001t-test, 2 sided
Secondary
Change in AzBio Sentences at 50 Decibels (dB) Sound Pressure Level (SPL)
Understanding of sentences at a soft presentation level at 6-months post-implant in the CI+HA (CI at poor ear; HA at better ear) condition compared to the pre-implant best aided condition. (Percent correct ranging from 0 to 100%; Higher scores indicate better performance.)
Time frame: Pre-implant and 6 months post-implant
Population: Both pre-implant and 6-month post-implant data were available for 36 participants.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cochlear Implantation | Change in AzBio Sentences at 50 Decibels (dB) Sound Pressure Level (SPL) | Pre-Implant Mean | 66.81 percentage of words correct | Standard Error 4.56 |
| Cochlear Implantation | Change in AzBio Sentences at 50 Decibels (dB) Sound Pressure Level (SPL) | 6-month Post-implant Mean | 83.06 percentage of words correct | Standard Error 3.14 |
| Cochlear Implantation | Change in AzBio Sentences at 50 Decibels (dB) Sound Pressure Level (SPL) | Group mean difference | 16.25 percentage of words correct | Standard Error 4.04 |
Comparison: Mean difference in percentage of understanding (words correct) at 6 months post-implant and pre-implant is reported.p-value: <0.001t-test, 2 sided
Secondary
Change in AzBio Sentence Scores at 60 dB SPL and 4-talker Babble at +8 dB Signal-to-noise Ratio (SNR)
Group mean difference in understanding of sentences in noise at 6-months post-implant in the CI+HA (CI at poor ear; HA at better ear) condition compared to the pre-implant best aided condition. (Percent correct scoring ranging from 0 - 100%; Higher scores indicate better performance.)
Time frame: Pre-implant and 6 months post-implant
Population: 36 participants had both pre-implant and 6-mongh post-implant AzBio scores in noise.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cochlear Implantation | Change in AzBio Sentence Scores at 60 dB SPL and 4-talker Babble at +8 dB Signal-to-noise Ratio (SNR) | Pre-Implant Mean | 64.39 percentage of words correct | Standard Error 4.16 |
| Cochlear Implantation | Change in AzBio Sentence Scores at 60 dB SPL and 4-talker Babble at +8 dB Signal-to-noise Ratio (SNR) | 6-Month Post-Implant Mean | 71.42 percentage of words correct | Standard Error 3.87 |
| Cochlear Implantation | Change in AzBio Sentence Scores at 60 dB SPL and 4-talker Babble at +8 dB Signal-to-noise Ratio (SNR) | Group Mean Difference | 7.03 percentage of words correct | Standard Error 2.72 |
Comparison: Mean difference in AzBio sentence scores in noise at 6 months post-implant and pre-implant is reported.p-value: <0.05t-test, 2 sided
Secondary
Change in AzBio Sentence Scores at 60 dB SPL for the Poor Ear Alone
Group mean difference in AzBio sentence scores in quiet for the poor ear alone with the CI at 6-months post-implant compared to pre-implant with a hearing aid. (Scores are percent of words correct and can range from 0 to 100%; higher scores indicate better performance.)
Time frame: Pre-implant and 6 months post-implant
Population: 36 participants had poor ear alone AzBio sentence scores at both the pre-implant and 6-month test intervals.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cochlear Implantation | Change in AzBio Sentence Scores at 60 dB SPL for the Poor Ear Alone | Pre-implant mean | 13.97 percentage of words correct | Standard Error 2.75 |
| Cochlear Implantation | Change in AzBio Sentence Scores at 60 dB SPL for the Poor Ear Alone | 6-month post-implant mean | 64.86 percentage of words correct | Standard Error 4.96 |
| Cochlear Implantation | Change in AzBio Sentence Scores at 60 dB SPL for the Poor Ear Alone | Group mean difference | 50.89 percentage of words correct | Standard Error 4.89 |
Comparison: Mean difference in AzBio sentence scores at 60 dB SPL for the poor ear alone at 6 months post-implant and pre-implant is reported.p-value: <0.001t-test, 2 sided
Secondary
Change in Bamford-Kowal-Bench Speech-in-Noise (BKB-SIN) Sentence Understanding With Noise to the Better Ear
Group mean difference in BKB-SIN scores in noise (dB SNR) 6-months post-implant in the CI+HA (CI at poor ear; HA at better ear) condition compared to the pre-implant best aided condition. Speech is from the front and noise to the better ear. (Scores are the signal to noise ration in decibels for approximately 50% understanding and can range from -7.5 dB to 23.5 dB; Lower scores indicate better performance.)
Time frame: Pre-implant and 6 months post-implant
Population: 36 participants had BKB-SIN scores for noise to the better ear at both the pre-implant and 6-month test intervals
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cochlear Implantation | Change in Bamford-Kowal-Bench Speech-in-Noise (BKB-SIN) Sentence Understanding With Noise to the Better Ear | Pre-implant mean | 6.61 dB Signal-to-Noise Ratio | Standard Error 0.83 |
| Cochlear Implantation | Change in Bamford-Kowal-Bench Speech-in-Noise (BKB-SIN) Sentence Understanding With Noise to the Better Ear | 6-month post-implant mean | 4.06 dB Signal-to-Noise Ratio | Standard Error 0.83 |
| Cochlear Implantation | Change in Bamford-Kowal-Bench Speech-in-Noise (BKB-SIN) Sentence Understanding With Noise to the Better Ear | Group mean difference | 2.56 dB Signal-to-Noise Ratio | Standard Error 0.81 |
Comparison: Mean difference in dB SNR for BKB-SIN sentences with noise to the better ear at 6-months post-implant and pre-implant is reported.p-value: <0.01t-test, 2 sided
Secondary
Change in Bamford-Kowal-Bench Speech-in-Noise (BKB-SIN) Sentence Understanding With Noise to the Poor Ear
Group mean difference in BKB-SIN scores in noise (dB SNR) 6-months post-implant in the CI+HA (CI at poor ear; HA at better ear) condition compared to the pre-implant best aided condition. Speech is from the front and noise to the poor ear. (Scores are the signal to noise ration in decibels for approximately 50% understanding and can range from -7.5 dB to 23.5 dB; Lower scores indicate better performance.)
Time frame: Pre-implant and 6 months post-implant
Population: 36 participants had BKB-SIN scores for noise to the poor ear at both the pre-implant and 6-month test intervals
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cochlear Implantation | Change in Bamford-Kowal-Bench Speech-in-Noise (BKB-SIN) Sentence Understanding With Noise to the Poor Ear | Pre-implant mean | 1.82 dB Signal-to-Noise Ratio | Standard Error 0.72 |
| Cochlear Implantation | Change in Bamford-Kowal-Bench Speech-in-Noise (BKB-SIN) Sentence Understanding With Noise to the Poor Ear | 6-month post-implant mean | 0.42 dB Signal-to-Noise Ratio | Standard Error 0.78 |
| Cochlear Implantation | Change in Bamford-Kowal-Bench Speech-in-Noise (BKB-SIN) Sentence Understanding With Noise to the Poor Ear | Group mean difference | 1.40 dB Signal-to-Noise Ratio | Standard Error 0.6 |
Comparison: Mean difference in the dB SNR scores for BKB-SIN sentences at 6 months post-implant minus pre-implant is reported.p-value: <0.05t-test, 2 sided
Secondary
Change in Health Utility Index (HUI3) Ratings
Questionnaire completed by participant regarding ability/disability across several health dimensions. Group mean difference in HUI3 ratings (total score) at 6 months post-implant compared to pre-implant. (Scores can range from 0.0 to 1.0; Higher scores indicate greater perceived health/ability.)
Time frame: Pre-implant and 6 months post-implant
Population: 39 participants completed the HUI3 at both the pre-implant and 6-month post-implant test intervals.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cochlear Implantation | Change in Health Utility Index (HUI3) Ratings | Pre-implant mean | 0.51 score on a scale | Standard Error 0.04 |
| Cochlear Implantation | Change in Health Utility Index (HUI3) Ratings | 6-month post-implant mean | 0.66 score on a scale | Standard Error 0.03 |
| Cochlear Implantation | Change in Health Utility Index (HUI3) Ratings | Group mean difference | 0.15 score on a scale | Standard Error 0.03 |
Comparison: Mean difference in HUI3 ratings at 6 months post-implant and pre-implant is reported.p-value: <0.001t-test, 2 sided
Secondary
Change in Hearing Handicap Inventory (HHIE)
Inventory completed by participant regarding emotional and social consequences of hearing loss. Group mean difference in the total HHIE ratings at 6-months post-implant compared to pre-implant. (Ratings can range from 0 to 100; Lower scores indicate less perceived hearing handicap - lower scores are better.)
Time frame: Pre-implant and 6 months post-implant
Population: 39 participants had completed the HHIE at both the pre-implant and 6-month post-implant test intervals.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cochlear Implantation | Change in Hearing Handicap Inventory (HHIE) | Pre-implant mean | 0.67 score on a scale | Standard Error 0.03 |
| Cochlear Implantation | Change in Hearing Handicap Inventory (HHIE) | 6-months post-implant mean | 0.46 score on a scale | Standard Error 0.04 |
| Cochlear Implantation | Change in Hearing Handicap Inventory (HHIE) | Group mean difference | 0.21 score on a scale | Standard Error 0.03 |
Comparison: Mean difference in HHIE reported scores at 6-months post-implant and pre-implant is reported.p-value: <0.001t-test, 2 sided
Secondary
Change in Hearing Impaired Impact - Significant Other Profile (HII-SOP) by 6 Months Post-implant
Questionnaire completed by participant's spouse/significant other indicating their perception of the impact of the participant's hearing loss on the spouse/significant other. Group mean difference in HII-SOP scores at 6 months post-implant compared to pre-implant. (Scores can range from 0 - 100; Lower scores are better - less impact of the hearing loss on the spouse/significant other.)
Time frame: Pre-implant and 6 months post-implant
Population: 26 participants had a spouse or significant other who completed the HII-SOP at both the pre-implant and 6 month post-implant test intervals.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cochlear Implantation | Change in Hearing Impaired Impact - Significant Other Profile (HII-SOP) by 6 Months Post-implant | Pre-implant mean | 55.96 score on a scale | Standard Error 4.71 |
| Cochlear Implantation | Change in Hearing Impaired Impact - Significant Other Profile (HII-SOP) by 6 Months Post-implant | 6-month post-implant mean | 22.98 score on a scale | Standard Error 4.63 |
| Cochlear Implantation | Change in Hearing Impaired Impact - Significant Other Profile (HII-SOP) by 6 Months Post-implant | Group mean difference | 32.98 score on a scale | Standard Error 4.31 |
Comparison: Mean difference in HII-SOP scores at 6 months post-implant and pre-implant is reported.p-value: <0.001t-test, 2 sided
Secondary
Change in Satisfaction With Amplification in Daily Use (SADL)
Questionnaire completed by participant regarding satisfaction of HA use (pre-implant) and bimodal (HA+CI) device use at 6 months post-implant. (Ratings can range from 1 to 7; Higher scores indicate greater satisifaction.)
Time frame: Pre-implant and 6 months post-implant
Population: 39 participants completed the HA version of the SADL pre-implant and also the bimodal version at 6 months post-implant (a modification of the original SADL).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cochlear Implantation | Change in Satisfaction With Amplification in Daily Use (SADL) | Pre-implant mean | 4.88 score on a scale | Standard Error 0.12 |
| Cochlear Implantation | Change in Satisfaction With Amplification in Daily Use (SADL) | 6-month post-implant mean | 5.36 score on a scale | Standard Error 0.15 |
| Cochlear Implantation | Change in Satisfaction With Amplification in Daily Use (SADL) | Group mean difference | 0.48 score on a scale | Standard Error 0.2 |
Comparison: Mean difference in SADL scores at 6 months post-implant and pre-implant are reported.p-value: <0.05t-test, 2 sided
Secondary
Change in Scores on the Communication Profile for the Hearing Impaired (CPHI)
The CPHI was completed by participant's spouse/significant other indicating their perception of how well the participant communicates in various situations. Group mean difference in CPHI ratings at 6 months post-implant compared to pre-implant. (Ratings can range from 1 to 5; Higher scores indicate better communication abilities as perceived by the spouse/significant other.)
Time frame: Pre-implant and 6 months post-implant
Population: 26 participants had a spouse or significant other who completed the CPHI at both the pre-implant and 6-month post-implant test intervals.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cochlear Implantation | Change in Scores on the Communication Profile for the Hearing Impaired (CPHI) | Pre-implant mean | 2.27 score on a scale | Standard Error 0.1 |
| Cochlear Implantation | Change in Scores on the Communication Profile for the Hearing Impaired (CPHI) | 6-month post-implant mean | 3.50 score on a scale | Standard Error 0.15 |
| Cochlear Implantation | Change in Scores on the Communication Profile for the Hearing Impaired (CPHI) | Group mean difference | 1.22 score on a scale | Standard Error 0.17 |
Comparison: Mean difference in the CPHI scores at 6 months post-implant and pre-implant are reported.p-value: <0.001t-test, 2 sided
Secondary
Change in Sound Localization
Sound localization in RMS error at 6-months post-implant in the CI+HA (CI at poor ear; HA at better ear) condition compared to the pre-implant best aided condition. (Root Mean Error Scores in degrees of error can range from 0 to approximately 80 degrees. Chance level performance is 64 degrees. Lower scores indicate better performance.)
Time frame: Pre-implant and 6 months post-implant
Population: 36 participants had both pre-implant and 6-month localization scores in the bilateral/bimodal condition
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cochlear Implantation | Change in Sound Localization | Pre-Implant Mean | 45.05 degrees RMS error | Standard Error 2.79 |
| Cochlear Implantation | Change in Sound Localization | 6 Month Post-Implant Mean | 39.07 degrees RMS error | Standard Error 1.57 |
| Cochlear Implantation | Change in Sound Localization | Group Mean Difference | 5.99 degrees RMS error | Standard Error 2.8 |
Comparison: Mean difference in degrees RMS error at 6 months post-implant and pre-implant is reported.p-value: <0.05t-test, 2 sided
Secondary
Change in Speech, Spatial and Sound Qualities (SSQ) by 12-months Post-implant
Questionnaire completed by participant regarding impact of hearing loss on various listening situations. Group mean difference in SSQ ratings at 12-months post-implant compared to pre-implant. (Ratings can range from 0 to 10; Higher scores indicate greater perceived abilities.)
Time frame: Pre-implant and 12 months post-implant
Population: 39 participants had SSQ ratings for both the pre-implant and 12-month post-implant test intervals. (These were not the same 39 who had SSQ ratings at both the 6-month and pre-implant test intervals.)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cochlear Implantation | Change in Speech, Spatial and Sound Qualities (SSQ) by 12-months Post-implant | Pre-implant mean | 3.37 score on a scale | Standard Error 0.23 |
| Cochlear Implantation | Change in Speech, Spatial and Sound Qualities (SSQ) by 12-months Post-implant | 12-month post-implant mean | 5.37 score on a scale | Standard Error 0.25 |
| Cochlear Implantation | Change in Speech, Spatial and Sound Qualities (SSQ) by 12-months Post-implant | Group mean difference | 2.00 score on a scale | Standard Error 0.25 |
Comparison: Mean difference in SSQ ratings at 12 months post-implant and pre-implant is reported.p-value: <0.001t-test, 2 sided
Secondary
Change in Speech, Spatial and Sound Qualities (SSQ) by 6-months Post-implant
Questionnaire completed by participant regarding impact of hearing loss on various listening situations. Group mean difference in SSQ ratings at 6-months post-implant compared to pre-implant. (Ratings can range from 0 to 10; Higher scores indicate greater perceived abilities.)
Time frame: Pre-implant and 6 months post-implant
Population: 39 participants had SSQ ratings at both the pre-implant and 6-month test intervals.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cochlear Implantation | Change in Speech, Spatial and Sound Qualities (SSQ) by 6-months Post-implant | Pre-implant mean | 3.42 score on a scale | Standard Error 0.23 |
| Cochlear Implantation | Change in Speech, Spatial and Sound Qualities (SSQ) by 6-months Post-implant | 6-month post-implant mean | 5.46 score on a scale | Standard Error 0.22 |
| Cochlear Implantation | Change in Speech, Spatial and Sound Qualities (SSQ) by 6-months Post-implant | Group mean difference | 2.03 score on a scale | Standard Error 0.26 |
Comparison: Mean difference in ratings for the SSQ total score at 6 months post-implant and pre-implant is reported.p-value: <0.001t-test, 2 sided