Trial Outcomes & Findings for Cochlear Implantation in Adults With Asymmetric Hearing Loss Clinical Trial (NCT NCT03052920)
NCT ID: NCT03052920
Last Updated: 2022-01-12
Results Overview
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.)
COMPLETED
NA
40 participants
Pre-implant and 6 months post-implant
2022-01-12
Participant Flow
Recruitment occurred from Summer 2017 through 2019.
Participant milestones
| Measure |
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.
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|---|---|
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Overall Study
STARTED
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40
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Overall Study
COMPLETED
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39
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|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
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.
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|---|---|
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Overall Study
Withdrawal by Subject
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1
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Baseline Characteristics
Cochlear Implantation in Adults With Asymmetric Hearing Loss Clinical Trial
Baseline characteristics by cohort
| Measure |
Cochlear Implantation
n=40 Participants
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.
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|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
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10 Participants
n=5 Participants
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Age, Categorical
>=65 years
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30 Participants
n=5 Participants
|
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Age, Continuous
|
68.96 years
STANDARD_DEVIATION 10.27 • n=5 Participants
|
|
Sex: Female, Male
Female
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17 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
35 Participants
n=5 Participants
|
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Ethnicity (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
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|
Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
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1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
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33 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
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Region of Enrollment
United States
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40 Participants
n=5 Participants
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Length of Deafness - Poor Ear
|
10.18 years
STANDARD_DEVIATION 12.06 • n=5 Participants
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PRIMARY outcome
Timeframe: Pre-implant and 6 months post-implantPopulation: 36 participants had both pre-implant and 6-month post-implant CNC scores for the poor ear alone.
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.)
Outcome measures
| Measure |
Cochlear Implantation
n=36 Participants
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.
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|---|---|
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Change in Poor Ear Alone CNC Monosyllabic Word Understanding in Quiet
Pre-Implant Mean
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0.09 percentage of words correct
Standard Error 0.016
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Change in Poor Ear Alone CNC Monosyllabic Word Understanding in Quiet
6 Month Post-Implant Mean
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0.53 percentage of words correct
Standard Error 0.422
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Change in Poor Ear Alone CNC Monosyllabic Word Understanding in Quiet
Group mean difference
|
0.44 percentage of words correct
Standard Error 0.039
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PRIMARY outcome
Timeframe: Pre-implant and 6 months post-implantPopulation: 36 participants had both pre-implant and 6-month post-implant Soundfield thresholds for the poor ear alone.
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.)
Outcome measures
| Measure |
Cochlear Implantation
n=36 Participants
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.
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|---|---|
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Change in Poor Ear Alone Soundfield Thresholds
6 Month Post-Implant Mean
|
26.54 Decibels
Standard Error 1.03
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Change in Poor Ear Alone Soundfield Thresholds
Pre-Implant Mean
|
54.95 Decibels
Standard Error 1.72
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Change in Poor Ear Alone Soundfield Thresholds
Group mean difference
|
28.41 Decibels
Standard Error 1.68
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SECONDARY outcome
Timeframe: Pre-implant and 6 months post-implantPopulation: 36 participants had both pre-implant and 6-month localization scores in the bilateral/bimodal condition
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.)
Outcome measures
| Measure |
Cochlear Implantation
n=36 Participants
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.
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|---|---|
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Change in Sound Localization
Pre-Implant Mean
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45.05 degrees RMS error
Standard Error 2.79
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Change in Sound Localization
6 Month Post-Implant Mean
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39.07 degrees RMS error
Standard Error 1.57
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Change in Sound Localization
Group Mean Difference
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5.99 degrees RMS error
Standard Error 2.80
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SECONDARY outcome
Timeframe: Pre-implant and 6 months post-implantPopulation: Both pre-implant and 6-month post-implant data were available for 36 participants.
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.)
Outcome measures
| Measure |
Cochlear Implantation
n=36 Participants
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.
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|---|---|
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Change in AzBio Sentences at 50 Decibels (dB) Sound Pressure Level (SPL)
Pre-Implant Mean
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66.81 percentage of words correct
Standard Error 4.56
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Change in AzBio Sentences at 50 Decibels (dB) Sound Pressure Level (SPL)
6-month Post-implant Mean
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83.06 percentage of words correct
Standard Error 3.14
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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
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SECONDARY outcome
Timeframe: Pre-implant and 6 months post-implantPopulation: 36 participants had both pre-implant and 6-mongh post-implant AzBio scores in noise.
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.)
Outcome measures
| Measure |
Cochlear Implantation
n=36 Participants
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.
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|---|---|
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Change in AzBio Sentence Scores at 60 dB SPL and 4-talker Babble at +8 dB Signal-to-noise Ratio (SNR)
Pre-Implant Mean
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64.39 percentage of words correct
Standard Error 4.16
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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
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71.42 percentage of words correct
Standard Error 3.87
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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
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SECONDARY outcome
Timeframe: Pre-implant and 6 months post-implantPopulation: 36 participants had BKB-SIN scores for noise to the better ear at both the pre-implant and 6-month test intervals
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.)
Outcome measures
| Measure |
Cochlear Implantation
n=36 Participants
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.
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|---|---|
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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
|
|
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
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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
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SECONDARY outcome
Timeframe: Pre-implant and 6 months post-implantPopulation: 36 participants had poor ear alone AzBio sentence scores at both the pre-implant and 6-month test intervals.
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.)
Outcome measures
| Measure |
Cochlear Implantation
n=36 Participants
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.
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|---|---|
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Change in AzBio Sentence Scores at 60 dB SPL for the Poor Ear Alone
Pre-implant mean
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13.97 percentage of words correct
Standard Error 2.75
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Change in AzBio Sentence Scores at 60 dB SPL for the Poor Ear Alone
6-month post-implant mean
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64.86 percentage of words correct
Standard Error 4.96
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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
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SECONDARY outcome
Timeframe: Pre-implant and 6 months post-implantPopulation: 39 participants had completed the HHIE at both the pre-implant and 6-month post-implant test intervals.
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.)
Outcome measures
| Measure |
Cochlear Implantation
n=39 Participants
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.
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|---|---|
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Change in Hearing Handicap Inventory (HHIE)
Pre-implant mean
|
0.67 score on a scale
Standard Error 0.03
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Change in Hearing Handicap Inventory (HHIE)
6-months post-implant mean
|
0.46 score on a scale
Standard Error 0.04
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Change in Hearing Handicap Inventory (HHIE)
Group mean difference
|
0.21 score on a scale
Standard Error 0.03
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SECONDARY outcome
Timeframe: Pre-implant and 6 months post-implantPopulation: 39 participants completed the HUI3 at both the pre-implant and 6-month post-implant test intervals.
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.)
Outcome measures
| Measure |
Cochlear Implantation
n=39 Participants
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.
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|---|---|
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Change in Health Utility Index (HUI3) Ratings
Pre-implant mean
|
0.51 score on a scale
Standard Error 0.04
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Change in Health Utility Index (HUI3) Ratings
6-month post-implant mean
|
0.66 score on a scale
Standard Error 0.03
|
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Change in Health Utility Index (HUI3) Ratings
Group mean difference
|
0.15 score on a scale
Standard Error 0.03
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SECONDARY outcome
Timeframe: Pre-implant and 6 months post-implantPopulation: 39 participants had SSQ ratings at both the pre-implant and 6-month test intervals.
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.)
Outcome measures
| Measure |
Cochlear Implantation
n=39 Participants
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.
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|---|---|
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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
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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
|
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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
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SECONDARY outcome
Timeframe: Pre-implant and 12 months post-implantPopulation: 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.)
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.)
Outcome measures
| Measure |
Cochlear Implantation
n=39 Participants
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.
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|---|---|
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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
|
|
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
|
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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
|
SECONDARY outcome
Timeframe: Pre-implant and 6 months post-implantPopulation: 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).
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.)
Outcome measures
| Measure |
Cochlear Implantation
n=39 Participants
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.
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|---|---|
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Change in Satisfaction With Amplification in Daily Use (SADL)
Pre-implant mean
|
4.88 score on a scale
Standard Error 0.12
|
|
Change in Satisfaction With Amplification in Daily Use (SADL)
6-month post-implant mean
|
5.36 score on a scale
Standard Error 0.15
|
|
Change in Satisfaction With Amplification in Daily Use (SADL)
Group mean difference
|
0.48 score on a scale
Standard Error 0.20
|
SECONDARY outcome
Timeframe: Pre-implant and 6 months post-implantPopulation: 26 participants had a spouse or significant other who completed the CPHI at both the pre-implant and 6-month post-implant test intervals.
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.)
Outcome measures
| Measure |
Cochlear Implantation
n=26 Participants
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.
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|---|---|
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Change in Scores on the Communication Profile for the Hearing Impaired (CPHI)
Pre-implant mean
|
2.27 score on a scale
Standard Error 0.10
|
|
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
|
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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
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SECONDARY outcome
Timeframe: Pre-implant and 6 months post-implantPopulation: 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.
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.)
Outcome measures
| Measure |
Cochlear Implantation
n=26 Participants
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.
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|---|---|
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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
|
|
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
|
|
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
|
SECONDARY outcome
Timeframe: Pre-implant and 6 months post-implantPopulation: 36 participants had BKB-SIN scores for noise to the poor ear at both the pre-implant and 6-month test intervals
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.)
Outcome measures
| Measure |
Cochlear Implantation
n=36 Participants
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.
|
|---|---|
|
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
|
|
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
|
|
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 0.60
|
Adverse Events
Cochlear Implantation
Serious adverse events
| Measure |
Cochlear Implantation
n=40 participants at risk
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.
|
|---|---|
|
Vascular disorders
Stroke
|
2.5%
1/40 • Number of events 1 • Approximately 15 months, from enrollment until 12-month evaluation.
|
|
Infections and infestations
Infection
|
2.5%
1/40 • Number of events 1 • Approximately 15 months, from enrollment until 12-month evaluation.
|
|
Vascular disorders
Coronary angioplasty and stint
|
2.5%
1/40 • Number of events 1 • Approximately 15 months, from enrollment until 12-month evaluation.
|
|
Gastrointestinal disorders
Gall bladder removal
|
2.5%
1/40 • Number of events 1 • Approximately 15 months, from enrollment until 12-month evaluation.
|
|
General disorders
Nausea
|
2.5%
1/40 • Number of events 1 • Approximately 15 months, from enrollment until 12-month evaluation.
|
|
Renal and urinary disorders
Kidney stone removal
|
2.5%
1/40 • Number of events 1 • Approximately 15 months, from enrollment until 12-month evaluation.
|
|
Musculoskeletal and connective tissue disorders
Tear of medial meniscus
|
2.5%
1/40 • Number of events 1 • Approximately 15 months, from enrollment until 12-month evaluation.
|
|
Cardiac disorders
Heart bypass surgery
|
2.5%
1/40 • Number of events 1 • Approximately 15 months, from enrollment until 12-month evaluation.
|
Other adverse events
| Measure |
Cochlear Implantation
n=40 participants at risk
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.
|
|---|---|
|
Ear and labyrinth disorders
Dizziness
|
17.5%
7/40 • Number of events 7 • Approximately 15 months, from enrollment until 12-month evaluation.
|
|
Ear and labyrinth disorders
Tinnitus
|
5.0%
2/40 • Number of events 2 • Approximately 15 months, from enrollment until 12-month evaluation.
|
|
Ear and labyrinth disorders
Swelling
|
5.0%
2/40 • Number of events 2 • Approximately 15 months, from enrollment until 12-month evaluation.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place