Trial Outcomes & Findings for Single-Sided Deafness in the Medicare Population (NCT NCT05250414)
NCT ID: NCT05250414
Last Updated: 2026-08-31
Results Overview
The primary effectiveness endpoint will be change on speech in noise when speech is presented to the front and noise is presented to the acoustic hearing (contralateral) ear. AzBio sentences in noise will be administered at 60 dB SPL with a signal-to-noise ratio of 0 dB SNR. Pre-operatively, sentence testing will occur with a CROS hearing aid. The pre-operative, best aided score will be compared to the 6-month and 12-month CI score for AzBio sentences in noise. AzBio sentences in noise are scored as a percentage of words correctly repeated back out of the total number of words presented on the list (range of score 0-100, higher score is better). Improvement is defined as greater than or equal to 10 percentage points.
COMPLETED
NA
18 participants
One year (12 months) post activation
2026-08-31
Participant Flow
Single-arm, multicenter study across three sites in the United States and Canada.
Two participants enrolled and elected not to go through with cochlear implantation under the study. One participant enrolled and surgery was attempted, but ossification of the cochlea precluded the ability to surgically place the electrode, so the participant was withdrawn from the study. Due to the withdrawal of these three subjects prior to implantation, their enrollment slots were reallocated. This resulted in a total enrollment of 18 subjects, however, only 15 subjects were implanted.
Participant milestones
| Measure |
Intervention Group
This group received a MED-EL cochlear implant system under the guidelines specified in the study protocol.
|
|---|---|
|
Overall Study
STARTED
|
18
|
|
Overall Study
COMPLETED
|
15
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Intervention Group
This group received a MED-EL cochlear implant system under the guidelines specified in the study protocol.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
|
Overall Study
Physician Decision
|
1
|
Baseline Characteristics
This study looked to enroll adults over 65 years of age who meet the indications as specified in the protocol. One participant was enrolled at the age of 64 and a protocol deviation was filed.
Baseline characteristics by cohort
| Measure |
Intervention Group
n=15 Participants
This group received a MED-EL cochlear implant system under the guidelines specified in the study protocol.
|
|---|---|
|
Age, Continuous
|
70.1 years
STANDARD_DEVIATION 4.9 • n=15 Participants
|
|
Age, Customized
60-64 years
|
1 Participants
n=15 Participants • This study looked to enroll adults over 65 years of age who meet the indications as specified in the protocol. One participant was enrolled at the age of 64 and a protocol deviation was filed.
|
|
Age, Customized
65-69 years
|
7 Participants
n=15 Participants • This study looked to enroll adults over 65 years of age who meet the indications as specified in the protocol. One participant was enrolled at the age of 64 and a protocol deviation was filed.
|
|
Age, Customized
70-74 years
|
3 Participants
n=15 Participants • This study looked to enroll adults over 65 years of age who meet the indications as specified in the protocol. One participant was enrolled at the age of 64 and a protocol deviation was filed.
|
|
Age, Customized
75-79 years
|
4 Participants
n=15 Participants • This study looked to enroll adults over 65 years of age who meet the indications as specified in the protocol. One participant was enrolled at the age of 64 and a protocol deviation was filed.
|
|
Sex: Female, Male
Female
|
12 Participants
n=15 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=15 Participants
|
|
Region of Enrollment
United States
|
10 Participants
n=15 Participants
|
|
Region of Enrollment
Canada
|
5 Participants
n=15 Participants
|
|
Hearing Loss Ear Side
Left
|
4 Participants
n=15 Participants
|
|
Hearing Loss Ear Side
Right
|
11 Participants
n=15 Participants
|
PRIMARY outcome
Timeframe: One year (12 months) post activationThe primary effectiveness endpoint will be change on speech in noise when speech is presented to the front and noise is presented to the acoustic hearing (contralateral) ear. AzBio sentences in noise will be administered at 60 dB SPL with a signal-to-noise ratio of 0 dB SNR. Pre-operatively, sentence testing will occur with a CROS hearing aid. The pre-operative, best aided score will be compared to the 6-month and 12-month CI score for AzBio sentences in noise. AzBio sentences in noise are scored as a percentage of words correctly repeated back out of the total number of words presented on the list (range of score 0-100, higher score is better). Improvement is defined as greater than or equal to 10 percentage points.
Outcome measures
| Measure |
Intervention Group
n=15 Participants
This group received a MED-EL cochlear implant system under the guidelines specified in the study protocol.
|
|---|---|
|
Performance of the Cochlear Implant System Will be Assessed Through Speech Perception Testing in Noise Completed Through One Year (12 Months) Post Activation.
6 Months Post-Activation
|
11.4 Percentage Point Change
Standard Deviation 23.3
|
|
Performance of the Cochlear Implant System Will be Assessed Through Speech Perception Testing in Noise Completed Through One Year (12 Months) Post Activation.
12 Months Post-Activation
|
11.1 Percentage Point Change
Standard Deviation 28.8
|
SECONDARY outcome
Timeframe: One year (12 months) post implantationSpeech in noise in two spatial conditions will demonstrate similar performance from the pre-operative, best-aided score to the CI score at 6- and 12-months post activation. AzBio sentences in noise will be administered at 60 dB SPL with a signal-to-noise ratio of 0 dB SNR. Pre-operatively, sentence testing will occur with a CROS hearing aid. The pre-operative, best aided score will be compared to the 6-month and 12-month CI score for AzBio sentences in noise. AzBio sentences in noise are scored as a percentage of words correctly repeated back out of the total number of words presented on the list (range of score 0-100, higher score is better). Percentage point change from baseline is reported where a positive change represents an improvement from baseline and a negative change represents a decrement from baseline.
Outcome measures
| Measure |
Intervention Group
n=15 Participants
This group received a MED-EL cochlear implant system under the guidelines specified in the study protocol.
|
|---|---|
|
Performance of the Cochlear Implant System Will be Summarized Through Speech Perception Testing in Noise Completed Through One Year (12 Months) Post Implantation.
Speech and Noise Presented from the Front (AzBio S0N0) Change from Baseline at 6 Months
|
12.8 Percentage Point Change
Standard Deviation 20.4
|
|
Performance of the Cochlear Implant System Will be Summarized Through Speech Perception Testing in Noise Completed Through One Year (12 Months) Post Implantation.
Speech and Noise Presented from the Front (AzBio S0N0) Change from Baseline at 12 Months
|
11.2 Percentage Point Change
Standard Deviation 20.9
|
|
Performance of the Cochlear Implant System Will be Summarized Through Speech Perception Testing in Noise Completed Through One Year (12 Months) Post Implantation.
Speech from the Front and Noise to the CI Ear (AzBio S0NCI) Change from Baseline at 6 Months
|
21.0 Percentage Point Change
Standard Deviation 18.5
|
|
Performance of the Cochlear Implant System Will be Summarized Through Speech Perception Testing in Noise Completed Through One Year (12 Months) Post Implantation.
Speech from the Front and Noise to the CI Ear (AzBio S0NCI) Change from Baseline at 12 Months
|
21.1 Percentage Point Change
Standard Deviation 19.5
|
SECONDARY outcome
Timeframe: One year (12 months) post implantationSpeech perception in quiet will be summarized for the CI ear at the pre-operative, 6-month, and 12-month intervals, and for the contralateral ear at the pre-operative and 12-month intervals. One 50-word CNC Words list will be used to assess speech perception in quiet at each visit, scored as the percent of words repeated correctly out of the total words presented (range of 0-100, higher is better). Percentage point change from baseline is reported where a positive change represents an improvement from baseline and a negative change represents a decrement from baseline.
Outcome measures
| Measure |
Intervention Group
n=15 Participants
This group received a MED-EL cochlear implant system under the guidelines specified in the study protocol.
|
|---|---|
|
Performance of the Cochlear Implant System Will be Assessed Through Speech Perception Testing in Quiet Completed Through One Year (12 Months ) Post Implantation.
Implant Ear - Speech in Quiet (CNC Words) Change from Baseline at 6 Months
|
44 Percentage Point Change
Standard Deviation 24.1
|
|
Performance of the Cochlear Implant System Will be Assessed Through Speech Perception Testing in Quiet Completed Through One Year (12 Months ) Post Implantation.
Implant Ear - Speech in Quiet (CNC Words) Change from Baseline at 12 Months
|
44 Percentage Point Change
Standard Deviation 20.5
|
|
Performance of the Cochlear Implant System Will be Assessed Through Speech Perception Testing in Quiet Completed Through One Year (12 Months ) Post Implantation.
Contra Ear - Speech in Quiet (CNC Words) Change from Baseline at 12 Months
|
-1.7 Percentage Point Change
Standard Deviation 5.2
|
SECONDARY outcome
Timeframe: One year (12 months) post implantationSubjective data will be collected via the Speech, Spatial, and Qualities of Hearing Scale (SSQ). The SSQ uses subjective responses to various questions related to speech, spatial, and other qualities of hearing reported on a Likert scale (range of score 0-10, higher score is a more positive subjective impression of ability or quality). Responses are averaged across the entire questionnaire for the overall score and across questions related to each subscale for individual subscale scores. Responses will be summarized from the pre-operative, 6-month, and 12-month intervals.
Outcome measures
| Measure |
Intervention Group
n=15 Participants
This group received a MED-EL cochlear implant system under the guidelines specified in the study protocol.
|
|---|---|
|
Subjective Benefit of the Cochlear Implant System Will be Assessed Through One Year (12 Months) Post Implantation.
Spatial Subscale Score - 12 Months Post-Activation
|
5.9 SSQ Score (0-10 Likert Scale)
Standard Deviation 1.8
|
|
Subjective Benefit of the Cochlear Implant System Will be Assessed Through One Year (12 Months) Post Implantation.
Overall Score - Baseline
|
4.1 SSQ Score (0-10 Likert Scale)
Standard Deviation 1.0
|
|
Subjective Benefit of the Cochlear Implant System Will be Assessed Through One Year (12 Months) Post Implantation.
Overall Score - 6 Months Post-Activation
|
6.6 SSQ Score (0-10 Likert Scale)
Standard Deviation 1.5
|
|
Subjective Benefit of the Cochlear Implant System Will be Assessed Through One Year (12 Months) Post Implantation.
Overall Score - 12 Months Post-Activation
|
6.7 SSQ Score (0-10 Likert Scale)
Standard Deviation 1.4
|
|
Subjective Benefit of the Cochlear Implant System Will be Assessed Through One Year (12 Months) Post Implantation.
Speech Subscale Score - Baseline
|
4.1 SSQ Score (0-10 Likert Scale)
Standard Deviation 1.4
|
|
Subjective Benefit of the Cochlear Implant System Will be Assessed Through One Year (12 Months) Post Implantation.
Speech Subscale Score - 6 Months Post-Activation
|
6.8 SSQ Score (0-10 Likert Scale)
Standard Deviation 1.5
|
|
Subjective Benefit of the Cochlear Implant System Will be Assessed Through One Year (12 Months) Post Implantation.
Speech Subscale Score - 12 Months Post-Activation
|
6.6 SSQ Score (0-10 Likert Scale)
Standard Deviation 1.4
|
|
Subjective Benefit of the Cochlear Implant System Will be Assessed Through One Year (12 Months) Post Implantation.
Spatial Subscale Score - Baseline
|
2.0 SSQ Score (0-10 Likert Scale)
Standard Deviation 1.1
|
|
Subjective Benefit of the Cochlear Implant System Will be Assessed Through One Year (12 Months) Post Implantation.
Spatial Subscale Score - 6 Months Post-Activation
|
5.9 SSQ Score (0-10 Likert Scale)
Standard Deviation 2.0
|
|
Subjective Benefit of the Cochlear Implant System Will be Assessed Through One Year (12 Months) Post Implantation.
Quality Subscale Score - Baseline
|
6.0 SSQ Score (0-10 Likert Scale)
Standard Deviation 1.4
|
|
Subjective Benefit of the Cochlear Implant System Will be Assessed Through One Year (12 Months) Post Implantation.
Quality Subscale Score - 6 Months Post-Activation
|
7.2 SSQ Score (0-10 Likert Scale)
Standard Deviation 1.3
|
|
Subjective Benefit of the Cochlear Implant System Will be Assessed Through One Year (12 Months) Post Implantation.
Quality Subscale Score - 12 Months Post-Activation
|
7.6 SSQ Score (0-10 Likert Scale)
Standard Deviation 1.3
|
Adverse Events
Intent-to-Treat Group
Intervention Group
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Intent-to-Treat Group
n=18 participants at risk
All enrolled participants
|
Intervention Group
n=15 participants at risk
This group received a MED-EL cochlear implant system under the guidelines specified in the study protocol.
|
|---|---|---|
|
General disorders
Altered taste
|
5.6%
1/18 • Number of events 1 • From enrollment until the end of the study, one-year post-activation
Unanticipated adverse device effects (UADE) were defined as any adverse event not previously defined in the investigational plan or informed consent as a potential risk of participation in the study. This definition could include an unanticipanted adverse effect or other serious adverse effect associated with the device, if the problem was not previously identified in nature, severity, or degree of incidence.
|
6.7%
1/15 • Number of events 1 • From enrollment until the end of the study, one-year post-activation
Unanticipated adverse device effects (UADE) were defined as any adverse event not previously defined in the investigational plan or informed consent as a potential risk of participation in the study. This definition could include an unanticipanted adverse effect or other serious adverse effect associated with the device, if the problem was not previously identified in nature, severity, or degree of incidence.
|
|
Ear and labyrinth disorders
Dizziness
|
11.1%
2/18 • Number of events 2 • From enrollment until the end of the study, one-year post-activation
Unanticipated adverse device effects (UADE) were defined as any adverse event not previously defined in the investigational plan or informed consent as a potential risk of participation in the study. This definition could include an unanticipanted adverse effect or other serious adverse effect associated with the device, if the problem was not previously identified in nature, severity, or degree of incidence.
|
13.3%
2/15 • Number of events 2 • From enrollment until the end of the study, one-year post-activation
Unanticipated adverse device effects (UADE) were defined as any adverse event not previously defined in the investigational plan or informed consent as a potential risk of participation in the study. This definition could include an unanticipanted adverse effect or other serious adverse effect associated with the device, if the problem was not previously identified in nature, severity, or degree of incidence.
|
|
Ear and labyrinth disorders
Observed cochlear ossification, unable to complete surgery
|
5.6%
1/18 • Number of events 1 • From enrollment until the end of the study, one-year post-activation
Unanticipated adverse device effects (UADE) were defined as any adverse event not previously defined in the investigational plan or informed consent as a potential risk of participation in the study. This definition could include an unanticipanted adverse effect or other serious adverse effect associated with the device, if the problem was not previously identified in nature, severity, or degree of incidence.
|
0.00%
0/15 • From enrollment until the end of the study, one-year post-activation
Unanticipated adverse device effects (UADE) were defined as any adverse event not previously defined in the investigational plan or informed consent as a potential risk of participation in the study. This definition could include an unanticipanted adverse effect or other serious adverse effect associated with the device, if the problem was not previously identified in nature, severity, or degree of incidence.
|
|
General disorders
Tongue numbness
|
5.6%
1/18 • Number of events 1 • From enrollment until the end of the study, one-year post-activation
Unanticipated adverse device effects (UADE) were defined as any adverse event not previously defined in the investigational plan or informed consent as a potential risk of participation in the study. This definition could include an unanticipanted adverse effect or other serious adverse effect associated with the device, if the problem was not previously identified in nature, severity, or degree of incidence.
|
6.7%
1/15 • Number of events 1 • From enrollment until the end of the study, one-year post-activation
Unanticipated adverse device effects (UADE) were defined as any adverse event not previously defined in the investigational plan or informed consent as a potential risk of participation in the study. This definition could include an unanticipanted adverse effect or other serious adverse effect associated with the device, if the problem was not previously identified in nature, severity, or degree of incidence.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place