Trial Outcomes & Findings for Evaluation of Hearing Aid Benefit (NCT NCT05198713)
NCT ID: NCT05198713
Last Updated: 2023-06-06
Results Overview
Speech intelligibility for monosyllabic words presented in quiet. The words are presented at a fixed level and the percentage of words correctly repeated is calculated. A higher percentage is better. This was done in both unaided and aided conditions.
COMPLETED
NA
15 participants
Day 1 and Day 15
2023-06-06
Participant Flow
Participant milestones
| Measure |
Experimental
All participants will be fit with the study hearing aid and under go the same testing conditions.
New hearing aid: Participants will complete testing while using a novel hearing aid which has been fit to compensate for their hearing loss.
|
|---|---|
|
Overall Study
STARTED
|
15
|
|
Overall Study
COMPLETED
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Experimental
n=15 Participants
All participants will be fit with the study hearing aid and under go the same testing conditions.
New hearing aid: Participants will complete testing while using a novel hearing aid which has been fit to compensate for their hearing loss.
|
|---|---|
|
Age, Continuous
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73 years
n=15 Participants
|
|
Sex: Female, Male
Female
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11 Participants
n=15 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=15 Participants
|
|
Region of Enrollment
United States
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15 participants
n=15 Participants
|
PRIMARY outcome
Timeframe: Day 1 and Day 15Population: It was discovered after data collection that the equipment used in this outcome measure was not functioning properly and the dB level presented was not the dB level that was indicated on the equipment. Therefore, this data was not used and no statistical analysis was done.
Speech intelligibility for monosyllabic words presented in quiet. The words are presented at a fixed level and the percentage of words correctly repeated is calculated. A higher percentage is better. This was done in both unaided and aided conditions.
Outcome measures
| Measure |
Experimental
n=15 Participants
All participants will be fit with the study hearing aid and under go the same testing conditions.
New hearing aid: Participants will complete testing while using a novel hearing aid which has been fit to compensate for their hearing loss.
|
|---|---|
|
Speech Intelligibility in Quiet.
Percent correct words repeated, in a quiet condition, unaided
|
92.3 percentage of correct responses
Interval 68.0 to 100.0
|
|
Speech Intelligibility in Quiet.
Percent correct words repeated, aided, in a quiet condition
|
90.6 percentage of correct responses
Interval 64.0 to 100.0
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SECONDARY outcome
Timeframe: Day 1 and Day 15Population: All study participants who were fit with study devices who underwent speech in noise testing in both unaided and aided conditions.
Speech intelligibility on key words for sentences presented in noise. Noise is presented at a fixed level, and the words are presented at adaptive levels, below and above the noise level. A negative number is better, because it indicates the participant can correctly repeat 50% of the words when the words are below the level of noise. This was done at baseline in the unaided condition on Day 1 of the study, and in the aided condition on Day 15.
Outcome measures
| Measure |
Experimental
n=15 Participants
All participants will be fit with the study hearing aid and under go the same testing conditions.
New hearing aid: Participants will complete testing while using a novel hearing aid which has been fit to compensate for their hearing loss.
|
|---|---|
|
Speech Intelligibility in Noise, Expressed as the Signal to Noise Ratio at Which Participant Can Correctly Repeat 50% of the Words
dB SNR aided condition
|
-9.83 dB Signal-to-Noise Ratio
Standard Deviation 1.74
|
|
Speech Intelligibility in Noise, Expressed as the Signal to Noise Ratio at Which Participant Can Correctly Repeat 50% of the Words
dB SNR unaided condition
|
-5.87 dB Signal-to-Noise Ratio
Standard Deviation 2.87
|
Adverse Events
Experimental
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place