Trial Outcomes & Findings for Hearing Aid Quality and Reliability Study (NCT NCT04995666)
NCT ID: NCT04995666
Last Updated: 2023-05-17
Results Overview
Test box electroacoustic measurements of hearing aid done at full on settings must meet manufacturer product specifications per manufacturer data sheet. This includes maximum and high frequency average output sound pressure level, maximum and high frequency average acoustic gain, frequency response range, total harmonic distortion and equivalent input noise level. This is done using an Audioscan Verifit2 electroacoustic analyzer. Electroacoustic measurements listed above will also be taken with hearing aid set to user settings, as a baseline measure for all future appointments.
COMPLETED
NA
19 participants
Day 1 of study
2023-05-17
Participant Flow
Participant milestones
| Measure |
Hearing Aid
Participants will wear Phonak rechargeable Audeo hearing aids
Phonak Audeo hearing aid: Rechargeable hearing aid
|
|---|---|
|
Overall Study
STARTED
|
19
|
|
Overall Study
COMPLETED
|
19
|
|
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 |
Hearing Aid
n=19 Participants
Participants will wear Phonak rechargeable Audeo hearing aids
Phonak Audeo hearing aid: Rechargeable hearing aid
|
|---|---|
|
Age, Continuous
|
70 years
n=19 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=19 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=19 Participants
|
|
Region of Enrollment
United States
|
19 participants
n=19 Participants
|
PRIMARY outcome
Timeframe: Day 1 of studyPopulation: All devices dispensed to study participants on day 1 of study tested on electroacoustic verification equipment
Test box electroacoustic measurements of hearing aid done at full on settings must meet manufacturer product specifications per manufacturer data sheet. This includes maximum and high frequency average output sound pressure level, maximum and high frequency average acoustic gain, frequency response range, total harmonic distortion and equivalent input noise level. This is done using an Audioscan Verifit2 electroacoustic analyzer. Electroacoustic measurements listed above will also be taken with hearing aid set to user settings, as a baseline measure for all future appointments.
Outcome measures
| Measure |
Hearing Aid
n=38 hearing aid devices
Participants will wear Phonak rechargeable Audeo hearing aids
Phonak Audeo hearing aid: Rechargeable hearing aid
|
|---|---|
|
Electroacoustic Evaluation of Hearing Aids in Accordance With Manufacturer Specifications, Day 1
Number of units that PASS manufacturer specifications
|
38 hearing aid devices
|
|
Electroacoustic Evaluation of Hearing Aids in Accordance With Manufacturer Specifications, Day 1
Number of units that FAIL manufacturer specifications
|
0 hearing aid devices
|
PRIMARY outcome
Timeframe: Day 45 of studyPopulation: All devices dispensed to study participants on day 1 of study tested on electroacoustic verification equipment
Test box electroacoustic measurements (using the Audioscan Verifit 2 Electroacoustic Analyzer) of hearing aid done at user gain settings after daily use for extended period of time. Results will be compared to baseline electroacoustic measures taken on day 1 of study. A "pass" means that devices were within tolerance levels (per ANSI S3.22-2014) of baseline measures. A "fail" means that devices were not within tolerance levels of one or more baseline measures (i.e. output, gain, frequency range, total harmonic distortion, or equivalent input noise level).
Outcome measures
| Measure |
Hearing Aid
n=38 hearing aid devices
Participants will wear Phonak rechargeable Audeo hearing aids
Phonak Audeo hearing aid: Rechargeable hearing aid
|
|---|---|
|
Electroacoustic Evaluation of Hearing Aids in Accordance With Manufacturer Specifications, Day 45
Number of devices that FAIL manufacturer specifications
|
0 hearing aid devices
|
|
Electroacoustic Evaluation of Hearing Aids in Accordance With Manufacturer Specifications, Day 45
Number of devices that PASS manufacturer specifications specifications
|
38 hearing aid devices
|
PRIMARY outcome
Timeframe: Day 90 of studyPopulation: All devices dispensed to study participants on day 1 of study tested on electroacoustic verification equipment. One participant lost a device, therefore total number of devices analyzed on Day 90 is 37.
Test box electroacoustic measurements of hearing aid done at user gain settings after daily use for extended period of time. Test box electroacoustic measurements of hearing aid done at user gain settings after daily use for extended period of time. Results will be compared to baseline electroacoustic measures taken on day 1 of study. A "pass" means that devices were within tolerance levels (per ANSI S3.22-2014) of baseline measures. A "fail" means that devices were not within tolerance levels of one or more baseline measures (i.e. output, gain, frequency range, total harmonic distortion, or equivalent input noise level).
Outcome measures
| Measure |
Hearing Aid
n=37 hearing aid devices
Participants will wear Phonak rechargeable Audeo hearing aids
Phonak Audeo hearing aid: Rechargeable hearing aid
|
|---|---|
|
Electroacoustic Evaluation of Hearing Aids in Accordance With Manufacturer Specifications, Day 90
Number of devices that PASS manufacturer specifications
|
35 hearing aid devices
|
|
Electroacoustic Evaluation of Hearing Aids in Accordance With Manufacturer Specifications, Day 90
Number of devices that FAIL manufacturer specifications
|
2 hearing aid devices
|
Adverse Events
Hearing Aid
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Hearing Aid
n=19 participants at risk
Participants will wear Phonak rechargeable Audeo hearing aids
Phonak Audeo hearing aid: Rechargeable hearing aid
|
|---|---|
|
Ear and labyrinth disorders
Complication
|
5.3%
1/19 • Number of events 1 • 90 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place