An interventional study of Phonak Audeo hearing aid in Hearing Loss, sponsored by Sonova AG. Completed at 1 site in United States. Open to participants aged 18 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-05-17.
Sponsored by Sonova AG · Not applicable, Interventional, and Treatment
Quality and reliability study of hearing aid. Adults with mild to severe hearing loss will wear hearing aids daily for approximately 3 months.
1,092 studies on the registry are indexed under Hearing Loss; 235 are open to participants now.
This study's enrollment of 19 is below the median of 40 across 764 interventional studies indexed under Hearing Loss.
Browse Hearing Loss studies →Sonova AG is the lead sponsor of 82 studies on the registry; 6 are open to participants now.
Of its 25 completed or terminated interventional studies of FDA-regulated products, 17 (68%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will wear Phonak rechargeable Audeo hearing aids
Device: Phonak Audeo hearing aid
Rechargeable hearing aid
Electroacoustic Evaluation of Hearing Aids in Accordance With Manufacturer Specifications, Day 1
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.
Time frame: Day 1 of study
Electroacoustic Evaluation of Hearing Aids in Accordance With Manufacturer Specifications, Day 45
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).
Time frame: Day 45 of study
Electroacoustic Evaluation of Hearing Aids in Accordance With Manufacturer Specifications, Day 90
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).
Time frame: Day 90 of study
| Milestone | Hearing Aid |
|---|---|
| Started | 19 |
| Completed | 19 |
| Not completed | 0 |
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.
| hearing aid devices | Hearing Aid |
|---|---|
| Number of units that PASS manufacturer specifications | 38 |
| Number of units that FAIL manufacturer specifications | 0 |
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).
| hearing aid devices | Hearing Aid |
|---|---|
| Number of devices that PASS manufacturer specifications specifications | 38 |
| Number of devices that FAIL manufacturer specifications | 0 |
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).
| hearing aid devices | Hearing Aid |
|---|---|
| Number of devices that PASS manufacturer specifications | 35 |
| Number of devices that FAIL manufacturer specifications | 2 |
Collected over 90 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Hearing Aid | 0/19 (0%) | 0/19 (0%) | 1/19 (5.3%) |
| Event | Hearing Aid |
|---|---|
| ComplicationEar and labyrinth disorders | 1/19 |
| Age, Continuous(years) | Hearing Aid |
|---|---|
| Mean | 70 (28 to 86) |
| Sex: Female, Male(Participants) | Hearing Aid |
|---|---|
| Female | 9 |
| Male | 10 |
| Race and Ethnicity Not Collected(Participants) | Hearing Aid |
|---|
| Region of Enrollment(participants) | Hearing Aid |
|---|---|
| United States | 19 |
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Plan to share: No
This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
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Sonova AG