Hearing Loss
Conditions
Brief summary
Quality and reliability study of hearing aid. Adults with mild to severe hearing loss will wear hearing aids daily for approximately 3 months.
Interventions
DEVICEPhonak Audeo hearing aid
Rechargeable hearing aid
Sponsors
Sonova AG
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
Yes
Inclusion criteria
* Adults with mild to moderate severe sensorineural hearing loss * Adults who were able to incorporate some type of physical activity into their day (i.e walking, excercise, gardening, etc.)
Exclusion criteria
* Unable or unwilling to wear study devices during a home trial * Unable or unwilling to come to lab for study visits
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Electroacoustic Evaluation of Hearing Aids in Accordance With Manufacturer Specifications, Day 1 | Day 1 of study | 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. |
| Electroacoustic Evaluation of Hearing Aids in Accordance With Manufacturer Specifications, Day 45 | Day 45 of study | 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). |
| Electroacoustic Evaluation of Hearing Aids in Accordance With Manufacturer Specifications, Day 90 | Day 90 of study | 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Hearing Aid Participants will wear Phonak rechargeable Audeo hearing aids
Phonak Audeo hearing aid: Rechargeable hearing aid | 19 |
| Total | 19 |
Baseline characteristics
| Characteristic | Hearing Aid | — |
|---|---|---|
| Age, Continuous | 70 years | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 19 participants | — |
| Sex: Female, Male Female | 9 Participants | — |
| Sex: Female, Male Male | 10 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 19 |
| other Total, other adverse events | 1 / 19 |
| serious Total, serious adverse events | 0 / 19 |
Outcome results
Primary
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
Population: All devices dispensed to study participants on day 1 of study tested on electroacoustic verification equipment
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| 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 |
| Hearing Aid | Electroacoustic Evaluation of Hearing Aids in Accordance With Manufacturer Specifications, Day 1 | Number of units that FAIL manufacturer specifications | 0 hearing aid devices |
Primary
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
Population: All devices dispensed to study participants on day 1 of study tested on electroacoustic verification equipment
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Hearing Aid | Electroacoustic Evaluation of Hearing Aids in Accordance With Manufacturer Specifications, Day 45 | Number of devices that PASS manufacturer specifications specifications | 38 hearing aid devices |
| 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 |
Primary
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
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| 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 |
| Hearing Aid | Electroacoustic Evaluation of Hearing Aids in Accordance With Manufacturer Specifications, Day 90 | Number of devices that FAIL manufacturer specifications | 2 hearing aid devices |