Hearing Aid Quality and Reliability Study

Study Overview
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Brief Summary
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Quality and reliability study of hearing aid. Adults with mild to severe hearing loss will wear hearing aids daily for approximately 3 months.

Official Title
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Hearing Aid Quality Check and Reliability Study

Conditions
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Hearing Loss

Intervention / Treatment
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* Device: Phonak Audeo hearing aid


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hearing Aid<br>Participants will wear Phonak rechargeable Audeo hearing aids | Device: Phonak Audeo hearing aid<br>* Rechargeable hearing aid<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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). | 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). | Day 90 of study |