Hearing Aid Quality and Reliability Study

Not Applicable

Completed

• Conditions: Hearing Loss
• Interventions: Device: Phonak Audeo hearing aid

• Registration Number: NCT04995666
• Lead Sponsor: Sonova AG

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-06-08
• Study First Submitted: 2021-06-11
• Study First Submitted QC: 2021-08-06
• Study First Posted: 2021-08-09
• Primary Completion: 2021-09-13
• Study Completion: 2021-10-31
• Results First Submitted: 2023-03-31
• Status Verified: 2023-04
• Results First Submitted QC: 2023-04-24
• Last Update Submitted: 2023-04-24
• Results First Posted: 2023-05-17
• Last Update Posted: 2023-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Hearing Aid	Phonak Audeo hearing aid	Participants will wear Phonak rechargeable Audeo hearing aids

Primary Outcome Measures

Name	Time	Method
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).

Trial Locations

Locations (1)

Sonova; 🇺🇸 Aurora, Illinois, United States