Hearing Aid Quality and Reliability Study

Sonova AG19 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hearing Loss

Interventions

Phonak Audeo hearing aidDEVICE

Rechargeable hearing aid

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Sonova

Aurora, Illinois, United States

Outcomes

Primary Outcomes

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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.