Hearing Aid Quality and Reliability Study

April 24, 2023 updated by: Sonova AG

Hearing Aid Quality Check and Reliability Study

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

19

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Aurora, Illinois, United States, 60504
        • Sonova

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hearing Aid
Participants will wear Phonak rechargeable Audeo hearing aids
Device: Phonak Audeo hearing aid
Rechargeable hearing aid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Electroacoustic Evaluation of Hearing Aids in Accordance With Manufacturer Specifications, Day 1
Time Frame: 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.
Day 1 of study
Electroacoustic Evaluation of Hearing Aids in Accordance With Manufacturer Specifications, Day 45
Time Frame: 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).
Day 45 of study
Electroacoustic Evaluation of Hearing Aids in Accordance With Manufacturer Specifications, Day 90
Time Frame: 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).
Day 90 of study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sonova AG

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 8, 2021

Primary Completion (Actual)

September 13, 2021

Study Completion (Actual)

October 31, 2021

Study Registration Dates

First Submitted

June 11, 2021

First Submitted That Met QC Criteria

August 6, 2021

First Posted (Actual)

August 9, 2021

Study Record Updates

Last Update Posted (Actual)

May 17, 2023

Last Update Submitted That Met QC Criteria

April 24, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SRF-368

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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