In Field Performance of a Hearing Aid Transducer

March 31, 2023 updated by: Sonova AG

A Study to Examine the Performance of a Hearing Aid Transducer During Typical, In-field Use

Study participants will be fit with previously released receiver-in-canal (RIC) hearing instruments. Participants will be asked to wear the instruments in their daily life for a minimum of 3 months, but have the option to continue to wear devices for six months.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

35

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
        • Phonak Audiology Research Center

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

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Mild to moderate sensorineural hearing loss
  • Adult

Exclusion Criteria:

  • Inability or unwillingness to wear study devices for extended period of time.

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: Other
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Receiver in the canal hearing instrument 3 month
Group of subjects who will get the receiver in the canal hearing instrument and wear for period of three months.
Device: Receiver-in-canal hearing instrument
Receiver-in-canal hearing instrument
Experimental: Receiver in the canal hearing instrument 6 month
Group of subjects who will get the receiver in the canal hearing instrument and wear for period of six months.
Device: Receiver-in-canal hearing instrument
Receiver-in-canal hearing instrument

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subjective Satisfaction of Hearing Aid Performance in Noisy Environments
Time Frame: Three months after initial appointment
Subject rates how satisfied they are with performance of hearing aid while listening in noisy environments. Ratings range from 1 (very dissatisfied) to 5 (very satisfied) with 3 = Neither satisfied or dissatisfied.
Three months after initial appointment
Subjective Satisfaction of Hearing Aid Performance in Noisy Environments
Time Frame: Six months after initial appointment
Subject rates how satisfied they are with performance of hearing aid while listening in noisy environments. Ratings range from 1 (very dissatisfied) to 5 (very satisfied) with 3 = Neither satisfied or dissatisfied.
Six months after initial appointment
Subjective Satisfaction of Hearing Aid Performance While Listening to Streamed Media
Time Frame: Three months after initial appointment
Subject rates how satisfied they are with performance of hearing aid when listening to a streamed signal (i.e. music, video, etc.) Ratings range from 1 (very dissatisfied) to 5 (very satisfied) with 3 = Neither satisfied or dissatisfied.
Three months after initial appointment
Subjective Satisfaction of Hearing Aid Performance While Listening to Streamed Media
Time Frame: Six months after initial appointment
Subject rates how satisfied they are with performance of hearing aid when listening to a streamed signal (i.e. music, video, etc.) Ratings range from 1 (very dissatisfied) to 5 (very satisfied) with 3 = Neither satisfied or dissatisfied.
Six months after initial appointment

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)

August 1, 2020

Primary Completion (Actual)

September 30, 2021

Study Completion (Actual)

December 31, 2021

Study Registration Dates

First Submitted

January 28, 2021

First Submitted That Met QC Criteria

March 3, 2021

First Posted (Actual)

March 8, 2021

Study Record Updates

Last Update Posted (Actual)

April 21, 2023

Last Update Submitted That Met QC Criteria

March 31, 2023

Last Verified

May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SRF-61

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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