Evaluation of Hearing Aid Benefit

May 10, 2023 updated by: Sonova AG
The present study will investigate the benefit of hearing aids for speech intelligibility (in both quiet and noisy environments) compared to the unaided condition. Participants will include adults with moderate to moderately severe hearing impairment. The participants will complete laboratory-based speech intelligibility assessments with binaural hearing aids and without hearing aids.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

15

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 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Moderate to moderately severe sensorineural hearing loss
  • Willingness to wear custom hearing instruments during the study.
  • Age-normal cognition
  • Ability to attend on-site 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: Experimental
All participants will be fit with the study hearing aid and under go the same testing conditions.
Device: New hearing aid
Participants will complete testing while using a novel hearing aid which has been fit to compensate for their hearing loss.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Speech Intelligibility in Quiet.
Time Frame: Day 1 and Day 15
Speech intelligibility for monosyllabic words presented in quiet. The words are presented at a fixed level and the percentage of words correctly repeated is calculated. A higher percentage is better. This was done in both unaided and aided conditions.
Day 1 and Day 15

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Speech Intelligibility in Noise, Expressed as the Signal to Noise Ratio at Which Participant Can Correctly Repeat 50% of the Words
Time Frame: Day 1 and Day 15
Speech intelligibility on key words for sentences presented in noise. Noise is presented at a fixed level, and the words are presented at adaptive levels, below and above the noise level. A negative number is better, because it indicates the participant can correctly repeat 50% of the words when the words are below the level of noise. This was done at baseline in the unaided condition on Day 1 of the study, and in the aided condition on Day 15.
Day 1 and Day 15

Collaborators and Investigators

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

Sponsor

Sonova AG

Investigators

  • Principal Investigator: Kevin Seitz-Paquette, AuD, 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)

January 18, 2022

Primary Completion (Actual)

March 4, 2022

Study Completion (Actual)

March 4, 2022

Study Registration Dates

First Submitted

January 5, 2022

First Submitted That Met QC Criteria

January 5, 2022

First Posted (Actual)

January 20, 2022

Study Record Updates

Last Update Posted (Actual)

June 6, 2023

Last Update Submitted That Met QC Criteria

May 10, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SRF-487

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.

No

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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