A Comparison of Hearing Aid Noise Programs on Speech Intelligibility

May 23, 2025 updated by: Sonova AG
Hearing impaired participants will be fit with study devices which will have three different hearing aid programs. Speech intelligibility will be measured using validated tests for each of the three hearing aid programs. The order of the hearing aid programs will be randomized across participants and each participant will be blinded as to the programs being tested.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Program 1 is the current default in the commercially available devices. Programs 2 and 3 are being tested against the current default.

Study Type

Interventional

Enrollment (Actual)

17

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Bilateral moderate to severe hearing loss (N3-N4)
  • Experienced hearing aid user
  • Fluent in English
  • Cognitively able to complete complex listening tasks

Exclusion Criteria:

  • Unilateral hearing loss
  • New hearing aid user
  • Unable or unwilling to complete complex listening tasks

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: Phonak Audeo RIC
All participants are fit with the Audeo RIC hearing aids, which are programmed with three different settings. All participants are tested with all three settings.
Device: Phonak Audeo Infinio Hearing Aid
Commercially available receiver-in-canal (RIC) style hearing aid manufactured by Sonova.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AZBio Speech in noise testing
Time Frame: Day 1 of 1 day study
A list of 20 sentences is presented from a speaker located in front of the participant. At the same time, background noise is presented from the same speaker at various SNR (Signal to Noise Ratio) levels. That is, speech may be presented 5 dB lower/softer than the noise up to 5 dB higher/louder than the noise. The number of words correct is counted and a percentage from the total number of words presented is calculated. A higher percentage is better and indicates better speech intelligibility. This test will be conducted for all three hearing aid program settings.
Day 1 of 1 day study

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subjective ratings of sound quality
Time Frame: Day 1 of 1 day study
Participants will be asked to choose between two of the hearing aid programs using an A/B comparison, on the following dimensions: clarity, speech naturalness, speech volume, noise intrusion, listening effort, overall sound quality, and preference. Participants will compare program setting 1 to program setting 2 and choose their preference for each above mentioned dimension. Additionally, participants will compare program setting 1 to program setting 3 and choose preference for each dimension. There is no better or worse, but a count will be taken of preferences for each program. Program 2 and 3 are not compared against each other as the objective of the measure is to compare programs 2 and 3 against the current default program (program 1).
Day 1 of 1 day 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)

April 22, 2025

Primary Completion (Actual)

May 1, 2025

Study Completion (Actual)

May 1, 2025

Study Registration Dates

First Submitted

April 22, 2025

First Submitted That Met QC Criteria

May 1, 2025

First Posted (Actual)

May 4, 2025

Study Record Updates

Last Update Posted (Actual)

May 30, 2025

Last Update Submitted That Met QC Criteria

May 23, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SRF-29404

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data collected in this study will only be available to Sonova researchers

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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