Sound Quality Comparisons With Different Hearing Aid Couplings and Venting Systems

June 9, 2023 updated by: Sonova AG

Sound Quality and Occlusion Comparisons With Different Hearing Aid Couplings and Venting Systems

Participants will be comparing the sound quality of their own voice and the sound quality of streamed music using universal couplings and a custom earmold with a dynamic vent.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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
        • Sonova US

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 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Mild to severe bilateral sensorineural hearing loss
  • hearing must be symmetrical below 500 Hz
  • must live within 30 miles of Aurora IL

Exclusion Criteria:

-

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: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Custom earmolds, then Open domes, then Vented domes
Participants first fit with Audeo 90P hearing aids and custom earmolds with dynamic venting, then fit with the same hearing aids using open domes, then fit with the same hearing aids using vented domes.
Device: Audeo P90 hearing aid with custom earmolds using dynamic venting
Audeo P90 hearing aids coupled to custom earmolds that use dynamic venting.
Device: Audeo P90 hearing aid with Open domes
Audeo P90 hearing aid coupled with non-custom, manufacturer open domes
Device: Audeo P90 hearing aid with Vented domes
Audeo P90 hearing aid coupled with non-custom, manufacturer vented domes
Experimental: Open domes, then Vented domes, then Custom earmolds
Participants first fit with Audeo 90P hearing aids and open domes, then fit with the same hearing aids using vented domes, then fit with the same hearing aids using custom earmolds with dynamic venting.
Device: Audeo P90 hearing aid with custom earmolds using dynamic venting
Audeo P90 hearing aids coupled to custom earmolds that use dynamic venting.
Device: Audeo P90 hearing aid with Open domes
Audeo P90 hearing aid coupled with non-custom, manufacturer open domes
Device: Audeo P90 hearing aid with Vented domes
Audeo P90 hearing aid coupled with non-custom, manufacturer vented domes
Experimental: Vented domes, then Custom earmolds, then Open domes
Participants first fit with Audeo 90P hearing aids and vented domes, then fit with the same hearing aids using custom earmolds with dynamic venting, then fit with the same hearing aids using open domes.
Device: Audeo P90 hearing aid with custom earmolds using dynamic venting
Audeo P90 hearing aids coupled to custom earmolds that use dynamic venting.
Device: Audeo P90 hearing aid with Open domes
Audeo P90 hearing aid coupled with non-custom, manufacturer open domes
Device: Audeo P90 hearing aid with Vented domes
Audeo P90 hearing aid coupled with non-custom, manufacturer vented domes

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sound Quality of Streamed Music Rating Scale
Time Frame: 1 day
subjective rating on scale from 0 (worst) to 100 (best) for sound quality of streamed signal
1 day
Own Voice Sound Quality Rating Scale
Time Frame: 1 day
subjective rating on a scale from 0 (worst) to 100 (best) for sound quality of participant's own voice quality.
1 day

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)

October 1, 2021

Primary Completion (Actual)

February 28, 2022

Study Completion (Actual)

April 22, 2022

Study Registration Dates

First Submitted

November 25, 2021

First Submitted That Met QC Criteria

January 5, 2022

First Posted (Actual)

January 6, 2022

Study Record Updates

Last Update Posted (Actual)

June 28, 2023

Last Update Submitted That Met QC Criteria

June 9, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SRF-465

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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