Sound Quality Comparisons With Different Hearing Aid Couplings and Venting Systems

NCT ID: NCT05180630

Last Updated: 2023-06-28

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-01

Study Completion Date

2022-04-22

Brief Summary

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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.

Detailed Description

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Conditions

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Hearing Loss, Sensorineural

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Audeo P90 hearing aid with custom earmolds using dynamic venting

Intervention Type DEVICE

Audeo P90 hearing aids coupled to custom earmolds that use dynamic venting.

Audeo P90 hearing aid with Open domes

Intervention Type DEVICE

Audeo P90 hearing aid coupled with non-custom, manufacturer open domes

Audeo P90 hearing aid with Vented domes

Intervention Type DEVICE

Audeo P90 hearing aid coupled with non-custom, manufacturer vented domes

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.

Group Type EXPERIMENTAL

Audeo P90 hearing aid with custom earmolds using dynamic venting

Intervention Type DEVICE

Audeo P90 hearing aids coupled to custom earmolds that use dynamic venting.

Audeo P90 hearing aid with Open domes

Intervention Type DEVICE

Audeo P90 hearing aid coupled with non-custom, manufacturer open domes

Audeo P90 hearing aid with Vented domes

Intervention Type DEVICE

Audeo P90 hearing aid coupled with non-custom, manufacturer vented domes

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.

Group Type EXPERIMENTAL

Audeo P90 hearing aid with custom earmolds using dynamic venting

Intervention Type DEVICE

Audeo P90 hearing aids coupled to custom earmolds that use dynamic venting.

Audeo P90 hearing aid with Open domes

Intervention Type DEVICE

Audeo P90 hearing aid coupled with non-custom, manufacturer open domes

Audeo P90 hearing aid with Vented domes

Intervention Type DEVICE

Audeo P90 hearing aid coupled with non-custom, manufacturer vented domes

Interventions

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Audeo P90 hearing aid with custom earmolds using dynamic venting

Audeo P90 hearing aids coupled to custom earmolds that use dynamic venting.

Intervention Type DEVICE

Audeo P90 hearing aid with Open domes

Audeo P90 hearing aid coupled with non-custom, manufacturer open domes

Intervention Type DEVICE

Audeo P90 hearing aid with Vented domes

Audeo P90 hearing aid coupled with non-custom, manufacturer vented domes

Intervention Type DEVICE

Eligibility Criteria

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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

\-
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sonova AG

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Sonova US

Aurora, Illinois, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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SRF-465

Identifier Type: -

Identifier Source: org_study_id

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