Evaluating Benefits of Hearing Aid Microphone Directionality Technologies

NCT ID: NCT04953390

Last Updated: 2022-11-09

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-03

Study Completion Date

2021-07-02

Brief Summary

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This study will evaluate the impact of hearing aid microphone directionality technologies and settings on speech understanding in noise for experienced hearing aid users. It will also evaluate the participant's spatial awareness of sounds using these different hearing aid microphone directionality technologies.

Detailed Description

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Conditions

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Hearing Loss

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

A single group of participants will be evaluating different directional microphone settings on commercially available hearing aids
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

During lab testing, participants will be aware of the device they are wearing, but will not be aware of which microphone setting is being tested.

Study Groups

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Experimental

All study participants wearing study devices and evaluating three different microphone settings in simulated noise environments in lab, and using study devices during home trial period.

Group Type EXPERIMENTAL

Phonak Audeo hearing aid

Intervention Type DEVICE

Commercially available hearing aid with three different microphone settings: DIR1, DIR2, and DIR3

Phonak hearing aid with multiple directionality settings, adjustable via a mobile app

Intervention Type DEVICE

Commercially available hearing aid with multiple directionality settings which will be adjustable by user via a mobile app during a home trial period.

Interventions

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Phonak Audeo hearing aid

Commercially available hearing aid with three different microphone settings: DIR1, DIR2, and DIR3

Intervention Type DEVICE

Phonak hearing aid with multiple directionality settings, adjustable via a mobile app

Commercially available hearing aid with multiple directionality settings which will be adjustable by user via a mobile app during a home trial period.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 18 years or older
* experienced hearing aid users
* moderate to moderate severe sensorineural symmetrical hearing loss defined as a difference of less than 10 dB between ears
* must be able to use app and smart phone

Exclusion Criteria

* asymmetrical hearing losses
* unable or unwilling to use app and smart phone
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sonova AG

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kevin Seitz-Paquette, AuD

Role: PRINCIPAL_INVESTIGATOR

Sonova AG

Locations

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Sonova

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-369

Identifier Type: -

Identifier Source: org_study_id

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