Evaluation of Software for Self-Fitting of Hearing Aids by People With Hearing Loss

NCT ID: NCT05280808

Last Updated: 2023-02-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-18

Study Completion Date

2022-11-29

Brief Summary

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The purpose of the study is to evaluate the efficacy of a prototype app for the self-fitting of hearing aids.

Detailed Description

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After being informed about the study and potential risks, clients giving written informed consent will be enrolled as participants. Each participant will use the app to self-fit and fine-tune the study aids over 30 days. Outcome measures include speech perception tests, questionnaires and the need for support with using the app. Own-aid performance is the reference, while unaided performance is the baseline.

Conditions

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Hearing Loss

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Experimental phone app

Experimental phone app for self-fitting of hearing aids

Group Type EXPERIMENTAL

Experimental phone app used for self-fitting of hearing aids

Intervention Type DEVICE

This software allows participants to set up hearing aids as appropriate for their hearing loss

Interventions

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Experimental phone app used for self-fitting of hearing aids

This software allows participants to set up hearing aids as appropriate for their hearing loss

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Online client
* Daily aid use
* Bilateral aid use
* Uses P70-R or P90-R aids (same model both ears)
* Does not use earmolds
* Uses same soft tip on both aids
* Owns iPhone7/iOS12 or later
* Willing to install prototype app on own phone and use it in study
* Willing to participate in study for 30 days

Exclusion Criteria

* Dexterity or cognitive issues that would be problematic for using the app in the study
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sonova Audiological Care Australia Pty Ltd

UNKNOWN

Sponsor Role collaborator

Sonova AG

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Justin A Zakis, PhD

Role: PRINCIPAL_INVESTIGATOR

Sonova Audiological Care Australia

Locations

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Melbourne Support Office and Clinic/Teleaudiology

Carlton, Victoria, Australia

Site Status

Countries

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Australia

Other Identifiers

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SRF-385

Identifier Type: -

Identifier Source: org_study_id

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