MyPhonak App Junior Pediatric Usability and Benefit Investigation

NCT ID: NCT05055453

Last Updated: 2024-06-25

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-04

Study Completion Date

2022-12-08

Brief Summary

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Participants age 8-17 with bilateral hearing loss will be fit with Phonak BTE (Behind-The-Ear) hearing aids and given access to the myPhonak Junior hearing app. The participants will use the app to adjust the hearing aid microphone and noise reduction settings.

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

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Experimental Study Group

Participants age 8-17 with bilateral hearing loss will be fit with Phonak BTE hearing aids and given access to the Phonak hearing app. The participants will use the app to adjust the hearing aid microphone and noise reduction settings.

Group Type EXPERIMENTAL

MyPhonak Junior App

Intervention Type DEVICE

The app is an accessory to the hearing aids which allows the user to make adjustments to their hearing aid in real-time. The hearing aid does not require the use of the app, but the objective of this study is to evaluate the effects of the user adjustments made via the app on the participant's speech intelligibility with the hearing aid.

Phonak Sky hearing aid

Intervention Type DEVICE

A Behind-The-Ear hearing aid (BTE) fit to hearing impaired persons with mild to severe hearing loss.

Interventions

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MyPhonak Junior App

The app is an accessory to the hearing aids which allows the user to make adjustments to their hearing aid in real-time. The hearing aid does not require the use of the app, but the objective of this study is to evaluate the effects of the user adjustments made via the app on the participant's speech intelligibility with the hearing aid.

Intervention Type DEVICE

Phonak Sky hearing aid

A Behind-The-Ear hearing aid (BTE) fit to hearing impaired persons with mild to severe hearing loss.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Children and adolescents between the ages of 7 and 17 years old.
* bilateral mild to severe hearing loss
* experienced hearing aid users for 6+ months

Exclusion Criteria

* any additional disabilities to the hearing impairment
* inability to complete the study procedures
Minimum Eligible Age

7 Years

Maximum Eligible Age

17 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

Principal Investigators

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Anne K Läßig, M.D, M.D.

Role: PRINCIPAL_INVESTIGATOR

Johannes Gutenberg University Mainz

Locations

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Universitätsmedizin Mainz, HNO-Klinik

Mainz, Rhineland-Palatinate, Germany

Site Status

Countries

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Germany

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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SRF-85, Sonova 2020_15

Identifier Type: -

Identifier Source: org_study_id

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