Tuned App Self-Fitting vs. Professional Fitting

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

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-01

Study Completion Date

2023-07-15

Brief Summary

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The aim of the study is to compare the perceived outcome of the self-fitting performed by the participants using the Tuned mobile application with the traditional professional fitting as performed by a licensed professional audiologist in subjects with mild to moderate sensorineural hearing loss.

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Detailed Description

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Conditions

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Hearing Loss

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Prospective, randomized crossover clinical study comparing two methods of fitting subjects with mild to moderate sensorineural hearing loss with hearing aids. Subjects will receive hearing aids and be assigned to professional-fitting arm or self-fitting arm, use the hearing aids for two weeks then switch to the other arm and use the hearing aids for another two weeks.

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Professional-fitting

Subject receives hearing aids and a licensed professional performs the hearing aid fitting using professional programing tools, and the thresholds that were obtained from the traditional audiometry.

Subject uses the professionally fitted hearing aids for two weeks then completes COSI and the IOI-HA questionnaires.

Group Type ACTIVE_COMPARATOR

professional fitting vs. self fitting

Intervention Type DEVICE

Licensed professional fits the hearing aid fitting using professional programing tools and thresholds obtained from the traditional audiometry vs. subject performs self-fitting of the hearing aids using the Tuned App.

Self-fitting

Subject receives hearing aids, downloads the Tuned self fitting App and performs self-fitting of the hearing aids including a self-hearing test.

Subject uses the self fitted hearing aids for two weeks then completes COSI and the IOI-HA questionnaires.

Group Type ACTIVE_COMPARATOR

professional fitting vs. self fitting

Intervention Type DEVICE

Licensed professional fits the hearing aid fitting using professional programing tools and thresholds obtained from the traditional audiometry vs. subject performs self-fitting of the hearing aids using the Tuned App.

Interventions

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professional fitting vs. self fitting

Licensed professional fits the hearing aid fitting using professional programing tools and thresholds obtained from the traditional audiometry vs. subject performs self-fitting of the hearing aids using the Tuned App.

Intervention Type DEVICE

Other Intervention Names

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Tuned App

Eligibility Criteria

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Inclusion Criteria

* Adult males and females, 18 years and older.
* Mild to moderate sensorineural hearing loss.
* Own and able to use a smart phone (Android or iOS).
* Able to read and understand Hebrew.

Exclusion Criteria

* Conductive mixed hearing loss.
* Unilateral hearing loss.
* Any external or inner ear malformations.
* Symptoms of ear disease or excessive cerumen.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No