Tuned App Self-Fitting vs. Professional Fitting

Study Overview
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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.

Official Title
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A Prospective, Crossover Randomized Controlled Trial to Compare Subjective Outcome of a Self-fitting Process Using Tuned App to a Licensed Professional Fitting

Conditions
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Hearing Loss

Intervention / Treatment
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* Device: professional fitting vs. self fitting


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Professional-fitting<br>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. | Device: professional fitting vs. self fitting<br>* 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.<br>* Other names: Tuned App;|
| Active Comparator: Self-fitting<br>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. | Device: professional fitting vs. self fitting<br>* 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.<br>* Other names: Tuned App;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of self fitting and professional fitting by COSI scores | To compare the professional fitting and the self fitting using the Tuned App, the scores of Client Oriented Scale of Improvement (COSI) questionnaire will be used. | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of self fitting and professional fitting by IOI-HA scores | To compare the subjects' self-reported outcomes between professional fitting and self fitting using the Tuned App, the scores of the International Outcome Inventory for Hearing Aids (IOI-HA) questionnaires will be used. | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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self fitting