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

Study Overview
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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.

Official Title
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Device Clinical Trial of the Efficacy of Using Novel Remote Self-fitting Software Compared With Standard Remote Fitting Software in the Customisation of Hearing-aid Settings for Adults With Hearing Loss

Conditions
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Hearing Loss

Intervention / Treatment
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* Device: Experimental phone app used for self-fitting of hearing aids


Participation Criteria
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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

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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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental phone app<br>Experimental phone app for self-fitting of hearing aids | Device: Experimental phone app used for self-fitting of hearing aids<br>* This software allows participants to set up hearing aids as appropriate for their hearing loss<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in speech perception after 30 days | The online Speech Perception Test developed by Blamey Saunders Hearing will be used to assess the effect of the intervention on speech perception. | Day 1 and Day 30 | 
| Change in self-rated hearing ability after 30 days | An expanded version of the Client Oriented Scale of Improvement questionnaire will be used to assess the effect of the intervention on self-rated hearing ability in different listening situations. | Day 1 and Day 30 | 
| Softest sounds that can be heard | The intervention will be used to measure the softest sounds that can be heard at different tone frequencies. | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in preferences for fitted settings and fitting method over 30 days | A custom questionnaire will be used to assess preferences for the fitted settings and fitting method of the intervention as these preferences evolve over time. | Day 1, Day 10, Day 20 and Day 30. | 
| Change in experimental self-fitting phone app use over 30 days | The use of the experimental self-fitting phone app will be automatically logged every day to assess changes in how the app is used over time. | Days 1-30 |