Patient-Centered Hearing Aid Trial

Study Overview
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Brief Summary
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Satisfaction and benefit from hearing aids fit using two patient self fit methods will be compared against those fit using audiology-based best practices. Individuals between the ages of 50 and 79 years of age will be randomly assigned to one of three fitting methods. Benefit and satisfaction will be evaluated six weeks and six months after the initial fitting.

Detailed Description
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Hearing aids are the most pertinent treatment for most adults with hearing loss, a pervasive chronic health problem in  40% of those over the age of 60 years. Only 20% of these individuals purchase and use hearing aids. The Over-the-Counter Hearing Aid Act of 2017 is designed to increase affordability and accessibility, and thereby adoption, of hearing aids. While this legislation directs the Food and Drug Administration (FDA) to create and administer this new channel of hearing aid provision by 2020, best practices related to hearing aid provision without the involvement of a professional, licensed provider have not been explored and established. Patients do not have the evidence they need to decide between modes of acquiring hearing aids. The current proposal addresses the specific knowledge gap of efficacious direct-to-consumer hearing aid delivery models. Two methods of patient-driven methods of selecting and fitting hearing aids will be compared against audiology-based best practice fitting. Individuals who perceive mild or moderate hearing difficulty will be randomly assigned to one of three fitting arms. Satisfaction and benefit from hearing aids will be assessed at six weeks and six months after initial fit.

Official Title
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Comparison of Direct to Consumer Delivery Models for Hearing Devices

Conditions
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Hearing Aids, Hearing Loss

Intervention / Treatment
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* Device: Hearing Aids


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 50 - 79 years old. Mild or moderate hearing difficulty. Normal cognition. No prior hearing aid experience. Ability and willingness to pay privately ($650.00) for hearing aids Ability to read and understand English Symmetric hearing loss, no greater than moderate in degree Exclusion Criteria: -

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 79 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Three arm blinded randomized control trial.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Audiology-Based Best Practice<br>Hearing aids will be fit using current best practices used by audiologists to fit hearing aids. | Device: Hearing Aids<br>* Receiver-in-the-ear hearing aids.<br>|
| Experimental: Consumer Decides<br>Hearing aids will be self fit by patients using an interactive application on a tablet computer. Patients will choose their preferred hearing aid settings after comparing four settings with varying loudness levels. | Device: Hearing Aids<br>* Receiver-in-the-ear hearing aids.<br>|
| Experimental: Efficient Fitting<br>Hearing aids will be self fit by patients using an interactive application on a tablet computer. Patients will choose their preferred hearing aid settings after comparing four settings with varying base and treble settings. | Device: Hearing Aids<br>* Receiver-in-the-ear hearing aids.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Profile of Hearing Aid Benefit | 66-item self-assessment, disability-based inventory. | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hearing Handicap Inventory for the Elderly | A self-administered scale to identify problems related to hearing loss. | 6 weeks |