Evaluation of New Fitting Characteristics for Extended Wear Hearing Aid Technology

Study Overview
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Brief Summary
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Two groups of hearing aid candidates will be fit with extended wear technology. One group will be fit with the commercially available models, and the other group will be fit with either the commercially available model or a new model with different fitting characteristic. After an appropriate trial period, the success rate of each group will be determined by the desire to purchase devices.

Detailed Description
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Hearing aid candidates will be assigned to either Group A or Group B. Group A will be fit only with extended wear devices that are commercially available. Group B will be fit with either the commercially available devices, or a set of devices that have a new fitting characteristic, depending on what is most appropriate and the best fit. Because extended wear devices are inserted by a hearing care professional and sit deep within the ear canal, participants will be blinded as to which devices they are wearing. After a typical hearing aid trial period (i.e. 30 days), participants will be asked to make a determination on whether they would purchase if given the option. The percentage of people that indicate a desire to purchase devices from Group A will be compared to the percentage of people that indicate a desire to purchase devices from Group B to determine if the offering of additional fitting options results in an increase in intent to purchase, or a trial to success rate.

Official Title
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Evaluation of New Fitting Characteristics for Extended Wear Hearing Aid Technology- Trial to Success Rate

Conditions
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Hearing Loss

Intervention / Treatment
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* Device: Lyric Hearing Aid- Experimental Design
* Device: Lyric Hearing Aid- Commercially Available


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Mild to moderate hearing loss New hearing aid users with no previous hearing aid experience interested in trying Lyric devices Must meet Lyric candidacy (see exclusion criteria) Exclusion Criteria: middle ear disease, including but not limited to history of tympanic membrane perforations, chronic otitis media, cholesteatoma, PE tubes radiation therapy to head or neck area participants who need regular MRI testing participants who regularly scuba dive or swim underwater

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: In this study, new hearing aid candidates will be randomly assigned to one of two groups, but such that each group will have an equal number of participants.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group A<br>Participants will be fit with commercially available Lyric devices, which range from size XXS to XXL. | Device: Lyric Hearing Aid- Commercially Available<br>* Extended wear hearing aid that is currently available<br>|
| Experimental: Group B<br>Participants will be fit either with the commercially available Lyric devices OR devices which are designed with a new fitting characteristic. This increases the pool of sizes from which the hearing care professional can choose to fit participant. | Device: Lyric Hearing Aid- Experimental Design<br>* Extended wear hearing aid with a fitting modification that is currently not available<br>Device: Lyric Hearing Aid- Commercially Available<br>* Extended wear hearing aid that is currently available<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Trial to Success Rate | Percentage of participants who express intent to purchase devices at end of study trial period. No statistical analysis was performed on this outcome measure. | Day 30 of study |