Evaluation of New Fitting Characteristics for Extended Wear Hearing Aid Technology

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-29

Study Completion Date

2022-09-30

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.

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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.

Conditions

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Hearing Loss

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Participants will not know which device they are wearing as these devices are placed deep in the ear canal by a licensed hearing care professional. The devices are designed to stay in the ear 24 hours a day, and can be worn for several weeks or months at a time.

Study Groups

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Group A

Participants will be fit with commercially available Lyric devices, which range from size XXS to XXL.

Group Type ACTIVE_COMPARATOR

Lyric Hearing Aid- Commercially Available

Intervention Type DEVICE

Extended wear hearing aid that is currently available

Group B

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.

Group Type EXPERIMENTAL

Lyric Hearing Aid- Experimental Design

Intervention Type DEVICE

Extended wear hearing aid with a fitting modification that is currently not available

Lyric Hearing Aid- Commercially Available

Intervention Type DEVICE

Extended wear hearing aid that is currently available

Interventions

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Lyric Hearing Aid- Experimental Design

Extended wear hearing aid with a fitting modification that is currently not available

Intervention Type DEVICE

Lyric Hearing Aid- Commercially Available

Extended wear hearing aid that is currently available

Intervention Type DEVICE

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

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes