Validating a Self-fitting Hearing Aid

NCT ID: NCT05246904

Last Updated: 2023-04-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-17

Study Completion Date

2023-02-28

Brief Summary

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Eargo, Inc. has developed a hearing aid that contains self-fitting gain software that allows adults with mild-to-moderate hearing loss to test their hearing sensitivity and program hearing aids to match their measured hearing loss. Traditionally, hearing aids are custom programmed by a hearing health professional based on a professional hearing test. This technology has the potential to improve affordability and accessibility of hearing aids for adults with mild-to-moderate hearing loss. We propose to validate Eargo's self-fitting software in a clinical trial comparing self-fitting hearing aid outcomes to the same hearing aid fit by a professional following usual clinical best practice for fitting hearing aids.

Detailed Description

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The study will recruit 30-50 adults age 18 and over with mild-to-moderate hearing loss in both ears. We will aim to recruit a sample with roughly equal number of males and females and new and experienced hearing aid users (defined by any hearing aid use within the previous 6 months). Hearing loss will be measured using the results of a standard clinical hearing test.

We will use a within-subject, crossover design in which all participants will complete both field trial hearing aid conditions (self-fit and clinically fit hearing aids). The order of the field trials will be randomized across participants to account for any potential order effects. After each field trial, participants will visit the lab to complete study outcome measures, including hearing aid benefit, subjective sound quality, and speech in noise intelligibility testing.

Conditions

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Hearing and Vision Loss

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Participants will be randomly assigned to arm 1 (audiologist fit) or arm 2 (self fit) first. After 2-3 weeks they will be tested and then assigned to the opposite arm.
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Participants
Participants will be randomly assigned and will not know which fit is first.

Study Groups

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audiologist arm

A research audiologist will fit the participant with the hearing devices according to usual clinical best practice procedures.

Group Type ACTIVE_COMPARATOR

Fitting algorithm

Intervention Type OTHER

The best fitting algorithm will be selected by the audiologist (arm 1) or software.

self-fit arm

Participants will follow manufacturer's printed instructions to complete the self-hearing test using the hearing aids and a provided app to program their hearing aids.

Group Type ACTIVE_COMPARATOR

Fitting algorithm

Intervention Type OTHER

The best fitting algorithm will be selected by the audiologist (arm 1) or software.

Interventions

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Fitting algorithm

The best fitting algorithm will be selected by the audiologist (arm 1) or software.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* mild to moderate hearing loss ability to follow written directions,

Exclusion Criteria

* inability to use software during first visit
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Minnesota

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of Minnesota

Minneapolis, Minnesota, United States

Site Status

Countries

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United States

Other Identifiers

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STUDY00015143

Identifier Type: -

Identifier Source: org_study_id

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