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OpenTrials
Completed

NCT Number: NCT05246904

Validating a Self-fitting Hearing Aid

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.

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Key information

Conditions

Hearing and Vision Loss Abnormalities, Multiple Blindness Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Deaf-Blind Disorders Deafness Ear Diseases Eye Diseases Hearing Disorders Hearing Loss Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms Vision Disorders

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • inability to use software during first visit

Treatment and study plan

Fitting algorithm

Other

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

Primary outcomes

  1. Abbreviated profile of hearing aid benefit

    Time frame: 2-3 weeks

    Survey of subjective benefit

  2. Speech in noise test, AZ Bio sentences

    Time frame: Immediately after fitting

    Sentence recognition test in background noise

Secondary outcomes

  1. Subjective sound quality rating

    Time frame: 2-3 weeks

    Participants rate the quality of sound through hearing aids

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Feb 18, 2022
Registry last updated
Apr 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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