Actively Recruiting

Phase Not Applicable
Age: 18Years - 89Years
All Genders
ID06499805

Barriers and Facilitators to OTC Hearing Aids Success

Led by Yu-Hsiang Wu · Updated on 2025-05-21

360

Participants Needed

2

Research Sites

N/A

Total Duration

On this page

Sponsors

Y

Yu-Hsiang Wu

Lead Sponsor

N

National Institute on Deafness and Other Communication Disorders (NIDCD)

Collaborating Sponsor

AI-Summary

What this Trial Is About

This research aims to compare the experiences and outcomes of adults with mild-to-moderate hearing loss who choose either the traditional audiologist-based pathway or the over-the-counter (OTC) pathway for obtaining hearing aids. The study focuses on evaluating how these different approaches affect hearing aid satisfaction, usage, and related hearing healthcare behaviors over time. It addresses the challenge that many people do not use hearing aids due to cost and accessibility barriers associated with the traditional method. Participants select their preferred pathway and proceed accordingly. In the audiologist-based (AUD) group, prescription hearing aids are fitted by audiologists using established procedures at university clinics. In the OTC group, participants self-diagnose their hearing loss, purchase OTC hearing aids directly from retailers or companies, and manage fitting and programming themselves. The study follows participants for 12 months, tracking their hearing aid use and related outcomes. Researchers contact participants at 1, 6, and 12 months after they begin using their hearing aids to assess satisfaction, overall hearing aid outcomes, quality of life related to hearing, and any issues with the devices. If participants stop or reduce hearing aid use, the study also evaluates their engagement with follow-up hearing care. The collected data from both pathways will be compared to better understand long-term effects and user experiences. The study is open to adults aged 18 to 89 years and does not involve masking or randomization.

CONDITIONS

Brief Title

Barriers and Facilitators to OTC Hearing Aids Success

Who Can Participate

Age: 18Years - 89Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults with adult-onset, perceived bilateral mild-to-moderate hearing loss
  • No previous hearing aid experience
Not Eligible

You will not qualify if you...

  • Non-native speaker of English

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 12 months

Participants choose their preferred hearing aid pathway and begin using their hearing aids either through audiologist-based fitting or over-the-counter fitting.

3 follow-up contacts at 1, 6, and 12 months

Trial Site Locations

Total: 2 locations

1

University of Iowa

Iowa City, Iowa, United States, 52242

Actively Recruiting

2

Vanderbilt University Medical Center

Nashville, Tennessee, United States, 37232

Actively Recruiting

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Research Team

Y

Yu-Hsiang Wu, PhD

E

Elizabeth Stangl, AuD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

The Effects of Service-Delivery Model and Purchase Price on Hearing-Aid Outcomes in Older Adults: A Randomized Double-Blind Placebo-Controlled Clinical Trial.

Larry E Humes, Sara E Rogers, Tera M Quigley...

https://pubmed.ncbi.nlm.nih.gov/28252160

Self-Adjusted Amplification Parameters Produce Large Between-Subject Variability and Preserve Speech Intelligibility.

Peggy B Nelson, Trevor T Perry, Melanie Gregan...

https://pubmed.ncbi.nlm.nih.gov/30191767