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Study on Over-the-Counter vs. Audiologist-Fitted Hearing Aids

This study is looking at how well over-the-counter (OTC) hearing aids work compared to traditional hearing aids fitted by an audiologist. Hearing aids can help people with hearing loss, but they can be expensive and hard to get. OTC hearing aids are designed to be more affordable and easier to access. This study will compare the experiences of people who choose to fit their own OTC hearing aids with those who have their hearing aids fitted by an audiologist. Researchers want to understand what helps or hinders success with both approaches over 12 months. You may be able to join if you are 18 to 89 years old, have mild-to-moderate hearing loss that started in adulthood, and have never used hearing aids before. The study is currently recruiting 360 participants.

Study design
This study is an interventional study where participants choose between two ways to get hearing aids: either fitted by an audiologist or self-fitted over-the-counter. About 360 people will participate.
What's involved
Participants will have their hearing aid outcomes tracked for 12 months.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 12 months after starting their hearing aid intervention.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06499805

Barriers and Facilitators to OTC Hearing Aids Success

Recruiting
NAAges 18–89InterventionalTreatment
Yu-Hsiang Wu
~360 participants
Updated 2025-05-21 on ClinicalTrials.gov
What's tested:Audiologist-based fittingOver-the-counter fitting

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Hearing aid satisfaction as measured by the Satisfaction with Amplification in Daily Life (SADL)
Measured over 1-, 6-, and 12-month post-intervention

Conditions

Hearing Loss, Sensorineural
Presbycusis

Explore related trials

Hearing Loss

Where it's being run

2 sites across 2 states
Iowa1
Tennessee1

Study leadership

  • Yu-Hsiang Wu, PhD · PRINCIPAL_INVESTIGATOR · University of Iowa

Who to contact

Yu-Hsiang Wu, PhD
[email protected]
319-335-8728
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

adult-onset, perceived bilateral mild-to-moderate hearing loss
no previous hearing aid experience

Exclusion

Non-native speaker of English

What this trial measures

  • Hearing aid satisfaction as measured by the Satisfaction with Amplification in Daily Life (SADL)1-, 6-, and 12-month post-intervention

    The SADL is a questionnaire designed to measures subject's perceived hearing aid satisfaction. The score ranges from 1 (low satisfaction) to 7 (high satisfaction).