What is this study trying to find out about hearing loss?

This study is evaluating how two methods of obtaining hearing aids—the traditional audiologist-based pathway and the over-the-counter (OTC) pathway—affect user satisfaction and hearing outcomes. It aims to understand barriers and facilitators for hearing aid success to improve accessibility and long-term use for adults with mild-to-moderate hearing loss.

Who may be eligible for this hearing loss clinical trial?

Adults aged 18 to 89 years with bilateral mild-to-moderate hearing loss and no previous hearing aid experience may be eligible. Participants must be native English speakers. Please review eligibility criteria for more details.

Is there any cost to participate in this hearing loss clinical trial?

Study-related care, including hearing aids and all trial visits, is provided at no cost for the audiologist-based group. In the OTC group, participants purchase their own hearing aids. Personal travel expenses may vary and are not guaranteed to be covered.

Actively Recruiting

Phase Not Applicable

Age: 18Years - 89Years

All Genders

ID06499805

Comparing Over-the-Counter and Audiologist-Based Hearing Aid Use in Adults with Mild-to-Moderate Hearing Loss

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

360

Participants Needed

Research Sites

N/A

Total Duration

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

How This Trial Compares With Other Options

This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.

Factors	OTC Hearing Aid Fitting	Audiologist-Based Fitting
What is it?	Participants select, purchase, and fit their own hearing aids without professional support, following self-led instruction and adjustment.	Hearing aids are selected, fitted, and adjusted by audiologists using established protocols, with professional guidance throughout.
Role in trial	Investigational: evaluates real-world outcomes for self-fitted OTC hearing aids in adults new to amplification.	Comparator: evaluates outcomes for hearing aids fitted by professionals, representing established care.
Primary use	Self-amplification to improve hearing for mild-to-moderate loss—no clinical evaluation required.	Professional hearing aid fitting and monitoring for individualized hearing restoration in mild-to-moderate loss.
How is it used or performed?	Participants independently select, fit, and adjust devices based on provided instructions. No formal clinical visit is required.	Participants undergo audiometric evaluation and receive tailored device selection, fitting, and follow-up from audiologists.
Evidence maturity	Emerging evidence suggests self-fitting OTC hearing aids can improve hearing and satisfaction, but outcomes vary widely among users and there is less long-term data.	Extensive evidence supports professional fitting as effective in improving hearing and satisfaction for mild-to-moderate loss, with consistent outcomes and long-term follow-up.
Important limitations	Success depends heavily on user capability; individuals may have difficulty selecting, fitting, or maintaining devices independently. Outcomes can vary and lack clinical follow-up.	Professional fitting requires clinical visits, may involve higher cost, and is less accessible for individuals without insurance or access to audiology services.

Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.

Who Can Participate

Age: 18Years - 89Years

All Genders

Eligibility Criteria

You may qualify if you...

Adults with adult-onset, perceived bilateral mild-to-moderate hearing loss
No previous hearing aid experience

You will not qualify if you...

Non-native speaker of English

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