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Barriers and Facilitators to OTC Hearing Aids Success
NCT06499805 · View on ClinicalTrials.gov ↗
Study Summary
Hearing aids can improve hearing, communication, and overall quality of life for people with hearing loss. However, not many people use hearing aids. A common reason is that hearing aids are expensive and hard to get. The traditional way to get hearing aids involves multiple visits to licensed audiologists for identifying hearing loss, customizing the aids, and ongoing maintenance. This traditional method is called the AUD pathway. Over-the-counter (OTC) hearing aids offer a different approach. They aim to make hearing aids more affordable and accessible, encouraging earlier use. In the OTC pathway, users diagnose their own hearing loss and fit and program the hearing aids themselves. Little is known about long-term effects of OTC hearing aids on users. This study aims to compare the experiences of people who choose the OTC pathway with those who choose the AUD pathway. It takes place in two locations: Iowa City, IA, and Nashville, TN. Participants, who have mild-to-moderate hearing loss, choose their preferred pathway and are followed for 12 months. In the OTC pathway, participants buy their hearing aids directly from OTC companies or retailers. In the AUD pathway, prescription hearing aids and fitting services are provided by audiology clinics at the University of Iowa and Vanderbilt University Medical Center. Participants are contacted 1, 6, and 12 months after starting to use their hearing aids. Researchers measure their satisfaction about hearing aids and other outcomes. If participants stop using their hearing aids, researchers assess their engagement with post-amplification hearing care. The results from both pathways are then compared.
Conditions Studied
Interventions
- DEVICE Audiologist-based fitting
- DEVICE Over-the-counter fitting
Study Locations (2)
Iowa
- University of Iowa — Iowa City
Tennessee
- Vanderbilt University Medical Center — Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 360 participants |
| Start Date | 2025-03-15 |
| Est. Completion | 2029-04-01 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06499805
The ClinicalTrials.gov registry entry for NCT06499805 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 360 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Yu-Hsiang Wu, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Hearing Loss, Sensorineural appearing as the primary indexed condition, and to 2 interventions — of which Audiologist-based fitting is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06499805 reports 2 study locations spanning 2 distinct geographic areas — top geographies include Iowa, Tennessee. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06499805 about?
NCT06499805 is a clinical study titled "Barriers and Facilitators to OTC Hearing Aids Success". Hearing aids can improve hearing, communication, and overall quality of life for people with hearing loss. However, not many people use hearing aids. A common reason is that hearing aids are expensive and hard to get. The traditional way to get hearing aids involves multiple visits to licensed audio...
What is the current status of trial NCT06499805?
This trial is currently recruiting. It is a NA study. The enrollment target is 360 participants. The study started on 2025-03-15. Estimated completion is 2029-04-01.
What conditions does trial NCT06499805 study?
This clinical trial studies the following conditions: Hearing Loss, Sensorineural, Presbycusis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06499805?
The interventions under investigation include: Audiologist-based fitting (DEVICE), Over-the-counter fitting (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06499805?
This trial is sponsored by Yu-Hsiang Wu, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06499805 being conducted?
This trial has 2 study locations across Iowa, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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