NCT06499805 Barriers and Facilitators to OTC Hearing Aids Success
| NCT ID | NCT06499805 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Yu-Hsiang Wu |
| Condition | Hearing Loss, Sensorineural |
| Study Type | INTERVENTIONAL |
| Enrollment | 360 participants |
| Start Date | 2025-03-15 |
| Primary Completion | 2029-04-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 360 participants in total. It began in 2025-03-15 with a primary completion date of 2029-04-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * adult-onset, perceived bilateral mild-to-moderate hearing loss * no previous hearing aid experience Exclusion Criteria: * Non-native speaker of English
Contact & Investigator
Yu-Hsiang Wu, PhD
PRINCIPAL INVESTIGATOR
University of Iowa
Frequently Asked Questions
Who can join the NCT06499805 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 89 Years, studying Hearing Loss, Sensorineural. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06499805 currently recruiting?
Yes, NCT06499805 is actively recruiting participants. Contact the research team at yu-hsiang-wu@uiowa.edu for enrollment information.
Where is the NCT06499805 trial being conducted?
This trial is being conducted at Iowa City, United States, Nashville, United States.
Who is sponsoring the NCT06499805 clinical trial?
NCT06499805 is sponsored by Yu-Hsiang Wu. The principal investigator is Yu-Hsiang Wu, PhD at University of Iowa. The trial plans to enroll 360 participants.