Home › Sensorineural Hearing Loss › NCT06499805
Barriers and Facilitators to OTC Hearing Aids Success
Who can join
Ages 18 to 89 · All sexes
Full 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
About the study
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.
What is being tested
- Audiologist-based fitting (device)
- Over-the-counter fitting (device)
Sponsor: Yu-Hsiang Wu · Participants: 360 · Started: Mar 15, 2025
Contact the study team
- Yu-Hsiang Wu, PhD · Phone: 319-335-8728
- Elizabeth Stangl, AuD · Phone: 319-335-9758
Official record on ClinicalTrials.gov — NCT06499805
Locations in the U.S.
| Iowa | University of Iowa, Iowa City |
| Tennessee | Vanderbilt University Medical Center, Nashville |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.