Barriers and Facilitators to OTC Hearing Aids Success

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 89
Healthy Volunteers: f
View:

• adult-onset, perceived bilateral mild-to-moderate hearing loss

• no previous hearing aid experience

Locations
United States
Iowa
University of Iowa
RECRUITING
Iowa City
Tennessee
Vanderbilt University Medical Center
RECRUITING
Nashville
Contact Information
Primary
Yu-Hsiang Wu, PhD
yu-hsiang-wu@uiowa.edu
319-335-8728
Backup
Elizabeth Stangl, AuD
elizabeth-stangl@uiowa.edu
319-335-9758
Time Frame
Start Date: 2025-03-15
Estimated Completion Date: 2029-04-01
Participants
Target number of participants: 360
Treatments
Active_comparator: AUD (audiologist-based)
In this group, the audiologist-based fitting will be used to provide prescription hearing aids.
Experimental: OTC (over-the-counter)
In this group, over-the-counter fitting will be used to provide over-the-counter hearing aids.
Related Therapeutic Areas
Sponsors
Leads: Yu-Hsiang Wu
Collaborators: National Institute on Deafness and Other Communication Disorders (NIDCD), Vanderbilt University Medical Center, University of Manchester

This content was sourced from clinicaltrials.gov