OTC vs Prescription Hearing Aids for Hearing Loss
Trial Summary
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications.
What data supports the effectiveness of the treatment Audiologist-based fitting, Over-the-counter fitting for hearing loss?
Research suggests that over-the-counter (OTC) hearing aids can increase accessibility and affordability for people with mild-to-moderate hearing loss, and a consumer-decides approach to selecting hearing aids has shown positive outcomes. However, audiologist-driven models tend to provide better results, indicating that professional guidance may enhance the effectiveness of OTC hearing aids.12345
Are over-the-counter (OTC) hearing aids safe for humans?
How do over-the-counter hearing aids differ from prescription hearing aids for hearing loss?
Over-the-counter (OTC) hearing aids are unique because they can be purchased directly by consumers without a prescription or fitting by an audiologist, making them more accessible and affordable compared to traditional prescription hearing aids. This new category aims to address barriers like high costs and stigma associated with hearing aid use, although there is limited research on their real-world effectiveness.238910
Research Team
Yu-Hsiang Wu, PhD
Principal Investigator
University of Iowa
Eligibility Criteria
This trial is for individuals with mild-to-moderate hearing loss, including sensorineural and age-related types. Participants can choose to fit their own over-the-counter (OTC) hearing aids or have them fitted by an audiologist. The study excludes certain people based on criteria not specified here.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Pathway Selection and Hearing Aid Acquisition
Participants choose their preferred pathway (OTC or AUD) and acquire hearing aids
Initial Use and Adjustment
Participants begin using their hearing aids and adjust to them
Follow-up
Participants are monitored for satisfaction and outcomes at 1, 6, and 12 months
Treatment Details
Interventions
- Audiologist-based fitting
- Over-the-counter fitting
Find a Clinic Near You
Who Is Running the Clinical Trial?
Yu-Hsiang Wu
Lead Sponsor
Vanderbilt University Medical Center
Collaborator
University of Manchester
Collaborator
National Institute on Deafness and Other Communication Disorders (NIDCD)
Collaborator