Barriers and Facilitators to OTC Hearing Aids Success

Part of paid clinical trials in Iowa City, Iowa.

Sponsor
Yu-Hsiang Wu
Study ID
NCT06499805
Status
Recruiting
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Conditions

  • Hearing Loss, Sensorineural
  • Presbycusis

Eligibility Criteria

Sex
ALL
Age
18 Years - 89 Years
Healthy Volunteers
Not accepted

Interventions

  • Audiologist-based fitting — DEVICE
    Description hearing aids will be fitted by audiologists using established procedures.
  • Over-the-counter fitting — DEVICE
    In this group, over-the-counter hearing aids will be used by subjects. Subjects will take the full initiative and responsibility for learning and using hearing aids.

Study Details

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.

Key Dates

Start date
Mar 15, 2025
Status verified
May 2025
Primary completion
Apr 1, 2029
Completion
Apr 1, 2029

Study Design

Enrollment
360 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Hearing aid satisfaction as measured by the Satisfaction with Amplification in Daily Life (SADL) [ Time Frame: 1-, 6-, and 12-month post-intervention ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
University of IowaIowa CityIowa52242
Yu-Hsiang Wu, PhD
Vanderbilt University Medical CenterNashvilleTennessee37232
Todd Ricketts, PhD

Find similar trials in Iowa City, IA

By research site
University of Iowa· Iowa City, IAVanderbilt University Medical Center· Nashville, TN

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