Recruiting

Observational Study

Sponsor:

Yu-Hsiang Wu

Code:

NCT06499805

Conditions

Hearing Loss, Sensorineural

Presbycusis

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Audiologist-based fitting

Over-the-counter fitting

Study Details

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.

Conditions

Hearing Loss, Sensorineural

Presbycusis

Study ID

NCT06499805

Start date

Mar 15, 2025

Status verified date

May, 2025

Completion date

Apr 1, 2029

Anticipated

Primary completion date

Apr 1, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • adult-onset, perceived bilateral mild-to-moderate hearing loss
  • no previous hearing aid experience

Exclusion Criteria:

  • Non-native speaker of English

Study Design

Enrollment

360 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Audiologist-based fitting

Description hearing aids will be fitted by audiologists using established procedures.

Over-the-counter fitting

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.

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 and Locations

Central contacts

Locations

University of Iowa

Recruiting

Iowa City, Iowa, United States, 52242

Vanderbilt University Medical Center

Recruiting

Nashville, Tennessee, United States, 37232

More Information

Sponsor

Yu-Hsiang Wu

Last update posted

May 21, 2025

Last verified

May, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Yu-Hsiang Wu on 2025-05-21.