Evaluating the Safety and Usability of an Over-the-Counter Medical Device for Adults With Mild to Moderate Hearing Loss: Formative and Summative Usability Testing.

ABSTRACT:

Background

Only 15% of the nearly 30 million Americans with hearing loss use hearing aids, partly due to high cost, stigma, and limited access to professional hearing care. Hearing impairment in adults can lead to social isolation and depression and is associated with an increased risk of falls. Given the persistent barriers to hearing aid use, the Food and Drug Administration issued a final rule to allow over-the-counter hearing aids to be sold directly to adult consumers with perceived mild to moderate hearing loss at pharmacies, stores, and online retailers without seeing a physician or licensed hearing health care professional.

Objective

We evaluated the safety and usability of an over-the-counter hearing aid prior to Food and Drug Administration approval and market rele

SUBMITTER: Salwei ME 

PROVIDER: S-EPMC11769691 | biostudies-literature | 2025 Jan

REPOSITORIES: biostudies-literature