Breaking: FDA Finalizes Rule Allowing OTC Access to Hearing Aids

Millions of Americans will soon have access to lower cost hearing aids, thanks to a final rule from the FDA aiming to improve access to them.¹ The rule creates a category of OTC hearing aids, which allows a patient with mild to moderate hearing impairment to purchase a hearing aid from a store or online retailer without a medical exam, prescription, or adjustment by an audiologist. The change is part of the Biden-Harris Administration’s goal to expand access to care while lowering care costs.

Some air-conduction hearing aids meant for people aged 18 years and old with perceived mild to moderate hearing impairment will be included in the OTC category created by this rule. Devices for patients younger than 18 years or those meant for severe hearing impairment will continue to be prescription device.

The rule was finalized at the agency received over 1000 comments during the public comment period. As a result of those comments, the FDA amended several things in the rule including maximum sound input, revising insertion depth limit, simplifying the language required on the device’s label, and requiring volume control that can be adjusted by the user.

Along with the final rule, the FDA released guidance on the difference between hearing aids, which are medical devices, and consumer products that amplify sounds.

“Hearing loss is a critical public health issue that affects the ability of millions of Americans to effectively communicate in their daily social interactions,” said Robert M. Califf, MD, FDA Commissioner. “Establishing this new regulatory category will allow people with perceived mild to moderate hearing loss to have convenient access to an array of safe, effective, and affordable hearing aids from their neigbhorhood store or online.”

Reference

1. FDA finalizes historic rule enabling access to over-the-counter hearing aids for millions of Americans. News Release. FDA. August 16, 2022. Accessed August 17, 2022. https://www.fda.gov/news-events/press-announcements/fda-finalizes-historic-rule-enabling-access-over-counter-hearing-aids-millions-americans