FDA Authorizes Apple’s “Hearing Aid Feature” to Allow AirPods to Function as OTC Hearing Aids

On Sept 12, 2024 the FDA issued the necessary authorization to Apple to allow their latest AirPods to have a “Hearing Aid Feature” and Hearing Protection. This is made possible by the FDA’s October 2022 authorization to allow for a new category of hearing devices called “Over-The-Counter Hearing Aids”. These differ from Prescription Hearing aids as they do not require a licensed professional, such as an Audiologist, to fit and dispense them. OTC Hearing Aids are intended for use by adults, 18 years of age and older, with perceived mild to moderate levels of hearing loss. They come in a variety of form factors from several companies and are designed to be “self-fit” but the end user. Typically OTC hearing aids utilize a smart phone app for set up. Unfortunately, hearing aids are not covered by insurance or Medicare so there is a financial barrier to access for those who need hearing help. The aim of these authorizations is is to increase access to amplification for millions of Americans with hearing loss.