FDA Greenlights First OTC Hearing Aid Software for Apple AirPods Pro

On Thursday, the U.S. Food and Drug Administration authorized the first over-the-counter hearing aid software intended to be used with compatible versions of the Apple AirPods Pro headphones.

Earlier this week, Apple (NASDAQ: AAPL) said its AirPods Pro 2 could now be “transformed” into a personalized hearing aid via an upcoming software update that would boost specific sounds in real-time, including parts of speech or elements within a user’s environment.

Apple said that this fall, AirPods Pro 2 users in more than 100 countries and regions will have access to new hearing health features.

Once installed and customized to the user’s hearing needs, the software enables versions of the AirPods Pro to serve as an OTC hearing aid, that is intended to amplify sounds for 18 years or older people with perceived mild-to-moderate hearing impairment, the health regulator said.

“Hearing loss is a significant public health issue impacting millions of Americans,” said Michelle Tarver, acting director of the FDA’s Center for Devices and Radiological Health.

More than 30 million American adults report some degree of hearing loss, which can be caused by aging, exposure to loud noises, certain medical conditions, and other factors.

The authorization of an over-the-counter hearing aid software advances the availability, accessibility, and acceptability of hearing support, Tarver added.

In 2022, the health regulator approved the sale of over-the-counter hearing aids that allowed adults with mild-to-moderate hearing impairment to access hearing aids directly from stores or online retailers without the need for a medical exam, prescription, or seeing an audiologist.

Apple’s Hearing Aid Feature, authorized on Thursday, is a software-only mobile medical application. It is set up using an iOS device like an iPhone, and the user’s hearing levels are accessed from the iOS HealthKit to customize the feature.

(Source: Reuters)