FDA authorizes first over-the-counter hearing aid software for use in Apple’s AirPods Pro

The U.S. Food and Drug Administration on Thursday approved the first over-the-counter hearing aid software to be used with compatible versions of Apple’s (AAPL.O) headphones, opening up a new tab for AirPods Pro.

Apple earlier this week said its AirPods Pro 2 would be able to be “transformed” into a personalized hearing aid via an upcoming software update that would amplify certain sounds in real time, including parts of speech or elements of the user’s environment.

Apple announced that new hearing health features will be available this fall for AirPods Pro 2 users in more than 100 countries and regions.

Once installed and the software is adjusted to the user’s hearing needs, AirPods Pro can be used as over-the-counter hearing aids designed to amplify sounds for people aged 18 and over with presumed mild or moderate hearing impairments, the health regulator said.

“Hearing loss is a serious public health problem that affects 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 age, exposure to loud noises, certain medical conditions, and other factors.

Tarver added that authorizing over-the-counter hearing aid software increases the availability, affordability and acceptability of hearing aids.

In 2022, the health regulator approved the sale of over-the-counter hearing aids, allowing adults with mild to moderate hearing impairment to access hearing aids directly from brick-and-mortar stores or online retailers without the need for a medical examination, prescription or visit to an audiologist.

The hearing aid feature Apple authorized Thursday is a software-only mobile health app that is configured using an iOS device such as an iPhone. The user’s hearing level is available in the iOS HealthKit app, which lets them customize the feature.