Apple's hearing aid features for AirPods Pro 2 get FDA clearance in US

Apple's hearing aid feature enables compatible versions of the AirPods Pro to serve as an over-the-counter (OTC) hearing aid, says FDA

Apple AirPods Pro 2 has received clearance for its new hearing aid feature from the Food and Drug Administration (FDA) in the US. Announced at the iPhone 16 launch event on September 9, the hearing health features for the AirPods Pro 2 are coming later this year. With these health features, Apple aims to offer new tools for prevention, awareness, and assistance to users experiencing hearing loss.

While announcing the new hearing health features for the AirPods Pro 2, Apple stated that it had not yet received FDA clearance. However, the FDA, in a document dated September 12, confirmed that Apple’s “over-the-counter (OTC) hearing aid software device” has been authorised.

“Once installed and customised to the user’s hearing needs, the hearing aid feature enables compatible versions of the AirPods Pro to serve as an OTC hearing aid, intended to amplify sounds for individuals aged 18 years or older with perceived mild to moderate hearing impairment,” said the FDA in the document.

Apple AirPods Pro 2: Hearing health features

Apple announced several new hearing health tools for the AirPods Pro 2 aimed at offering prevention, awareness, and assistance to users. These new features will be rolled out to AirPods Pro 2 with a firmware update later this year.

To prevent hearing-related health issues, the AirPods Pro 2 will offer Loud Sound Reduction, helping users avoid loud environmental noises. The AirPods Pro 2 will also feature a Hearing Test that uses pure-tone audiometry to assess the user's hearing. The results of the Hearing Test will be displayed in the user’s personalised hearing profile within the Health app, which can be shared with healthcare providers for further consultation.

To assist users with mild to moderate hearing loss, Apple will be rolling out the new software-based Hearing Aid feature. Now authorised by the FDA in the US, this tool will analyse the user’s personalised hearing profile and amplify sound in real-time accordingly. In addition to assisting users in conversations and interactions, the Hearing Aid tool will be integrated across music, movies, and calls.

Apple said that the feature will be available in more than 100 countries and regions, including the United States, Germany, and Japan.