FDA Authorizes AirPods Pro 2 as First Over-the-Counter Hearing Aid Device

The U.S. Food and Drug Administration has announced authorization of AirPods Pro 2 as the first over-the-counter (OTC) hearing aid device when used with Apple's new Hearing Aid feature.

Once installed and customized 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 18 years or older with perceived mild to moderate hearing impairment.

"Hearing loss is a significant public health issue impacting millions of Americans," said Michelle Tarver, M.D., Ph.D., acting director of the FDA's Center for Devices and Radiological Health. "Today's marketing authorization of an over-the-counter hearing aid software on a widely used consumer audio product is another step that advances the availability, accessibility and acceptability of hearing support for adults with perceived mild to moderate hearing loss."




The Hearing Aid Feature (HAF) is a software-only mobile medical application that is intended to be used with compatible versions of the AirPods Pro. The HAF utilizes a self-fitting strategy, and users may adjust it to meet their hearing needs without the assistance of a hearing professional. The HAF is set up using an iOS device (e.g., iPhone, iPad), and the user's hearing levels are accessed from the iOS HealthKit to customize the HAF. Users can refine the volume, tone and balance settings after setting up the HAF.

The HAF was evaluated in a clinical study with 118 subjects with perceived mild to moderate hearing loss, at multiple U.S. sites. The results demonstrated that subjects who used the HAF self-fitting strategy achieved similar perceived benefit as subjects who received professional fitting of the same device. Results also showed comparable performance for tests measuring levels of amplification in the ear canal, as well as a measure of speech understanding in noise. No adverse events related to the device were observed in this study.

This application was reviewed under the FDA's De Novo premarket review pathway, a regulatory pathway for some low- to moderate-risk devices that are novel and for which there is no prior legally marketed device.


You can learn more about the upcoming Hearing Aid feature for AirPods Pro 2 here:
● Apple Details New Health Features for Apple Watch and AirPods

Apple says its Hearing Test and Aid features will be supported with AirPods Pro 2 with the latest firmware when paired with a compatible iPhone or iPad, and will be available this fall in more than 100 countries and regions, including the U.S., Germany, and Japan.

If you don't already have AirPods Pro 2, they are on sale today for $199 ($50 off)!

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