FDA Authorizes First Over-the-Counter Hearing Aid Software

The U.S. Food and Drug Administration authorized the first over-the-counter (OTC) hearing aid software device, Hearing Aid Feature, intended to be used with compatible versions of the Apple AirPods Pro headphones. 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.”

More than 30 million American adults report some degree of hearing loss. Hearing loss can be caused by aging, exposure to loud noises, certain medical conditions, and other factors. Hearing loss can have a negative effect on communication, relationships, school or work performance and emotional well-being. Using hearing aids has been linked to reductions in the frequency or severity of cognitive decline, depression and other health problems in older adults.

The FDA’s OTC hearing aid regulationsExternal Link Disclaimer established in October 2022 represented a significant step toward helping ensure that adults with mild to moderate hearing loss have improved access to more safe and effective product options. The rule enabled consumers with perceived mild to moderate hearing impairment to purchase hearing aids directly from stores or online retailers without the need for a medical exam, prescription or seeing an audiologist. Today’s authorization exemplifies the FDA’s continued commitment to provide safe and effective solutions for those with hearing loss, while also fostering innovation and convenience.

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.

As part of the Center for Devices and Radiological Health’s strategic priority to advance health equity, the Center will continue to support innovation that expands access to important technologies and brings health care directly to patients.

The FDA granted marketing authorization of the Hearing Aid Feature to Apple Inc.