In a move aimed at broadening access to hearing assistance, the U.S. Food and Drug Administration (FDA) has authorized the first over-the-counter (OTC) hearing aid software device designed for Apple AirPods Pro.

Dubbed the Hearing Aid Feature (HAF), this software allows certain versions of AirPods Pro to function as hearing aids for adults aged 18 and older with perceived mild to moderate hearing impairment. The FDA's announcement was made on Sept. 12.

"Hearing loss is a significant public health issue impacting millions of Americans," Michelle Tarver, M.D., Ph.D., acting director of the FDA's Center for Devices and Radiological Health, said in a news release. "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 experience some form of hearing loss, a condition that can stem from aging, exposure to loud noises, medical conditions and other factors. The effects of hearing loss extend beyond communication difficulties, impacting emotional well-being, relationships and even work or school performance. Research shows that hearing aids can help reduce the risk of cognitive decline and depression in older adults.

The FDA's authorization of HAF follows the agency's 2022 OTC hearing aid regulations, which made it easier for consumers to purchase hearing aids without needing a medical exam, prescription or audiologist consultation. These rules, which focus on adults with mild to moderate hearing loss, have opened the door to more affordable and accessible options according to the release.

The newly approved HAF is a software-only application designed for iOS devices, such as iPhones and iPads. The application uses a self-fitting strategy that allows users to adjust volume, tone, and balance settings based on their specific hearing needs, all without the need for professional help. The software is tailored using the user's hearing data stored in Apple's HealthKit, enabling a personalized hearing aid experience.

Per the release, a clinical study involving 118 participants with perceived mild to moderate hearing loss demonstrated that those using HAF achieved similar results to those who received professional fittings. Participants reported comparable performance in speech understanding in noisy environments and sound amplification, with no adverse effects recorded.

The FDA reviewed this application through its De Novo premarket review pathway, which is used for novel, low- to moderate-risk medical devices.

Apple Inc. has been granted marketing authorization for the Hearing Aid Feature.