FDA Clears Apple AirPods Pro 2 As ‘Clinical Grade’ Hearing Aids

Image via Apple

Ears pricked up as Apple’s AirPods Pro 2, launched in 2022, received an unexpected boost during the tech giant’s flagship Glowtime event on Monday. Now, the US Food and Drug Administration (FDA) has given the popular earbuds the green light to function as clinical-grade hearing aids, a decision that could amplify the quality of life for millions of Americans.

This landmark approval allows Apple to release a software update that will transform the AirPods Pro 2 into over-the-counter hearing aids for adults 18 and older with mild to moderate hearing impairment. The feature—the first FDA-approved hearing aid software for a mainstream device—is set to roll out before the end of 2024.

The Hearing Aid Feature (HAF) is a software-based solution that allows users to adjust their hearing aid settings without needing a professional fitting, just a quick test they’ll complete on their iPhone or iPad. By connecting the AirPods Pro 2 to an iOS device, users can customize the volume, tone, and balance based on their individual hearing needs. The software pulls data from the iOS HealthKit, making the setup process simple and personalized.

Image via Apple

Image via Apple

In clinical trials involving 118 participants with mild to moderate hearing loss, the AirPods Pro 2’s hearing aid functionality performed comparably to professionally installed devices, says the FDA. Users found that the self-fitted AirPods provided similar levels of sound amplification and speech recognition in noisy environments, validating the device's effectiveness as a hearing aid alternative.

Image via Apple

Apple’s approach goes beyond basic amplification. The system integrates personalized hearing profiles that automatically adjust to various audio content, from music and movies to games and phone calls without requiring constant manual adjustments.

“Hearing loss is a significant public health issue impacting millions of Americans,” explains Michelle Tarver, MD, PhD, 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.” 

With more than 30 million American adults experiencing some degree of hearing loss, this FDA approval could offer a transformative, affordable alternative to traditional hearing aids, which have long been costly and difficult to access.

[via Forbes, AppleInsider, 9to5Mac, images via Apple]