Apple and consumers scored a major win, with the US Food & Drug Administration authorizing the AirPods Prp as “the first over-the-counter (OTC) hearing aid software device.”

Apple introduced a number of new hearing health features at its recent iPhone event, including Hearing Test and Hearing Aid.

“With AirPods 4, customers can enjoy Active Noise Cancellation and the most advanced audio experience ever in an open-ear design,” said John Ternus, Apple’s senior vice president of Hardware Engineering. “And with a revolutionary update to the world’s best-selling headphones, AirPods Pro will deliver groundbreaking new capabilities — including Hearing Test and Hearing Aid features — to help more than a billion people affected by hearing loss.”

The FDA has now approved Apple’s software in an industry first.

“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 FDA said the new technology was tested extensively, with the findings confirming that Apple’s AirPods Pro delivered similar results as professional hearing aids.

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.

With more than 30 million Americans impacted by some degree of hearing loss, democratizing solutions is a step that will make it much easier for individuals to gain relief.