Apple’s AirPods Pro 2 gain FDA approval as over-the-counter hearing aids

Why it matters: With a $250 price tag, Apple’s AirPods Pro 2 qualify as a premium set of earbuds. However, recent FDA authorization has transformed the device into one of the most affordable hearing aids on the market. Beginning later this year, Apple’s advanced hardware and software will offer consumers a flexible and accessible way to manage mild to moderate hearing loss.

Apple introduced new hearing health functionality for the AirPods Pro 2 during its recent Glowtime product showcase. Shortly afterward, the US Food and Drug Administration classified the device and Apple’s hearing software as over-the-counter-grade hearing aids.

While some prescription hearing aids can cost tens of thousands of dollars, Apple’s premium earbuds could significantly lower the cost of hearing assistance, making it accessible o millions of people with mild to moderate hearing loss. Additionally, iOS apps will offer extensive customization options, surpassing the capabilities of traditional hearing aids.

The FDA’s approval specifically applies to Apple’s “Hearing Aid” app, which allows users to fine-tune how their AirPods manage noise levels and respond to various external sounds. Ear health professionals can create audiograms for the app, which were tested using proven scientific methods. All users can generate a personalized hearing profile, affecting how the AirPods process music, videos, games, and other audio inputs. Additionally, AirPods Pro 2 will receive software to help users prevent and diagnose hearing loss.

With the release of iOS 18 on September 16, AirPods Pro 2 will introduce a new “Hearing Protection” feature, automatically engaged across all listening modes. The ear tips will activate passive noise reduction, while the device’s H2 processor protects against loud, intermittent sounds 48,000 times per second. If a user attends a live concert while wearing AirPods Pro, a high dynamic range algorithm will protect their ears without compromising the music’s quality.

Later this year, the Hearing Aid app will launch, offering an easy-to-use hearing test based on pure-tone audiometry and acoustic science. Users tap an icon on the screen to indicate when they hear a noise during the test, and the results, presented in straightforward language, can assist doctors in assessing hearing health. Even if the results show little to no hearing loss, the AirPods can analyze which frequencies a user hears most easily and optimize the audio experience accordingly.

The Hearing Aid functionality, exclusive to AirPods Pro 2, will be available in over 100 countries, including the US, Japan, and Germany.