Apple receives FDA approval to transform AirPods Pro into hearing aids

Just days after Apple unveiled a new hearing aid feature for its second-generation AirPods Pro, the U.S. Food and Drug Administration (FDA) has granted approval for the software behind this functionality. In a press release, the FDA referred to Apple’s solution as “the first over-the-counter (OTC) hearing aid software device.”

The feature was “evaluated in a clinical study involving 118 participants with perceived mild to moderate hearing loss,” according to the FDA, with results showing that those using Apple’s self-fitting strategy experienced a comparable benefit to those who received a professional fitting for the same device.

The ability to use AirPods Pro as clinical-grade hearing aids is one of several new features Apple is introducing to the second-generation AirPods Pro this fall, as part of its ongoing commitment to hearing health. The earbuds will also include a Hearing Protection mode that shields ears in noisy environments like concerts. This mode, enabled by default, will maintain “natural and vibrant” sound quality at live performances.

Additionally, AirPods Pro users will have access to a new Hearing Test feature, where they tap the screen when hearing various tones through the earbuds. The test results, displayed in Apple’s Health app, will be used to create a personalized audio profile for the hearing aid function.

This advancement in hearing aid functionality for the AirPods Pro marks a major step forward in reducing stigma and lowering costs for consumers aiming to protect their hearing. According to the World Health Organization, around 1.5 billion people worldwide experience some degree of hearing loss.

Apple’s platforms already offer several features to alert users when they are exposed to dangerously loud environments or listening at levels that could cause permanent hearing damage—a logical progression from the company that introduced the iPod and later the iPhone.

The FDA also noted that Apple’s application was evaluated under De Novo classification, intended for “low- to moderate-risk devices that are novel and for which there is no prior legally marketed device.”