Apple AirPods Are Now FDA-Approved Hearing Aids — Here's What That Means

Forbes

a day ago

SAN FRANCISCO, CA - SEPTEMBER 07: A pair of the new Apple AirPods are seen during a launch event on ... More September 7, 2016 in San Francisco, California. Apple Inc. unveiled the latest iterations of its smart phone, the iPhone 7 and 7 Plus, the Apple Watch Series 2, as well as AirPods, the tech giant's first wireless headphones. (Photo by)
Apple's AirPods Pro 2 now officially double as hearing aids.
With FDA clearance granted late last year, the earbuds can be used as over-the-counter hearing devices for adults with mild to moderate hearing loss, marking a notable development in Apple's healthcare story.
The feature is rolling out to more countries this month, including Australia, Indonesia, Taiwan, and Vietnam, CEO Tim Cook confirmed in a July 15 post on X. In the same update, Apple expanded access to another health-oriented tool: sleep apnea detection for newer Apple Watch models.
The hearing aid function was first announced in 2024, alongside a suite of hearing health updates, and Apple at the time noted that it was still awaiting FDA clearance. That approval came in September, allowing the company to market the feature as an over-the-counter medical tool.
Unlike traditional hearing aids, which are often expensive and require in-person fittings, the AirPods Pro 2 update allows users to assess and manage their hearing through software alone. The process begins with a five-minute hearing test delivered via iPhone or iPad, which measures the user's ability to hear tones at varying frequencies. That data is then used to generate a custom hearing profile, stored in the iOS Health app, which automatically adjusts audio playback across calls, music, and other media.
Apple has also introduced a passive hearing protection mode that reduces exposure to loud environmental noise in real time — a feature the company says will remain always on.
The FDA cleared a new class of over-the-counter hearing aids in 2022 — the rule was designed to expand access to basic hearing care and lower costs, especially for adults with mild to moderate loss, a group the FDA estimates includes roughly 30 million Americans. While other companies including Bose and Eargo have launched OTC hearing aids since the rule took effect, Apple's entry arrives not through a medical device but via an update to an existing consumer product already owned by millions.
According to the World Health Organization, 1.5 billion people globally — nearly 20% of the population — live with some form of hearing loss, and the vast majority do not use hearing aids. That disconnect is often attributed to stigma, limited access, and cost — problems Apple is now attempting to address by integrating hearing assistance into mainstream, albeit also expensive, hardware.
This is definitely not Apple's first step into health tech, but it may be one of its more consequential ones: While features like heart-rate tracking and fall detection on the Apple Watch have been marketed as wellness tools, the new hearing and sleep offerings edge closer to medical-grade territory.
Meanwhile, the firm's sleep apnea detection tool, which uses wrist motion data to flag 'breathing disturbances' during sleep, also received clearance from the U.S. Food and Drug Administration — the feature is available on the Apple Watch Series 9, Series 10, and Ultra 2, and is now rolling out in over 150 countries.
Apple said the tool was trained and validated using a large clinical dataset and will analyze a user's breathing patterns over time to determine whether they show signs of moderate or severe sleep apnea. The results, categorized as 'elevated' or 'not elevated,' are viewable in the Health app, along with a report users can share with their physicians. According to Apple, the algorithm has been clinically validated and is intended to support, rather than replace, formal diagnosis or treatment.
Separately, Samsung also secured FDA clearance for its Galaxy Watch sleep apnea tracking last year.
As wearables increasingly take on functions once reserved for medical devices, the regulatory, ethical and consumer sentiment underpinning them may be ones to watch. Apple has so far walked a careful line, framing these tools as supplemental, useful for early detection or lifestyle awareness, but not total replacements for clinical care. In the case of the AirPods, the device now technically qualifies as a hearing aid under FDA rules, but its software-only setup also means that users are managing their own hearing support without audiologist involvement.
Whether this kind of DIY model will meet user needs as well as clinical standards is so far unknown, but perhaps it could alter expectations for what health tech looks like and, if embraced at scale, who its users are. For those who already own AirPods Pro 2, the update could offer a way to detect and manage early-stage hearing loss at no additional cost, and for Apple, it marks a push towards building medical capabilities into its most popular devices — whether or not the public views them as medical-grade tech, or simply smarter accessories.