Apple AirPods Pro 2 qualify as hearing aids for mild to moderate hearing loss

In September 2024, Apple received FDA clearance allowing its AirPods Pro 2 to be marketed as over-the-counter hearing aids for adults with mild to moderate hearing loss. This development marked a significant evolution in the integration of technology and healthcare, showcasing Apple’s commitment to expanding its role in health tech through mainstream devices already owned by many. The approval followed the FDA's 2022 introduction of a new category for over-the-counter hearing aids aimed at improving access to affordable hearing care, which is estimated to benefit approximately 30 million Americans. Unlike traditional hearing aids, which can be costly and require professional fittings, the AirPods Pro 2 enable users to manage their hearing health via software. A five-minute hearing test is conducted through an iPhone or iPad, measuring the user’s hearing at various frequencies. This data is then used to generate a custom hearing profile viewable in the iOS Health app, which alters audio settings for calls, music, and other audio sources according to individual needs. This approach signifies a shift towards self-managed healthcare, allowing users to take charge of their hearing needs without needing direct involvement from audiologists. Additionally, Apple has implemented a passive hearing protection feature that reduces exposure to loud noises, which operates continuously to help safeguard users from excessive environmental sounds. This initiative aligns with a notable trend wherein many adults who suffer from hearing loss do not use conventional hearing aids, often due to stigma, cost, and accessibility issues. With nearly 1.5 billion individuals worldwide experiencing some form of hearing loss, the integration of such features into widely-used consumer electronics could potentially reshape public views on hearing aids and increase their adoption. Moreover, Apple's advancements in health technology are not limited to hearing aids. The company has also acquired FDA clearance for a sleep apnea detection feature on its Apple Watch series. This tool uses wrist motion data to identify breathing disruptions during sleep, and it is designed to complement, rather than replace, traditional medical assessments for sleep disorders. Apple's objective appears to be to broaden its health tech capabilities while reaching a larger audience with functions initially seen merely as wellness tracking. The incorporation of these medical-grade features in popular consumer devices could alter expectations about the convergence of health technology and daily life, paving the way for easier access to health management tools.