Apple AirPods Pro 2 is now officially the first over-the-counter hearing aid device

The US Food and Drug Administration (FDA) has finally authorised the first over-the-counter (OTC) hearing aid software compatible with Apple AirPods Pro headphones. This new feature, which will be integrated into the AirPods Pro 2 through a software update, will allow the earbuds to function as personalised hearing aids. The feature is aimed at helping users with their perceived mild-to-moderate hearing impairment.
Earlier this week, Apple announced that its AirPods Pro 2 could be “transformed” into hearing aids with the upcoming software update. This new update, which was awaiting the green light from the FDA, will boost specific sounds in real time, including parts of speech and environmental noises. Now that the feature has been authorised, it is expected to be available to AirPods Pro 2 users in more than 100 countries and regions this fall.
Notably, the FDA’s decision to authorise OTC hearing software for AirPods Pro 2 follows its 2022 approval of OTC hearing aids, which allowed adults with mild-to-moderate hearing impairment to purchase hearing aids directly from retailers or online, bypassing the traditional requirements of a medical exam, prescription, or audiologist consultation.
With around 1.5 billion people worldwide living with hearing loss, Apple now aims to help by transforming AirPods Pro 2 into tools for prevention, awareness, and assistance.
Once the feature is released, the Hearing Aid software for AirPods Pro 2 will help users with three key features:
Prevention: The update will introduce a new Loud Sound Reduction feature to help users avoid harmful noise levels without compromising their listening experience. Unlike previous methods that relied on notifications, this feature actively reduces loud, intermittent sounds in real time, whether on public transport, at a concert, or when using noisy household devices. This will help users protect their hearing more effectively in various environments.
Awareness: AirPods Pro 2 will also include a Hearing Test feature that lets users check their hearing at home using their iPhone or iPad. The test uses pure-tone audiometry, a common clinical method, to create a personalised hearing profile. Results are then stored in the Health app, allowing users to track their hearing health and share data with healthcare providers if needed.
Assistance: For those with mild to moderate hearing loss, AirPods Pro 2 will also offer an over-the-counter Hearing Aid feature. Using the personalised hearing profile from the Hearing Test, the AirPods will adjust sounds in real time, enhancing conversations and improving environmental awareness. This feature is aimed at providing a basic hearing aid function through the AirPods, offering support for users needing assistance with everyday hearing.
These new updates will make the AirPods Pro 2 useful for managing hearing health, addressing prevention, awareness, and assistance needs. Notably, the Hearing Aid feature is a software-only mobile medical application that integrates with iOS devices like iPhones. The setup process will include using the iOS HealthKit to assess the user’s hearing levels, allowing the AirPods Pro 2 to be customised to the individual’s specific hearing needs.
The FDA’s authorisation of this hearing aid software for Apple’s AirPods Pro 2 will now allow the device to be used as an OTC hearing aid without the need for a prescription or a visit to an audiologist. The software is intended for individuals aged 18 and older who experience perceived mild-to-moderate hearing loss, which affects over 30 million American adults. This demographic often faces hearing challenges due to factors such as ageing, prolonged exposure to loud noises, and certain medical conditions.