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Apple AirPods Pro 2 gets FDA approval, is now the first over-the-counter hearing aid device

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Apple AirPods Pro 2 gets FDA approval, is now the first over-the-counter hearing aid device

Apple AirPods Pro 2 have received FDA approval to work as an over-the-counter hearing aid through a software update. The feature is intended to help users with mild to moderate hearing loss by amplifying sounds in real-time.

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Apple AirPods Pro 2 gets FDA approval, is now the first over-the-counter hearing aid device

The US Food and Drug Administration (FDA) has finally authorized 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 via a software update, will allow the earbuds to function as a personal hearing aid. The feature is intended to help users with their perceived mild-to-moderate hearing loss.

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Earlier this week, Apple announced that its AirPods Pro 2 could be “transformed” into hearing aids with an 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 authorized, 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 authorize OTC hearing software for AirPods Pro 2 follows its 2022 approval for OTC hearing aids, which allowed adults with mild to moderate hearing loss to purchase hearing aids directly from retailers or online, bypassing traditional requirements for a medical exam, prescription, or audiologist consultation.

With around 1.5 billion people worldwide living with hearing loss, Apple now wants to help by turning the AirPods Pro 2 into a tool for prevention, awareness, and support.

AirPods Pro 2 will now become more than just an audio device

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, which will 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 it’s on public transport, at a concert, or while using noisy home appliances. This will help users protect their hearing more effectively in different 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 personalized hearing profile. The results are then stored in the Health app, allowing users to track their hearing and share the data with healthcare providers if necessary.

Help: For people with mild to moderate hearing loss, AirPods Pro 2 will also offer an over-the-counter hearing aid feature. Using a personalized hearing profile from a hearing test, AirPods will adjust sounds in real time, enhancing conversations and improving environmental awareness. This feature aims to provide a basic hearing aid function through AirPods, providing support for users who need help with everyday hearing.

These new updates will make the AirPods Pro 2 useful for addressing hearing loss management, prevention, awareness, and assistance needs. Notably, the hearing aid feature is a software-only mobile medical application that integrates with iOS devices such as iPhones. The setup process will involve using iOS HealthKit to assess a user’s hearing level, allowing the AirPods Pro 2 to be customized to the individual’s specific hearing needs.

Hearing aid availability in Apple AirPods Pro 2

The FDA authorization of this hearing aid software for Apple’s AirPods Pro 2 allows the device to be used as an OTC hearing aid without the need for a prescription or visit to an audiologist. The software is intended for individuals 18 years of age or older who experience mild to moderate hearing loss, which affects more than 30 million U.S. adults. This demographic often faces hearing challenges due to factors such as aging, prolonged exposure to loud noise, and certain medical conditions.

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