US FDA authorises first OTC hearing aid software to be used in Apple’s AirPods Pro

New hearing health features will be available this fall for AirPods Pro 2 users in more than 100 countries and regions, Apple had said.

Apple AirPods 4 now come with Active Noise Cancellation. (Image Source: Apple)

The US Food and Drug Administration on Thursday authorised the first over-the-counter hearing aid software that is intended to be used with compatible versions of the Apple AirPods Pro headphones.

Earlier this week, Apple said its AirPods Pro 2 could now be “transformed” into a personalised hearing aid via an upcoming software update that would boost specific sounds in real time, including parts of speech or elements within a user’s environment.

New hearing health features will be available this fall for AirPods Pro 2 users in more than 100 countries and regions, Apple had said.

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Once installed and customised to the user’s hearing needs, the software enables versions of the AirPods Pro to serve as an OTC hearing aid, that is intended to amplify sounds for 18 years or older people with perceived mild-to-moderate hearing impairment, the health regulator said.

“Hearing loss is a significant public health issue impacting millions of Americans,” said Michelle Tarver, acting director of the FDA’s Center for Devices and Radiological Health.

More than 30 million American adults report some degree of hearing loss, which can be caused by aging, exposure to loud noises, certain medical conditions, and other factors.

The authorisation of an over-the-counter hearing aid software advances the availability, accessibility and acceptability of hearing support, Tarver added.

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In 2022, the health regulator approved the sale of over-the-counter hearing aids that allowed adults with mild-to-moderate hearing impairment to access hearing aids directly from stores or online retailers without the need for a medical exam, prescription or seeing an audiologist.

Apple’s Hearing Aid Feature, authorised on Thursday, is a software-only mobile medical application and is set up using an iOS device like an iPhone and the user’s hearing levels are accessed from the iOS HealthKit to customise the feature.

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