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FDA Authorizes First Over-the-Counter Hearing Aid Software


The FDA authorized the first over-the-counter hearing aid software device intended to be used with compatible versions of the Apple AirPods Pro headphones.

Using hearing aids has been linked to reductions in the frequency or severity of cognitive decline, depression and other health problems in older adults. Today’s authorization exemplifies the FDA’s continued commitment to provide safe and effective solutions for those with hearing loss, while also fostering innovation and convenience. The Hearing Aid Feature (HAF) is a software-only mobile medical application that is intended to be used with compatible versions of the AirPods Pro.

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