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

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On Sep. 12, 2024, the the U.S. Food and Drug Administration (FDA) authorized the first over-the-counter (OTC) hearing aid software device, Hearing Aid Feature, intended to be used with compatible versions of the Apple AirPods Pro headphones.

Once installed and customized to the user’s hearing needs, the Hearing Aid Feature enables compatible versions of the AirPods Pro to serve as an OTC hearing aid, intended to amplify sounds for individuals 18 years or older with perceived mild to moderate hearing impairment.

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

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Source: U.S. Food and Drug Administration
Credit: Photo: Apple AirPods. Courtesy: Apple.