FDA approves Apple’s AirPod’s hearing aid capability

( The Hill ) — Apple’s new Airpod Pros will double as an over-the-counter hearing aid.

On Thursday, the Food and Drug Administration (FDA) approved a hearing aid feature, which is a software-only mobile medical application.

“Today’s marketing authorization of an over-the-counter hearing aid software on a widely used consumer audio product is another step that advances the availability, accessibility and acceptability of hearing support for adults with perceived mild to moderate hearing loss,” said  Michelle Tarver, acting director of the FDA’s Center for Devices and Radiological Health.

According to the FDA, over 30 million Americans report some degree of hearing loss. Through Apple’s new mobile feature, users can customize the device with the offered self-fitting strategy which will allow the adjustment of hearing needs — all without the assistance of a hearing professional.

Since October 2022, due to new FDA hearing aid regulations , consumers can purchase products from stores or online retailers without a medical exam, prescription or an audiologist visit.

The AirPods Pro 2 will offer a “clinical grade” hearing test and professional grade hearing aid for iPhone and iPad users, in what the company claims is the world’s first software-enabled hearing aid feature.

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