Apple AirPods Pro granted FDA approval to serve as hearing aids

2 months ago 14
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The iPhone 16 took center stage at Apple’s “Glowtime” event, but the most interesting tidbit came from a different line entirely. Indeed, among a sea of new hardware came an intriguing software update to one already on the market: the AirPods Pro 2.

Apple announced that its most premium earbuds would double as an over-the-counter hearing aid, courtesy of a software update, pending approval from the U.S. Food and Drug Administration.

The FDA on Thursday announced that it has granted what it calls “the first over-the-counter (OTC) hearing aid software device, Hearing Aid Feature.” Specifically, it has approved the software update that enables that functionality.

“Hearing loss is a significant public health issue impacting millions of Americans,” the FDA’s Michelle Tarver notes in a statement. “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.”

The news was made possible in part by the FDA’s October 2022 move to allow for the sale of hearing aids without a prescription. That move has given rise to an new industry of more easily accessible hearing devices.

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