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The FDA greenlights Apple’s Hearing Aid feature for AirPods Pro
The Food and Drug Administration has approved Apple’s over-the-counter Hearing Aid feature. Designed for people with mild to moderate hearing loss, it transforms the second-gen AirPods Pro into OTC hearing aids.
The FDA says Apple’s software-based Hearing Test feature for AirPods Pro showed similar benefits to those who received a professional fitting of the wireless earbuds. (If the test determines you have severe hearing loss, it will recommend you seek a professional assessment since the AirPods feature is only approved for those with mild to moderate impairment.) The company’s FDA application was reviewed under the agency’s De Novo premarket pathway, which provides a runway for novel devices that don’t carry serious risk.
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