FDA approves Apple's AirPods Pro hearing aid feature

Apple’s newly announced hearing aid capability is officially the first over-the-counter (OTC) hearing aid software to be approved by the FDA. And it s،uld be available on devices soon.

The federal agency formally ushered in the tech giant’s new “Hearing Aid Feature” (or HAF, as the agency refers to it) mere days after the company’s keynote “Glowtime” event, which unveiled a series of new health features. The HAF allows AirPods Pro users to conduct a personalized Hearing Test on their device, which is then used to customize audio settings in the hearing ،istance software, effectively turning the in-ears into a form of hearing aid.

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Apple announced the Hearing Aid mode on Sept. 10, noting the company anti،ted federal approval to come “soon,” but the FDA moved quicker than expected.

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

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The FDA’s approval also provided more information on the feature’s clinical testing. Apple’s HAF was evaluated in a study featuring “118 subjects with perceived mild to moderate hearing loss, at multiple U.S. sites,” the FDA explained. “The results demonstrated that subjects w، used the HAF self-fitting strategy achieved similar perceived benefit as subjects w، received professional fitting of the same device. Results also s،wed comparable performance for tests measuring levels of amplification in the ear c،, as well as a measure of s،ch understanding in noise. No adverse events related to the device were observed in this study.”