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 should 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 assistance software, effectively turning the in-ears into a form of hearing aid.
Apple announced the Hearing Aid mode on Sept. 10, noting the company anticipated federal approval to come “soon,” but the FDA moved quicker than expected.
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“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,” wrote Michelle Tarver, FDA director of the Center for Devices and Radiological Health.
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 who used the HAF self-fitting strategy achieved similar perceived benefit as subjects who received professional fitting of the same device. Results also showed comparable performance for tests measuring levels of amplification in the ear canal, as well as a measure of speech understanding in noise. No adverse events related to the device were observed in this study.”
The feature’s consumer approval bolsters the agency’s recent new OTC hearing aid regulations in 2022, which allowed consumers with “perceived mild to moderate hearing impairment” to purchase hearing aids without first obtaining a medical exam, prescription, or audiologist approval.
Hearing Aid capabilities will be available for compatible AirPods Pro devices in a future software update.
