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Apple Gets FDA Greenlight To Sell AirPods as Hearing Aids
Apple has received the Food and Drug Administration's imprimatur to market its AirPods Pro 2 product as over-the-counter, clinical-grade hearing aids.
Specifically, the FDA has approved Apple's "hearing aid feature," a new capability that will be delivered in a software update this fall to AirPods Pro 2 users in over 100 countries.
The approval, announced Thursday, is the first issued by the FDA for over-the-counter hearing aid software.
"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, in a prepared statement.
Apple first described the hearing aid feature earlier this week, ahead of the FDA approval. Best used to alleviate mild to moderate hearing impairment, the feature will let AirPods Pro 2 users configure their devices to magnify sounds in real time, whether they’re in the middle of a phone call, an in-person conversation or a movie playing on their iOS device.
The feature can be customized to suit the user's specific needs. For example, AirPods Pro 2 devices with the update can access a user's audiogram results -- obtained from a doctor -- from the iOS Health app. Alternatively, users can take a hearing test directly on their compatible iOS device. The AirPods will automatically adjust their audio levels based on the results.
"Using the personalized hearing profile from the Hearing Test, this new feature seamlessly transforms AirPods Pro into a clinical-grade hearing aid," Apple said. "After setup, the feature enables personalized dynamic adjustments so users have the sounds around them boosted in real time."
The FDA tested the hearing aid feature in a 118-person clinical study, and found no negative effects from its use. Instead, the participants reported hearing improvements that are on par with professionally fitted hearing aids.
"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," the agency said.
More information on the hearing aid feature can be found on this Apple product page.