FDA Approves OTC Hearing Aid Software for Apple AirPods Pro

The U.S. Food and Drug Administration on Thursday approved the first over-the-counter hearing aid software that is compatible with Apple AirPods Pro.

The news comes just days after Apple unveiled a new hearing aid feature and a clinically proven hearing test feature for compatible AirPods Pro.

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Apple says users will be able to simply complete a convenient five-minute hearing test from the comfort of their home, and then the user’s personalized hearing profile will be reflected in the listening experience provided by AirPods Pro.

“For decades, Apple has been a leader in designing products for everyone and supporting users across a broad spectrum of hearing abilities,” said Sarah Herrlinger, Apple’s senior director of Global Accessibility Policy and Initiatives. “These features in AirPods Pro will impact so many people by raising awareness of hearing health and giving people new, customizable tools to help them stay connected.”

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Apple said its new Hearing Aid feature has been clinically validated in a randomized, controlled trial and hopes it will offer help to millions of people experiencing hearing loss. The feature is expected to become available to users in an upcoming iOS software update.

“Hearing loss is a serious public health problem that affects millions of Americans,” said Dr. Michelle Tarver, acting director of the FDA’s Center for Devices and Radiological Health. “Today’s approval of over-the-counter hearing aid software in a commonly used consumer audio product is another step that increases the availability, affordability and acceptability of hearing support for adults with perceived mild to moderate hearing loss.”