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's AirPods Pro.

The announcement comes just days after Apple unveiled a new Hearing Aid feature and clinically validated Hearing Test feature for compatible AirPods Pro earbuds.

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According to Apple, users will be able to simply take a convenient hearing test in about five minutes right from the comfort of their home, and then the user's personalized hearing profile will be reflected in the AirPods Pro listening experience.

“For decades, Apple has led the way in designing products for everyone and supporting users with a broad spectrum of hearing abilities,” said Sarah Herrlinger, Apple’s senior director of Global Accessibility Policy and Initiatives. “These features on AirPods Pro will make an impact on so many people by driving more awareness around hearing health and empowering individuals with new customizable tools to help them stay connected.”

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Apple said its new Hearing Aid feature was clinically validated in a controlled, randomized study, and hopes it will offer assistance to the 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 significant public health issue impacting millions of Americans,” said Dr. Michelle Tarver,, acting director of the FDA's Center for Devices and Radiological Health. “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.”