More than 30 million American adults report some degree of hearing loss. Hearing loss can result from aging, exposure to loud noises, medical conditions, and other factors. It can negatively affect communication, relationships, and emotional well-being. Studies have linked hearing aids to reductions in cognitive decline, depression, and other health issues in older adults. The development of OTC hearing aids for mild to moderate hearing loss is an exciting step forward in addressing this public health concern.

On September 12, 2024, the U.S. Food and Drug Administration (FDA) authorized the first over-the-counter (OTC) hearing aid software device, Hearing Aid Feature. This innovative technology is designed to work with compatible versions of the Apple AirPods Pro headphones. The Hearing Aid Feature allows the AirPods Pro to function as an OTC hearing aid, amplifying sounds for adults over 18 years old with mild to moderate hearing impairment.

“Hearing loss is a significant public health issue impacting millions of Americans,” said Michelle Tarver, M.D., Ph.D., 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.”

How exciting is this news? Think about the adults in your life who are struggling with hearing loss. Simply purchasing this software and a pair of AirPods could be life-changing! Spread the word!

Stay well and stay informed!

For more information:

De Novo Classification Request | FDA

Federal Register :: Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the-Counter Hearing Aids