FDA authorizes first OTC hearing aid software to be used in Apple’s AirPods Pro

On Thursday, the U.S. Food and Drug Administration (FDA) authorized the first over-the-counter (OTC) hearing aid software for use with compatible Apple AirPods Pro headphones. This new development allows AirPods Pro 2 to function as personalized hearing aids through a software update, set to enhance specific sounds, such as speech and environmental elements, in real time.

Airpods

Earlier this week, Apple announced that the AirPods Pro 2 would receive this software upgrade, which can transform the earbuds into hearing aids tailored to the user’s hearing needs. The feature is expected to be available this fall for users in over 100 countries and regions.

Once installed and configured, the software is designed to assist adults aged 18 and older who have perceived mild to moderate hearing loss by amplifying sounds. According to the FDA, this OTC hearing aid option aims to make hearing support more accessible for the millions of Americans affected by hearing impairment.

“Hearing loss is a major public health concern, impacting millions across the country,” said Michelle Tarver, acting director of the FDA’s Center for Devices and Radiological Health. Tarver noted that more than 30 million adults in the U.S. experience some degree of hearing loss, which can result from factors such as aging, exposure to loud noises, or medical conditions.

The authorization of Apple’s hearing aid software builds on previous steps to make hearing support more widely available. In 2022, the FDA approved OTC hearing aids, enabling adults with mild to moderate hearing loss to purchase them directly from stores or online, bypassing the need for a medical exam or audiologist consultation.

Apple’s new feature, which was authorized on Thursday, is a software-only mobile medical application. Users can set it up using an iOS device, like an iPhone, and customize it based on their hearing profile through the iOS HealthKit.