Silver Spring, Maryland: On Thursday, the U.S. Food and Drug Administration (FDA) granted authorization for the first over-the-counter (OTC) hearing aid software designed to be used with Apple’s AirPods Pro headphones. This groundbreaking development allows users to convert their AirPods Pro into a personalized hearing aid with the upcoming software update.
Apple announced that its AirPods Pro 2 will soon feature enhanced hearing capabilities through a software update, enabling real-time amplification of specific sounds, including speech and environmental noises. These new hearing health features will be accessible this fall to AirPods Pro 2 users in over 100 countries and regions.
Once installed and tailored to individual hearing needs, the software will enable the AirPods Pro to function as an OTC hearing aid. This technology is intended to assist individuals aged 18 and older with mild-to-moderate hearing impairment by amplifying sounds effectively, according to the FDA.
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“Hearing loss is a significant public health issue impacting millions of Americans,” said Michelle Tarver, acting director of the FDA’s Center for Devices and Radiological Health. She noted that more than 30 million American adults experience some level of hearing loss due to aging, exposure to loud noises, medical conditions, and other factors. The approval of OTC hearing aid software marks a significant step forward in making hearing support more accessible and acceptable.
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In 2022, the FDA approved the sale of OTC hearing aids, allowing adults with mild-to-moderate hearing loss to purchase hearing aids directly from stores or online without needing a medical exam, prescription, or audiologist visit. The newly authorized Hearing Aid Feature for Apple’s AirPods Pro, a software-only mobile medical application, will be set up using an iOS device like an iPhone, with hearing levels customized via iOS HealthKit.
