The U.S. Food and Drug Administration (FDA) has officially approved Apple's AirPods Pro 2 to receive clinical-grade hearing aid features in a future software update. First announced during Apple’s "Glowtime" event, the update promises to bring vital support for individuals dealing with hearing loss.
This marks the FDA’s first-ever authorization of an "over-the-counter hearing aid software device," tailored specifically for users aged 18 or older with perceived mild to moderate hearing impairment. With this new development, AirPods Pro 2 will function not just as high-end audio devices, but also as hearing aids.
"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. She highlighted that this approval is a critical step in improving the accessibility of hearing aid technology.
The software update was evaluated through a clinical study involving 118 people with mild to moderate hearing loss. Results showed that self-installation of the update offered similar benefits to professional installation, including improved amplification and better speech clarity in noisy environments.
Although Apple has yet to announce an exact release date, the hearing aid feature is expected to roll out before the end of 2024.
