Apple has received FDA approval for its newly announced new hearing aid feature for its AirPods Pro 2 wireless headphones.
According to the FDA, the hearing aid feature was evaluated in a clinical study involving 118 people with mild to moderate hearing loss, and no adverse events related to the device were reported in this study.
“Today’s approval of a software-based hearing aid is another step forward in advancing the availability and support of hearing for adults with mild to moderate hearing loss,” said Michelle Tarver, director of the FDA’s Center for Health Devices, in a press release.
The Hearing Aid feature is the first of its kind, and is based on special software designed to help users with mild to moderate hearing loss.
This feature makes personalized adjustments to hearing and enhances ambient sounds in real time to improve hearing ability, after a certified hearing test that the user performs via his iPhone within 5 minutes at home.
FDA approval is a necessary step before the feature is widely available, as Apple plans to launch it for AirPods Pro 2 wireless headphones owners in more than 100 countries and regions around the world.
Apple is expected to launch the Hearing Aid feature via a software update in the fall, and it will be available for the AirPods Pro 2 when paired with iPhones or iPads running iOS 18 or iPadOS 18.
The World Health Organization previously indicated that hearing loss in its various degrees is a global problem that affects about 1.5 billion people around the world. Factors contributing to hearing loss include aging, exposure to loud sounds, and some medical conditions.