On Thursday, the U.S. Food and Drug Administration (FDA) approved the first over-the-counter hearing aid software designed for use with compatible versions of Apple’s (AAPL.O) AirPods Pro headphones.
Earlier this week, Apple announced that its AirPods Pro 2 can be transformed into a personalized hearing aid through an upcoming software update.
Apple to Launch New Hearing Health Features for AirPods Pro 2 Users in Over 100 Countries This Fall
Once installed and tailored to the user’s hearing needs, the software enables compatible versions of AirPods Pro to function as an over-the-counter hearing aid. Consequently, it amplifies sounds for individuals aged 18 and older who experience mild-to-moderate hearing loss, according to the health regulator.
“Hearing loss is a major public health concern affecting millions of Americans,” stated Michelle Tarver, acting director of the FDA’s Center for Devices and Radiological Health.
“Hearing loss is a significant public health concern impacting millions of Americans,” said Michelle Tarver, the acting director of the FDA’s Center for Devices and Radiological Health.
In 2022, the health regulator approved the sale of over-the-counter hearing aids, allowing adults with mild-to-moderate hearing loss to obtain them directly from stores or online retailers without needing a medical exam, prescription, or a visit to an audiologist.
Apple’s newly authorized Hearing Aid Feature is a software-only mobile medical application that users set up on their iOS devices, such as an iPhone. The feature customizes itself based on the user’s hearing levels, which the application retrieves from iOS HealthKit.