Apple just got the approval it needs from the U.S. Food and Drug Administration to make the latest AirPods Pro into medical-grade hearing aids.
Once Apple releases a software update for the wireless earbuds, they’ll be able to help those with mild to moderate hearing loss.
AirPods Pro 2 double as hearing aids
During the “It’s Glowtime” event on Monday, Apple announced that it would soon upgrade AirPods Pro 2 genuine medical-grade hearing aids. But in the U.S. that requires approval by the FDA — an approval the iPhone-maker received on Thursday.
“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, in a statement. “Today’s marketing authorization of an over-the-counter hearing aid software on a widely used consumer audio product is another step that advances the availability, accessibility and acceptability of hearing support for adults with perceived mild to moderate hearing loss.”
Many people resist getting a hearing aid because they think they’re too young to need one, or are too self-conscious about looking old. Soon, this group can wear AirPods and no one needs to know that they’re being used as hearing aids.
An ‘over-the-counter hearing aid software’
The FDA apparently calls Apple’s feature upgrade for AirPods Pro 2 a “hearing aid software device” because it’s a software upgrade for an existing product. Previous Bluetooth earbuds that have received FDA approval to be marketed as helping with hearing loss were designed for that purpose. AirPods are the first entertainment-oriented devices to be upgraded with the capability.
The upgrade includes a clinically validated hearing test taken with the Airpods and iPhone. This enables the earbuds to boost the specific sounds the wearer needs.
Coming this autumn
Sumbul Desai, MD, Vice President of Health at Apple, promised at Monday’s event that the necessary AirPods Pro 2 software upgrade will launch “this fall in over 100 countries and regions, including the US, Germany and Japan.”
To be clear, the hearing aid functionality is coming only to AirPods Pro 2, and surely the third-generation version when it launches in 2025. Original AirPods Pro from 2019 are not compatible. Nor are AirPods 4 announced Monday.
