FDA approves Apple AirPods as hearing aids

Apple’s AirPods Pro 2 come with software that lets you use the device as a hearing aid. Image courtesy of Apple/Release

September 13 (UPI) — The U.S. Food and Drug Administration has approved software that could turn the latest version of Apple’s AirPods Pro headphones into hearing aids.

The federal agency’s announcement on Thursday came just four days after the U.S. tech giant on Monday unveiled its revamped AirPods line of headphones, including the AirPods Pro 2 with a clinical-grade, over-the-counter hearing aid and a clinical hearing test that users can access through their iPhones.

According to Apple, users will be able to use their iPhone with the new AirPods Pro to create a personalized hearing profile that will “seamlessly transform AirPods Pro into a clinical-grade hearing aid.”

The U.S. Food and Drug Administration (FDA) said Thursday it is the first-ever product approval decision for over-the-counter hearing aid software.

“Today’s approval for the sale of over-the-counter hearing aid software on a commonly used consumer audio product is another step that increases the availability, affordability and acceptability of hearing support for adults with perceived mild to moderate hearing loss,” Michelle Tarver, acting director of the FDA’s Center for Devices and Radiological Health, said in a statement.

According to the FDA, the hearing assistance feature in AirPods Pro is intended for people 18 years of age and older with mild to moderate hearing impairment.

The device’s software-enabled hearing aid feature uses a “self-adjusting strategy” that lets users adjust AirPods Pro to their hearing needs without the help of a professional, the administration said. Adjustments are made via an iPhone or iPad, and the user’s hearing level is available through the HealthKit app on the device’s operating system.

The federal government said a clinical trial of 118 people in the United States found that the self-fitting strategy produced similar results to having the same device fitted by a professional.

“The results also showed comparable performance on tests measuring the level of amplification in the ear canal, as well as on a measure of speech understanding in noise,” the FDA said. “No device-related adverse events were observed in this study.”

According to the FDA, approximately 30 million adults report some form of hearing loss, and this impairment can negatively impact communication, relationships, productivity, and well-being.

AirPods Pro 2 is available for purchase for $249 on Apple’s website and in the company’s retail stores.