Apple AirPods Pro 2 Now Receives FDA Authorization for Use in Hearing Aids

During its big It’s Glowtime event, Apple announced that its AirPods Pro 2 headphones will get a groundbreaking new feature that will let people use them as mainstream hearing aids — a first of its kind.

Following this announcement, the U.S. Food and Drug Administration (FDA) announced that it had granted Apple authorization for the “first over-the-counter (OTC) hearing aid software, Hearing Aid Feature (HAF), for use with compatible versions of Apple AirPods Pro.”

According to the FDA, when adjusted to the hearing needs of the AirPods Pro 2 user, already some of the best wireless earbuds you can get, they can amplify sounds for people with mild to moderate hearing loss. The government agency also noted that the feature is intended for users 18 years and older.

“Today’s approval to sell over-the-counter hearing aid software in a commonly used consumer audio product is another step that increases the availability, affordability and acceptability of hearing support for adults with mild to moderate hearing loss.”
Dr. Michelle Tarver, FDA

A key part of the FDA’s announcement is the mention that users can adjust AirPods Pro 2 to their hearing needs without the help of a hearing professional. For those who don’t want — or can’t afford — to see a doctor, the ability to adjust volume, tone, and balance on their own is a great option.

The FDA says it tested the Hearing Aid Feature with 118 adults with mild to moderate hearing loss in multiple locations across the U.S. They found that Apple’s AirPods Pro 2 had similar benefits to professionally fitted hearing aids. “The self-fitting HAF strategy produced similar perceived benefits to those who received a professional fit for the same device,” the FDA report says. “No device-related adverse events were observed in the study.”

Speaking about the significance of an OTC hearing aid for the public, Michelle Tarver, MD, PhD, Acting Director of the FDA’s Center for Devices and Radiological Health, said, “Today’s approval 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 mild to moderate hearing loss.”

More than 30 million American adults have some degree of hearing loss, whether it’s due to natural aging, exposure to loud noise, medical conditions, or other factors. Having a device like the AirPods Pro 2 on hand, the FDA notes, could reduce the frequency or severity of mental decline, depression, and health problems in older adults.