Apple AirPods Pro 2 to Function as Hearing Aids with FDA Clearance

Apple AirPods Pro 2 can soon be used as hearing aids, after they received Food and Drug Administration (FDA) clearance, in what experts call a game changer for the hearing aid market.

FDA Authorization for Hearing Aid Feature

The FDA authorized a piece of software called Hearing Aid Feature (HAF) that will allow Apple AirPods Pro 2 and other compatible Apple AirPods Pro devices to function as hearing aids when paired with an iOS 18-compatible iPhone or iPad. This is the first time the FDA has authorized an over-the-counter hearing aid software.

iOS 18 Release and HAF Availability

iOS 18, the software through which HAF will be available, is set to arrive by October, according to Apple.

Impact on Hearing Loss Community

The new HAF is aimed at the estimated 30 million Americans who suffer from mild to moderate hearing loss due to aging, exposure to loud noises, certain medical conditions, and other factors. The application features a hearing test, whose results are used to customize the volume, tone, and balance settings that are built into the hearing aid.

“Hearing loss is a significant public health issue impacting millions of Americans,” said Michelle Tarver, acting director of the FDA’s Center for Devices and Radiological Health. “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.”

Over-the-Counter Hearing Aid Regulations

In October 2022, the FDA established over-the-counter hearing aid regulations, allowing consumers to purchase the devices in stores, versus at a physician’s office. This regulation aims to make it easier for many to access assistive devices at a lower price point.

Cost and Accessibility

Apple AirPods Pro 2 retail for $249, which is far less than the thousands of dollars other models of OTC hearing aids can cost. Otolaryngologists hope Apple’s foray into the hearing aid market will compel more people who suffer from hearing loss to seek out assistance. These devices could also help reduce the stigma around hearing aids, given how ubiquitous ear buds, including Apple AirPods, are among all populations.

Expert Opinion

“The price point is well below some of the other OTC quality products, and the fact that it’s so mainstream — we know that when you design something for all, it helps people with hearing loss,” Barbara Kelley, executive director of the Hearing Loss Association of America, told CBS MoneyWatch. “With Apple coming in, and the way Apple does things with a big splash, it really draws attention to hearing health and treating hearing loss, which is part of overall health.”