FDA approves Apple AirPods Pro 2 to be used as hearing aids

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.The FDA on Thursday authorized a piece of software called Hearing Aid Feature (HAF) that will allow Apple AirPods Pro 2 ear buds and other compatible Apple AirPods Pro devices to function as hearing aids when paired with an iOS 18-compatible iPhone or iPad. It’s the first time the FDA has authorized an over-the-counter hearing aid software, the agency said. iOS 18, the software through which HAF will be available is set to arrive by October, Apple previously said.

The new HAF is for 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 FDA said. The application will also feature a hearing test, the results of which are used to customize the volume, tone and balance settings that are built into hearing aid. “Hearing loss is a significant public health issue impacting millions of Americans,” Michelle Tarver, acting director of the FDA’s Center for Devices and Radiological Health, said in a statement Thursday. “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.”

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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, making it easier for many to access the assistive devices at a lower price point.

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. The devices could also help reduce the stigma around hearing aids, given how ubiquitous ear buds including Apple AirPods are among all populations, including those who don’t suffer from hearing loss. “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.”