Apple AirPods Pro 2 Free Hearing Aid Feature FDA Authorized

The iPhone 16 may have been the focal point of Apple’s GlowTime event, but the company had another announcement to pair with its new $799 smartphone — a free update to the $250 AirPods Pro 2, which Apple refreshed last year, to make the earbuds double as hearing aids.

“We’re really excited to announce that this fall, AirPods Pro will have a clinical grade, over-the-counter hearing aid feature,” Dr. Sumbul Desai, vice president of health at Apple, said at the event.

On Thursday, the FDA authorized the Hearing Aid Feature for Apple’s AirPods Pro, for people 18 and over who have mild or moderate hearing issues.

The new software works with Apple’s AirPods Pro to act as an over-the-counter hearing aid accessed through HealthKit. It customizes to a user’s needs and will enhance sounds as needed.

The FDA’s Center for Devices and Radiological Health Acting Director, Michelle Tarver, said in a statement that “hearing loss is a significant public health issue” impacting at least 30 million Americans.

“[Thursday’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,” Tarver said.

Related: FDA Finalizes Rule To Make Hearing Aids Over-the-Counter

The free download will be available this fall. Anyone with a pair of AirPods Pro 2 and an updated iPhone will be able to access a five-minute, at-home, clinically validated hearing test. All they have to do is tap their iPhone screen in response to auditory cues. Based on the results of the hearing test, Apple promises that the AirPods will become personalized hearing aids sensitive to their needs.

Apple also added an “on by default” for everyone hearing protection mode, which actively filters out loud background noise, like the sound of a lawn mower, for hearing health.

Around 20% of the world’s population, or about 1.5 billion people, experience hearing loss, according to the World Health Organization. In the U.S., about 36 million people have mild to moderate hearing loss, while 1.8 million people experience severe hearing loss.

Related: Why Investing in the Accessibility Space Is a Smart Business Move

Hearing aids can be expensive, priced anywhere from $2,000 to $7,000 per pair, though some over-the-counter devices can cost as little as $30. The price variation arose in 2022 after the FDA passed a rule allowing for over-the-counter, lower-cost hearing aids. Though the quality and fit of over-the-counter options may be less satisfactory than prescription options, “very few” insurance policies cover the cost of prescription devices. So over-the-counter could be the affordable alternative.

^{The Apple AirPods Pro 2. Photographer: Nic Coury/Bloomberg via Getty Images}

Apple isn’t the first to offer affordable hearing aids. Sony has multiple self-fitting, FDA-cleared hearing aids ranging between $799 and $1,099, with its first two options released in 2022. Sennheiser introduced its own over-the-counter hearing aids in August 2023 and priced them at $999.

Apple differentiates the AirPods Pro 2 by saying that the device’s hearing updates form “the world’s first end-to-end hearing health experience.” About 100 million people around the world use AirPods, emphasizing the broad reach of hearing updates Apple could roll out in the years to come.

The AirPods Pro 2 has been available since 2022 but the company refreshed the product last year with USB-C charging and adaptive noise control. The earbuds did not get any hardware changes this year; Apple announced this free software update instead.

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