Soon, people with AirPods in their ears may no longer drown you out—they may be wearing them to hear you better.
Apple announced Monday that its AirPods Pro 2 headphones will become an FDA-cleared hearing aid through a software update in the coming weeks. That means adults with mild or moderate hearing loss — about 30 million Americans, according to the Food and Drug Administration — will be able to use Apple earbuds to amplify certain sounds they want to hear better.
“After you take a hearing test, your AirPods Pro become a personalized hearing aid that amplifies the specific sounds you need in real time, such as parts of speech or elements in your environment,” said Sumbul Desai, Apple's vice president of health, in the feature's introductory video.
The announcement is the latest example of Apple's strategy to enter the healthcare industry, which RBC Capital Markets says is a potential $15 trillion market by 2030. Apple CEO Tim Cook has called healthcare features the company's “most important contribution to humanity.”
That strategy includes developing FDA-approved features for its wearable products and replacing the often more expensive, purpose-built medical devices. Since 2020, Apple has added an irregular heartbeat notification service, an atrial fibrillation reader and an ECG reader to its Apple Watch, according to FDA filings.
The new feature is a free software update for some AirPods models and will be included with Apple's $249 AirPods Pro 2.
Many over-the-counter hearing aids are much more expensive, according to buying guides from the advocacy group Hearing Loss Association of America. While some over-the-counter hearing aids cost as little as $99, most range from $799 to several thousand dollars.
“The really cool thing about Apple now saying its AirPods can be over-the-counter hearing aids is that we're seeing this technological innovation at a price and in a product that's very mainstream,” said Barbara Kelley, executive director of the Hearing Loss Association of America.
Apple is trying to boost AirPod sales after a few weak years.
The company doesn't release separate statistics on the AirPods, but the wearables category saw a 2% decline in the most recent quarter for which sales figures are available. Analysts say adding health features like a hearing aid expands the market for the device, which could boost sales.
“The hearing aid is a very specific use case,” said Gene Munster, founder of Deepwater Asset Management. He estimates that AirPods account for about 5% of Apple's total revenue. “It opens up a different market.”
How it works
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Apple's hearing health experience requires a pair of Apple AirPods Pro headphones and an iPhone.
The company has built a hearing test into its devices in the Settings app. After checking that the headphones are properly seated in the user's ears, the program plays a series of tones over about five minutes. The user must tap the screen when they hear a sound.
This creates a profile with different frequencies and volume settings that the user may have difficulty hearing. These are stored in the Health app. This profile can be applied to turn the AirPods Pro into personalized hearing aids.
Apple said the test was scientifically sound and based on data the company collected from its sound detection apps and a study of 160,000 participants that began in 2019.
In a promotional video, Apple showed a mother using AirPods to hear her son better on her birthday.
Over the counter
Apple's launch was helped by a recent change in the law.
Until now, all hearing aids required a prescription after an examination by a licensed audiologist. In 2022, the FDA opened the market for over-the-counter hearing aids, which were significantly less expensive through the use of audio testing software or at-home fitting.
However, Apple's AirPods will not immediately make other hearing aids obsolete.
Limitations include the battery, which only lasts six hours, which is not enough for the all-day wear that some over-the-counter hearing aids can handle.
Additionally, the AirPods Pro are only suitable for people with mild or moderate hearing loss, meaning those who have difficulty understanding speech in noisy environments. Anyone with “severe” or “profound” hearing loss will still need to see a licensed audiologist, experts said.
Apple's hearing aids were approved by the FDA on Thursday. The agency said Apple's hearing test was evaluated in a study of 118 subjects in the US and produced “comparable results” to a professional fitting. The approval was granted under a de novo process that regulates medical devices with no clear predecessors on the market.
Bridget Dobyan, executive director of the Hearing Industries Association, said she welcomed Apple's entry into the market to raise awareness of hearing health, but there are still many cases of hearing loss that require medical treatment.
“For adults with mild to moderate hearing loss, over-the-counter hearing aids may be appropriate, but a visit to an audiologist can also help identify individual hearing problems,” Dobyan said.
It's not uncommon for Apple's foray into healthcare to be met with criticism from established companies who say the technology company's features cannot replace real medical devices.
For example, Joe Kiani, CEO of Masimo, a medical device maker currently in litigation with Apple over intellectual property and trade practices, said earlier this year that the Apple Watch's pulse oximeter feature was disguised as a “reliable medical pulse oximeter.”
Following a legal victory in patent matters, Masimo forced Apple in January to turn off the pulse oximeter on newly sold Apple Watch devices.
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