Soon, people with AirPods in their ears might not be drowning out your voice — they might be wearing them to hear you better.
Apple announced on Monday that its AirPods Pro 2 headphones will become FDA-approved hearing aids through a software update in the coming weeks. This means adults with mild or moderate hearing loss (about 30 million Americans, according to the U.S. Food and Drug Administration) will be able to use Apple headphones to amplify the specific sounds they want to hear better. sound.
“After taking a hearing test, your AirPods Pro will transform into personalized hearing aids that instantly enhance the specific sounds you need, such as parts of speech or elements in your environment,” said Sumbul Desai, Apple’s vice president of health, in a video announcing the feature.
The announcement is the latest example of Apple’s strategy to enter the health industry, a market that could potentially be worth $15 trillion by 2030, according to RBC Capital Markets. Apple CEO Tim Cook emphasized that health features are the company’s “most important contribution to humanity.”
The strategy includes developing FDA-approved features for its wearable products and replacing specialized medical devices that are often more expensive. Since 2020, Apple has added an arrhythmia notification service, an atrial fibrillation reader, and an electrocardiogram reader to its Apple Watch, according to FDA filings.
The new feature is a free software update for certain AirPods models and will be included in Apple’s $249 AirPods Pro 2.
Many over-the-counter hearing aids are significantly more expensive, according to buying guides Cited by Hearing Loss Association of America, an advocacy group. While some OTC hearing aids cost as little as $99, most range in price from $799 to thousands of dollars.
“It’s really cool that Apple is now claiming their AirPods can be used as over-the-counter hearing aids because we’re seeing technological innovation at a price point and in a very mainstream product,” said Barbara Kelley, the company’s executive director.
Apple is trying to boost AirPods sales after several years of weakness.
The company doesn’t break out separate statistics for AirPods, but its wearables category saw sales decline 2% annually in the most recent quarter. Analysts say adding health features such as hearing aids could expand the market for the device and help sales.
“Hearing aids are a very specific use case,” said Gene Munster, founder of Deepwater Asset Management, who estimates AirPods account for about 5% of Apple’s total revenue. “It really opens the door to different markets.”
how it works
Apple’s hearing health experience requires a pair of Apple AirPods Pro headphones and an iPhone.
The company has built a hearing test feature into its device’s Settings app. After the program checks to make sure the headphones fit the user’s ears correctly, it plays a series of tones for about five minutes. When the user hears the tone, they must click on the screen.
This creates profiles of various frequency and volume settings that the user may have difficulty hearing, and these profiles are stored in the Health app. This profile can be used to turn AirPods Pro into personalized hearing aids.
Apple says the test is scientifically valid and is based on data collected from its noise detection app and a study starting in 2019 involving 160,000 participants.
exist promotional videoApple showed a mother wearing AirPods on her birthday to better hear her son’s voice.
over the counter
Apple’s launch has been fueled by recent regulatory changes.
Previously, all hearing aids required testing by a licensed audiologist before being prescribed. In 2022, the FDA opened the market to over-the-counter hearing aids, which are significantly less expensive thanks to the use of audio testing software or home accessories.
However, Apple’s AirPods won’t immediately make other hearing aids obsolete.
One of its limitations is the battery, which only lasts six hours. This is not enough for all-day wear that some over-the-counter hearing aids can provide.
Additionally, AirPods Pro are only suitable for people with mild or moderate hearing loss, meaning people who have difficulty hearing speech in noisy environments. Experts say anyone with “severe” or “profound” hearing loss still needs to see a licensed audiologist.
In addition, Apple’s hearing aids still need FDA approval.
An FDA press officer told CNBC that devices that use technology or software to customize hearing aid fit or settings will need premarket approval from the agency. Apple said on Monday it was awaiting approval from the FDA and regulatory approvals around the world.
Bridget Dobyan, executive director of the Hearing Industry Association, said she welcomes Apple’s entry into the market to raise awareness about hearing health, but there are still many cases of hearing loss that require a physician-based approach.
“Over-the-counter hearing aids may be appropriate for adults with mild to moderate hearing loss, but consultation with a licensed hearing care professional can also help identify unique hearing health needs,” Dobian said.
It’s not uncommon for Apple’s foray into health to draw criticism from incumbents, who say the tech company’s capabilities cannot replace actual medical devices.
For example, Joe Kiani, CEO of medical device company Masimo, is currently in litigation with Apple over intellectual property rights and trade practices. said earlier this year The Apple Watch’s pulse oximeter function is “disguised” as a “reliable medical pulse oximeter.”
Masimo forced Apple in January to shut down pulse oximeters on new Apple Watch devices after winning a patent lawsuit.
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