Apple is popping AirPods into hearing aids, underscoring its efforts to capture the large healthcare market

Soon you would possibly not be drowning out individuals with AirPods in your ears – they is likely to be wearing them to listen to you higher.

Apple announced Monday that its AirPods Pro 2 headphones will develop into an FDA-approved hearing aid through a software update in the approaching weeks. That means adults with mild or moderate hearing loss — about 30 million Americans, in line with the Food and Drug Administration — can use Apple earbuds to raised amplify certain sounds they need to hear.

“After you take a hearing test, your AirPods Pro transform into a personalized hearing aid that amplifies the specific sounds you need in real time, such as parts of speech or elements in your environment,” Apple's vice chairman of health, Sumbul Desai, said in Introductory video of the feature.

According to RBC Capital Markets, the announcement is the newest example of Apple's technique to penetrate the healthcare industry, a possible $15 trillion market by 2030. Apple CEO Tim Cook has identified healthcare features because the “most important contribution “Company for Humanity”.

That strategy includes developing FDA-approved features for its wearable products and replacing often more expensive purpose-built medical devices. Since 2020, Apple has added an irregular heartbeat 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 some AirPods models that will be included in Apple's $249 AirPods Pro 2.

According to buying guides, many over-the-counter hearing aids are much more expensive quoted by the Hearing Loss Association of America, an advocacy group. While some OTC 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 could be over-the-counter hearing aids is that we're seeing this technology innovation at a price and in a product that could be very mainstream,” said Barbara Kelley, executive director of the Hearing Loss Association of America.

Apple is trying to boost AirPods sales after a few weak years.

The company doesn't break out AirPods stats individually, but the wearables category fell 2% annually in the most recent quarter for which sales 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, who estimates that AirPods account for about 5% of Apple’s total sales. “It opens it up to a different market.”

The Apple listening experience requires a pair of Apple AirPods Pro headphones and an iPhone.

The company has integrated a hearing test into its devices in the Settings app. After the program checks that the headphones fit properly on the user's ears, it plays a series of tones for about five minutes. The user has to tap the screen when they hear a sound.

This creates a profile of different frequencies and volume settings that the user may not be able to hear, which 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 valid and based on data the company collected with its sound recognition apps and a study of 160,000 participants that began in 2019.

In a promotional videoApple showed a mother using AirPods on her birthday to help her son hear better.

Apple's launch was spurred by a recent regulatory change.

Previously, all hearing aids required a prescription, which had to be completed after testing by a licensed audiologist. In 2022, the FDA opened the market to over-the-counter hearing aids, which were significantly cheaper through the use of audio testing software or at-home fitting.

However, Apple's AirPods won't immediately make other hearing aids obsolete.

Among its limitations is the battery, which lasts six hours. That's not enough for all-day wear that some OTC hearing aids can handle.

In addition, the AirPods Pro are only suitable for people with mild to moderate hearing loss, i.e. people who have difficulty understanding speech in noisy environments. Anyone with “severe” or “profound” hearing loss still needs to see a licensed audiologist, experts said.

Apple's hearing aids were deleted from the FDA on Thursday. The agency said Apple's hearing test was evaluated in a study of 118 subjects in the U.S., with “comparable results” to professional fitting, and was approved through a de novo process, which includes medical devices without a clear predecessor on the market regulated.

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 hearing loss situations that require a medical approach.

“OTC hearing aids may be appropriate for adults with mild to moderate hearing loss, but visiting a licensed hearing care professional can also help determine individual hearing health needs,” Dobyan said.

It's not uncommon for Apple's foray into the healthcare industry to be criticized by mainstream companies who claim the tech company's features aren't a replacement for real medical devices.

For example, Joe Kiani, CEO of Masimo, a medical device company currently engaged in an intellectual property and trade practices dispute with Apple, said earlier this year that the Apple Watch's pulse oximeter feature “masqueraded” as a “reliable, medical-grade pulse oximeter.”

After a legal victory over patents, Masimo forced Apple in January to turn off the pulse oximeter on newly sold Apple Watch devices.