Apple turning AirPods into hearing aids highlights attempt to tap into big health market

Soon, people with AirPods in their ears might not be letting you down — they might just be wearing them to hear you better.

Apple announced on Monday that its headline AirPods Pro 2 will be a hearing aid cleared by the FDA in the coming weeks with a software update. 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’s earphones to amplify certain sounds. which they want to hear better.

“After performing a hearing test, your AirPods Pro are turned into a personal hearing aid, amplifying the specific sounds you need in real time, such as parts of speech, or parts of your environment,” the assistant Apple’s president of health, Sumbul Desai, said in a video to launch the episode.

The announcement is the latest example of Apple’s plan to enter the health industry, a market that could reach $15 trillion by 2030, according to RBC Capital Markets. Apple CEO Tim Cook highlighted the health aspects as “the most important contribution to mankind” of the company.

That strategy includes developing FDA-cleared components for its wearable products and replacing them with often more expensive purpose-built devices. As of 2020, Apple has added a notification service for irregular heartbeats, an atrial fibrillation monitor and an electrocardiogram monitor 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 too expensive, according to a consumer guide cited 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 thousands of dollars.

“It’s great for Apple now to say that their AirPods can be the hearing aids of the internet, so we’re seeing that technological innovation at an affordable price and a very popular product,” said Barbara Kelley, CEO. the head of the company. American Association of Hearing Loss.

Apple is trying to jumpstart sales of AirPods after a few easy years.

The company doesn’t disclose numbers for AirPods per se, but its Wearables group fell 2% year-over-year for the most recent quarter in which sales are available. Analysts say adding health features such as hearing aids will increase the market for the device, which could help sales.

“The hearing aid piece is a huge use case,” said Deepwater Asset Management founder Gene Munster, who estimates that AirPods make up 5% of Apple’s revenue. “It opens it up to a different market.”

Apple’s healthy hearing experience requires Apple’s AirPods Pro headphones and an iPhone.

The company has tested the sensitivity of its devices in the Settings app. After the program checks to make sure the headphones fit the user’s ears properly, it plays a series of tones over five minutes. The user has to tap on the screen when he hears a sound or hears a sound.

This creates a profile of the different frequencies and sound settings that the user may have hearing loss, which is stored in the Health app. This feature can be used to turn AirPods Pro into personal hearing aids.

Apple said the test was scientifically valid and based on data it collected from its noise detection systems and a study with 160,000 participants that began in 2019.

In a promotional video, Apple showed and installed AirPods to hear his son better on his birthday.

Apple’s start has been boosted by a recent change in management.

Previously, all hearing aids required a prescription after an examination by a licensed audiologist. In 2022, the FDA opened the market to over-the-counter hearing aids that were more affordable through the use of audio testing software or home devices.

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

Among its shortcomings is the battery, which lasts for six hours. That’s not enough for the all-day wear that other OTC hearing aids can manage.

Also, AirPods Pro are for those with mild or moderate hearing loss, which means people who have difficulty speaking in loud form. Anyone with “severe” or “profound” hearing loss still needs to see a licensed audiologist, experts said.

Apple’s hearing aids were cleared by the FDA on Thursday. The agency said that Apple’s hearing test was evaluated in a study with 118 subjects in the US, with “comparable results” and suitable for professionals, and was canceled through the De Novo process which regulates off-the-shelf medical devices.

Bridget Dobyan, executive director of the Hearing Industries Association, said she welcomed Apple’s entry into the market to increase awareness of hearing health, but there were still many cases of hearing loss that needed treatment. doctor based.

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

Apple’s unusual foray into health has drawn criticism from activists who say parts of the tech company are no substitute for real medical devices.

For example, Joe Kiani, CEO of Fields, a medical device company that is currently in litigation with Apple over intellectual property and business practices, said earlier this year that the Apple Watch’s pulse oximeter feature was it “masquerades” as a “reliable, medical method. oximeter.”

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