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FDA approves Apple AirPods as hearing aids

A forthcoming software update will add a hearing aid feature to the AirPods Pro 2.

3 min
Apple's AirPods Pro 2. The earbuds have a hearing aid feature, which will be pushed to eligible devices through a software update in the coming weeks. (Business Wire/AP)

If you have mild to moderate hearing loss, your AirPods could soon function as hearing aids.

The Food and Drug Administration said Thursday it has approved a piece of software that will transform the latest model of Apple’s AirPods Pro earbuds into over-the-counter hearing aids. The company’s hearing aid feature will be pushed to eligible devices through a software update in the coming weeks, Apple said.

The move, which comes two years after the FDA first approved over-the-counter hearing aids, could help more Americans with hearing loss start getting help, the FDA said in a statement.

The feature works by amplifying some sounds, such as voices, while minimizing others, such as ambient noise. Users can take a hearing test in the Apple Health app, and their AirPods will adjust sound level automatically based on the results. The feature is only available on the AirPods Pro 2, which cost $249.

The FDA says it tested Apple’s hearing aid feature in a clinical study with 118 subjects who believed they had mild or moderate hearing loss. The study found that people who set up their AirPods using Apple’s hearing test noticed similar benefits as people who had a professional set up the earbuds.

Over-the-counter hearing aids are best for people with mild to moderate hearing loss, audiologists say, many of whom don’t seek treatment. A consumer device that doubles as a hearing amplifier could act like a “bridge” for people who otherwise wouldn’t seek hearing help because of cost, access or cosmetic concerns, said Jackie Clark, a clinical professor in the audiology program at University of Texas at Dallas.

“We know that even with a mild hearing loss, individuals lose some quality of life by isolating themselves from their community,” Clark said. “I would see the AirPods as offering a bridge for hard-of-hearing consumers to get back in touch with some parts of the world of sound that they have been missing.”

Apple is one of the most popular headphone brands, with 19.2 percent market share globally, according to market research firm IDC. Some people already have a pair of AirPods Pro 2, while others may find the earbuds a more attractive option than traditional hearing aids, which require a hearing test, prescription and often thousands of dollars upfront.

“Many brands have tried to push their way into the OTC hearing aid market, as there’s a segment of consumers, usually 40-plus in age, that faces early hearing loss, but they fear getting a real hearing aid because it may make them appear older,” said Jitesh Ubrani, a research manager at IDC. “By including this feature on AirPods, Apple could potentially have a lasting impact on this market.”

However, consumer earbuds aren’t a good solution for people with severe hearing loss, experts maintain, and most over-the-counter hearing devices will still require a trip to the audiologist for some fine-tuning.

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