During its glossy product announcement event on Tuesday, Apple unveiled a new role for its latest AirPods Pro model: medical device. The company said the wireless headphones will double as clinical-grade over-the-counter hearing aids for those who need them.
“We’re adding this groundbreaking capability to help more than 1 billion people living with mild to moderate hearing loss,” said Sumbul Ahmad Desai, Apple’s vice president of health.
Apple said its hearing aid feature will boost frequencies “so sounds are clearer and more vibrant to your ears.” The company also said the feature will use “machine learning to make real-time adjustments as you go about your day.”
On Thursday, the US Food and Drug Administration authorized Apple’s hearing aid feature. Apple said the feature would become available to AirPods Pro 2 owners this fall through a software update in over 100 countries, including the United States, Germany, and Japan.
Prescription hearing aids can cost thousands of dollars. At $249, Apple’s AirPods Pro 2 may be significantly cheaper and more accessible for those who have suffered hearing loss — but they won’t work for everyone. Here’s what you need to know:
Apple’s announcement follows FDA changes
Close to 30 million US adults have some degree of hearing loss, but only about one-fifth of those people seek assistance for the issue, according to the FDA.
For people with untreated hearing loss, using hearing aids can reduce the rate of cognitive decline and may lower the risk of depression, according to the FDA. However, experts have said that the high cost of doctor visits and hearing aids kept some from seeking treatment.
Apple’s announcement comes two years after the FDA greenlit the sale of over-the-counter hearing aids. Since then, adults with mild to moderate hearing loss have been able to buy hearing aids directly from stores or manufacturers online without the help of a doctor.
To access the new hearing aid feature, AirPods Pro 2 users will have to take a test that will analyze their hearing loss by playing a series of tones.
“After you take a hearing test, your AirPods Pro are transformed into a personalized hearing aid, boosting specific sounds you need in real-time, like parts of speech or elements within your environment,” said Desai.
But over-the-counter hearing aids like these aren’t always the solution for hearing loss. The FDA still requires people under 18 years old to purchase hearing aids by prescription. Over-the-counter hearing aids, such as Apple’s offering, also are not a treatment for “severe or profound” hearing loss, according to the FDA. Those with significant hearing loss should still consult a health care professional.
“Today’s marketing authorization of an over-the-counter hearing aid software on a widely used consumer audio product is another step that advances the availability, accessibility and acceptability of hearing support for adults with perceived mild to moderate hearing loss,” said Michelle Tarver, acting director of the FDA’s Center for Devices and Radiological Health in a statement on Thursday.
This isn’t the first time Apple has dabbled in the health care space. Apple’s Watch can detect irregular heart rhythms associated with atrial fibrillation or AFib, which can lead to blood clots, stroke and heart failure, according to the American Heart Association.
On Tuesday, Apple announced that its latest Apple Watch 10 can also alert users to sleep apnea, a condition in which breathing stops and starts repeatedly during sleep.
High hopes for Apple’s new hearing aid feature
Barbara Kelley, the executive director of Hearing Loss Association of America, said she had hoped for an announcement like Apple’s after the FDA opened up the market to over-the-counter offerings two years ago.
“This is what we wanted in the market, to see technology innovation to really get people to pay attention to their hearing health,” Kelley said.
Kelley said she hoped Apple’s new product would encourage more people to address hearing loss.
“There’s still a stigma attached to hearing loss coming with aging,” Kelley said. “But my goodness, I see elementary school kids with these AirPods in their ears. If it can also serve as a hearing aid, I think that’s really exciting.”
Apple’s announcement was applauded by some hearing aid users on social media, as well. But many noted one clear advantage traditional hearing aids have over AirPods: Hearing aids have battery life measured in days, not hours.
“As someone who is hearing impaired, this was the most exciting thing from today’s event,” one Reddit user posted Tuesday. “I am hoping that they can make battery life better than 3-6 hours. It’d be nice to get 8 hours.”
This story has been updated with additional information.