Over the past week, the FDA cleared two of Apple's new health features: The agency approved AirPods Pro 2's new hearing-aid feature, as well as sleep apnea detection on compatible Apple Watches.
Apple, of course, is now marketing these features alongside its products. But what does FDA clearance actually mean, and how does it pertain to the quality and effectiveness of these new benefits?
If a company wants to market a product as a medical device, they must be cleared by the FDA to do so. This is called Premarket Notification (PMN) or 510(k). To get 510(k) clearance, the company needs to show that their device is as safe and effective as another device already on the market.
So, Apple proved to the FDA that certain Apple Watches and AirPods Pro 2 were at least just as good at their marketed medical features as existing devices that the FDA previously approved. That way, you're safe knowing the AirPods Pro 2 you bought is as reliable as another FDA-approved hearing aid on the market, or that your Apple Watch Series 10 is able to detect sleep apnea as well as a dedicated sleep apnea device.
With watchOS 11, your Apple Watch Series 9, Series 10, or Ultra 2 can now look for signs of sleep apnea. Apple says the watch uses its accelerometer (a sensor that detects changes in velocity) to watch for movements throughout the night. If the watch detects certain movements from your wrist, it can determine it to be a break in sleep. This is tracked by the watch's new Breathing Disturbances mode, which saves all data in the Health app. You'll see your Breath Disturbances labeled as "elevated" or "not elevated" throughout the night.
Every 30 days, this feature will analyze the data collected, looking for indications of sleep apnea. If your watch thinks you have sleep apnea, it will alert you, including the time these signs occurred, resources for learning more about treatment, and a PDF featuring three months of breathing disturbance data. If you decide to seek medical advice, you can hand over this data to a healthcare professional.
According to Apple, the company developed this feature with machine learning based on data accrued over thousands of nights of official sleep apnea tests. The FDA cleared the feature following what Apple says is the largest study ever conducted for an FDA clearance of a device meant for detecting sleep apnea.
This sleep apnea detection feature is not the first of Apple's to receive FDA clearance: The FDA has previously cleared both the ECG app and irregular rhythm notification feature for users 22 and older with no prior history of AFib.
Even in 2024, it seems a bit rude to keep your AirPods in while having a conversation with someone. That social norm might have to change, however: Last week, the FDA cleared AirPods Pro 2 to act as a "clinical-grade hearing aid," the first over-the-counter (OTC) hearing aid software device. If you have a pair of the second-generation Pros, you also have a pair of legitimate hearing aids.
The move follows a change in the FDA's OTC hearing aid regulations back in 2022, that allowed consumers to buy OTC hearing aids from stores without needing to take an exam or receive a prescription first. According to Apple's briefing, users can set up their hearing aids through the personalized hearing profile feature found in iOS' new Hearing Test. Not only will these adjustments boost the sounds in the environment around you, but your Apple devices will set and synchronize audio levels based on the results of this test. However, Apple does say if you have little to no hearing, this feature might not work for you.
AirPods have had volume-boosting benefits before, but with the FDA clearance, the feature is fit for those with legitimate hearing issues. This was made possible through a clinical study of 118 subjects, all of whom had "perceived" mild to moderate hearing loss. The study showed that participants who used this feature with Apple's AirPods experienced the same benefits as those who were professionally fitted for traditional hearing aids: Users were able to understand speech in both scenarios, and the study found there were no negative events when using the AirPods as hearing aids.
Hearing aids are wildly expensive: The National Council on Aging's top pick, for example, costs $799 to $1,995 per pair, while their "most affordable" choice costs $489 per pair. AirPods Pro 2 are $249. Not cheap by any means, but remember, they're also earbuds you can use for listening to music, watching movies, or taking calls.
If you aren't sure whether you need hearing aids, and you have a pair of AirPods Pro 2, you can use the new Hearing Test to see what iOS thinks. The test is five minutes long, and plays sounds in your ears. When you hear the tone, you tap the screen. iOS maps your performance, and returns a result for each ear.
