These Apple Devices Are Now FDA Approved
Over the past week, the FDA has approved two new Apple health features: The agency approved a new feature for the AirPods Pro 2 hearing aid, as well as sleep apnea detection on compatible Apple Watches.
Apple, of course, is now promoting these features with its products. But what does FDA approval actually mean and how does it relate to the quality and effectiveness of these new benefits?
What does it mean to receive FDA approval?
If a company wants to market a product as a medical device, it must obtain FDA approval to do so . This is called a pre-market notification (PMN) or 510(k). To obtain 510(k) clearance, a company must demonstrate that its device is as safe and effective as another device already on the market.
In this way, Apple has proven to the FDA that certain Apple Watches and AirPods Pro 2 are at least as good as existing devices previously approved by the FDA in their claimed medical functions. This way, you can rest assured that the AirPods Pro 2 you buy are as reliable as any other FDA-approved hearing aid on the market, or that your Apple Watch Series 10 is capable of detecting sleep apnea as well as a dedicated sleep apnea device. dream.
Apple Watch now recognizes sleep apnea
With watchOS 11, your Apple Watch Series 9, Series 10, or Ultra 2 can now monitor signs of sleep apnea . Apple says the watch uses an accelerometer (a sensor that detects changes in speed) to track movements throughout the night. If the watch detects certain movements on your wrist, it can determine that this is a break in your sleep. This tracks the watch’s new Breathing Disorders mode, which stores all data in the Health app. Throughout the night, you will see breathing disturbances labeled as “elevated” or “not elevated.”
Every 30 days, this feature will analyze the collected data to look for signs of sleep apnea. If your watch thinks you have sleep apnea, it will alert you with the timing of these symptoms, resources for more information about treatment, and a PDF of three months of breathing data. If you decide to seek medical care, you may give this information to a health care professional.
According to Apple, the company developed the feature using machine learning based on data collected from thousands of nights of official sleep apnea tests. The FDA approved the feature after Apple said it was the largest study ever conducted toward FDA approval of a device designed to detect sleep apnea.
This sleep apnea detection feature is not the first Apple feature to receive FDA clearance: The FDA previously cleared both the ECG app and the irregular rhythm notification feature for users 22 and older who have no previous history of atrial fibrillation.
You can use AirPods Pro 2 as a hearing aid
Even in 2024, it seems a little impolite to hold AirPods while talking to someone. However, this social norm may have to change: Last week , the FDA cleared the AirPods Pro 2 to act as a “clinical-grade hearing aid,” the first software-based hearing aid device sold over the counter. If you have a pair of second generation Pro hearing aids, you also have a pair of real hearing aids.
The move follows an FDA rule change on over-the-counter hearing aids made back in 2022 that allowed consumers to purchase over-the-counter hearing aids in stores without first having to take an exam or get a prescription. According to Apple’s briefing , users can customize their hearing aids using the Personalized Hearing Profile feature found in the new iOS Hearing Test. Not only will these settings improve the ambient sounds, but your Apple devices will set and sync sound levels based on the results of this test. However, Apple says that if you have little to no hearing, this feature may not be suitable for you.
AirPods have had volume boosting benefits before, but thanks to FDA clearance, this feature is suitable for people with legitimate hearing problems. This was made possible through a clinical study of 118 subjects, all of whom “perceived” mild to moderate hearing loss. The study found that participants who used the feature with Apple AirPods experienced the same benefits as those who professionally wore traditional hearing aids: users were able to understand speech in both scenarios, and the study found that there were no negative effects when using AirPods consequences. as hearing aids.
Hearing aids are extremely expensive: for example, the National Council on Aging’s top pick costs between $799 and $1,995 per pair, while their “most affordable” option costs $489 per pair. AirPods Pro 2 cost $249. Not cheap by any means, but remember that these are also headphones that can be used for listening to music, watching movies or taking calls.
If you’re not sure if you need hearing aids and you have a pair of AirPods Pro 2, you can use a new hearing test to see what iOS thinks. The test lasts five minutes and sounds are played in your ears. When you hear a beep, tap the screen. iOS displays your performance and returns the result for each ear.