FDA approves Apple AirPods Pro 2 as a hearing aid

Apple has a penchant for adding health features to non-medical devices: ECG, blood oxygen measurement, optical heart rate sensor, irregular heartbeat notifications, women’s cycle tracking, etc. While all of these are available on the Apple Watch, the company is now adding the feature to the AirPods Pro 2, and the FDA just cleared the earbuds to operate as “devices with hearing aid software.”

Apple Announces New AirPods Features

Apple held its annual event on September 9 to unveil the next iPhone series – iPhone 16, as well as the new Apple Watch and new AirPods products, colors, and features. One of the features added to the AirPods Pro 2 is that they can act as hearing aids.

While Apple has been working on adding a number of heart-related health features over the past few years, this year it’s all about the ears, specifically hearing. You can use the AirPods Pro 2 to take a hearing test. Apple’s earbuds will check the fit and assess ambient noise, then perform the test and provide the results instantly. The AirPods will also provide hearing protection to make sure you’re not exposed to loud ambient noise. Check out this guide if you’re wondering if there’s a connection between hearing loss and headphones.

But it was the hearing aid capabilities that required FDA approval. Apple explains that this is the first hearing aid feature to be supported by software. If you take the test on AirPods Pro 2 and discover that you have mild or moderate hearing loss, you’ll be directed to the hearing aid features.

Set up, adjust the settings, and then start hearing more clearly. Alternatively, ask your doctor to set them up with an audiogram. The hearing aid feature is powered by advanced computational audio and the H2 chip. Frequencies are amplified to make everything heard clearer and more vivid. Machine learning adjusts the process throughout the day.

Good to know: If you don’t suffer from hearing loss and are looking for an alternative to AirPods, check out these options.

FDA approves AirPods Pro 2 as a hearing aid

The problem came when Apple announced the Hearing Aid feature at the event. They didn’t yet have FDA regulatory approval to call the AirPods Pro 2 an over-the-counter medical technology, yet they were still advertising it as a medical device. Apple can be pretty powerful, and they managed to get the AirPods Pro fast-tracked authorization from the FDA to work as a “hearing aid software device.”

This is the first time the software has been used as a solution with an existing device for the hearing impaired. The FDA explained that it conducted a clinical trial with 118 people with mild to moderate hearing loss. It found no adverse effects for people using the AirPods software to treat hearing loss.

Hearing Aid will be available on AirPods Pro 2 in the fall. This was an executive order from US President Joe Biden in 2022 that allowed the FDA to consider OTC hearing aids without a prescription. If you are a disabled student or have a disabled child, check out these great AI tools.

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