Apple secures FDA approval for its AirPods Pro 2 hearing aids feature

Apple has secured US FDA approval for the AirPods Pro 2 “hearing aids” feature. The new TWS earbuds from Apple will be able to serve as hearing aids for people with mild to moderate hearing loss.

Apple gets FDA permission to treat the AirPods Pro 2 as hearing aids

Apple recently announced the AirPods Pro 2’s hearing aids feature. With this feature activated, these premium True Wireless Stereo (TWS) earbuds can reportedly transform into Over the Counter (OTC) hearing aids.

In an official announcement granting its approval to the AirPods Pro 2 hearing aids feature, the FDA stated that Apple’s software-based “Hearing Test” feature for AirPods Pro offered similar benefits to those who received a professional fitting of the wireless earbuds.

“Results also showed comparable performance for tests measuring levels of amplification in the ear canal, as well as a measure of speech understanding in noise.”

In other words, the second-gen AirPods Pro can successfully replicate the functions of hearing aids. This could also mean that the earbuds improve the hearing ability and audio quality perceived by the wearer.

The agency also added that it didn’t observe any “adverse events” from using the device as an OTC hearing aid. This implies AirPods Pro 2 users shouldn’t experience any detrimental side effects or sub-par performance compared to regular hearing aids.

When will the Apple earbuds offer the hearing aids feature?

It is important to note that the new hearing aids feature needs second-gen AirPods Pro to work. Apple claims it developed the feature, “using 150,000 real-world audiograms and millions of simulations”.

Apple’s Hearing Aid feature is baked into iOS 18, which should arrive soon. It starts with a hearing test on the user’s paired iPhone or iPad. The feature relies on the earbuds forming a good seal with the ears. Hence, it activates Active Noise Cancellation (ANC) and then asks users to perform a series of tests. The results are recorded on the iOS Health app.

Incidentally, the new feature was greenlit because the FDA relaxed its rules governing consumer devices with medical benefits. In 2022, the FDA allowed adults with less-than-severe impairment to use corrective consumer hearing devices without a professional test, prescription, or fitting. Called the De Novo premarket pathway, the policy allows fast-tracking “novel devices that don’t carry serious risk.”