AirPods Pro 2 Gets FDA Approval as Over-the-Counter Hearing Aids

• The U.S. Food and Drug Administration (FDA) has approved Apple’s new AirPods Pro 2 headphones for use as hearing aids.
• The American institution says it is the first over-the-counter device to receive such approval.
• This feature will be available on AirPods 2 Pro via an iOS 18 update.

Apple unveiled several new devices earlier this week, with the iPhone 16 series being the focus of most of the attention. One of the other major announcements, however, was the AirPods 2 Pro and their ability to act as hearing aids.

This was an option presented by Apple, but with the stipulation that customers would only be able to use it after obtaining regulatory approval.

In the case of the United States, such approval has already been received, as confirmed by the Food and Drug Administration (FDA).

“The U.S. Food and Drug Administration has approved the first over-the-counter hearing aid software, Hearing Aid Feature, for use with compatible versions of Apple AirPods Pro,” the company said in an official statement.

This means that people with hearing problems in the United States will now be able to use hearing aids without needing a prescription.

“Once installed and adjusted to the user’s hearing needs, the hearing aid feature enables compatible versions of AirPods Pro to function as an over-the-counter hearing aid intended to amplify sounds for people aged 18 and older with a perceived mild to moderate hearing loss,” it added.

Much of this functionality is thanks to the new hearing test feature that Apple is introducing in iOS 18.

“The test is simple to perform, uses a standard clinical approach called pure tone audiometry, leverages advanced acoustic science, and provides users with an interactive experience. Once the test is complete, users will see an easy-to-understand summary of their results in a personalized hearing profile for AirPods Pro that is stored privately and securely in the Health app,” the Cupertino company noted of the new feature.

“This new feature seamlessly transforms AirPods Pro into a clinical-grade hearing aid. Once set up, the feature enables personalized dynamic adjustments so users have the sounds around them amplified in real time. This helps users better engage in conversation and keeps them connected to the people and environments around them,” Apple emphasized after the launch of the new AirPods Pro 2.

The question remains whether other regulators around the world will also give their approval to the AirPods Pro 2 once they go on sale, but given the FDA’s approval, the prospects are undoubtedly promising.

Therefore, we wouldn’t be surprised if other wireless headphone manufacturers planned similar functionality in their future devices.