Apple AirPods Pro 2 are FDA-cleared to function as hearing aids
During Apple’s “It’s Glowtime” special event, the tech giant revealed a pretty major and powerful health feature coming to AirPods Pro 2. That, of course, is the upcoming “Hearing Aid” functionality, paired with hearing protection and a hearing test feature — all of which are said to arrive in a software update at no additional cost.
Now, three days after Apple unveiled the feature and said it was awaiting FDA approval, the green light has just been given. The U.S. Food and Drug Administration (also known as the FDA) authorized the AirPods Pro hearing aid feature as the “first over-the-counter (OTC) hearing aid software device.”
It’s a crucial step for Apple, as they needed this approval to roll out the feature. Plus, it’s a big deal for the over-the-counter hearing aid industry, and Apple’s first-ever authorization is a significant step.
The acting director of the FDA’s Center for Devices and Radiological Health said, “Today’s marketing authorization of over-the-counter hearing aid software on a widely used consumer audio product is another step toward improving the availability, accessibility, and acceptability of hearing support for adults with perceived mild to moderate hearing loss.”
The FDA evaluated the feature “in a clinical study involving 118 subjects with perceived mild to moderate hearing loss, at multiple sites in the U.S.,” and the results “demonstrated that subjects using the HAF self-fitting strategy achieved a similar perceived benefit as subjects who received a professional fitting of the same device.” This validation by the FDA led to the feature’s general marketing authorization for Apple, which likely reflects the testing and studies the tech company conducted internally.
AirPods Pro getting the hearing aid feature is a big step, especially for those with mild to moderate hearing loss. As an over-the-counter solution, and essentially a software update that will appear on existing AirPods Pro 2, it offers an alternative to purchasing other over-the-counter hearing aids, which can be more expensive.
Once the hearing aid feature is available, you’ll take the hearing aid test to establish a hearing profile, and AirPods Pro 2 will then adjust the sound in real time to amplify the sound. Apple notes that AirPods Pro 2 will function as a “clinical-grade hearing aid,” with users able to adjust the tone, volume, and balance on the fly.
Additionally, this FDA clearance allows Apple to roll out the hearing test feature on AirPods Pro 2, that TechRadar Editor-in-Chief Lance Ulanoff had the chance to testThis feature, as well as the functionality of hearing aids and other hearing protection built into AirPods Pro 2, make the earbuds more than just a device for listening and connecting with others. It builds on the volume level alerts for what you’re listening to on AirPods and ambient noise alerts built into Apple Watch.
Now that Apple has received FDA clearance for its AirPods Pro Hearing Aid feature, we’re likely one step closer to the feature’s rollout. As shared during the keynote and in a press release, Apple plans to roll out the Hearing Test and Hearing Aid features to over 100 countries this fall, including the US, Germany, and Japan.
These updates come in the form of a software update for AirPods Pro 2 when paired with an iPhone or iPad running iOS 18 or iPadOS 18.
