US government’s FDA has approved Apple AirPods Pro 2 as ‘clinical grade’ hearing aids

Apple’s AirPods Pro 2, launched in 2022, just got a major upgrade. At their Glowtime event, Apple revealed that the US Food and Drug Administration (FDA) has approved these popular earbuds to work as clinical-grade hearing aids. This means millions of Americans with mild to moderate hearing loss could see a big boost in their daily lives.

What’s new? Apple is rolling out a software update that will turn AirPods Pro 2 into over-the-counter hearing aids for adults 18 and older. This is the first time FDA-approved hearing aid software has been made available for such a mainstream device, and it’s expected to be ready by the end of 2024.

The new Hearing Aid Feature (HAF) is a clever software solution. Instead of visiting a specialist, users can adjust their hearing settings themselves through their iPhone or iPad. By connecting the AirPods Pro 2 to an iOS device, users can easily tweak the volume, tone, and balance based on their hearing needs. The setup pulls data from the iOS HealthKit, making it straightforward and personalised.

In trials with 118 participants, the AirPods Pro 2’s hearing aid feature performed similarly to professional devices, offering comparable sound amplification and speech recognition, even in noisy places.

Apple’s system goes beyond just amplifying sound. It offers personalised hearing profiles that automatically adjust to different types of audio, from music to phone calls, without needing constant tweaks.

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Michelle Tarver, MD, PhD, from the FDA, noted that this approval is a big step forward in making hearing support more available and affordable. With over 30 million Americans dealing with hearing loss, this could be a game-changer compared to traditional, often pricey, hearing aids.