Apple's AirPods Pro 2 have cleared a crucial regulatory hurdle: the US FDA has approved their incoming hearing aid features.
According to experts, the new hearing aid mode in Apple's AirPods Pro 2 could be a game-changer. But it's a game-changer that requires regulatory approval, particularly in the US where insurers won't pay for medical accessories if they don't have FDA certification.
So today's news is a big step forward for Apple's hearing health plans: the AirPods Pro 2 hearing aid mode is now FDA-approved. That means the new features are on track for their intended Autumn launch not just in the US, but worldwide.
That's a big deal not just for Apple and would-be buyers but for the wider marketplace, because this is the first time that the FDA has approved what it calls "the first over-the-counter (OTC) software device, Hearing Aid Feature". In other words, it's given regulatory approval not to a piece of hardware, but to a software update that adds new features.
Why FDA approval is a really big deal
Regulatory approval is crucial for health-related hardware, and the approval of earbuds with hearing aid features is a significantly disruptive step: as the FDA put it, it "advances the availability, accessibility and acceptability of hearing support for adults with perceived mild to moderate hearing loss.”
Until 2022, the US hearing aid market was a closed one. But that changed when the FDA relaxed the regulations to allow the sale of over-the-counter devices, a move that's seen big names such as Bose and Sony move further into hearing health. That's already helping to lower the price of hearing hardware, and the ripples are likely to continue: as Brent Lucas, CEO of Envoy Medical, told us, "I see a lot more people with iPhones and AirPods than I do with traditional hearing aids". This could ultimately expand the hearing aid market while continuing to drive prices downwards.
Apple is getting into health hardware in a big way, whether that's in the AirPods Pro 2 hearing features or the ever-evolving Apple Watch. And I think that's in part because it's an issue close to Apple executives' hearts, sometimes literally: with many Apple leaders now in or approaching their sixties, health issues are likely to matter more to them than some other issues: less AAA gaming and more AAA my back hurts. Five years ago Tim Cook said that he believed Apple's greatest contribution would be to people's health, and it's clear that Apple is still putting serious effort into making that happen.
