In development for some time, AirPods could finally get the FDA label this fall.
Apple’s AirPods Pro are getting closer to becoming fully fledged hearing aids and marketed as such, according to Bloomberg’s Mark Gurman. The move could have a large impact on the hearing aid market, which has already been recently shaken up by over-the-counter models.
Gurman writes that AirPods Pro are due to receive a hearing-aid function in iOS 18, arriving this fall and likely to be announced and outlined at a Worldwide Developers Conference in June. The Wall Street Journal reported in the fall of 2021 that Apple was working toward a future AirPods Pro model that functioned as a hearing aid and would also be able to monitor body posture and even body temperature.
It was not clear from Gurman or the Journal’s reporting whether the hearing aid function would be available only in a new model of AirPods Pro or offered as a software update on prior models. Since the Journal’s report, Apple has released both a second-generation model of AirPods Pro and a refresh of that model with a USB-C port.Advertisement
“Hearing aid” may also not be technically accurate, depending on Apple’s aims. The US Food and Drug Administration in 2022 provided for a new category of “Personal sound amplification products,” or PSAPs, that do not need to meet the stricter requirements for an FDA-approved hearing aid. This new category offered huge cost savings to people with mild to moderate hearing loss and kicked off a generation of hearing aids that connected to a smartphone over Bluetooth for setup, tuning, and monitoring. These are distinct from over-the-counter hearing aids, which, while still notably cheaper than “professional fit” hearing aids, are still regulated by the FDA.
A study in late 2022 found that first-generation AirPods Pro, with their “Live Listen” feature activated, could meet four of the five PSAP standards and just barely missed a sound-pressure threshold. Notably, the AirPods Pro, tested in relatively quiet environments, helped people hear about as well as hearing aid models that cost up to $10,000, within the PSAP standards.
The next version of Apple’s mobile operating system, iOS 18, is rumored to contain a multitude of features beyond AirPods updates. MacRumors (leaning on Gurman’s subscriber-only newsletter reporting) suggests that generative AI features, RCS support for text messages, and revamps to many core Apple apps are due.
