Navigate the healthcare industry
Healthcare Brew covers pharmaceutical developments, health startups, the latest tech, and how it impacts hospitals and providers to keep administrators and providers informed.
While most Apple megafans are freaking out about the upcoming iPhone 16 Pro, we’ve got our eyes—and ears—on a new software update.
On Thursday, the FDA gave marketing authorization to an Apple feature that will allow users with mild to moderate hearing loss to turn their AirPods Pro 2 into hearing aids. The AirPods will automatically adjust sounds around a user based on the results of their individual hearing profile, according to a September 9 Apple press release.
Though the FDA approved over-the-counter hearing aids in October 2022, this is the first time the agency has approved an over-the-counter software for hearing loss.
“Today’s marketing authorization of an over-the-counter hearing aid software on a widely used consumer audio product is another step that advances the availability, accessibility, and acceptability of hearing support for adults with perceived mild to moderate hearing loss,” Michelle Tarver, acting director of the FDA’s Center for Devices and Radiological Health, said in the release.
The deets. About 48 million people in the US have hearing loss, according to the Hearing Loss Association of America, but only one in five people who need hearing aids actually use them.
There are real consequences to untreated hearing loss: Study after study suggests it can lead to cognitive impairment and dementia. Yet, there are barriers to getting treatment, like high costs or stigma associated with wearing hearing aids, according to the National Council on Aging.
Apple’s solution. That’s why Apple is bringing solutions straight to consumers, according to the release.
Apple’s iPhones and iPads will offer a pure-tone audiometry hearing test—a gold standard method used in most doctor’s offices to identify hearing issues—which involves playing tones at different pitches and frequencies and asking the patient to signal when they hear a sound.
The results of that test or an audiogram done by a health professional will program a user’s AirPods.
The tech is backed by a 118-participant clinical study that found fitting hearing aids with Apple’s app was just as effective as getting them fitted by a professional, according to the FDA’s release.
link