When coupled with an iOS 18-compliant iPhone or iPad, the FDA approved Hearing Aid Feature (HAF) on Thursday, enabling Apple AirPods Pro 2 earbuds and other compatible Apple AirPods Pro devices to operate as hearing aids. According to the FDA, this is the first time that software for over-the-counter hearing aids has been approved.
According to Apple's prior announcement, iOS 18, the software that will make HAF available, is scheduled to be released in October.
According to the FDA, "aging, exposure to loud noises, certain medical disorders, and other variables" are the causes of the estimated 30 million Americans who have mild to moderate hearing loss and are eligible for the new HAF. A hearing test will also be included in the application; the results of this test will be used to adjust the volume, tone, and balance settings on hearing aids.
Michelle Tarver, acting head of the FDA's Center for Devices and Radiological Health, stated in a statement on Thursday that "hearing loss is a critical public health concern impacting millions of Americans." "Another step toward improving the accessibility, acceptance, and availability of hearing support for adults with mild to moderate hearing loss is today's marketing permission of an over-the-counter hearing aid software on a widely used consumer audio product."
When the FDA approved over-the-counter hearing aid regulations in October 2022, it became easier for many people to obtain assistive devices at a reduced cost because they could now buy the devices in stores rather than at a doctor's office.
At $249, the Apple AirPods Pro 2 are far less expensive than other over-the-counter hearing aid devices, which may go into the thousands of dollars.
Otolaryngologists are hopeful that Apple's entry into the hearing aid industry would encourage more individuals experiencing hearing loss to get help. Given how commonplace earbuds, like Apple AirPods, are among all demographics, even those without hearing loss, the gadgets may also aid in lessening the stigma associated with hearing aids.
Barbara Kelley, executive director of the Hearing Loss Association of America, told CBS MoneyWatch, "We know that when you create something for everyone, it helps those with hearing loss." "The price point is much below some of the other OTC quality items," Kelley added. "Apple's entry into the market and its big splash approach truly bring attention to addressing hearing loss, which is a component of overall health,"