After Apple previewed the technology earlier this week, the FDA has now given the green light to the hearing aid features of its premium AirPods.
The agency’s de novo clearance marks its first for a piece of over-the-counter hearing aid software—and hails the long-awaited entry of the consumer tech giant to a sector that has anticipated its arrival since the FDA officially opened the door to prescription-free hearing aid technology, back in 2022.
“Hearing loss is a significant public health issue impacting millions of Americans,” Michelle Tarver, M.D., Ph.D., acting director of the FDA’s device center, said in an agency statement.
“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,” Tarver said.
Earlier this week—alongside the reveal of upcoming sleep apnea detection for its Apple Watch—Apple described the hearing aid feature coming to its AirPods Pro 2 earbuds as “clinical-grade,” alongside a self-administered, five-minute hearing test to help program the devices.
Users with mild to moderate hearing loss can adjust their volume, tone and balance settings after setup, and that profile will also carry over to calls, music and other sounds played through their connected Apple hardware.
The FDA estimates that more than 30 million adults in the U.S. report some degree of hearing loss, whether due to aging, exposure to loud noises or other medical conditions.
According to the agency, a clinical study submitted by Apple found that a self-fitting approach led to similar benefits compared to people who made an appointment with a hearing professional.
The FDA issued its regulatory rule creating a pathway for over-the-counter hearing aids in late 2022 after being directed to do so by Congress, and urged on by an executive order from the Biden administration, in the pursuit of lowering the cost and improving access to the technology.
The agency outlined certain design requirements, including volume limits and restricted placements within the ear canal. Devices intended for users under the age of 18 or for those with severe hearing loss still require a prescription.
A subsequent study found that some models of Apple’s AirPods could meet most of the criteria, despite not being marketed as an alternative to hearing aids, while being priced considerably cheaper.