Meta's smart glasses just got FDA clearance to work as a hearing aid.
The company's new Hearing Enhancement software has received clearance from the U.S. Food and Drug Administration, letting Meta market it as an alternative to traditional hearing aids. It runs on Meta's smart glasses and will be sold as a $150 add-on. That undercuts prescription hearing aids, which routinely run into the thousands of dollars, and even most over-the-counter models, which typically cost several hundred dollars.
This puts Meta in the same regulatory lane as Apple, which won similar clearance for a hearing aid feature in its AirPods Pro 2 in 2024. Both moves lean on a 2022 FDA rule that created an over-the-counter hearing aid category, lowering the bar for consumer electronics makers to compete with medical device incumbents. For Meta, it's also a reason to wear the glasses beyond photos and AI assistants: a health use case that could nudge reluctant buyers.
Whether $150 software beats a properly fitted hearing aid for anyone with more than mild hearing loss remains an open question, one the FDA clearance doesn't answer.