People with hearing loss could soon buy hearing aids without needing to have an exam, prescription or special fitting first.
Driving the news: In a move years in the making, the FDA on Tuesday issued a final rule allowing over-the-counter sales of hearing aids to adults with mild or moderate hearing loss. They could become available as soon as October when the rule takes effect.
Why it matters: The FDA estimates that 30 million people in the U.S. suffer from hearing loss, and fewer than one-fifth who could benefit from a hearing aid seek intervention.
State of play: The devices can cost thousands of dollars. Insurance coverage is limited and Medicare doesn't cover them. The stigma of hearing loss has also prevented millions from using them.
Between the lines: Advocates and lawmakers who have long pushed for over-the-counter hearing aids say the market for the products would look like the eye care industry, in which consumers have choices to purchase reading glasses and bifocals through their doctor's office or elsewhere.
- Cowen analyst Eric Assaraf wrote in a note the move will allow consumer electronics manufacturers to move into a space now dominated by specialty companies like ReSound, Sonova and William Demant.
