FDA greenlights over-the-counter hearing aids

Hearing aid sales can be done over the counter in the US. The final rule from the Food and Drug Administration allows the sale of hearing aids for mild to moderate impairment. The measure is expected to go into effect in October.

Severe hearing loss and anyone under 18 need a prescription. Design and performance requirements for over-the-counter aids have been set by the FDA. The rule comes in response to feedback from the public and industry.

Congress passed laws requiring over-the-counter hearing aids in order to lower healthcare costs. As access and technology improves, more people will wear the devices. The FDA didn't propose a rule for fully implementing the Wearables until October 2021.

There are already offerings here or in the works, but it could be awhile before there is a wide range of choices. Lexie started selling the B1 using technology from Bose's hearing aid division. Early on, companies like Jabra jumped in. When aids cost thousands of dollars before insurance, the prices are relative bargains.