“The FDA is preparing to approve lower-cost, over-the-counter hearing devices in the near future, and new technology is emerging to enable self-serve hearing testing and care,” Pensa said.
Currently, people must undergo an exam by a licensed professional in order to buy hearing aids. Congress in 2017 required the FDA to develop regulations for over-the-counter hearing aids in a bid to make them more affordable and thereby more accessible.
The law requires the FDA to draft its regulations by 2020, though actually implementing them may take longer.
There are currently no FDA-approved hearing aid products that can be sold over the counter. The FDA in October approved Bose hearing aids that are self-fitting but are considered direct-to-consumer rather than over-the-counter, meaning they are subject to federal and state regulations dictating how they can be sold.
Amplifiers are not subject to the same requirements, meaning they can be purchased in stores. CVS sells eight of these products at its HealthHUB stores in Houston, Texas, Pensa said. Prices range from $40 to $500.