Hearing aids: What you should know

If you have hearing aids, you probably remember the price tag. Who could forget at an average of $4,000 to $6,000 a pair (and no Medicare coverage)? But at least some adults with hearing loss might be able to access hearing aids at a much lower price, thanks to a new Food and Drug Administration (FDA) rule that allows manufacturers to sell certain types of hearing aids without a prescription.

The rule, which was finalized in August, establishes a new category of over-the-counter air conduction (acoustic) hearing aids to treat perceived mild to moderate hearing loss in adults only, according to National Public Radio. Like prescription air conduction hearing aids, the new over-the-counter devices will be worn inside or over the ear with components that reach into the ear to amplify sound. The new rule also limits the maximum volume of the device and insertion depth into the ear.

Alongside the new hearing aid rule, the FDA published guidance on personal sound amplification products (PSAPs) to delineate when these devices will be considered hearing aids and subject to FDA oversight. While many PSAPs look like hearing aids and function similarly, the FDA notes that PSAPs are intended to help individuals with normal hearing amplify sound in certain situations and not treat hearing loss.

The new class of devices isn’t appropriate for everyone — children and individuals with severe hearing loss will still need prescription hearing aids. But for adults with mild to moderate loss, the new rule will likely make hearing aids significantly more accessible and encourage more competitors to enter the market. According to CNN, just five companies control 90 percent of the global hearing aid market.