FDA finalizes over-the-counter hearing aid rule

An estimated 28.8 million Americans could benefit from hearing aids

The Food and Drug Administration on Tuesday finalized a rule making hearing aids for people with mild to moderate hearing loss available without requiring them to see a doctor.
The rule will take effect in 60 days and hearing aids could be available over-the-counter for Americans in early October.
 (Joe Raedle/Getty Images file photo)
The Food and Drug Administration on Tuesday finalized a rule making hearing aids for people with mild to moderate hearing loss available without requiring them to see a doctor. The rule will take effect in 60 days and hearing aids could be available over-the-counter for Americans in early October. (Joe Raedle/Getty Images file photo)
Posted August 16, 2022 at 12:23pm

The Food and Drug Administration on Tuesday finalized a rule making hearing aids for people with mild to moderate hearing loss available without requiring them to see a doctor.

The rule will take effect in 60 days, and hearing aids could be available over the counter for Americans in early October.

An estimated 28.8 million Americans could benefit from hearing aids, according to the National Institutes of Health. But just 16 percent of eligible people aged 20-69 currently use them, and just 30 percent of eligible seniors older than 70 use them.

The steep price is often a reason. Hearing aids typically range between $1,000 to $4,000 per ear. The Biden administration hopes that making the devices available over the counter will boost competition and lower prices.

"This action makes good on my commitment to lower costs for American families, delivering nearly $3,000 in savings to American families for a pair of hearing aids and giving people more choices to improve their health and wellbeing," President Joe Biden said in a statement Tuesday morning, praising the final rule.

The rule was first proposed in October following a July executive order by Biden, and distinguishes between medical-grade hearing aids and personal sound amplification devices that are often used for recreational use. The FDA also Tuesday finalized separate guidance on recreational amplification devices.

Qualified hearing aids will be limited in how much amplification they can offer — as well as other technical requirements — in a bid to steer patients with severe hearing loss toward audiologists. Capping the volume also aims to lessen the risk of people accidentally worsening their hearing loss.

"There is going to be the option for people to go into the prescription space to see an audiologist . . . None of these options are taken away. This just opens up consumer options for people that have relatively simple hearing loss problems that can be helped by an over-the-counter product." FDA Commissioner Robert Califf told reporters on a press call Tuesday.

Making hearing aids available over-the-counter is a popular, bipartisan idea. Sens. Elizabeth Warren, D-Mass., and Charles E. Grassley, R-Iowa, led the passage of the 2017 law requiring the FDA to implement the rule. Also, a provision requiring the agency to finalize the rule was recently included in a sweeping FDA reauthorization bill.

"We've pressed the FDA to take action every step of the way – holding both Republican and Democratic administrations accountable – and fought back against entrenched special interests. We are thrilled that the FDA has finalized these guidelines and that safe, effective, accessible and affordable hearing aids will now be available over-the-counter for millions of Americans," Warren and Grassley said in a statement Tuesday.

But the Biden administration had to contend with lobbying from hearing aid manufacturers and audiologists after proposing the rule, which garnered nearly 1,100 comments. The American Academy of Audiology and manufacturers like Starkey Hearing Technologies previously pressed the FDA to tighten requirements for both safety purposes and to target the devices to younger populations with milder hearing loss.

Manufacturers of hearing aids sold prior to the effective date of the rule will have 240 days to comply with new or revised requirements.

Ariel Cohen contributed to this report.