Nov 07, 2016 - Washington, DC -- U.S. Senators Elizabeth Warren (D-Mass.) and Chuck Grassley (R-Iowa) announced that they will introduce the Over-the-Counter Hearing Aid Act of 2016. The bipartisan legislation would make certain types of hearing aids available over the counter (OTC) and remove unnecessary and burdensome requirements that currently create barriers for consumers who could benefit from hearing aids. Approximately 30 million Americans experience age-related hearing loss, yet only about 14 percent of those with hearing loss use assistive hearing technology, often because they cannot afford costly hearing aids.
"Millions of people in Massachusetts and across the country experience hearing loss as they get older, but they are unable to get the hearing aids they need because of high costs and complicated regulations," Warren said. "This bipartisan bill is a simple fix that that will make hearing aids easier to access and - unlike in the current marketplace - will make it easier for consumers to shop for the best value."
"I hear from Iowans about the high cost of hearing aids, and I understand the concern," Grassley said. "If you can buy non-prescription reading glasses over the counter, it makes sense that you should be able to buy basic, safe hearing aids, too. The goal is that by making more products more easily available to consumers, competition will increase and lead to lower costs. More consumer choice and convenience are what we want to accomplish with this legislation. This won't affect those who need professional expertise to be fitted for hearing aids or have hearing aids implanted. The over-the-counter option is for those who would benefit from a simpler device."
The Over-the-Counter Hearing Aid Act of 2016 would allow hearing aids that are intended to be used by adults to compensate for mild to moderate hearing impairment to be sold over the counter, and would eliminate the requirement that people get a medical evaluation or sign a waiver in order to acquire these hearing aids. It also asks the FDA to issue regulations containing safety and labeling requirements for this new category of OTC hearing aids and update its draft guidance on Personal Sound Amplification Products (PSAPs).
The Over-the-Counter Hearing Aid Act implements recommendations from the President's Council of Advisors on Science and Technology (PCAST) and the National Academies of Sciences, Engineering, and Medicine, which have both recommended making some types of hearing aids available over the counter and removing the requirement of a medical evaluation in order to allow millions more Americans to access hearing aids. Out of pocket costs for a single hearing aid currently average around $2,400. According to a report by PCAST, "There is considerable evidence that hearing aids can be profitably sold for a fraction of today's end-user cost."
The text of the senators' bill is available here, and a fact sheet is available here. The legislation will be introduced when the Senate returns to session.
