Are you listening? Stage set for OTC hearing aids

WASHINGTON — Sens. Elizabeth Warren, D-Mass., Chuck Grassley, R-Iowa, Maggie Hassan, D-N.H., and Johnny Isakson, R-Ga., on Tuesday reintroduced legislation to make hearing aids for those with mild to moderate hearing loss available over the counter. The move already has the blessing of the Food and Drug Administration. The agency in December announced its commitment to OTC hearing aids with the promise of new, innovative and lower-cost products to millions of consumers.



A companion bill led by Reps. Joe Kennedy III, D-Mass., and Marsha Blackburn, R-Tenn., was also introduced in the House.



Titled "The Over-the-Counter Hearing Aid Act of 2017," the bill would make certain types of hearing aids available without a prescription for those Americans with mild to moderate hearing impairment. In addition, the proposed legislation would require the FDA to write regulations monitoring this new category as medical devices.



"Allowing hearing aids to be sold over the counter will help bring down costs and expand consumer choices so that millions more Americans can find affordable hearing aids," Warren stated. "This bill will loosen up outdated regulations and, with the right protections in place, let the market bring great products ... at far lower costs."



"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," Grassley added. "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."



The bill wouldn't take away more complex hearing aid solutions for those with greater hearing loss, the Senators cautioned, but rather create a new class of hearing aids and expand the market.



"Getting [Personal Sound Amplification Products] on the same shelf as over-the-counter eyeglasses would be a major win for consumers," commented Gary Shapiro, CEO and president,  Consumer Technology Association. "Consumers are, quite literally, paying the price for these restrictions; they are forced to unnecessarily spend up to 10 times more on traditional hearing aids. The high cost of hearing aids, combined with the inconvenience and cost of doctor appointments, results in most adults with mild hearing loss not getting the hearing assistance they need. PSAPs can provide a less expensive, readily available array of products that can aid the millions of Americans living with mild hearing loss. More, opening this market will bring the innovation that robust competition fosters.”



"This commonsense legislation will benefit millions of Americans who depend on hearing aids to communicate with their friends and family and live a full life," Isakson said. "This step will drive down costs, increase competition and simply make it easier for individuals with hearing loss to obtain this basic but essential product."



The FDA is already on board. The agency in December issued a guidance document explaining that it does not intend to enforce the requirement that individuals 18 and up receive a medical evaluation or sign a waiver prior to purchasing most hearing aids, effective immediately. The FDA also announced its commitment to consider an OTC category of hearing aids that could deliver new, innovative and lower-cost products to millions of consumers. “Today’s actions are an example of the FDA considering flexible approaches to regulation that encourage innovation in areas of rapid scientific progress,” then FDA commissioner Robert Califf, stated. “The guidance will support consumer access to most hearing aids while the FDA takes the steps necessary to propose to modify our regulations to create a category of OTC hearing aids that could help many Americans improve their quality of life through better hearing.”



Nearly 30 million Americans experience age-related hearing loss, including over half of adults between the ages of 70 to 79. Yet only a small share of Americans with hearing loss - around 14% - use hearing aids, primarily due to their high cost.



Hearing aids are not covered by Medicare or most private insurance plans and out-of-pocket costs for a single hearing aid average $2,400.