Q: Will more affordable hearing aids approved by the FDA be available soon?
A: I’ve got good news for Iowans who’ve been waiting too long for less expensive, over-the-counter hearing aids to reach the marketplace. According to the Food and Drug Administration (FDA), nearly 38 million American adults have hearing loss. Having difficulties with hearing make it harder to socialize and easier to become isolated, especially for older Americans. Advances in medical technology can help Americans turn up the volume and shake the stigma associated with hearing aids. But for too long, too many people who would benefit from hearing assistive devices are priced out of the market. Unlike common reading glasses available off-the-shelf in the local pharmacy, the sale of hearing aids are tangled in a complex web of federal regulations that make it harder and more expensive to obtain. For decades, FDA rules have required Americans to get a prescription to obtain hearing aids. That obviously requires a hearing exam by an audiologist or health care specialist. Once a patient makes it through several appointments and fittings, they also face sticker shock to fill the prescription, to the tune of several thousand dollars. A few years ago, I co-sponsored bipartisan legislation with Sen. Elizabeth Warren called Over-the-Counter Hearing Aid Act to cut cumbersome red tape that was keeping more affordable hearing aids for tens of millions of Americans off the shelves. Our bill directed the FDA to issue regulations for a new category of hearing aids for over-the-counter sales. As with other industries, opening up the gates to the free marketplace would accelerate competition, expand consumer choice and drive down prices. President Trump signed our bill into law in 2017. Since then, we’ve been riding herd on the FDA under both the Trump and Biden administrations to get off the dime and write the rules. Finally, the FDA has given the green light to get these rules finalized. At long last, technology companies can put their foot on the gas to secure approval for FDA-regulated over-the-counter hearings aids to be marketed and sold in the United States. Patient advocacy and consumer groups agree this development is music to the ears for the hearing impaired. Imagine the possibilities when high-tech companies compete and innovate to deliver FDA-vetted, over-the-counter hearing aid technology to improve public health at more affordable price points. For tens of millions of Americans, new state-of-the-art products will transform hearing aids as we have come to know them. Patients won’t have to schedule appointments with specialists and put off getting the help they need. Medical experts and patient advocates say hearing loss is associated with isolation, dementia and cognitive decline. I’m glad to report help will soon be on the way. As always, listening first-hand to the concerns of Iowans helps me deliver results at the policymaking tables. Getting over-the-counter hearings aids available once and for all is worth the effort. It reflects how representative government and problem-solving can make a meaningful difference in people’s lives.
Q: How can Iowans share their views with the FDA before it finalizes how OTC hearing aids come to market?
A: It’s likely most Iowans have a family member, friend or neighbor who experiences difficulty with hearing. I encourage Iowans to help spread the word to their loved ones and make their voices heard on this important public health issue. For the next 90 days, the FDA will collect feedback from consumers to inform its regulatory decision-making that will guide enforcement of the law. When Sen. Warren and I wrote the bill, we did so to help bring lower priced hearing aids to Americans, with a lot less hassle involved. I’ll be continuing my oversight work to ensure the law is implemented as intended. In the meantime, Iowans can leave a public comment through Jan. 18, 2022 online. Click the green button “submit a formal comment” found here: https://www.federalregister.gov/documents/2021/10/20/2021-22473/medical-devices-ear-nose-and-throat-devices-establishing-over-the-counter-hearing-aids. Your feedback can help ensure safe, effective, lower-priced, over-the-counter hearing aids are available for sale off-the-shelf when you or a loved one needs them.
Author: Charles Grassley
Chuck Grassley of New Hartford has represented Iowa in the United States Senate since 1980.
