Q&A: Over-the-Counter Hearing Aids
With US Senator Chuck Grassley
Q: Will more affordable FDA approved hearing aids be available soon?
A: I have good news for the people of Iowa who have been waiting too long for cheaper over-the-counter hearing aids to hit the market. According to the Food and Drug Administration (FDA), nearly 38 million American adults have hearing loss. Hearing difficulties make socialization more difficult and isolation easier, especially for older Americans. Advances in medical technology can help Americans turn up the volume and shake off the stigma associated with hearing aids. But for too long, too many people who could benefit from hearing aids are overpriced. Unlike common reading glasses commercially available at local drugstores, the sale of hearing aids is tangled up in a complex web of federal regulations that make them harder and more expensive to obtain. For decades, FDA rules have required Americans to obtain a prescription for hearing aids. This obviously requires a hearing test by an audiologist or health specialist. Once a patient has gone through several appointments and adjustments, they also face sticker shock to fill the prescription, to the tune of several thousand dollars. A few years ago, I co-sponsored bipartite legislation with Senator Elizabeth Warren called Over-the-Counter Hearing Aid Act to cut red tape that kept tens of millions of Americans from buying more affordable hearing aids. Our bill ordered the FDA to issue regulations for a new class of hearing aids for over-the-counter sales. As with other industries, opening the doors to the free market would accelerate competition, increase consumer choice and lower prices. President Trump enacted our bill in 2017. Since then we have straddled the FDA under the Trump regime.and Biden administrations to get the dime down and write the rules. Finally, the FDA has given the green light to finalize these rules. Finally, tech companies can step up to the plate to gain approval for FDA-regulated over-the-counter hearing aids to be marketed and sold in the United States. Patient advocates and consumer groups agree that this development is music to the hearing impaired. Imagine the possibilities when high-tech companies compete and innovate to provide FDA-approved over-the-counter hearing aid technology to improve public health at more affordable prices. For tens of millions of Americans, new, cutting-edge products will transform hearing aids as we know them. Patients won’t have to make appointments with specialists and delay getting the help they need. Medical experts and patient advocates say hearing loss is associated with isolation, dementia and cognitive decline. I am happy to report that help will be on the way soon. As always, listening to the concerns of the people of Iowa firsthand helps me get results at the decision tables. Getting over-the-counter hearing aids once and for all is worth the effort. It reflects how representative government and problem solving can make a significant difference in people’s lives.
Q: How can the people of Iowa share their views with the FDA before it finalizes the commercialization of over-the-counter hearing aids?
A: Most people in Iowa are likely to have a family member, friend, or neighbor who has difficulty hearing. I encourage the people of Iowa to help spread the word to their loved ones and have their voices heard on this important public health issue. Over the next 90 days, the FDA will be collecting consumer feedback to inform its regulatory decision making that will guide law enforcement. When Senator Warren and I drafted the bill, we did it to help Americans provide hearing aids at low prices, with much less hassle. I will continue my monitoring work to ensure that the law is implemented as intended. In the meantime, the Iowans can leave a public comment until Jan. 18, 2022 online. Click on the green “submit formal comment” button located here: https://www.federalregister.gov/documents/2021/10/20/2021-22473/medical-devices-ear-nose-and-throat- devices-establishing-hearing-aids-for-sale-for-sale. Your feedback can help ensure that safe, effective, and inexpensive hearing aids are commercially available when you or a loved one needs them.