Grassley Op-Ed | Hear at Last: Over-the-Counter Hearing Aids Coming to a Pharmacy Near You

Nearly five years ago, Congress passed bipartisan legislation I led alongside Senator Warren of Massachusetts to make certain types of hearing aids easily available to Americans with mild to moderate hearing loss. Our proposal, the Over-the-Counter Hearing Aid Act, was signed into law in August of 2017, but years went by before the Food and Drug Administration (FDA) established regulations needed to make affordable hearings aids a reality. After continuously pressuring the FDA over the last several years, the administration has officially finalized necessary guidelines to put our legislation into practice. Safe, effective, accessible and affordable hearing aids will now be available to millions of Americans.

 

I’ve heard from a number of Iowans who look forward to benefiting from over-the-counter hearing aids. Jean Helm from Des Moines said, “I want to clearly hear my grandkids tell me all about baseball and school, which means I know I’m going to need to invest in hearing aids soon.” She’s looking forward to having more affordable options. This is just one example, but it demonstrates how fixing hearing problems is essential to maintaining a healthy and strong quality of life – especially when it comes to spending time with family.

 

Similarly, audiologists in Iowa are looking forward to the new over-the-counter hearing aid guidelines. Audiologists are critical health care providers who will continue to provide much-needed audiology services to seniors. Dr. Jason Aird, who runs an audiology practice in Coralville – serving communities throughout southeast Iowa – believes these new guidelines will serve to highlight the essential role that independent audiologists play in offering consumers a safe, streamlined process for obtaining hearing aids and access to diagnostic and treatment services that they may need.

 

According to the National Institute on Deafness and Other Communication Disorders (NIDCD), nearly 38 million Americans experience some degree of hearing loss. Nearly half of adults 75 or older and one-third of adults between 65 and 74 experience difficulty hearing. However, only a small percentage – around 14 percent – of those who could benefit from hearing aids use them, oftentimes due to high costs.

 

In 2017, I introduced the bipartisan Over-the-Counter Hearing Aid Act to help make hearing aids more affordable and accessible. Specifically, the bill required the FDA to establish regulations making hearing aids available at your local pharmacy, audiologist’s office or elsewhere over-the-counter. By including the FDA in the regulatory process, individuals buying over-the-counter hearing aids can have confidence that existing safety, labeling and manufacturing protections are maintained. Additionally, the legislation removed outdated and burdensome regulations that blocked consumer access to affordable hearing aids. It will introduce more competition into the market, providing consumers with additional options at a more affordable price.

 

Unfortunately, after our commonsense bill was signed into law, we ran into some bureaucratic hurdles and pushback from the “Big Five” hearing aid manufacturers. The FDA slow-rolled the regulatory-crafting process, missing its first statutory deadline by a year. After the public comment period closed on January 18 of this year, and the FDA failed to provide a clear timeline for finalizing regulations, I joined Senator Warren to ramp up pressure by introducing the Delivering Over-the-Counter Hearing Aids Now Act. The bill required the FDA to speed up its timeline for issuing its final regulations.

 

We also faced pushback from the five dominant manufacturers in the highly-concentrated hearing aid industry. The Big Five control 90 percent of the market. Senator Warren and I issued a report and immediately sent it to the FDA, shining a light on the nefarious tactics of these five companies.

 

Although these final guidelines are long overdue, millions of Americans impacted by hearing loss now have access to hearing aids over-the-counter beginning in October. This achievement wouldn’t have been possible without the strong advocacy of impacted Iowans, audiologists and my colleagues in Congress.