WEST DES MOINES, IOWA — After years of bipartisan efforts, affordable hearing aids will be available over-the-counter in the United States in just two months.
On Tuesday, The Food and Drug Administration officially established a category for over-the-counter (OTC) hearing aids to be sold. The fight for this to happen stems back years ago with U.S. Senators Chuck Grassley (R-IA) and Elizabeth Warren (D-MA) pushing through the bipartisan Over-the-Counter Hearing Aid Act in 2017.
“We’ve pressed the FDA to take action every step of the way – holding both Republican and Democratic administrations accountable – and fought back against entrenched special interests. We are thrilled that the FDA has finalized these guidelines and that safe, effective accessible and affordable hearing aids will now be available over-the-counter for millions of Americans,” said Grassley and Warren in a press release on Tuesday.
An audiologist in West Des Moines echoed both Grassley and Warren’s sentiments about the cost of hearing aids. She said that with OTC aids available there will be more cost-effective options for those that do not have insurance or their insurance does not cover the hearing aids.
“I think one of the big goals with the government approving this is to give more affordability for hearing healthcare,” said Dr. McKenzie Rosdail Kaus, a clinical audiologist at the Iowa Ear Center. “Right now hearing healthcare is hard for some people, they don’t always have good coverage for devices. So having the availability to buy something readily there, you don’t have to wait for someone, you can try it at home and then just have the opportunity to let it grow with you until you are ready for that next step.”
The next step being a more sophisticated hearing aid device if the patient’s hearing gets worse. Rosdail Kaus said that OTCs will cost anywhere from a couple hundred dollars to one thousand; and the professional grade devices can cost a couple thousand all the way to ten thousand.
So, does more access to cheaper devices mean that audiology clinics will sell less prescriptions of the advanced devices? Not exactly. There are clinics that are currently developing and testing their own OTC devices so they can recommend them to their patients with mild to moderate hearing loss. The Iowa Ear Center has their own OTC aid ready for use.
“I think it is a stepping stone and getting their foot in the door, an introduction to the hearing healthcare world and an idea of what they are missing out on,” said Rosdail Kaus. “We were kind of embracing the over-the-counter technology because it does offer the affordability and access. So we will be honest with you, if we think that’s a great candidate for you.”
The over-the-counter hearing aids can be sold in drug stores and clinics starting on October 17, 2022.