The FDA estimates the rule change will create a savings of $2,800 on a pair of hearing aids.
Hearing aids will become more accessible thanks to a new rule change. The U.S. Food and Drug Administration announced on Tuesday that people can now buy hearing aids directly from a store or online, making them cheaper and more accessible, said FDA Commissioner Dr. Robert Califf. Before, Americans could only get a hearing aid with a prescription, visiting a hearing health professional and having a custom fitting. The new rule change will help those with mild to moderate hearing loss to buy hearing aids over the counter, reported CNN.
The FDA estimates the rule change will help people save $2,800 on a pair of hearing aids. The FDA Commissioner said he expects hearing aids to be available over the counter as early as October. "Today's action will not only help adults who have perceived mild to moderate hearing loss gain access to more affordable and innovative production options, but we expect that it will unleash the power of American industry to improve the technology in a way that it will impact the enormous burden of disability from hearing loss affecting the world," he said.
The American Speech-Language-Hearing Association (ASHA) lauded the rule change implemented by the FDA. "ASHA fully supports the creation of this new category of over-the-counter hearing devices, which will increase the availability and affordability of hearing aids for many Americans," said Janice R. Trent, vice president for audiology practice for the group's Board of Directors. "It is important the public understands these devices are only for adults with perceived mild to moderate hearing loss and to strongly consider getting a hearing assessment by a certified audiologist as a first step before they purchase anything."
Senator Elizabeth Warren was one of the sponsors of the bill and she gave the FDA until August 2020 to issue the regulations. She and co-sponsor Senator Chuck Grassley sent several letters calling on the FDA to act. In July 2021, President Biden signed an executive order to speed up the process. FDA said the pandemic had put a spanner in the works. Some health associations raised concerns at the time about how the devices would still require the help of a professional.
The change in rule still doesn't ensure hearing aids are covered by insurance. Hearing aids often burn a huge hole in people's pockets with a pair costing $4,000, according to a 2020 study published in JAMA. There is also very less competition, considering five large companies control 90% of the global marketplace for hearing aids. FDA is counting on the rule change to bring down prices and invite more players into the market. "Reducing health care costs in America has been a priority of mine since Day One and this rule is expected to help us achieve quality, affordable health care access for millions of Americans in need," said Health and Human Services Secretary Xavier Becerra. "I think today's a standout day," said Becerra. "Americans who need help with their hearing aids—and that includes my mom—help is on the way. So over-the-counter hearing aids—get ready, folks, you're going to get to save a lot of money, and we're all going to benefit."
"I have a big smile on my face right now," said Dr. Frank Lin, director of the Cochlear Center for Hearing and Public Health. Lin added that companies making earphones could also enter the market. "In 1977, because of the technology at the time, the only way for hearing aids to be safe and effective is if they were programmed and fitted and professionally adjusted by a licensed provider," said Lin, adding that the rule change could alter the dynamics of the market. "This will allow companies like Samsung, Apple, Google, companies that are already making innovative earbuds, they can now enter the market. They really couldn't before."