An employee of GN, the world’s fourth largest maker of hearing aids, demonstrates the use of a hearing aid at an industry forum in Vienna on November 22, 2013. File photo by REUTERS/Heinz-Peter Bader
The Senate passed a bill Thursday allowing people to purchase hearing aids without a doctor’s prescription. Advocates of the change say it will make hearing aids more accessible and significantly reduce costs by increasing competition in the marketplace.
The measure was part of the larger Food and Drug Administration Reauthorization Act, which will revise and extend the user-fee programs for prescription drugs, medical devices, and generic drugs. The House passed the FDA reauthorization bill last month. It now heads to President Donald Trump’s desk.
Approximately 48 million Americans live with hearing loss, and 80 percent of people who could benefit from the devices do not wear them, according to the Hearing Loss Association of America.
The average cost of a single hearing aid is $2,300, and the devices are not covered by Medicare and most insurance companies. The industry group estimates that 86 percent of people who need hearing aids don’t buy them because of the cost.
Current law requires consumers to buy hearing aids through certified audiologists who are trained to treat hearing problems, which drives up the price. The new proposal would allow people to bypass the licensed audiologist.
The move could open up the market to a number of tech companies, including Apple, that have already begun to develop hearing assistance devices.
The proposed change represents “an unprecedented opportunity for audiologists to provide valuable services to more of the 80 percent of American adults with hearing loss who don’t currently seek treatment,” the Academy of Doctors of Audiology, an advocacy group, said in a statement.
The Hearing Loss Association of America also issued a statement praising the bill. “Finally there will be affordable options for adults with mild to moderate hearing loss, especially those who are not seeking help now,” the group said.
The bill faced opposition from the world’s top six hearing aid manufacturers, which combined control roughly 90 percent of the hearing aid market.
But the Senate passed the bill with overwhelming bipartisan support. Sen. Bernie Sanders, I-Vt., who had advocated for allowing medical drugs to be imported from other countries, was the sole vote against the broader Food and Drug Administration Reauthorization Act, which included the provision on hearing aids.
Under the bill, the agency would have three years to create a new regulatory category for over-the-counter hearing aid products. The department would then be authorized to ensure products meet the designated safety, consumer labeling and manufacturing standards.
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