Earlier this month, the Senate approved a bill that, among other things, would allow hearing aids to be sold over the counter. Now, William Demant, the leading manufacturer of hearing aids, says it wants in on the OTC market if demand for such devices jumps in the U.S.
William Demant makes a range of hearing care devices, including traditional hearing aids and cochlear implants, as well as diagnostic tools. Europe and North America are its largest markets.
"I do not expect any significant change in the U.S. market, but should sales of products like these become substantial, … we will produce some as well,” CEO Soren Nielsen said to Reuters.
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About 15% of American adults—37.5 million—reported they had some trouble hearing, according to the National Institute on Deafness and Other Communication Disorders. And while some people with hearing loss would benefit from using hearing aids, only about one-third of adults 70 and older have ever used one. This number is even lower for adults aged 20 to 69: about one-sixth. Some private insurers may cover hearing aids in part or in full, but Medicare does not.
On average, a hearing aid costs more than $2,000, according to a 2015 report by then-President Barack Obama’s Council of Advisors on Science and Technology. At the time, the council called on the FDA and the Federal Trade Commission to decrease the cost of hearing aids and increase consumer choice. In January 2016, the FDA announced new efforts to improve patient access to the devices and advance hearing aid technology.
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Current regulations require patients to work with an audiologist to obtain a hearing aid, which drives up the cost. Making hearing aids available over the counter would make them cheaper and more accessible.
The new legislation is part of the FDA Reauthorization Act, which will revise and extend the user-fee programs for prescription and generic drugs, biosimilars and medical devices. The Senate passed the measure on Aug. 3, while the House passed it in July.