Move by FDA to support lower cost, innovative hearing aids

Regulation

FDA decision on hearing aids
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The White House blog website posted an article on December 7 indicating that the US Food and Drug Administration (FDA) is launching a process to facilitate the availability of over-the-counter hearing aids.

The first step in the FDA’s move would be to no longer enforce the requirement for adults in the United States to first get a medical evaluation before obtaining most hearing aids. In practice, the vast majority of people waive this requirement in any case. In the current market, audiological services are bundled into the overall price of a hearing aid. This is the result of bulk purchasing arrangements between hearing aid dispensers and the six major manufacturers. The plan would enable the sale of over-the-counter hearing aids.

The purpose of the move towards over-the-counter hearing aids, sold like eye glasses, would be to make devices accessible at a fraction of the current cost, “helping more of the 30 million Americans who need assistance [with hearing],” according to the post.

The reasoning behind the initiative is explained based on the numbers. 30 million Americans currently have hearing loss and that number is growing every year. This is partly the result of the aging population, with 10,000 Americans turning 65 every single day. Hearing aids currently cost an average of USD 2,300 apiece, so USD 4,600 if both ears are to be fitted. Fewer than one in five Americans who could benefit from hearing aids to improve their quality of life actually get the devices. And lastly, there are only six manufacturers producing nearly all hearing aids worldwide, and only one of these companies is based in the United States. It is hoped the move would stimulate competition and innovation in the market.

Source: Whitehouse.gov

C.S.