The U.S. House of Representatives passed by voice vote the Over-the-Counter (OTC) Hearing Aid Act that would create a new class of hearing aids that that could be sold over the counter without the need for prescription this week. Under the new legislation, the regulations for OTC hearing aids would have to provide reasonable assurances of safety and efficacy, establish output limits and labeling requirements, and describe requirements for the sale of hearing aids in-person, by mail, online, without prescription. State and local governments may also not establish or continue in-effect requirements specifically applicable to hearing products that are not identical to the Food and Drug Administration (FDA) requirements and that restrict or interfere with servicing or sale of OTC hearing aids. The bill also dictates that the FDA must update and finalize its draft guidance on hearing products, and they must clarify which products are medical devices.
The Over-the-Counter Hearing Aid Act, which drew widespread bipartisan support, will proceed to a floor vote at the Senate. While the Senate has not announced a timeline for holding a vote on the bill, organizations like the Academy of Doctors of Audiology are confident that the bill will pass and become law this year. “ADA anticipates that this legislation will be enacted in 2017, and views it as an 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 said in a press release. ADA also stressed the important of awareness, and pointed to a recent survey conducted by The Hearing Journal that showed the lack of information and apprehension among some audiologists about the proposed changes in the future of hearing aid delivery.
Published: 7/17/2017 10:40:00 AM