The Regulation of OTC Hearing Aids As 510(k) Devices

Inside Health Policy, an insider’s  look at precedent-setting actions taken by federal regulators, has published  an in-depth review review of the 510 (k) program.

The report states:

Jim Tozzi, head of the Center for Regulatory Effectiveness and a former White House Office of Management and Budget official, and Kate Carr, president of the Hearing Industries Association, met with OMB’s Office of Information and Regulatory Affairs and FDA on Sept. 13 and Sept. 28, respectively.

In his presentation materials, Tozzi asserts that OTC hearing aids should be subject to FDA’s 510(k) premarket notification requirements because they will be similar to the already-existing category of self-fitting hearing aids. In 2019, Tozzi explains, FDA established a new generic category of self-fitting air-conducting hearing. FDA said in its Final Order that manufacturers of devices that similarly incorporate self-fitting technology, including software, could use the 510(k) process to obtain premarket  clearance

“Because OTC hearing aids will incorporate technology analogous to the De Novo device, they too should be subject to a 510(k) premarket notification requirement. This will serve as the basis for a strong enforcement program,” Tozzi says.”


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