CDRH: Hearing Aids Cannot Yet be OTC Products

Regulatory NewsRegulatory News | 24 July 2018 |  By 

FDA’s Center for Devices and Radiological Health (CDRH) sent a letter to manufacturers Tuesday to caution against marketing hearing aid devices as over-the-counter (OTC) products.
“Currently, hearing aids continue to be restricted devices, for which sales must follow applicable federal and state requirements,” William Maisel, CDRH chief medical officer, wrote in the letter.
The letter makes reference to policies under section 709 of the FDA Reauthorization Act of 2017 (FDARA) in which “Congress enacted a definition, outlined certain requirements, and set forth a process for establishing a category” of OTC hearing aids. The requirements relate to output limits, labeling designs and FDA premarket reviews, among others, Maisel noted.
Under the cited FDARA section, a manufacturer cannot legally claim a hearing aid device to be an OTC product in marketing until a new categorization is finalized. The new statutory process requires FDA to propose new regulations by 18 August 2020 prior to finalizing categorizations.
This “reflects a careful balance between consumer access to new technologies and consumer protections to assure the safety and effectiveness of OTC hearing aids,” Maisel said.
CDRH has pushed for striking the right balance between access and hearing aid safety before.
The center issued immediately in effect guidance in December 2016 to reduce regulatory burden on manufacturers by not enforcing a requirement on medical evaluations before patients can obtain certain hearing aids. This "could start a movement toward” OTC hearing aids costing “a fraction of the $2,300 apiece of current products,” the White House said following the announcement.


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