Authored by the FDA’s Center for Devices and Radiological Health (CDRH) Chief Medical Officer William Maisel, MD, MPH, the letter states that the OTC hearing aid category does not currently exist, and until it is established, “no products that are claimed to address hearing loss are, or can claim to be, OTC hearing aids…Currently, hearing aids continue to be restricted devices, for which sales must follow applicable federal and state requirements.”
There has been a proliferation of hearing devices marketed as “OTC hearing aids” since Congress passed and President Trump signed into law 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. In particular, some start-up and personal sound amplification (PSAP) manufacturers have marketed OTC hearing aids. However, as Maisel pointed out in his letter, any applicable technical and quality standards, as well as marketing and labeling requirements, have not yet been established for the OTC hearing aids by the Agency. In fact, there has been a lot of debate regarding technical requirements and the barriers that the new device category is intended to address (see “NASEM Committee Looks at Regulations for OTC Hearing Aids” and “HIA Comments on FTC ‘Now Hear This’ Workshop and OTC Hearing Aids”).
The FDA has until August 18, 2020 to propose new regulations that will define and regulate the new OTC hearing aid device category, and this will be followed by a public comment period which will almost certainly present the various desires and concerns of consumers, professionals, and industry. The Agency will then have up to 180 days after the close of the comment period to publish the new regulations. 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.
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 stated.
CDRH points out that the FDA has pushed for striking the right balance between access and hearing aid safety. On December 7, 2016, The FDA’s Eric Mann, MD, PhD, announced the Agency was eliminating the so-called “physician waiver” system which required consumers first to seek a physician for a medical evaluation or sign a waiver prior to obtaining a hearing aid (certain state law requirements may still apply).
The letter by Dr Maisel emphasizes the fact that marketing of hearing devices cannot use the phrase “OTC hearing aids” in their marketing since the FDA definition of this hearing aid class—which would probably include severity of loss and other important safety, quality, and labeling requirements—has not yet been established.