Statutory deadline for OTC hearing aid rule missed by FDA

Regulatory NewsRegulatory News | 17 November 2020 |  By 

Despite ongoing assurances that it will address the matter of over-the-counter hearing aids, the US Food and Drug Administration (FDA) has missed another deadline to issue a proposed rule on the devices.
According to correspondence sent by two US senators to FDA Commissioner Stephen Hahn, MD on 13 October, FDA has missed its statutory deadline of 18 August 2020 to issue proposed guardrails for the marketing of over-the-counter (OTC) hearing aids, as required in the 2017 Over-the-Counter (OTC) Hearing Aid Act.
Senator Elizabeth Warren (D-MA) and Senator Charles Grassley (R-IA) jointly issued the letter; they were among the co-sponsors of the act. “The law removes outdated regulations blocking consumer access to affordable hearing aids by amending the Food, Drug, and Cosmetic Act and allowing the FDA to categorize certain hearing aids as over-the-counter,” wrote the senators.
FDA originally announced that the Fall 2018 Unified Agenda would have proposed OTC hearing aid rules as a priority, even stating that the rules would be ready ahead of the deadline. At that time, FDA indicated in 2019 that the proposed rules would be issued in November 2019.
In February 2020 FDA said it would deliver the proposed rule by 18 August 2020, though no rule has yet been issued. The most recent letter follows a December 2019 letter from the Senators similarly calling then-acting FDA Commissioner Brett Giroir to task for the agency’s missing its self-imposed deadlines.
The FDA’s consumer-facing website on hearing aids includes a test box dated 24 July 2018 entitled “Status on Over the Counter (OTC) Hearing Aids.” The box notes that the FDA Reauthorization Act of 2017 included requirements for establishing a category of OTC hearing aids.
The box also notes that “At this time, there are no products that can claim to address hearing loss that 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.”
A link within the text box takes readers to a July 2018 form letter to hearing aid manufacturers delineating the current regulatory status of hearing aids as restricted devices. A Google search for “over-the-counter hearing aids” yields multiple hits of direct-to-consumer websites selling hearing-enhancing devices designed to be worn within the ear.
Grassley-Warren letter



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Tags: devices, FDA, medical, US

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