FDA Final OTC Hearing Aid Rules Move Forward from OMB

The FDA’s final regulations for OTC hearing aids appear to be at or near the publication stage. According to an online post by the Office of Information and Regulatory Affairs (OIRA), the review of the US Food and Drug Administration’s (FDA) final proposed rules for over-the-counter (OTC) hearing aids was completed by the Office of Management and Budget (OMB) on August 5. Presumably, this would mean the document is back in the hands of FDA for final consideration and revision. 

The OIRA had up to 90 days to complete its review, but took less than 30 days after receiving the FDA guidance. Although it’s unknown how much further work and review is needed by the FDA for completion of the final regulations, the OIRA’s conclusion of the guidance review would suggest publication of the final rules is near.

The rulemaking technically started with the OTC Hearing Aid Act in March 2017 and the signing of the FDA Reauthorization Act of 2017 (FDARA) by President Trump in August 2017. Thus, they have been 5 years in the making—blowing through the original statutory deadline of August 18, 2020 set by Congress. Without a doubt, the pandemic’s demand on FDA resources, the Agency’s subsequent backlog of work, and the complexity surrounding OTC hearing aid rules—particularly regarding individual state regulations for hearing aid dispensing—has contributed to the delay.

In particular, the FDA has been under intense pressure by Senators Chuck Grassley (R-IA), Elizabeth Warren (D-MA), and other members of Congress, as well as the Biden Administration, to “finalize the rule without delay and in a manner that is consistent with congressional intent.” Senators Grassley and Warren introduced a bill on April 7 which would force the agency to “issue a final rule within 30 days following enactment.” The two senators also issued a strong follow-up letter, as well as a report on June 29 accusing the “Big 5” hearing aid manufacturers of an “astroturf” lobbying campaign to influence FDA and weaken the OTC rule. (For more information, see the HearingTracker article “Over the Counter Hearing Aids” which includes at the bottom a timeline of significant events in the genesis and evolution of the rules.)

The final FDA OTC hearing aid regulations will provide manufacturers and dispensing professionals with rules for a new class of self-fitting air-conduction devices intended for adults (ages 18+ years). Designed to make hearing aids more affordable and accessible for people with mild-to-moderate hearing loss, the proposed regulations published on October 20, 2021 were far more extensive than most people expected. It essentially called for a clean slate when it comes to the various state dispensing laws, although it appeared that licensure laws would remain intact unless they violated the original intent of the OTC regulations. Among the most consequential and controversial regulatory issues at stake are loudness limits, electroacoustic and 510(k) premarket notification requirements, returns-for-credit and consumer recourse, and a wide range of labeling issues.

This article is still being edited.