The Office of Management and Budget (OMB) has finally published its official Spring 2021 Unified Agenda, which includes a tentative agenda for the Department of Health and Human Services (HHS). Hearing industry watchers, like myself, have been eagerly awaiting the publication of the Agenda, to find out when the FDA plans to take the next step on addressing Over-The-Counter (OTC) hearing aids.

Timeline

According to the newly published Rule, the FDA tentatively plans to meet on OTC hearing aids during the current rulemaking session and publish a notice of proposed rulemaking (NPRM) through the Federal Register. Once the NPRM is published, a ~60 day public comment period begins, after which the FDA has up to 180 days to issue the final regulations. Conservatively, there is an ~8 month delay from rulemaking meeting to regulation issuance, so depending on when the FDA publishes the NPRM, we’re probably looking at sometime from early to mid 2022.

A precedence of delays

The Over-the-Counter (OTC) hearing aid rulemaking process has been delayed session after session, with the FDA missing previous NPRM statutory deadlines in at least four previous rulemaking sessions (Spring 2019, Fall 2019, Spring 2020, and Fall 2020). Could 2021 finally be the year that the NPRM is published?

External Pressure

In December, 2019, Senators Warren and Grassley, who originally introduced the Over-the-Counter Hearing Aid Act of 2016, co-authored a letter to then Acting FDA Commissioner, Brett Giroir, seeking answers. The FDA continued to fail to issue OTC rules, and the senators wanted to know when Giroir expected to finalize the OTC hearing aid rules.

Pressure has also come from the Hearing Loss Association of America (HLAA), the “nation's leading organization representing consumers with hearing loss”, and Mass Eye and Ear (MEE), who both called on the FDA to prioritize rulemaking for FDA hearing aids. The letter from HLAA cited consumer confusion resulting from “bad actors” advertising OTC products (when no such category exists, yet), and MEE reminded the FDA of the persistent high prices that keep traditional hearing aids out of reach for many.

False and Misleading Advertising

While we wait for an official OTC category for hearing aids, misinformation abounds. Websites, like this one, promote OTC hearing aids, while others promote Personal Sound Amplification Products (PSAPs) as a treatment for hearing loss, in direct violation of the FDA’s guidance. The situation has gotten so out of hand that Dr Cliff, AuD recently published an April Fools’ joke on YouTube, suggesting that the FDA was taking action and “shutting down” bad actors.

Correction: An earlier version of this article predicted that the FDA would issue regulations by May 2022.