- Published on 11 April 2021
When is the US Food and Drug Administration (FDA) going to announce its long awaited regulations on the sale of over-the-counter (OTC) hearing aids? A delay until at least mid-2022—possibly longer—is now a distinct possibility.
The six-month agenda for the FDA’s rulemaking, which recently has been including the subject of OTC hearing aids, is published by the U.S. Department of Health and Human Services (HHS). But this body’s Spring 2021 Regulatory Agenda, released on March 31, did not include “Establishing Over-the-Counter Hearing Aids and Streamlining Regulations”, as has been reported by the independent online hearing aid consumer resource, Hearing Tracker.
If not dealt with by the FDA in its current session, the rules on OTC hearing aids may not appear until mid-2022, and with delays built into the process—a 60-day public comment period; 180 days which the FDA has for issuing final regulations—a session in autumn of 2021 would mean an earliest date of June 2022, or even a longer wait until early 2023.
But the FDA may still move now on the OTC issue despite its absence from the HHS agenda , as Hearing Tracker points out, quoting Ian D. Ostermiller, a policy advisor at the FDA’s Office of Policy, who is quoted by the online resource as commenting that “the semiannual HHS inventory does not list all actions that FDA has on the Unified Agenda”, and may only include “those prospective HHS rulemakings likely to have a significant economic impact on a substantial number of small entities.”
What is certain is that the rules must come. Access to hearing aids as competively-priced as non-prescription reading glasses was a goal pursued aggressively by certain US politicians, and the law to make it happen—the OTC Hearing Aid Act of 2017—was passed by Congress and signed by President Donald Trump on August 18, 2017.
The law has fuelled controversy as well as loud industry voices against its effects. But coronavirus pandemic measures led to the FDA’s rulemaking being delayed, and amidst the noise of Covid, the silence on OTC regulations has been its most conspicuous feature.
Also in a kind of limbo, however, is the FDA itself, which awaits a Biden adminstration decision on who will run the agency. Unless there is a spring announcement from the Office of Management and Budget (OMB) on imminent attention for OTC in the FDA’s plans, this crucial hearing industry issue may not have its anticipated impact on the market for another year or so.
Source: Hearing Tracker