WASHINGTON, D.C. — On July 9, U.S. President Biden signed a sweeping executive order that is said to be aimed at helping “promote greater competition in the American economy”. One particular section of the order addresses the long-anticipated rules on the classification of over-the-counter (OTC) hearing aids.
The President’s order directs the U.S. Department of Health and Human Services “to consider issuing proposed rules within 120 days for allowing hearing aids to be sold over the counter.”
Overdue OTC Hearing Aid Rules
First introduced in 2016 by Senators Elizabeth Warren (D-Mass) and Chuck Grassley (R-Iowa), Congress ultimately passed a bill in 2017 directing the U.S. Food and Drug Administration (FDA) to develop regulations for a new category of OTC hearing aids.
The OTC provision of the legislation, better known as the Over-The-Counter Hearing Aid Act, would allow hearing aids to be used “by adults to compensate for mild to moderate hearing impairment” to be sold over the counter. Additionally, the bill directed the FDA to issue regulations containing safety and labeling requirements for the new OTC category of hearing aids within the next three years.
However, the FDA failed to meet the 2020 deadline and has yet to issue the proposed rules – this has prompted criticism from Senators Warren and Grassley, as well as consumer advocacy groups.
Inclusion of the OTC hearing aid rule within President Biden’s executive order is welcome news to many who championed the legislation.
“This is good news. The sooner we have FDA guidelines, the sooner these new products will be available for the millions of Americans with hearing loss who need them.”
“The hearing care community awaits the delayed release of the FDA’s OTC draft guidelines,” said Amyn Amlani, Ph.D., President of Otolithic Consulting and Editor of Hearing Economics at HHTM.
“Assuming that the FDA adheres to President Biden’s Executive Order and makes guidelines available within 120 days, manufacturers, providers, and patients will have an opportunity to gauge the general direction of the forthcoming frontier in hearing care intervention and patient management. This information will be helpful to the profession and industry as it relates to early considerations, for example, in service delivery, state licensure, academic training, distribution channels, and consumer education.”
When Will OTC Hearing Aids Become Available for Sale?
Even with latest order issued by President Biden, the new OTC category of hearing aids will likely not be available to consumers for some time.
“The practicability to act on these considerations will take effect upon the FDA releasing its final draft,” commented Dr. Amlani. “The final draft is expected within the next 18 months, after the completion of a public comment period and re-review of the guidelines.”
“There have been many calls on the FDA to release the much delayed OTC draft regulation. We hope that President Biden’s Executive Order will result in definitive action by the FDA within 120 days. Once the draft regulation is released, we anticipate a public comment period, followed by further FDA review. It could take up to nine months or more for the final regulation to be released. Effectively, OTC hearings aids are not likely to be available to consumers until mid to late 2023.”
–Kate Carr, President, Hearing Industries Association