Dive Brief:

• Two leading Senate lawmakers last week called for FDA to release a proposed rule on over-the-counter hearing aid sales without delay.

• FDA was required to release a proposed rule in August under the terms of a 2017 law but missed the deadline. Senators Chuck Grassley, R-Iowa, and Elizabeth Warren, D-Mass., want the agency to prioritize the release of the rule.

• Days later, The New England Journal of Medicine published an opinion piece from a pair of doctors associated with a Harvard teaching hospital saying FDA needs to "break its silence" on the regulation and recommending 510(k) review be required for all OTC hearing aids.

Dive Insight:

In 2017, President Trump Signed the OTC Hearing Aid Act into law. The bipartisan act required FDA to create regulations to support the OTC sale of hearing aids for use by people with mild-to-moderate hearing impairment. Congress passed the act in the belief high costs and excessive regulations are limiting access to hearing aids. 

Grassley, the Senate Finance Committee Chairman, and Warren, a member of the Senate Health, Education, Labor and Pensions Committee, were among the lawmakers who originally introduced the legislation. Late last year, the senators asked FDA for an update about the proposed rule. FDA, which said the regulation was a priority as far back as fall 2018, responded by committing to developing a proposed rule by Aug. 18, the deadline set by the Act. 

FDA made the commitment in February, shortly before COVID-19 disrupted the agency's operations and became its top priority. Grassley and Warren acknowledged the effect of the pandemic on FDA in their latest letter. However, the senators want the agency to make issuing OTC hearing aid regulations a priority, noting that hearing loss has remained a problem for millions of Americans throughout the pandemic.   

The senators’ call for FDA to release the proposed rule without delay was echoed in an opinion piece by physicians at Harvard teaching hospital Massachusetts Eye and Ear. As well as calling for FDA to break its silence on OTC hearing aids, the clinicians shared thoughts on how to regulate the sector. Notably, they want FDA to require OTC hearing aids to follow the 510(k) pathway.

"This level of regulatory control ... could help assure the safety and effectiveness of OTC devices in the absence of traditional postmarket clinical oversight," the physicians wrote.

The authors of the NEJM piece cited concerns that OTC sales could cause patients to forgo required care or damage their hearing through overamplification to make their case for 510(k) oversight. With OTC hearing aids undergoing premarket review, FDA could set maximum sound levels that prevent overamplification and require labels to carry details of symptoms that require medical attention.