Regulatory Focus
Posted 09 December 2019 | By
In a letter to Acting US Food and Drug Administration (FDA) Commissioner Brett Giroir last week, Senators Chuck Grassley (R-IA) and Elizabeth Warren (D-MA) raised questions about the agency’s plans to issue rules to regulate over-the-counter (OTC) hearing aids.
“Hearing aids can greatly assist those with hearing loss to lead normal lives. Sadly, although hearing aids are considered prescription products, they are not generally covered by health insurance or Medicare and can cost thousands of dollars,” Grassley and Warren wrote, noting that many Americans with age-related hearing loss are unable to afford hearing aids.
Under the FDA Reauthorization Act of 2017, FDA is required to propose rules for OTC hearing aids that establish requirements for labeling, output limits and demonstrating a reasonable assurance of safety and effectiveness for such products.
While the statutory deadline for FDA to issue the proposed rule is not until August 2020, FDA indicated it would issue the proposed rules in November 2019, according to the latest unified agenda.
“In October of 2018, the FDA announced these rules would be a priority on their Fall 2018 Unified Agenda and would be able to deliver the proposed rules well in advance of the August 2020 statutory deadline. It is now December of 2019 and we have yet to see these regulations come to fruition,” Grassley and Warren wrote.
In response, the two senators called on Giroir to provide an update within two weeks on the agency’s current status with regard to issuing rules and regulations for OTC hearing aids.
