Trump Signs Law on New Category of Over-the-Counter Hearing Aids; Labeling Requirements to Follow
President Donald Trump on Aug. 18 signed into law legislation that will make certain types of hearing aids available over the counter to Americans with mild or moderate hearing impairment, requiring the Department of Health and Human Services to determine whether the devices need a 510(k) premarket submission. The 510(k) submissions are required for companies that want to market an FDA Class I, II or III device not subject to a formal premarket approval, in order to demonstrate that products are safe and effective, and substantially equivalent to a legally marketed device. The language was included in the Food and Drug Administration Reauthorization Act, after Sens. Chuck Grassley, R-Iowa, and Elizabeth Warren, D-Mass., introduced similar language last Congress that didn’t gain traction (see 1611080028).
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The bill requires HHS, which includes the Food and Drug Adminsitration, to issue proposed regulations to establish a category of over-the-counter hearing aids by Aug. 18, 2020, to include requirements for labeling conspicuously stating that the device is “only intended for adults age 18 and older,” information on how consumers may report "adverse events,” information on any “contraindications, conditions, or symptoms” of medically treatable causes of hearing loss, and advisements to consult “promptly with a licensed health care practitioner,” according to the legislation. The legislation will require the regulations to ensure the new category of hearing aids meets the same safety, labeling and manufacturing protections as “all medical devices,” Grassley’s office said in a statement.