Senators to Introduce Legislation to Require New Guidance on Hearing Aids
Sens. Chuck Grassley, R-Iowa, and Elizabeth Warren, D-Mass., plan to introduce the Over-the-Counter Hearing Aid Act, which would require the Department of Health and Human Services (HHS), which includes the Food and Drug Administration, to determine whether such devices require a 510(k) premarket submission, the senators announced Nov. 7 (here). 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.
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The legislation also contains language that would ban HHS from using a 2013 draft guidance (here), which says devices marketed under claims that they address problems associated with hearing loss -- such as difficulty listening to people nearby, challenges understanding conversations in crowded rooms, and struggles to understand movie dialogue in a theater -- should not be considered personal sound amplification products (PSAPs) (see 13110610). These products are not devices defined for regulation in the Federal Food, Drug, and Cosmetic Act, and are not subject to regulatory classification, product code or definition under that law, and do not require registration of manufacturers and listing these products with the FDA, because they aren’t intended to address a disease or alter the function of the body, according to the draft guidance.
HHS would be required to issue proposed guidance to replace the 2013 draft within three years of the legislation’s enactment, and final guidance within 180 days of the proposal, according to the bill text. Until that is issued, 2009 guidance directing hearing aid and PSAP marketing processes would be reinstated pursuant to the legislation. That guidance does not contain language akin to that laid out in the 2013 guidance, which excludes PSAPs from being designated as hearing aids in specific situations. Final regulations on the matter will replace prior guidance, and would be required to clarify what products meet the definition of a “device” and what products meet the definition of a personal sound amplification product.
The bill would also require the new HHS regulations to include requirements providing reasonable assurances of the safety and efficacy of over-the-counter hearing aids, such as appropriate consumer labeling, and describing the conditions under which the sale of such hearing aids would be allowed without the "supervision, prescription, or other order, involvement, or intervention of a licensed person, to consumers through in-person transactions, by mail, or online,” the bill text says. "This bipartisan bill is a simple fix that ... will make hearing aids easier to access and -- unlike in the current marketplace -- will make it easier for consumers to shop for the best value,” Warren said in a statement.