FDA has issued its long-proposed rule on over-the-counter hearing aids. Excerpted from Pathways' Picks October 20: FDA Commish Watch, OTC Hearing Aids, Aussie Reforms.
On October 20, FDA issued a long-awaited proposed rule to establish a category of over-the-counter hearing aids to expand access to the products and likely make it easier for a broader set of manufacturers to get into the market. The proposed rule would set labeling and output volume limit standards, among other requirements, for the new OTC category, while also clarifying labeling and expectations for prescription hearing aids. Notably, the proposed rule would not change the fundamental 510(k) submission requirements for different categories of hearing aids. For instance, legacy and wireless air-conduction hearing aids, in the new OTC category, have been 510(k)-exempt and will continue to be, but self-fitting air-conduction aids, also appropriate for OTC, will continue to require a 510(k) as they have in the past.
Other categories of hearing aids, including bone-conduction and tympanic membrane contact devices, will not be available OTC and will continue to require 510(k)s. The proposed rule also clarifies the distinction between hearing aids and personal sound amplification products, which augment normal hearing and are not considered medical devices. FDA issued a draft guidance in parallel to the proposed rule to distinguish between these two categories. FDA was supposed to issue the proposed rule by August 2020, but the document was held up by COVID-19 and other delays. Public comments are due January 18.
Excerpted from Pathways’ Picks October 20: FDA Commish Watch, OTC Hearing Aids, Aussie Reforms,” Market Pathways, October 20, 2021.
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