The U.S. Food and Drug Administration (FDA) is taking action to ease public access to over-the-counter (OTC) hearing aids and other personal sound amplification devices.
In a Proposed Rule published in the Federal Register in late October, the FDA sets out its plan to create a new regulatory category for OTC hearing devices and to update the regulatory framework applicable to these devices. Specifically, the Proposed Rule details requirements that would be specifically applicable to OTC hearing devices, modifies existing labeling requirements, and repeals conditions applicable to their sale.
The Proposed Rule does not change the requirements that apply to prescription hearing aids but would provide a clearer definition of prescription devices to minimize the risk of confusion.
According to the FDA, an estimated 38 million people in the U.S. have some degree of hearing loss. If adopted the proposed rules could significantly facilitate access to safe and effective hearing assistance solutions that are more affordable than currently available options.
Read the complete text of the FDA’s proposed regulations applicable to OTC hearing aid devices. Public comments on the proposed regulations are due by mid-January 2022 and can be posted to the Federal eRulemaking Portal at www.regulations.gov (reference Docket No. FDA-2021-N-0555).
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