FDA Proposes the Creation of a Regulatory Category for OTC Hearing Aids

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The Consumer Healthcare Products Association (CHPA) issued the following statement today from Marcia Howard, Ph.D., CAE, Vice President, Scientific and Regulatory Affairs, upon the U.S. Food and Drug Administration (FDA) issuance of a Proposed Rule and Draft Guidance for establishing a regulatory category for over-the-counter (OTC) hearing aids:

“CHPA applauds FDA for issuing this long-awaited proposed rule which has the potential to positively affect the lives of millions of consumers by increasing access to affordable over-the-counter (OTC) hearing aids and personal sound amplification products for those who experience hearing loss.

“Approximately 30 million Americans experience hearing loss; however, hearing aids today are only available by prescription, and data show that fewer than one-out-of-five people who have hearing loss actually use them. Access to OTC medical devices such as hearing aids could help them overcome mild to moderate hearing impairment, improving consumers’ quality of life without a prescription.

“The consumer healthcare industry has been waiting for this FDA-proposed rule mandated by the OTC Hearing Aid Act of 2017. While CHPA and our members have strongly encouraged FDA to act, we have been pleased by the momentum around this issue over the last year, including President Biden’s Executive Order (EO) in July 2021 that included a provision allowing hearing aids to be sold over-the-counter.

“Consumer medical devices and other OTC products provide Americans with accessible, affordable, and trustworthy personal healthcare products which are more important now than ever. CHPA shares FDA’s commitment to consumer access, safety, and innovation and we look forward to working on this important public health effort.

“CHPA is currently reviewing the proposed rule and draft guidance, and we look forward to providing the Agency with perspective from the consumer healthcare industry.”

The Consumer Healthcare Products Association (CHPA), founded in 1881, is the national trade association representing the leading manufacturers and marketers of consumer healthcare products, including over-the-counter (OTC) medicines, dietary supplements, and consumer medical devices. CHPA is committed to empowering self-care by ensuring that Americans have access to products they can count on to be reliable, affordable, and convenient, while also delivering new and better ways to get and stay healthy. Visit www.chpa.org.