Devices

OTC Hearing Aid Proposed Rule Issued

FDA will accept comments for 90 days on a proposed rule to establish a regulatory category for over-the-counter (OTC) hearing aids and to make related amendments to update the hearing aid regulatory framework. In the proposed rule, FDA says it will:

define OTC hearing aids and establish applicable requirements;
amend existing rules for consistency with a new OTC category;
repeal the conditions for sale applicable to hearing aids;
amend the existing labeling requirements for hearing aids; and
update regulations relating to decisions on applications for exemption from federal preemption that would become obsolete as a result of changes to hearing aid requirements.

“This action, if finalized, would more clearly define prescription hearing aids; however, it would not change the classification of existing device types,” the agency says. “In creating a regulatory category for OTC hearing aids and amending existing rules, we intend to provide reasonable assurance of safety and effectiveness for these devices as well as foster access to, and innovation in, hearing aid technology, thereby protecting and promoting the public health.”

The proposal says OTC hearing aids will be intended to address perceived mild to moderate hearing loss in people age 18 and older.

FDA also issued a draft guidance, Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products, for 90 days of public comment. The document supersedes an 11/7/2013 draft guidance and, if finalized, would describe hearing aids and personal sound amplification products, their respective intended uses, and regulatory requirements applying to both types of products.

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