On August 17, 2022, the U.S. Food and Drug Administration (FDA) issued a final rule (the "Rule") that enables adult consumers (18 years of age or older) with perceived mild to moderate hearing impairment to purchase certain hearing aids over-the-counter (OTC) without the need for a medical examination, a prescription, supervision, fitting adjustment, or other order by a licensed professional.
The Rule, which goes into effect on October 17, 2022 (the "Effective Date"), is expected to make hearing aids more accessible and reduce the cost of hearing aids for the adult consumer; on average the cost of one hearing aid (for a single ear) is approximately $2,000.
The issuance of the Rule was prompted by President Joe Biden's July 9, 2021 Executive Order on Promoting Competition in the American Economy that compelled the Secretary of Health and Human Services to comply with requirements set forth in Section 709 of the FDA Reauthorization Act of 2017 (FDARA) (Pub. L. 115–52), which obligate the promulgation of regulations that establish a category of OTC hearing aids. In accordance with FDARA, and to implement the requirements of the same, the Rule establishes an OTC category of hearing aids that applies to certain air-conduction hearing aids. Under the Rule, an OTC hearing aid is defined as follows:
[A]n air-conduction hearing aid that does not require implantation or other surgical intervention, and is intended for use by a person age 18 or older to compensate for perceived mild to moderate hearing impairment. The device, through tools, tests, or software, allows the user to control the hearing aid and customize it to the user's hearing needs. The device may use wireless technology or may include tests for self-assessment of hearing loss. The device is available over-the-counter, without the supervision, prescription, or other order, involvement, or intervention of a licensed person, to consumers through in-person transactions, by mail, or online, provided that the device satisfies the requirements in this section.
The Rule necessitates relabeling all current hearing aids according to applicable hearing aid labeling requirements. As for OTC hearing aids, they must have certain prescribed labeling, including, but not limited to, warnings, cautions, notices, and information related to the use and maintenance of the hearing aids. Such labeling must be displayed on the outside of the package; the inside of the package; the device itself; the user instructional brochure accompanying the device; and any OTC hearing aid software not distributed with the hearing aid or amplification platform. Further, the OTC hearing aid must adhere to certain output and electroacoustic performance limits and design requirements. Moreover, the Rule amends existing rules related to hearing aids to be consistent with the new OTC category; repeals applicable conditions for sale related to hearing aids; and updates regulations pertaining to Federal preemption.
For hearing aids legally offered for sale prior to the Effective Date, including hearing aids with 510(k) clearance, compliance with the new or revised requirements must be achieved by April 14, 2023, which is 240 days after the publication of the final rule (Note, the Rule arguably has an inconsistent time frame for compliance with the new or revised requirements, but April 14, 2023 is included here as it is the earlier date, by one day, and is specifically referenced in the Dates section of the Rule). For hearing aids not legally offered for sale prior to the Effective Date, or have been offered for sale but are required to submit a new 510(k), compliance with the new or revised requirements or obtaining 510(k) clearance must be achieved before marketing the device on or after the Effective Date.
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