FDA Final Rule Allows Over-the-Counter Hearing Aids – Food and Drug Act

The rule, which will take 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 a hearing aid (for one ear) is about $2,000.

The issuance of the rule was prompted by President Joe Biden’s July 9, 2021 Executive Order on Promoting Competition in the U.S. Economy which required the Secretary of Health and Human Services to comply with the requirements set forth in the Section 709 of the FDA Reauthorization Act of 2017 (FDRAA) (Pub. L. 115–52), which requires the promulgation of regulations establishing a category of over-the-counter hearing aids. Consistent with FDARA, and to implement FDARA requirements, the rule establishes an OTC category of hearing aids that applies to certain air conduction hearing aids. Under the rule, an over-the-counter hearing aid is defined as:

[A]n an air conduction hearing aid that does not require implantation or other surgery and is intended for use by a person 18 years of age or older to compensate for a perceived mild to moderate hearing loss. The device, through tools, tests or software, allows the user to control the hearing aid and to customize it according to their hearing needs. The device may use wireless technology or may include self-assessment hearing loss testing. 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, mail or online transactions , provided the device meets the requirements in this section.

The rule requires all current hearing aids to be relabeled in accordance with the labeling requirements for hearing aids. As for over-the-counter hearing aids, they must have certain prescribed labeling, including but not limited to warnings, cautions, notices and information related to the use and care of the aids auditory. This labeling must be displayed on the outside of the packaging; inside the package; the device itself; the instructions for use leaflet accompanying the appliance; and any OTC hearing aid software not distributed with the hearing aid or amplification platform. In addition, the OTC hearing aid must meet certain power and electroacoustic performance limits and design requirements. Additionally, the rule modifies existing hearing aid rules to be consistent with the new OTC category; repeals the applicable terms of sale relating to hearing aids; and updates federal preemption regulations.

For hearing aids legally offered for sale before the effective date, including hearing aids with 510(k) clearance, compliance with the new or revised requirements must be achieved no later than April 14, 2023, i.e. 240 days after the publication of the final rule. (Note that the ruler probably has a inconsistent compliance deadlines
with the new or revised requirements, but April 14, 2023 is included here because it is the earlier date, one day, and is specifically referenced in the Appointment part of the Rule). For hearing aids that are not legally offered for sale prior to the effective date, or have been offered for sale but must submit a new 510(k), compliance with the new or revised requirements or the 510(k) clearance must be obtained prior to placing the device on the effective date.

The content of this article is intended to provide a general guide on the subject. Specialist advice should be sought regarding your particular situation.

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