As part of the FDA Reauthorization Act of 2017 (FDARA), the U.S. Food and Drug Administration (FDA) is required to promulgate regulations establishing a new category of hearing aids called “over-the-counter (OTC) hearing aids.” FDA was required under FDARA to publish a draft version of these regulations by August 18, 2020. Not surprisingly, given the ongoing, global COVID-19 pandemic, the FDA missed this deadline.
At some point down the road, the FDA will soon publish its draft OTC hearing aid regulations. These regulations are necessary to provide reasonable assurances of the safety and effectiveness of OTC hearing aids, including establishing appropriate device output limits, labeling requirements, and terms of sale.
Similar to traditional hearing aids, OTC hearing aids will be treated as medical devices subject to critically important federal and state regulations. However, unlike traditional hearing aids, OTC hearing aids will be available for purchase over-the-counter without the involvement of a licensed hearing care professional.
Potential Issues Related to Federal Preemption
As part of the regulatory process creating OTC hearing aids, the FDA must evaluate how existing state laws governing hearing aids might interfere with this new category of devices. Importantly, as required by FDARA, any state law that the FDA believes to “restrict or interfere with the servicing, marketing, sale, dispensing, use, customer support, or distribution of over-the-counter hearing aids” will be preempted by federal law.
Preemption is a legal doctrine that commonly arises when there is a conflict between federal and state law, particularly as part of the regulatory process. The doctrine arises out of the Supremacy Clause found in the U.S. Constitution, which provides that “the Laws of the United States . . . shall be the supreme Law of the Land.” To put it simply, preemption not only forbids states from propagating new laws that interfere with federal law at issue, but it also renders any existing conflicting state laws invalid.
In the context of OTC hearing aids, the FDA is faced with the difficult task of making these important determinations—all while patients and consumers hang in the balance under the protection of important state-based consumer protections that may soon be in jeopardy.
Here’s the good news.
To assist the FDA in fully understanding the practical implications regarding the application of its preemption mandate, including any potential unintended consequences, the Hearing Industries Association (HIA) conducted a 50-state survey of existing laws and regulations that could be impacted. HIA identified five primary areas of consumer protection that it strongly encourages the FDA to preserve at the state level as it promulgates OTC hearing aid regulations: (1) licensure-related requirements for the fitting, dispensing, or sale of hearing aids; (2) receipt requirements; (3) strong return periods; (4) important promotion and advertising restrictions, and (5) assistive technology device warranties.
What does it all mean?
As the FDA continues to evaluate how best to implement the broad preemption mandate of FDARA to accommodate the new OTC hearing aid category, the FDA should strive to maintain strong existing state-based consumer protections, including across the five areas identified by HIA. Doing so will be critically important to ensuring OTC hearing aids, as well as traditional hearing aids, are safe and effective.
Here at HAH, we are actively communicating with stakeholders and government officials to ensure this happens, and we hope you will join us in advocating for strong patient safety measures. You can do this by following us on Facebook, Twitter, and Instagram and sharing our content.