‘Til I Hear It From Congress: FDASLA to Direct Publication of Final OTC Hearing Aid Rules

June 22, 2022By Sara W. Koblitz & Jeffrey N. Gibbs

There is a lot to unpack in the 430 pages of FDASLA, which means that some provisions are falling a little under the radar.  One of those provisions is an unusual one in which Congress directs FDA to issue final rules concerning Over-the-Counter hearing aids.  Section 904 of the Senate version of the must-pass user fee legislation states:

Not later than 30 days after the date of enactment of this Act, the Secretary of Health and Human Services shall issue a final rule to establish a category of over-the-counter hearing aids, as defined in subsection (q) of section 520 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360j), as described in section 709(b) of the FDA Reauthorization Act of 2017 (Public Law 115–52).

This provision adds nothing substantive to the OTC hearing aid regulatory scheme—it merely tells FDA that it has 30 days from enactment of the user fee legislation to issue its final rules governing OTC hearing aids.  Directing FDA to issue rules isn’t out of the ordinary.  Nor is it unusual for FDA to give FDA a deadline (which is often missed).  What makes this relatively unusual is that FDA, in the last round of user fee legislation, already directed FDA to do the very same thing.

Back in the 2017 user fee package, the FDA Reauthorization Act (also called “FDARA”), Congress set forth a process for establishing a category of OTC hearing aids—hearing aids that may be sold directly to patients without the intervention of a medical provider.  In that legislation, Congress instructed FDA to publish proposed OTC hearing aid rules by August 2020 and to finalize those rules within 180 days after the closing of the public comment period for those proposed rules.  Though FDA failed to meet that deadline (by over a year), it did eventually issue proposed rules establishing OTC hearing aids in October 2021, after President Biden issued an Executive Order in July 2021 commanding publication.  The Comment Period for those rules closed on January 18, 2022 with over 1100 comments submitted to the docket.  Based on FDARA, FDA should be publishing final rules governing OTC hearing aids on July 15 (technically July 17, but that’s a Sunday).

The statutorily-mandated final rule publication date has not passed, yet Congress already seems convinced that FDA won’t meet that deadline.  While it’s certainly understandable that Congress would doubt FDA’s punctuality in the context of OTC hearing aid rules, it’s not common practice for Congress to pass additional legislation reminding FDA of its obligation to be timely.  It’s even more unusual for the legislation to impose a deadline (30 days after the effective date of FDASLA) which is later than the existing deadline (July 15) that hasn’t yet been missed.  Likely, the inclusion of this provision in must-pass legislation signals Congress’s frustration with the lack of action here on the part of FDA.  Indeed, it took an actual order from the President for the Agency to issue the proposed rules.  And that frustration is understandable given the political pressure to reduce medical costs and the fact that this push for OTC hearing aids has been in motion for 5 years.

Yet there are some serious concerns with mandating the timeline for FDA to release a final rule.  It’s one thing to do so when it’s a proposed rule at stake; FDA can tinker and perfect the rule as it finalizes it.  But rushing a final rule in any context comes with serious consequences, as establishment of an inadequate or unclear regulatory scheme raises safety or effectiveness concerns.

Lack of clarity in the proposed rule is one of the major reasons that FDA needs to carefully evaluate the rule it has proposed.  As many of the 1100+ comments note, the rules provide no clear distinction between the types of OTC hearing aids exempt from or subject to FDA’s 510(k) requirements.  Under the proposed rule, OTC hearing aids are exempt except “self-fitting” hearing aids, which are subject to testing requirements and special controls.  The problem is most of the terms that FDA uses in distinguishing “self-fitting” from “non-self-fitting” hearing aids greatly overlap.  This blurring of the line between an OTC hearing aid and an OTC self-fitting hearing aid would allow hearing aids that do require “self-fitting” to be sold as “non-self-fitting” without clinical testing and conformance to the parameters, software analysis, and usability testing required for self-fitting hearing aids.

One might dismiss these concerns because enforcement tools will protect patients from unsafe hearing aids, but that raises the important question of who will be responsible for that enforcement.  For those unfamiliar with the hearing aid industry, the industry faces regulations on all fronts: FDA regulates the devices while states regulate their distribution and impose conditions of sale via their licensing authority over “hearing health professionals” including audiologists or hearing aid dispensers.  While some state regulations overlap, each state has its own regulatory scheme, and that regulatory scheme currently imposes some of the most significant consumer protections for patients.  These consumer protections have evolved over time based on consumer experience and now include requirements that hearing aids are distributed with receipts providing detailed information about the device and services provided, mandatory return policies to ensure that the selected device is appropriate for a given patient, and warranties in case the device doesn’t work or otherwise malfunctions.   Absent these state laws, these protections vanish.  And under FDA’s proposed rules, many of them will, in fact, vanish.

Because of the interplay between the state and federal hearing aid regulatory scheme, Congress added a preemption clause to FDARA. The basic purpose was to make sure that state laws would not stand in the way of the availability of OTC hearing aids.  The preemption clause provides that no state:

shall establish or continue in effect any law, regulation, order, or other requirement specifically related to hearing products that would restrict or interfere with the servicing, marketing, sale, dispensing, use, customer support, or distribution of over-the-counter hearing aids  . . . through in-person transactions, by mail, or online, that is different from, in addition to, or otherwise not identical to, the regulations promulgated under this subsection, including any State or local requirement for the supervision, prescription, or other order, involvement, or intervention of a licensed person for consumers to access over-the-counter hearing aids.

But Congress left it to FDA to figure out how to effectuate that preemption.  In so doing, FDA’s proposal has been to broadly preempt any state regulations related to hearing aids, which would include licensing provisions (as states cannot impose licensing requirements on the distribution of OTC hearing aids, and, logically, no state licensing requirements distinguish between OTC and other hearing aids since OTC hearing aids don’t yet exist).  And, given that most consumer protection laws are imposed through the licensee, FDA inadvertently preempted virtually all consumer protection requirements.  This means that states need to rewrite all of their regulations to ensure that the consumer protections for hearing aids remain.  There’s no way that can happen in the 60 days that FDA currently provides between publication of the final rule and implementation.  Additionally, the ambiguity in FDA’s approach to preemption raises some other concerns, some of which are addressed in comments from the National Association of Attorneys General.

All of this is the long way to say that Congress’s concern about delays in the issuance of a final rule is fully understandable.  We are approaching 5 years since Congress directed FDA to issue the OTC rules.  Yet this is a complex matter that will affect tens of millions of consumers, and there are serious risks in rushing implementation of a final rule.  Because of the complicated issues here, as well as the 1100+ comments, many assumed that FDA would need significantly longer than 180 days to publish final regulations.  And FDA may still take longer than that, as its no stranger to ignoring congressional deadlines, which is probably why Congress might think that it could get away with doing nothing—with apologies to the Gin Blossoms—’til it hears it from Congress.

Categories: Medical Devices