Mum’s the Word on Hearing Aids

August 19, 2020By Sara W. Koblitz

Earlier this week, FDA was supposed to issue proposed rules—years in the making—implementing over-the-counter (OTC) hearing aid rules, as required by the Food and Drug Administration Reauthorization Act (FDARA) (read HPM’s summary here).  Under FDARA, FDA is required to issue proposed rules three years from the Act’s approval on August 18, 2017 and issue final rules 180 days after the close of the proposed regulation comment period.  August 18, 2020 has now come and gone with no sign of the proposed rule.  In fact, it hasn’t even been added to OMB’s dashboard, suggesting that it hasn’t been sent to OMB for review (though, we note the possibility that the rule could skip OMB review).

Given the current state of the world, and FDA’s significant role in addressing COVID-19, it’s not entirely surprising that FDA missed the statutorily mandated release date, but it does have us guessing as to the reasons for the hold-up. Given that many of the technical aspects of the rule were likely addressed in last year’s Bose de novo review, our best guess is that the broad preemption provisions are giving FDA trouble.  For those of you unfamiliar, the statute provides:

No State or local government 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.

FDA therefore has to figure out how to go about preempting the hodge-podge of state consumer protections that currently govern hearing aids, applied through the licensing scheme.  That’s no easy feat.

As Bridget Dobyan, Director of Public Policy and Advocacy at the Hearing Industries Association, and I detail in a recent article in Hearing Review, preemption raises significant concerns about the future of several consumer protections that flow through the hearing aid professional license.  Specifically, we flag for FDA the following major areas that preemption could impact:

  • licensing;
  • receipt requirements;
  • return periods;
  • promotion and advertising; and
  • assistive technology device warranties.

Figuring out a scheme to preempt restrictive state rules while maintaining important consumer protections will be incredibly tricky, and we look forward to seeing how FDA decides to address it.  For now, we continue to anxiously await the release of FDA’s proposed OTC hearing aid rules, as we have for the last three years.

Categories: Medical Devices