Within the last week, both the U.S. Senate and the U.S. Food and Drug Administration (FDA or the Agency) have taken significant steps to deregulate a large portion of hearing aid devices. Despite the benefits that hearing aid deregulation could afford consumers, the deregulatory approach may impact consumers’ ability to use their hearing aids with the most ubiquitous technology of our time: wireless phones.
First, on December 1, 2016, Sens. Elizabeth Warren (D-Mass.) and Chuck Grassley (R-Iowa) introduced The Over-the-Counter Hearing Aid Act of 2016, legislation which would, among other things, permit hearing aids for adults with mild to moderate hearing impairment to be sold over the counter (OTC). Under FDA’s current “Conditions for Sale” regulation (21 C.F.R. § 801.421(a)), such hearing aids are only available upon a medical evaluation or by signing a waiver to forego such an evaluation.
Following closely behind Sens. Warren and Grassley, FDA announced Wednesday via a rare “immediately in effect” guidance document that it does not intend to enforce the Agency’s hearing aid “Condition for Sale” requirements described above. Although FDA will consider public comments on the guidance, the document is “immediately in effect,” meaning that it is implemented without prior public comment because it “presents a less burdensome policy that is consistent with public health,” per the Agency. The guidance applies to: (1) hearing aids that are regulated as class I air-conduction hearing aids under 21 C.F.R. § 874.3300(b)(1); and (2) class II wireless air-conduction hearing aids under 21 C.F.R. § 874.3305. As with all of its guidance, FDA indicated that the document represents the Agency’s current thinking on the topic, and that it does not establish any rights for any person and is not binding on FDA or the public. With that said, because the guidance outlines the Agency’s planned enforcement discretion (i.e., its decision not to enforce certain of its regulations), it does have more of an impact than a run-of-the-mill FDA guidance document.
While FDA’s deregulatory action is not all that surprising, given the October 2015 recommendations of the President’s Council of Advisors on Science and Technology (PCAST), the comments received at FDA’s April 2016 workshop (“Streamlining Good Manufacturing Practices (GMPs) for Hearing Aids”), and the June 2016 report of the National Academies of Sciences, Engineering and Medicine (NAS) (“Hearing Health Care for Adults: Priorities for Improving Access and Affordability”), the timing of the Agency’s announcement so close to the introduction of the Warren/Grassley bill is interesting.
Despite the benefits that hearing aid deregulation could afford consumers, from decreased cost to increased choice and convenience, one must wonder how the deregulatory approach being proposed will impact consumers’ ability to use their hearing aids with the most ubiquitous technology of our time: wireless phones. As many hearing impaired consumers well understand, coupling a hearing aid device with a wireless handset can be incredibly challenging. In order to successfully couple hearing aids with wireless handsets, hearing impaired consumers need to understand the hearing aid compatibility (HAC) ratings both of their wireless handsets and of their hearing aid devices. While the wireless industry already provides HAC ratings of handsets on a large scale, both of their own accord and per Federal Communications Commission (FCC) requirements, consumers still do not have ready access to HAC ratings of their hearing aid devices. With a large portion of hearing aids slated for deregulation, it seems possible that hearing aid device HAC ratings could become an unintended casualty. Without the assistance of professionals to assist hearing impaired consumers with coupling their hearing aids with their wireless handsets, it will be up to FDA to engage the hearing aid industry so that consumers have access to hearing aid device HAC ratings.
If you have any questions regarding an issue raised in this alert, or if you would like assistance drafting and filing comments with FDA, please contact one of the authors.