Eric Mann, MD, PhD, announced this morning that, effective immediately, the US Food and Drug Administration (FDA) will be eliminating the so-called “physician waiver” system which requires consumers first to seek a physician for a medical evaluation or sign a waiver prior to obtaining a hearing aid. Dr Mann is the Clinical Deputy Director (ENT devices branch) at FDA, and made the announcement at today’s “Dissemination Meeting: Hearing Health Care for Adults: Priorities for Improving Access and Affordability” held by the National Academies of Sciences, Engineering, Medicine (NAS). The elimination of the waiver system was Recommendation #3 in the NAS’s recent 12 recommendations. He also stated that the FDA is pursuing the NAS recommendation for creating a new category for over-the-counter (OTC) hearing devices (Recommendation #7).
Dr Mann was careful to clarify two points with respect to the new physician waiver guidance:
- It does not apply to children (they will continue to have the medical evaluation requirement without the option of a waiver);
- The guidance indicates that dispensers are still required at this point to make available, and provide consumers the opportunity to review, the User Instruction Brochure that contains information about possible Red Flags prior to the sale of a hearing aid.
“Today’s actions are an example of the FDA considering flexible approaches to regulation that encourage innovation in areas of rapid scientific progress,” said FDA Commissioner Robert Califf, MD, in the press release. “The guidance will support consumer access to most hearing aids while the FDA takes the steps necessary to propose to modify our regulations to create a category of OTC hearing aids that could help many Americans improve their quality of life through better hearing.”
In October 2015, the President’s Council of Advisors on Science and Technology (PCAST) issued recommendations intended to facilitate hearing aid device innovation, and improve affordability and patient access. Additionally, the FDA and other federal agencies and a consumer advocacy group sponsored a study published by the National Academies of Sciences, Engineering and Medicine (NAS) in June 2016.
Both PCAST and NAS cited FDA regulations regarding conditions for sale as a potential barrier to availability and accessibility of hearing aids, and concluded that the regulation was providing little to no meaningful benefit to patients. PCAST noted that, at present, hearing aids often cost more than $2,000 a piece, and such barriers to distribution channels may limit new entrants who could achieve technological breakthroughs that could offer a greater variety of lower-cost hearing aid options to those suffering from hearing loss. The regulation requires that all prospective hearing aid users have a medical evaluation by a licensed physician to determine the cause of hearing loss and whether medical or surgical treatments would be more appropriate. Individuals 18 and up may waive the requirement for a medical evaluation by signing a waiver statement.
For the guidance document issued today, the FDA considered recommendations from the PCAST and NAS reports and public comments received on a draft guidance issued in 2013, as well as comments received at an April 2016 FDA workshop.
Under the new guidance, the FDA will continue to enforce the medical evaluation requirement for prospective hearing aid users under 18. Under the FDA’s hearing aid regulations, hearing aid labeling must include information about medical conditions that should be evaluated by a licensed physician. In addition, the FDA requires that information and instructions about hearing aids be provided to consumers before any purchase from a licensed hearing aid dispenser.
The guidance is “Immediately in Effect,” which means it is implemented without prior public comment because it presents a less burdensome policy that is consistent with public health. The public can still comment on the guidance, and the FDA will consider all comments received and revise the guidance document as appropriate.
Key reasons behind new guidance document. At the NAS Dissemination Meeting, Dr Mann further explained the rationale behind the new guidance. “As noted in the NAS report,” said Mann, “the medical evaluation requirement does not appear to provide any meaningful benefits to hearing-impaired adults for several reasons. First, the [NAS] Committee conducted a thorough review of the literature regarding medically treatable causes of hearing loss, as well as reviewing data from the VA and the DoD databases, and concluded that the serious causes of hearing loss requiring urgent attention are rare. And, when they do occur, they often present with symptoms such as ear drainage or pain that would prompt most individuals to seek medical attention. Secondly, although there are no reliable statistics in this area, it’s clear that the majority of consumers are currently signing the waiver statement in lieu of obtaining the medical evaluation…The statistics cited in the report were anywhere between a 60% to 95% waiver rate. Thirdly, the current labeling requirements ensure that the Red Flag symptoms indicating the need for a medical evaluation are already present in the [mandated] User Instructional Brochure of the hearing aid, and this is for the benefit of both the consumer and the dispenser. So given these reasons, and the potential financial and other barriers that the medical evaluation requirement may pose for millions of Amerian adults with untreated hearing loss, FDA has concluded that we agree with NAS Recommendation #3, and we will be pursuing modifications to the conditions for sale regulation regarding the medical evaluation through the usual rule-making procedures with news of these procedures in the Federal Register. However, as this can be a lengthy process, we are issuing the immediately in effect guidance today to indicate that we will no longer be enforcing the medical evaluation requirement while the rule-making process moves forward.”
“We want to acknowledge that this step by FDA may be controversial and that some individuals and professional organizations may have concerns regarding the removal of this regulation,” concluded Mann. “However, we at FDA have carefully considered the totality of the available information, and have concluded that the benefits of easier and potentially less costly access to hearing aids outweigh any demonstrable benefits that are being achieved with the current conditions-for-sale regulation. However, as always, we welcome further input from all stakeholders on the guidance [issued today], and we will review and consider these comments as we move forward.”
OTC category proposals to come. The FDA also intends to consider and address PCAST and NAS recommendations regarding a regulatory framework for OTC hearing aids without the requirement for consultation with a credentialed dispenser. The agency is committed to seeking additional public input before proposing such an approach, said Mann.