The U.S. Food and Drug Administration today announced important steps to better support consumer access to hearing aids. The agency issued a guidance document explaining that it does not intend to enforce the requirement that individuals 18 and up receive a medical evaluation or sign a waiver prior to purchasing most hearing aids. This guidance is effective immediately. Today, the FDA is also announcing its commitment to consider creating a category of over-the-counter (OTC) hearing aids that could deliver new, innovative and lower-cost products to millions of consumers.
“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, M.D. “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.”
The FDA has cited that hearing loss affects some 30 million people in the United States and can have a significant impact on communication, social participation and overall health and quality of life. Despite the high prevalence and public health impact of hearing loss, only about one-fifth of people who could benefit from a hearing aid seek intervention.
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.
The FDA intends to consider and address PCAST and NAS recommendations regarding a regulatory framework for over-the-counter 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.