The U.S. Food and Drug Administration (FDA) has announced steps to better support consumer access to hearing aids. The agency said it will not enforce the requirement that individuals aged 18 and older receive a medical evaluation or sign a waiver prior to purchasing most hearing aids.
The FDA also announced 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.
Despite the high prevalence and public health impact of hearing loss, the FDA says that only approximately one-fifth of individuals who can benefit from a hearing aid seek intervention.
In October 2015, the President’s Council of Advisors on Science and Technology (PCAST) under then-President Obama 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.