July 9, 2021
Today, President Biden signed a comprehensive Executive Order (EO) designed to promote greater competition in the American economy. One section of the EO addresses the long-anticipated rules on the classification of over-the-counter (OTC) hearing aids. Specifically, the President directed the U.S. Department of Health and Human Services “to consider issuing proposed rules within 120 days for allowing hearing aids to be sold over the counter.”
ASHA appreciates the President’s attention to these long overdue rules. In 2017, Congress directed the U.S. Food and Drug Administration (FDA) to develop regulations for OTC hearing aids. Recognizing a careful balance between affordability and access to new hearing technology, the law classified OTC hearing aids as devices for adults with perceived mild to moderate hearing loss. ASHA worked in collaboration with allied stakeholders and developed a series of evidence-based recommendations for the FDA to consider that ensured the safety, effectiveness, and proper marketing of OTC hearing aids, as well as the importance of an audiologist in hearing health care. ASHA is hopeful that this EO, coupled with the placement of this rule on the Administration’s most recent regulatory agenda, will finally prompt necessary action.
Some parts of the EO require important clarification. Most importantly, the anticipated rule does not encompass all hearing aids. Hearing aids are medical devices that are already regulated by the FDA. OTC hearing aids will be newly regulated devices for adults with perceived mild to moderate hearing loss. A person with moderate to profound hearing loss needs to seek the services of a hearing health professional, such as an audiologist, and the proper technology customized to compensate and correct for that person’s hearing impairment.
Furthermore, while a medical evaluation may not be necessary for every instance of hearing loss, ASHA considers consultation with an audiologist to be a critical component of ensuring good hearing health and consumer protection—even if a consumer choses to purchase an OTC hearing aid. Studies have shown that adults tend to underestimate their hearing loss when undertaking a self-assessment. Audiologists are trained to assess medically treatable causes of hearing loss and to ensure that any technology used to assist with hearing loss is appropriate or safely customized for each individual patient. Hearing loss is different in every person!
ASHA looks forward to the upcoming rule on OTC hearing aids and remains committed to advocating for policies that support a robust hearing health care delivery system and technology that is safe, effective, and affordable.