August 25, 2022

U.S. Food and Drug Administration (FDA) Rule Allows Over-The-Counter Hearing Aids

Center for Disability Health and Wellness Co-Director Dr. Michael McKee shares his perspective on the new FDA rule.

Detail of a hearing aid

On August 16, 2022, the FDA announced a rule to improve access to hearing aids. The action by the federal government allows for the creation of a new category of over the counter (OTC) hearing aids targeted at consumers with mild to moderate hearing impairment. These devices can be purchased directly from stores without the need for a medical exam, prescription, or a fitting adjustment by an audiologist. The announcement by the FDA stated that this rule could offer a low-cost alternative for the approximately thirty million Americans who could benefit from hearing aid use.

Michael McKee

CDHW Co-Director Michael McKee, M.D., is an associate professor and practitioner in the Department of Family Medicine at the University of Michigan. He is also a physician with a hearing loss who has clinical and research expertise in disability health. Dr. McKee expressed enthusiasm about this announcement: “[The new FDA rule] is an exciting step forward to help reduce the cost of hearing aids. Unfortunately, many patients with hearing loss struggle with poor access to hearing aids due to a general lack of insurance coverage for hearing aids, difficulties accessing hearing health specialists, and ongoing hearing loss stigma.” It is estimated that only 30 percent of adults aged seventy and older with hearing loss have ever used hearing aids. Dr. McKee echoed the FDA’s hope that this new rule will make devices more affordable: “OTC hearing aids will allow for [a] greater number of manufacturers to enter the hearing aid market, lowering costs.”

However, he also noted that this rule will not help all individuals who are currently unable to afford hearing aids. OTC devices will not be available for those with more severe losses or children with hearing loss. These individuals will still need the help of an audiologist and, at times, otolaryngologists. In addition, these devices can be very sophisticated and difficult for some to use, as Dr. McKee explained: “It is expected that many of these over-the-counter hearing aids will require a fair amount of comfort with technology, including smartphones and apps.” This may be an issue for many older Americans. The Pew Research center recently reported that only four in ten seniors own smartphones.

Nonetheless, Dr. McKee is hopeful that this rule will help millions of Americans who are currently lacking access to hearing aids. He also remarked that “this step is just one of several moving forward to ensure equitable and accessible hearing health care for all.” Other useful measures include a growing number of U.S. states mandating insurance coverage of hearing aids for children and adults and a federal bill that would require Medicare to pay for certain audiological services.

For more information: FDA Finalizes Historic Rule Enabling Access to Over-the-Counter Hearing Aids for Millions of Americans.