The Academy submitted a letter to the DC Council expressing concerns about a recently introduced bill, the Hearing Aid Sales Amendment Act of 2019.
Under current District of Columbia regulations, all prospective hearing aid users must receive medical clearance prior to receiving a hearing aid. This bill would replace the single medical clearance requirement with two separate requirements—one for children and one for adults. Children younger than 18 must receive medical clearance within the preceding three months and adults older than 18 must receive medical clearance within the preceding six months.
The Academy’s comments point out that maintaining and reinforcing the medical clearance requirement for adults stands in direct contradiction with current Food and Drug Administration (FDA) efforts to promote the availability and accessibility of hearing aids. The FDA announced in a 2016 guidance document that it “does not intend to enforce the medical evaluation (21 CFE 801.421(a)) or record keeping (21 CFR 801.421(d)) requirements prior to the dispensing of certain hearing aid devices to individuals 18 years of age and older.” In addition, the FDA Reauthorization Act of 2017 directed the FDA to establish an over-the-counter (OTC) category of hearing aids for adults with mild to moderate hearing loss, and the agency is currently working on implementing regulations. The American Academy of Otolaryngology-Head and Neck Surgery supported the creation of the OTC hearing aid category.