Even Republicans and Democrats agree that hearing loss is a major health and wellness issue in the U.S. According to the Hearing Loss Association of America, 1 in 5 people report having some level of hearing impairment. Among adults 65 and older, 1 in 3 have hearing loss. According to White House archives, in 2016 the FDA launched a process to facilitate easier and less expensive access to hearing aids for people with mild impairment. The FDA stated that conventional hearing aids cost an average of $2,300 per ear. The FDA further stated that “Due to the high cost and the overly burdensome steps needed to access hearing aids,” fewer than 1 in 5 people who could benefit from hearing technology actually received hearing assistance.
People in the U.S. who have a mild hearing impairment may soon be able to buy appropriate hearing aids without a prescription. Current law specifies that hearing aids are only available via a prescription from a medical professional or a signed waiver from the patient (although the FDA announced last December that it was going to stop enforcing this requirement). However, House Bill H.R.1652, the 2017 Over-the-Counter Hearing Aid Act was accepted unanimously by the House and approved by the Senate 94 to 1 August 3, 2017 (Bill S.670). The bill now awaits signing by President Trump to become law.
The gist of the new act is consumers will have the option of buying an FDA-regulated hearing device at a lower cost than prescription hearing aids. The act is part of the Food and Drug Administration (FDA) Reauthorization Act. The FDA Reauthorization Act requires that certain types of hearing aids can be sold over the counter to Americans with mild to moderate hearing impairment. The FDA must apply the same standards for safety, consumer labeling and manufacturing protections as all medical devices.