Since the passage of the Over-the-Counter Hearing Aid Act of 2017 the Food and Drug Administration (FDA) has been working to create regulations regarding this new category of hearing device. OTC devices specifically for people with hearing loss are not yet on the market. If you are considering purchasing a device that claims to be in this new category, buyer beware. The next step will be a Notice of Proposed Rule Making (NPRM) issued by the FDA, followed by an open comment period and then the final rules. After the final rules are in place, you still need to be an educated consumer: learn all you can about the device before you make that purchase. As of November 30, 2020, the proposed rules have not been issued by the FDA for public comment. We will update this page as we get more information.