By David Fabry This article is a part of the July/August 2018, Volume 30, Number 4, Audiology Today issue. In the classic movie, “The Wizard of Oz,” Dorothy realizes in order to reach the Emerald City, she must first travel through the dark and unfamiliar Enchanted Forest. Worried that they will be attacked, the Tinman predicts the forest will be filled mostly with “lions and tigers and bears.” In recent years, audiology has faced threats due to a variety of factors—some of our own making—that have some fearful of the future. In the United States, an estimated 30 million individuals have measurable hearing loss, yet according to MarkeTrak IX (2015), only 30.2 percent of those with hearing loss own hearing aids. In recent years, numerous federal agencies have focused their attention on increasing hearing aid use, primarily though improving accessibility and affordability. Beginning in 2009, the Food and Drug Administration (FDA) introduced a guidance document for personal sound amplification products (PSAPs). To avoid classification as a medical device, PSAPs cannot be marketed in the United States as products intended for individuals with hearing loss or to compensate for hearing loss (FDA 2009, 2013). Some of these products have technical and performance characteristics that are quite similar to the Class I and Class II hearing aids that the FDA regulates. The determination of whether a product is a “device” that the FDA may regulate is based on the Federal Food, Drug, and Cosmetic Act (FDCA) definition of a device as one “intended for use in diagnosis of disease or other conditions, or in the cure, mitigation, treatment or prevention of disease” (FDCA, 1938). The FDA does not regulate PSAPs as medical devices, although they may regulate them under the electronic provisions of the FDCA. Furthermore, the Consumer Product Safety Commission has the authority to examine safety concerns regarding PSAPs. Concerns regarding the safety and efficacy of PSAPs led to a series of hearings on whether to create a new category of “over-the-counter” (OTC) hearing aids designed for those with hearing loss that would be regulated by FDA. After a process spanning several years, President Donald Trump signed into law the Food and Drug Administration’s (FDA) Reauthorization Act of 2017 on August 18, 2017. The legislation included the Over-the-Counter Hearing Aid Act designed to provide greater accessibility and affordability to hearing aids for those individuals with hearing loss. This content is an exclusive benefit for American Academy of Audiology members. If you're a member, log in and you'll get immediate access. Member Login If you're not yet a member, you'll be interested to know that joining not only gives you access to top-notch resources like this one, but also invitations to member-only events, inclusion in the member directory, participation in professional forums, and access to patient resources, tools, and continuing education. Join today!