Abstract
Purpose: The purpose of this clinical focus article is to provide an overview of the United States Food and Drug Administration's (FDA) over-the-counter (OTC) hearing aid rule, and discuss opportunities for clinicians to support individuals who self-direct their hearing care. Conclusions: The introduction of OTC hearing aids has implications for potentially all U.S. audiologists, even those who do not plan to directly interact with the devices. This clinical focus article provides audiologists with an overview of the historical background on OTC hearing aids and summarizes the FDA's rule. It also introduces recent studies that explore dimensions of patient outcomes with self-fitting hearing aids, including satisfaction with service delivery. In addition, readers are provided with clinical applications, or ways in which they can support patients who pursue OTC hearing aids, including by providing support services that help patients navigate the emotional and psychosocial aspects of hearing loss.
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