By Christopher Spankovich
This article is a part of the May/June 2024, Volume 36, Number 3, Audiology Today issue.
In August 2022, the U.S. Food and Drug Administration (FDA) released regulations for over-the-counter (OTC) hearing aids. The regulation indicated that persons 18 years of age and older with perceived mild to moderate hearing loss/impairment are candidates for OTC devices, implying those with greater than moderate perceived hearing loss/impairment should consider “prescription” hearing aids. The focus on self-perceived hearing impairment minimizes need for a licensed provider, thus staying true to the idea of an OTC platform. In the regulation, the FDA declined to define mild to moderate hearing impairment in terms of pure-tone audiometry. Instead, the FDA uses descriptions of common symptoms of mild to moderate impairment in the labeling. Of note, the terms “hearing impairment” and “hearing loss” are used interchangeably by the FDA across platforms.
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