Technology Update SessionSession 1A On August 17, 2022, the FDA published its final rules concerning a new classification of medical devices - over-the-counter (OTC) hearing aids. Since then, new and established manufacturers, consumers, and clinicians have attempted to adjust to these new rules which were designed to improve the affordability and accessibility of hearing health care by allowing adults with mild to moderate hearing loss to self-manage their care; i.e., to purchase hearing devices directly without a requirement for a prescription or related professional services. Not unexpectedly, this fundamental change to an established decades-long, distribution and regulatory system has created exciting opportunities as well as significant challenges. One of these challenges is the emergence of myths, misconceptions, and misunderstandings associated with this new classification of hearing aids. Jabra Hearing (formerly Lively Hearing) is an innovative teleaudiology company that has been providing direct-to-consumer products and services for over 5 years. We will demythologize 8 common myths concerning OTCs capitalizing on our experience and the data we've assembled following FDA's Final Rule.
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