This article covers the ins and outs of what we now know about OTC hearing aid products. Including an overview of the technology, gain and output limitations, and whether they are self-fitting or not? Further discussion if FDA 510(k) is required? Where will they be sold? Return for credit allowed? How do they relate to state dispensing laws? And much more.
Course created on November 14, 2022
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- After this course, participants will be able to describe the regulatory changes (OTC) that will impact the delivery system for hearing health products and services and discuss the candidates for the OTC hearing aids.
- After this course, participants will be able to review the events and organizations that were involved in providing input to the OTC legislation.
- After this course, participants will be able to discuss the gain and output limitations contain in the regulations and compare the ways hearing healthcare professionals may be involved in the OTC market.
Thomas A. Powers
Thomas A. Powers, PhD, is the Founder/Managing Member of Powers Consulting, LLC, providing management consulting to the hearing health industry. Dr. Powers serves an expert audiology consultant and strategic advisor for the Hearing Industries Association, limited partner in RemotEar, LLC, and Executive Consultant to Healthcare Technologies and Methods, LLC. Dr. Powers received his BS from the State University of New York at Geneseo, and his MA and PhD in Audiology from Ohio University.
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Content Disclosure: This learning event does not focus exclusively on any specific product or service.
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Association of Hearing Instrument Practitioners of Ontario
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American Speech-Language-Hearing Assn.
0.1 ASHA CEUs
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California Hearing Aid Dispensers Bureau
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Texas Department of Licensing and Regulation
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