Attention on the emerging OTC hearing aid market increased dramatically in all of the major media channels, business publications, and industry journals this summer following President Biden’s executive order in July directing the FDA to issue proposed rules allowing hearing aids to be sold over the counter (OTC). The aids would still fall under the FDA’s purview as medical devices.

While the hearing healthcare professional industry is justifiably concerned over the intrusion of OTC devices in their market and the competition likely to ensue, there has been some controversy over which paths the industry should pursue in response.

Seeking to provide greater insight into this topic Sycle hosted a panel discussion, Over the Counter (OTC) Hearing Aids: Their Impact on the Marketplace, as part of the company’s Thought Leadership Series. The webinar is available for viewing or downloading. Taking part in a panel discussion was RiseENT Executive VP Kyle Acker, AuD; Matt Dearing, VP of Marketing at My Hearing Centers; Eargo Hearing Aids COO Bill Brownie, Hearing Review Editor in Chief Karl Strom. The panel was moderated by Sycle Co-Founder and CTO Sean Shoffstall

In addition, Stephanie Grein, Sycle’s Vice President of Sales and Enterprise Services, authored a detailed whitepaper on the history and development of the OTC hearing aid market, How OTC Hearing Aids Will Impact the Industry.

Together, these two in-depth reviews of the OTC hearing aid market highlight key issues:

  • Will hearing aid manufacturers and clinics need to change their business models to compete with OTC devices?
  • Can the industry provide viable solutions to the problem of affordability as a significant barrier to wider adoption of hearing aids?
  • How will hearing healthcare professionals support the fundamental need for testing and evaluation?
  • From a medical perspective, will bypassing hearing evaluations deprive consumers of pertinent information concerning the origin and severity of their hearing loss and lead to inaccurate treatments?
  • Will the market become segmented along price and service levels?
  • Will the industry or the FDA respond to the issue of some manufacturers promoting OTC hearing aid devices prior to the publication of the FDA’s proposed rules and standards?

Sycle will continue to explore and host discussions on topics and technologies vital to the hearing aid industry and we invite your feedback and suggestions for future subjects.

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