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OTC: Over the Counter or Over the Cliff

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1.  The OTC legislation as signed into law in 2016 2017 2018 Is still pending

2.  The OTC legislation provides for the following EXCEPT Sale of both air conduction and wireless hearing devices to adults over 18 years of age PSAP are excluded from the regulations Specific pricing for this new class of devices The devices specifically are to address mild-moderate hearing losses

3.  What has initiated the recent focus on Hearing health Recognizing Hearing Loss as a Public Health Priority and a Societal Responsibility Rapidly Changing Technologies Changes in Health Care Paradigms All of the above

4.  Tele-audiology offers the following options to improve the delivery of hearing healthcare Remote assessment of hearing Remote trouble-shooting and programming Home-based auditory rehabilitation All of the above

5.  The FDA must include in the final regulations all of the follow EXCEPT Establish output limits and labeling requirements How consumers can report adverse effects to use of these devices Directs FDA to finalize its PSAP Guidance Document to clarify which products are medical devices A provision for inclusion of a hearing test by a hearing professional

6.  The FTC (Federal Trade Commission workshop in 2017 focus on which of their following missions to protect consumers to promote competition to regulate hearing devices Both A and B

7.  The NASEM issues 12 recommendations. Which one of these has already been enacted? Improve Population-Based Information Improve Access to Hearing Health Care for Underserved and Vulnerable Populations Remove FDA Regulation for Medical Evaluation or Waiver to Purchase a Hearing Aid Improve Affordability of Hearing Health Care

8.  As the OTC class of devices becomes available - we expect that consumers arriving in our offices will Be more informed and have specific opinions about hearing loss Have already tried OTC hearing aids or PSAPs Have an expectation that you can fix, reprogram or modify devices with which you are not familiar All of the above

9.  How will current hearing professional compete in the new distribution system with OTC devices? Practice using evidence-based processes Have a robust hearing aid selection process Conduct fitting verification and validation procedures All of the above

10.  It is expected that the new class of OTC devices will Expand the market Cannibalize the existing hearing aid market Have no impact on the existing market It is impossible to predict at this point