But Wait…There’s More! Part 2 – Labeling

“Peeling the Onion” is a monthly column by Harvey Abrams, PhD.   This is the second of three posts that summarizes the Hearing Industries Association’s (HIA) recommendations to the Food and Drug Administration’s (FDA) Office of Device Evaluation, the office primarily responsible for promulgating the OTC hearing aid rules following the passage and signing of…

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But Wait…There’s More! (Part 1)

“Peeling the Onion” is a monthly column by Harvey Abrams, PhD.   As widely reported, President Donald Trump signed the FDA Reauthorization Act into law on August 18th. As part of this law, the Food and Drug Administration (FDA) is directed to create and regulate a new category of hearing aids that can be sold…

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Relationship between OTC Price and Behavioral Performance: A Guiding Light

by Amyn Amlani, PhD   The reality of over-the-counter (OTC) products becoming federally regulated took one step closer to certainty last week. The FDA Reauthorization Act of 2017 (HR 2430), which includes provisions for OTC hearing aids for adults with perceived mild-to-moderate hearing loss, passed successfully through the US House of Representatives in July 2017…

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And Now, The Rest of the Story (with apologies to Paul Harvey)

by Harvey Abrams, PhD. “Peeling the Onion” is a monthly column by Harvey Abrams, PhD.    Disclaimer: I am a paid consultant to the Hearing Industries Association (HIA) and contributed to the post-workshop filing submitted to the FTC on behalf of HIA which I review in this article. However, the opinions expressed here are entirely…

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The Plural of Anecdote is NOT Data

by Harvey Abrams, PhD. “Peeling the Onion” is a monthly column by Harvey Abrams, PhD. I participated in two events this week. One informed the other. The first event was the Federal Trade Commission (FTC) Workshop held in Washington DC on April 18th. The other was the March for Science  which, in my current geographical…

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