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Don't miss the opportunity to attend Tinnitus Quest's online Q&A with Dr. Susan Shore and Jon Pearson, CEO of Auricle on October 13. We will hear the latest about the Susan Shore Device.
Yes, they banned it mostly due to the fact it lacks evidence proving efficacy as a supplement - it is still offered as a drug. This is not about adverse outcomes as much as regulating sale of the product for uses not originally intended.
It's not being recalled due to safety, it's being pulled from OTC sale because of the FDA because it was first approved as a respiratory drug in 1963. Honestly, it's a bit shady and suspect of a move by the FDA.