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My feeling is that the Tinnitus UK “support“ member knows nothing. I know that effective October 1, 2023, the CDRH of the FDA - which has jurisdiction over medical devices such as Auricle - enacted rules that any submissions pursuant to 510 (k) must be submitted electronically to speed up...

Dr. Shore’s was a double blind, placebo controlled study - the gold standard. Neuromod’s Lenire was not. Dr. Shore had NIH funding and a diverse study group. As Lenire was approved, there is no reason not to approve Auricle - a clearly superior device to Lenire and a superior study to Lenire.