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Comparison of acoustic therapies for tinnitus suppression: a preliminary trial

Despite submitting two written responsesone in October 2024, another in January 2025the FDA deemed the corrective actions inadequate. The resulting warning letter reads like a play-by-play of what happens when 503B expectations arent met

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10.1056/NEJMoa1607751 52

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The formula is: BAC = [Alcohol consumed in grams / (Body weight in grams R)] 100 *R indicates the alcohol distribution ratiotypically 0.55 for females and 0.68 for males