Herman A. Jenkins, M.D. – FDA Warning Letter, May 28, 2010

The FDA issued a Warning Letter to Dr. Herman A. Jenkins, M.D., following an inspection from April 21 to May 28, 2010, at his clinical site in Aurora, CO. The inspection assessed compliance with federal regulations for the "Fully-Implantable MET? Ossicular Stimulator Clinical Trial" (G040052), a device study.

The letter cited serious violations of 21 CFR Part 812 – Investigational Device Exemptions. Key deficiencies included:

1. **Failure to report Unanticipated Adverse Device Effects (UADEs):** Dr. Jenkins failed to report several UADEs to the sponsor and IRB within 10 working days, including instances of "horrid pain," "feedback and pain with sound," and "VERY loud high-pitched shrieking noise" causing nausea. His response, stating these were not considered "serious adverse effects," was deemed inadequate as it lacked corrective and preventive actions.

2. **Failure to conduct the investigation according to the investigational plan:** Violations included using mastoid placement for bone oscillator measurements instead of the protocol-specified forehead placement, enrolling subjects who met exclusion criteria (e.g., not using hearing aids for 3 months, conductive/mixed hearing loss), and testing only one ear for safety evaluations when the protocol required both. His response, acknowledging deviations but not believing they impacted scientific validity, was inadequate due to an