FDA Red Flags

Red Flags from the FDA

  1. Visible Congenital or Traumatic Deformity of the Ear
  2. History of Active Drainage from the Ear in the Previous 90 Days.
  3. History of Sudden or Rapidly Progressive Hearing Loss within the Previous 90 Days.
  4. Acute or Chronic Dizziness
  5. Unilateral Hearing Loss of Sudden or Recent Onset within the Previous 90 Days.
  6. Audiometric Air Bone Gap Equal to or Greater than 15dB at .5kHz, 1kHz, and 2kHz.
  7. Visible Evidence of Significant Cerumen Accumulation/Foreign Body in the Ear Canal.
  8. Pain or Discomfort in the Ear.