Contraindicators - FDA Red Flags

Red Flags from the FDA

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