FDA Warning Signs

The FDA advises prospective hearing aid users to consult promptly with a licensed physician (preferably an ear specialist) before purchasing a hearing aid if the user has any of the following conditions:

  1. Visible congenital or traumatic deformity of the ear.
     
  2. History of active drainage from the ear within 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 15 decibels at 500 hertz (Hz), 1,000 Hz, and 2,000 Hz.
     
  7. Visible evidence of significant cerumen (wax) accumulation or a foreign body in the ear canal.
     
  8. Pain or discomfort in the ear.

Important Notice for Prospective Hearing Aid Users

Good health practice requires that a person with a hearing loss have a medical evaluation by a licensed physician (preferably a physician who specializes in diseases of the ear) before purchasing a hearing aid. Licensed physicians who specialize in diseases of the ear are often referred to as otolaryngologists, otologists or otorhinolaryngologists. The purpose of medical evaluation is to assure that all medically treatable conditions that may affect hearing are identified and treated before the hearing aid is purchased. Federal law permits a fully informed adult to sign a waiver statement declining the medical evaluation.