FDA Medical Waiver
STATEMENT OF MEDICAL WAIVER
I have been advised by ion Hearing that the Food and Drug
Administration has determined that my best interest would be served if I had a medical
evaluation by a licensed physician (preferably a physician who specializes in diseases of the ear)
before purchasing a hearing aid. I do not wish a medical evaluation before purchasing a hearing
I further understand that a copy of this statement will be kept on file by ion Hearing
for a period of three years from this date, in accordance with the Food and Drug Administration
Please consult a ear specialists or licensed physician if you experience any of the following:
(i) Visible congenital or traumatic deformity of the ear.
(ii) History of active drainage from the ear within the previous 90 days.
(iii) History of sudden or rapidly progressive hearing loss within the previous 90 days.
(iv) Acute or chronic dizziness.
(v) Unilateral hearing loss of sudden or recent onset within the previous 90 days.
(vi) Audiometric air-bone gap equal to or greater than 15 decibels at 500 hertz (Hz), 1,000 Hz, and 2,000 Hz.
(vii) Visible evidence of significant cerumen accumulation or a foreign body in the ear canal.
(viii) Pain or discomfort in the ear"