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How to Reset
FDA STATEMENTS
Warning to hearing aid dispensers
A hearing aid dispenser should advise a prospective hearing aid user to consult promptly with a
licensed physician (preferably an ear specialist) before dispensing a hearing aid if the hearing aid
dispenser determines through inquiry, actual observation, or review of any other availableinformation
concerning the prospective user, that the prospective user has any of the following conditions:
Visible congenital or traumatic deformity of the ear.
History of active drainage from the ear within the previous 90 days.
History of sudden or rapidly progressive hearing loss within the previous 90 days.
Acute or chronic dizziness.
Unilateral hearing loss of sudden or recent onset within the previous 90 days.
Audiometric air-bone gap equal to or greater than 15 decibels at 500 hertz (Hz), 1,000 Hz, and
2,000 Hz.
Visible evidence of significant cerumen (earwax) accumulation or a foreign body in the ear canal.
Pain or discomfort in the ear.
Special care should be exercised in selecting and fitting a hearing aid whose maximum sound
pressure level exceeds 132 decibels because there may be risk of impairing the
remaining hearing of the hearing aid user. (Ovation Hearing aids as manufactured do not have this
level of output)
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