REGULATORY INFORMATION
Warning to hearing aid dispensers
A hearing aid dispenser should advise a prospective hearing aid user to con-
sult promptly with a licensed physician (preferably an ear specialist) before
dispensing a hearing aid if the hearing aid dispenser determines through in-
quiry, actual observation, or review of any other available information con-
cerning the prospective user, that the prospective user has any of the fol-
lowing conditions:
(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.
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.
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