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9. For the US market only, complies
with the FDA regulations
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 available information concerning the prospective
user, that the prospective user has any of the following
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.
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