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accelerated accumulation of cerumen (earwax).
Also in rare cases, the otherwise non-allergenic
material may cause a discharge from the ear,
allergic reaction, or any other unusual condi-
tion. Please seek immediate consultation with a
physician if these conditions occur.
Warning to Hearing Instrument Dispensers
A hearing instrument dispenser should advise a
prospective hearing instrument user to consult
promptly with a licensed physician (preferably
an ear specialist) before dispensing a hearing
instrument if the hearing instrument dispenser
determines through inquiry, actual observation,
or review or any other available information con-
cerning the prospective user, that the prospec-
tive 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.
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