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al immediately for modification of the hearing system or earmold at the
point of irritation. A hearing system or earmold may cause an 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 condition. Please seek immediate consultation with a
physician if these conditions occur.
Warning to Hearing System Professionals
A hearing system professional should advise a prospective hearing
system user to consult promptly with a licensed physician (preferably an
ear specialist) before dispensing a hearing system if the hearing system
professional determines through inquiry, actual observation, or review or
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 previ-
ous 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), 1000 Hz and 2000 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 system
whose maximum sound pressure level exceeds 132 decibels because
there may be risk of impairing the remaining hearing of the hearing system
user.
Important Notice for Prospective Hearing System Users
Good health practice requires that a person
with a hearing loss have a medical evaluation
by a licensed physician (preferably a physician who specializes in diseases
of the ear) before purchasing a hearing system. Licensed physicians who
specialize in diseases of the ear are often referred to as otolaryngologists,
otologists, or otorhinolaryngologists. The purpose of medical evaluation
Summary of Contents for AQ X-mini
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