Opticon INO MINIBITE, Instructions For Use Manual

Page: 16 / 66

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Warning to hearing instrument dispensers
A hearing instrument dispenser should advise a prospective hearing instrument user
to consult immediately 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 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.
(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 instrument whose
maximum sound pressure capability exceeds 132 dB SPL as there may be risk of impairing
the remaining hearing of the hearing instrument user. Important notice for prospective
hearing instrument users