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oticon Opn Series - Safety and Warnings; Warnings for Users Under 18

oticon Opn Series
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WARNING: People younger than
18 should go to a doctor before
using this.
People younger than 18 years old
need specialized care, and using this
without a medical evaluation may
worsen impairment or disability.
A hearing aid user who is younger
than 18 should have a recent medical
evaluation from a doctor, preferably
an ear-nose-throat doctor (an ENT).
Before using this, a doctor should
determine that the use of a hearing
aid is appropriate.
WARNING to Hearing Aid Dispensers:
You should advise a prospective hearing
aid user to consult promptly with a doctor,
preferably an ear specialist such as an
ENT, before dispensing a hearing aid if
you determine 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:
Visible deformity of the ear, either
congenital or traumatic
Fluid, pus, or blood coming out of the
ear within the previous 6 months
Pain or discomfort in the ear
History of excessive ear wax or suspicion
that something is in the ear canal
Dizziness, either recent or long-standing
Sudden, quickly worsening, or fluctuating
hearing loss within the previous 6 months
Hearing loss or ringing (tinnitus) only
in one ear or a noticeable difference in
hearing between ears
Audiometric air-bone gap equal to or
greater than 15 dB at 500 Hz, 1000 Hz,
and 2000 Hz

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