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Warnings, Cautions, & Notices
REQUIRED HEARING AID INFORMATION
The following additional information is provided in compliance
with U.S. Food and Drug Administration (FDA) regulations:
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
WARNING to Hearing Aid Dispenser, Outputs
over 132 dB SPL:
You should exercise special care in selecting and fitting a hearing
aid with a maximum output that exceeds 132 dB SPL because it may
impair the remaining hearing of the hearing aid user.
CAUTION: This is not hearing protection.
You should remove this device if you experience overly loud sounds,
whether short or long-lasting. If you’re in a loud place, you should
use the right kind of hearing protection instead of wearing this device.
In general, if you would use ear plugs in a loud place, you should
remove this device and use ear plugs.
Warnings, Cautions,
& Notices
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