Miracle-Ear CONNECT 5/4 RIC 312 BL User Manual page 2

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 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
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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People younger than 18 should go to a doctor before using this.
to Hearing Aid Dispensers: