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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 uctuating 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 tting a
hearing aid with a maximum output that exceeds 132 dB SPL
FDA Required Information
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