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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
FDA Required Information
