FDA warnings and cautions (USonly)
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.
WARNINGS 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 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.
FDA warnings and cautions (USonly) 3
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