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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
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WARNINGS, CAUTIONS, & NOTICES
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.
WARNING:
If Portable Radio Frequency communications equipment is used
closer than 30 cm (12 inches) from your hearing aid, degradation of the performance
of your hearing aid could result. If this occurs, move away from the communications
equipment.
WARNING:
The stability of the hearing aid is designed for normal use. Avoid
physical impacts to the ear when wearing a hearing aid that may cause the device to
break or component of the device to become detached. This may lead to lacerations of
the ear canal or perforation of the ear drum. If this occurs, it is strongly recommended
to see a physician for evaluation and safe removal.
WARNING:
If the hearing aid drops onto a hard surface, it could cause the
hearing aid to break or become damaged. This includes mechanical stress or shock
of the device. Ensure the hearing aid is intact before placing it in the ear. If you find
the device is damaged, discontinue use and see your hearing professional.
WARNING:
Repeated stress to the removal handle may cause it to break. If
the removal handle breaks and you're unable to remove the device carefully, it is
recommended to see a physician for safe removal.
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