Starkey CIC R NW - Warnings, Cautions, & Notices; Required Hearing Aid Information

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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
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.