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Warnings, Cautions, & Notices 3
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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.
International Use
Your hearing aids are approved to operate at a radio frequency that
is specific to your country or region and might not be approved for
use outside your country or region. Be aware that operation during
international travel may cause interference to other electronic
instruments, or other electronic instruments may cause interference
to your hearing aids.
Warnings, Cautions,
& Notices
We are required by regulations to provide the following warnings:
WARNING: Use of wireless hearing aids directly next to other
electronic equipment should be avoided because it could result in
improper performance. If such use is necessary, note as to whether
your hearing aids and the other equipment are operating normally.
WARNING: Use of accessories, components or replacement
parts other than those provided by the manufacturer of your hearing
aids could result in increased electromagnetic emissions and
decreased electromagnetic immunity and could result in degradation
of performance.
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.
WARNING TO HEARING CARE PROFESSIONAL
A hearing care professional should advise a prospective sound
generator (tinnitus masker) user to consult promptly with a licensed
physician (preferably an ear specialist) before using a sound generator
if the hearing care professional determines through inquiry, actual
observation or review or any other available information concerning
the prospective user that the prospective user has any of the following
conditions:
• Visible congenital or traumatic deformity of the ear
• History of active drainage from the ear within the previous 90 days
• History of sudden or rapidly progressive hearing loss within
the previous 90 days
• Acute or chronic dizziness
• Unilateral hearing loss of sudden or recent onset within the
previous 90 days
Warnings, Cautions,
& Notices
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