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2 | 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
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 certain components of the hearing aid may cause
breakage. If any component breaks and you're unable to remove the device carefully, please
see a physician for safe removal.
WARNING
A hearing care practitioner should advise a prospective sound generator
user to consult promptly with a licensed physician (preferably an ear specialist) before using a
sound generator if the hearing care practitioner 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.
WARNING
There are some potential concerns associated with the use of any sound
generating tinnitus therapy instrument. Among them are the potential for worsening of tinnitus,
a possible change in hearing thresholds, and possible skin irritation at the point of contact with
the hearing aid.
Multiflex Tinnitus Technology has been designed to minimize these concerns. However, should
you experience or notice any of the above conditions or any dizziness, nausea, headaches or heart
palpitations, you should immediately discontinue use of the instrument and seek a consultation
with a medical, audiology or other hearing professional.
As with any instrument, misuse of the tinnitus therapy instrument could present some potentially
harmful effects. Care should be taken to prevent the unauthorized use and to keep the instrument
out of the reach of children and pets.
WARNINGS
•
Batteries are hazardous and must be kept away from children and pets.
•
Batteries can cause serious injuries if swallowed or placed in any part of the body.
•
Medical advice must be sought immediately if it is suspected that the battery has been
swallowed or placed in any part of the body.
Warnings, Cautions, & Notices | 3
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