2 | Warnings, Cautions, & Notices Warnings, Cautions, & Notices | 3
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 (ENT). Before using this, a doctor should
determine that the use of a hearing aid is appropriate.
WARNING to Hearing Aid Dispenser:
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.
CAUTION: This is not hearing protection.
You should remove this device if you experience overly loud
sounds, whether short or long-lasting. If you’re in a loud place,
you should use the right kind of hearing protection instead of
wearing this device. In general, if you would use ear plugs in a
loud place, you should remove this device and use ear plugs.
CAUTION: The sound output should not be
uncomfortable or painful.
You should turn down the volume or remove the device if the
sound output is uncomfortably loud or painful. If you consistently
need to turn the volume down, you may need to further adjust
your device.
CAUTION: You might need medical help if a piece
gets stuck in your ear.
If any part of your hearing aid, like the eartip, gets stuck in your
ear, and you can’t easily remove it with your fingers, get medical
help as soon as you can. You should not try to use tweezers or
cotton swabs because they can push the part farther into your ear,
injuring your eardrum or ear canal, possibly seriously.
NOTE: What you might expect when you start using a
hearing aid.
A hearing aid can benefit many people with hearing loss. However,
you should know it will not restore normal hearing, and you may
still have some difficulty hearing over noise. Further, a hearing
aid will not prevent or improve a medical condition that causes
hearing loss.
People who start using hearing aids sometimes need a few weeks
to get used to them. Similarly, many people find that training or
counseling can help them get more out of their devices.
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