User's Manual

27
FDA Information (valid for USA only)
Use Your Hearing Systems All Day Long
The best way to ensure better hearing is to practice listening with your hear-
ing systems until you are able to wear them comfortably all day.
Generally, infrequent use of the hearing system does not provide you with
the full benefit of amplification.
Your hearing systems will not restore normal hearing. Hearing systems will
not prevent or improve hearing impairment resulting from a physiological
condition. Hearing systems will help you to make better use of your residual
hearing.
The use of hearing systems is only part of hearing rehabilitation; auditory
training and lip reading instruction may be required as weIl.
Possible Side Effects
The hearing system or earmold is a custom-made product. If you are expe-
riencing discomfort, see your audiologist or hearing system dispenser im-
mediately for modification of the hearing system or earmold at the point of
irritation. A hearing system or earmold may cause an accelerated accumula-
tion of cerumen (earwax). Also in rare cases, the otherwise non-allergenic
material may cause a discharge from the ear, allergic reaction, or any other
unusual condition. Please seek immediate consultation with a physician if
these conditions occur.
Warning to Hearing System Professionals
A hearing system dispenser should advise a prospective hearing system user
to consult promptly with a licensed physician (preferably an ear specialist)
before dispensing a hearing system if the hearing system dispenser deter-
mines 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:
(i) Visible congenital or traumatic deformity of the ear.
(ii) History of active drainage from the ear within the previous 90 days.
(iii) History of sudden or rapidly progressive hearing loss within the previous
90 days.
(iv) Acute or chronic dizziness.
(v) Unilateral hearing loss of sudden or recent onset within the previous 90
days.
(vi) Audiometric air-bone gap equal to or greater than 15 decibels at 500
hertz (Hz), 1000 Hz and 2000 Hz.