Regulatory Information | 41
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�
Required Information
The following additional information is provided in compliance with U�S� Food
and Drug Administration (FDA) regulations:
WARNING TO HEARING AID DISPENSERS
A hearing aid dispenser should advise a prospective hearing aid user to
consult promptly with a licensed physician (preferably an ear specialist) before
dispensing a hearing aid if the hearing aid dispenser determines 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:
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), 1,000 Hz and 2,000 Hz�
vii� Visible evidence of significant cerumen accumulation or a foreign body
in the ear canal�
viii� Pain or discomfort in the ear�
IMPORTANT NOTICE FOR PROSPECTIVE
HEARING AID USERS
Good health practice requires that a person with a hearing loss have a medical
evaluation by a licensed physician (preferably a physician who specializes in
diseases of the ear) before purchasing a hearing aid� Licensed physicians who
specialize in diseases of the ear are often referred to as otolaryngologists,
otologists, or otorhinolaryngologists� The purpose of the medical evaluation
is to assure that all medically treatable conditions that may affect hearing are
identified and treated before the hearing aid is purchased�
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