Operations Manual

Regulatory Information | 45 44 | Regulatory Information
Use on Aircrafts
The optional wireless capabilities that may be featured in your hearing aids can be
used on an aircraft as hearing aids are exempt from the rules applied to other
personal electronic instruments on an aircraft�
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�
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�
DO NOT OPEN HEARING AID OR CHARGER,
NO USER-SERVICEABLE PARTS INSIDE
The Synergy Charger has a rating of IP 5X per IEC 60529� This means that the
Synergy Charger is protected from dust�
The service life of the Synergy Charger is 3 years�
Required Hearing Aid 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 otorhynolaringologists� 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�
Following the medical evaluation, the physician will give you a written statement
that states that your hearing loss has been medically evaluated and that you may
be considered a candidate for a hearing aid� The physician will refer you to an
audiologist or hearing aid dispenser, as appropriate, for a hearing aid evaluation�
The audiologist or hearing aid dispenser will conduct a hearing aid evaluation
to assess your ability to hear with and without a hearing aid� The hearing aid
evaluation will enable the audiologist or dispenser to select and fit a hearing
aid to your individual needs�