ExSilent YTango, User Manual

Page: 25 / 200

English 25
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.
RF Immunity Level
These hearing instruments have a cell phone
immunity rating of M4. For your cell phone to
be compatible with these hearing instruments,
the cell phone needs an immunity rating of
FDA Warning