GN Danalogic Ambio BRIE - Important Notice for Prospective Sound Generator Users; Tinnitus Sound Generator Warnings; Tinnitus Sound Generator Precautions; Tinnitus Sound Generator Warning to Hearing Care Professionals

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13.4.2 i TinnitusSoundGeneratorwarningtohearingcareprofessionals
A hearing care professional should advise a prospecve sound generator
user to consult promptly with a licensed physician (preferably an ear
specialist) before geng a sound gen-erator.
If the hearing care professional determines through inquiry, actual
observaon, or review of any other available informaon concerning
the prospecve user that the prospecve user has any of the following
condions:
1. Visible, congenital or traumac deformity of the ear
2. History of acve drainage from the ear within the previous 90 days
3. History of sudden or rapidly progressive hearing loss within the
previous 90 days
4. Acute or chronic dizziness
5. Unilateral hearing loss of sudden or recent onset within the previous
90 days 6.
6. Audiometric air-bone gap equal to or greater than 15 dB at 500 hertz
(Hz), 1,000 Hz, and 2,000 Hz
7. Visible evidence of signicant cerumen accumulaon or a foreign
body in the ear canal
8. Pain or discomfort in the ear
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CAUTION: THE MAXIMUM OUTPUT OF THE SOUND GENERATOR
FALL INTO THE RANGE THAT CAN CAUSE HEARING LOSS
ACCORDING TO OSHA REGULATIONS. IN ACCORDANCE WITH NIOSH
RECOMMENDATIONS, THE USER SHOULD NOT USE THE SOUND
GENERATOR FOR MORE THAN EIGHT (8) HOURS A DAY WHEN SET TO
S LEVEL OF 85 DB SPL OR ABOVE. WHEN THE SOUND GENERATOR
IS SET TO LEVELS OF 90 DB SPL OR ABOVE, THE USER SHOULD NOT
USE THE SOUND GENERATOR FOR MORE THAN TWO (2) HOURS PER
DAY. IN NO CASE SHOULD THE SOUND GENERATOR BE WORN AT
UNCOMFORTABLE LEVELS.
13.3.4Importantnoceforprospecvesoundgeneratorusers
A nnitus masker is an electronic device intended to generate noise of
sucient intensity and bandwidth to mask internal noises. It is also used as
an aid in hearing external noises and speech.
Good health pracce requires that a person with a nnitus condion have
a medical evaluaon by a licensed physician (preferably a physician who
specializes in diseases of the ear) before using a sound generator. Licensed
physicians who specialize in diseases of the ear are oen referred to as
otolaryngologists, otologists or otorhinolaryngologists.
The purpose of medical evaluaon is to assure that all medically treatable
condions that may aect nnitus are idened and treated before the
sound generator instrument is used.
The sound generator instrument is a tool to generate sounds to be used
with appropriate counseling and/ or in a nnitus management programme
to relieve paents suering from nnitus.
13.4 i Tinnitus Sound Generator warnings
1. Sound generator can be dangerous if improperly used
2. Sound generators should only be used as advised by your doctor,
audiologist, or hearing care professional
3. Sound generators are not toys and should be kept out of reach of
anyone who might cause themselves injury (especially children and
pets)
13.4.1 i TinnitusSoundGeneratorprecauons
Should the user develop any side eects from using the sound generator,
such as dizziness, nausea, headaches, perceived decrease in auditory
funcon or increase in nnitus percepon, the user should disconnue use
of the sound generator and seek medical evaluaon.
To prevent unintended usage by paediatric or physically or mentally
disabled users, the volume control must, if enabled, be congured to only
provide a decrease of the sound generator output level.