Advanced Bionics M Listening Check CI-5827 User manual

M Listening Check™
CI-5827
instructions for use
English, Français, Español, Deutsch, Nederlands, Italiano

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Contents
PURPOSE AND SCOPE OF IFU 5
LIMITATIONS AND CONTRAINDICATIONS 5
PRECAUTIONS, CAUTIONS, AND WARNINGS 5
UNDESIRABLE SIDE EFFECTS 6
PRODUCT DESCRIPTION 6
INDICATIONS FOR USE 7
INTENDED PURPOSE 8
Intended Users 9
Intended Use Environment 10
COMPATIBILITY 10
OPERATING INSTRUCTIONS 10
Listening to the desired input 10
CARE AND MAINTENANCE 16
Storing the M Listening Check 16
Cleaning and Maintenance 16
Recommended Operating, Storage Temperature,
and Humidity Ranges 17
Expected Life 17
Ingress Protection (IP) Ratings 17
DISPOSAL AND HAZARDOUS MATERIALS 17
AVAILABLE PRODUCT OPTIONS AND
MODEL NUMBERS 18
CLINICAL BENEFITS 18

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SYMBOLS TABLE
Labeling symbols and their meanings
European Community Mark of Conformity.
Date of Manufacture
Manufacturer
Model number
LOT number
European authorized representative
Unique Device Identifier
MD Medical Device
Suitable temperature range for transport
and storage
See Instructions for Use
Fragile
Do not get wet
XXXX-XX-XX

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Suitable relative humidity range for transport
and storage
Caution (refer to “Cautions & Warnings”
section for further information)
Dispose of in accordance with applicable
national and local regulations
MR Unsafe

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PURPOSE AND SCOPE OF IFU
This IFU is designed to help cochlear implant recipients,
and their caregivers if applicable, to understand the use
and care of the M Listening Check. It is also meant to be
used by hearing care professionals trained in the fitting of
cochlear implants to counsel the recipients on the use of
the M Listening Check and to troubleshoot problems.
Limitations and Contraindications
As the M Listening Check is a component of the HiResolutionTM
Bionic Ear System, the following contraindications stated
for the HiResolution Bionic Ear System are applicable:
Deafness due to lesions of the acoustic nerve or central
auditory pathway; cochlear ossification that prevents electrode
insertion; absence of cochlear development.
Precautions, Cautions, and Warnings
• CHOKING HAZARD: Contains small parts that pose
a hazard of inhalation, choking, or ingestion. If any
parts are swallowed or inhaled, consult a physician or
hospital immediately.
• Do not leave children unattended with or allow children
to play with the M Listening Check.
• Do not allow children to place the M Listening Check
in the mouth.
• Do not attempt to service or modify the Naída CI M,
SkyCI M, or its accessories. Doing so may compromise
system performance and will void the manufacturer’s
warranty. Products should be serviced only at
Advanced Bionics and damaged products should
bereturned to Advanced Bionics.

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Undesirable Side Effects
Undesirable side eects of your Naída CI M or Sky CI
Msystem may include skin irritation and discomfort from
pressure on the ear, device overheating, or overly loud
sounds.
Product Description
The M Listening Check is an accessory for the Naída CI
M and Sky CI M Sound Processors to allow someone the
ability to listen to the Advanced Bionics Naída CI M and
Sky CI M Sound Processor input sound sources via the
MListening Check Earbuds.
M Listening Check

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Sound Processor
Connector
Battery Connector
Auxiliary Jack
INDICATIONS FOR USE
The M Listening Check is an external component of
theHiResolution Bionic Ear System, which is intended
to restore a level of auditory sensation to individuals
with severe-to-profound sensorineural hearing loss via
electrical stimulation of the auditory nerve.
Adults
• 18 years of age or older.
• Severe-to-profound bilateral sensorineural hearing
lossor severe-to-profound unilateral hearing loss.
• Post-lingual onset of severe or profound hearing loss.
• Limited benefit from appropriately fitted hearing aids,
defined as scoring 50% or less on a test of open-set
sentence recognition (HINT Sentences).

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Children
• 12 months through 17 years of age.
• Severe-to-profound bilateral sensorineural deafness or
severe-to-profound unilateral hearing loss.
• Use of appropriately fitted hearing aids for at least
6months in children 2 through 17 years of age, or at
least 3 months in children 12 through 23 months of age.
The minimum duration of hearing aid use is waived if
x-rays indicate ossification of the cochlea.
• Little or no benefit from appropriately fitted hearing aids.
In younger children (< 4 years of age), lack of benefit is
defined as a failure to reach developmentally appropri-
ate auditory milestones (such as spontaneous response
to name in quiet or to environmental sounds) measured
using the Infant-Toddler Meaningful Auditory Integration
Scale or Meaningful Auditory Integration Scale or
≤20% correct on a simple open-set word recognition
test (Multisyllabic Lexical Neighborhood Test) adminis-
tered using monitored live voice (70 dB SPL). In older
children (≥ 4 years of age), lack of hearing aid benefit
is defined as scoring ≤12% on a dicult open-set word
recognition test (Phonetically Balanced-Kindergarten
Test) or ≤ 30% on an open-set sentence test (Hearing
In Noise Test for Children) administered using recorded
materials in the sound field (70 dB SPL).
Intended Purpose
The M Listening Check is an accessory of an auditory active-
implantable system, the HiResolution Bionic Ear system.
The HiResolution Bionic Ear system is intended to provide
auditory sensation via electrical stimulation of the auditory

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nerve for individuals with severe to profound bilateral or
unilateral sensorineural hearing loss. Severe hearing loss
isdefined as audiometric thresholds greater than or equal
to 70 dB HL, but less than 90 dB HL. Profound hearing
loss isdefined as audiometric thresholds greater than or
equal to 90 dB HL. The external components work together
with the implant to bypass the damaged part of the inner
ear and convert sound picked up by the microphone or
streamed viawireless communication into electrical signals
that are used by the cochlear implant to enable hearing.
The M Listening Check is intended to allow someone the
ability to listen to the Advanced Bionics Naída CI M and
Sky CI M Sound Processor input sound sources via the
Listening Check Earbuds.
Intended Users
The intended users of the M Listening Check are
recipients of the Naída CI M or SkyCI M Sound
Processors, their caregivers if applicable, and hearing
care professionals.
The recipient, or their caregiver, should, at a minimum,
becapable of changing the battery, connecting the earhook,
placing and removing the sound processor from their ear, and
placing and removing the headpiece from the implant site.
The hearing care professional should be trained in the use
and fitting of the cochlear implant system.

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Intended Use Environment
The intended use environments of the M Listening Check
are healthcare and daily living environments. It is not worn
by the recipient and there is no minimum or maximum limit
on the time that it can be used.
Compatibility
The M Listening Check is compatible with the Naída CI M
and Sky CI M sound processors, the M Batteries, the M
Zn-Air Battery Pak, and the Listening Check Earbuds from
Advanced Bionics.
Operating Instructions
The M Listening Check can be used to listen to
thefollowing sound sources:
• Microphones (front and rear, headpiece, T-Mic)
• T-Coil
• Wireless input (via Bluetooth, Phonak Roger
transmitters, or Phonak AirStream accessories)
Listening to the desired input
Remove the battery from the sound processor (if not
already removed). Hold the M Listening Check with one
hand using the grip indents on the sides for traction.
Usingthe other hand, grasp the M Listening Check over
the AB logo and pull out.

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Turn the AB logo portion of the M Listening Check
90degrees.
Bring your hands together, sliding the AB logo portion into
the portion of the M Listening Check in your other hand.
You should feel the two portions snap into place. Once
inplace, the sound processor and M Battery connectors
will be exposed.

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Carefully align the battery connector on the sound
processor with the battery connector on the M Listening
check and connect the top of the M Listening Check
module to the sound processor.
Carefully align the battery connector on the power source with
the battery connector on the M Listening check and connect
the bottom of the M Listening Check to the power source.

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Connect the supplied earbuds to the 3.5mm auxiliary jack
on the side of the M Listening Check.
Place earbuds in ears of the listener. When the M Listening
Check is attached, the sound processor immediately
enters listening check mode. You will be listening to the
input sound source of the start-up program. If you would
like to listen to the other sound source configurations,
use the program button to cycle through the programs or
begin wireless streaming from the wireless device.

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If you select a T-coil program, make sure you are synced
to either a loop or Roger myLink. If you begin wireless
streaming from a wireless device, be cautious and turn
volume down on that wireless device. If listening to
aRoger transmitter or the PartnerMic, provide input to the
Roger transmitter or PartnerMic to assess audio quality.
Once listening check is complete, disconnect the
MListening Check from the M Battery.
Remove the sound processor from the M Listening Check.
Reconnect the M Battery to sound processor and select
desired settings for use.

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To close the M Listening Check when not in use, remove
earbuds, and then grasp the grip indents on the side of
the M Listening Check with one hand while grasping the
sound processor and battery interfaces with the other
hand. Carefully pull your hands apart until the two pieces
disconnect.
Turn one piece 90 degrees, align the AB logo piece to slide
into the other piece. Push together until it snaps into place.

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Note:The M Listening Check requires a charged
power source to function correctly. If the power source
being used to conduct the listening check has been
depleted to an inadequate charge level, the user will
not be able to complete the task. If the user attaches
adischarged rechargeable M Battery or a discharged
M Zn-Air Battery Pak, no sound will be heard through
the Listening Check Earbuds.
CARE AND MAINTENANCE
Storing the M Listening Check
Store the M Listening Check in the box or case provided.
Cleaning and Maintenance
Wipe the outside of the M Listening Check with a soft,
drycloth. Do not insert foreign objects into the M Listening
Check in an attempt to clean it. If the M Listening Check
is exposed to humidity or moisture, it may be necessary to
dry it with a drying system.

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Recommended Operating, Storage Temperature, and
Humidity Ranges
Condition MiniMuM MaxiMuM
Operating Temperature 0˚C (32˚F) 45˚C (115˚F)
Storage Temperature -20˚C (-13˚F) 55˚C (131˚F)
Relative Humidity 0% 95%
Expected Life
The expected life of the M Listening Check is 1 year.
Ingress Protection (IP) Ratings
The following product configuration has an IP rating of 22
(protection against insertion of solid objects ≥ 12.5 mm
diameter; protection against failure due to dripping water
when tilted up to 15˚):
• The Naída™ CI M90 sound processor with the
MListening Check, an M Battery or M Zn-Air Battery
Pak, an MT-Mic™ microphone, M Earhook, or
MAcoustic Earhook, and a headpiece.
DISPOSAL AND HAZARDOUS MATERIALS
Dispose of the M Listening Check in accordance with
applicable national and local regulations. Hazardous
materials: not applicable to this product.

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AVAILABLE PRODUCT OPTIONS AND
MODEL NUMBERS
ProduCt oPtion Model nuMber
M Listening Check CI-5827
Listening Check Earbuds CI-5822
CLINICAL BENEFITS
The Intended Clinical Benefit of the M T-Mic and M Earhooks
as part of the HiResolution Bionic Ear System is to:
• provide useful hearing to individuals with severe-to-
profound hearing loss via electrical stimulation of
theauditory nerve.
• provide a combined type of stimulation, electric plus
acoustic, when sound processors are enabled with
theAcoustic Earhook.
Users of the M Listening Check should report any
serious incident to their local competent authority
and to Advanced Bionics.