Advanced Bionics M T-Mic CI-5837 User manual

M T-Mic™ Microphone and M Earhooks
CI-5837, CI-5711
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 8
INTENDED PURPOSE 9
Intended Users 10
Intended Use Environment 11
COMPATIBILITY 11
OPERATING INSTRUCTIONS 11
Connecting the M T-Mic or M Earhook to
thesoundprocessor 11
Removing the M T-Mic or M Earhook 14
Attaching the T-Mic cover 15
Removing the M T-Mic cover 16
CARE AND MAINTENANCE 17
Storing the M T-Mics and M-Earhooks 17
Cleaning and Maintenance 17
Recommended Operating, Storage Temperature,
andHumidity Ranges 18
Expected Life 18
Ingress Protection (IP) Ratings 18

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DISPOSAL AND HAZARDOUS MATERIALS 19
AVAILABLE PRODUCT OPTIONS AND
MODEL NUMBERS 19
M T-Mic 19
M Earhook 20
Earhook Pin and Pin Tool 20
CLINICAL BENEFITS 20

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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
Type of Protection: BF
Suitable temperature range for transport
and storage
See Instructions for Use
Fragile
XXXX-XX-XX

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Do not get wet
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 T-Mic and M Earhooks. It is also meant to
be used by hearing care professionals trained in thefitting
of cochlear implants to counsel recipients on the use of
theM T-Mic and M Earhooks and to troubleshoot problems.
Limitations and Contraindications
As the M T-Mic and M Earhooks are 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
• This device should be used only by the individual for
whom it is prescribed.
• 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 T-Mic or M Earhook.
• Do not allow children to place the M T-Mic or
M Earhook in the mouth.

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• In the event that you experience any issues with
your product, please contact your cochlear implant
professional or the manufacturer. 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.
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 T-Mic is an attachment to the Advanced Bionics
Naída™ CI M and Sky CI™ M sound processors. TheM
T-Mic is a microphone which is designed to fit at the natural
opening of the ear canal when the sound processor is worn
in a behind-the-ear configuration. This enables access to cell
phones, consumer audio electronics, and assistive listening
devices. Sound from this microphone is sent to the Naída
CI M or Sky CI M sound processor. There are three sizes of
the M T-Mic to accommodate dierent ear sizes and shapes:
Small, Medium and Large.

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Connector
Microphone
The M Earhooks serve to hold the sound processor on
theear when the microphone within the sound processor
is utilized. The M Earhooks are available in two sizes:
small and standard, each one with or without an additional
retention grip.
Earhook without Grip
Earhook with Grip

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The connector pins and pin removal tool are also included.
Conector Pin
Pin Removal
Tool
INDICATIONS FOR USE
The M T-Mic and M Earhooks are 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).
Children
• 12 months through 17 years of age.
• Severe-to-profound bilateral sensorineural deafness or
severe-to-profound unilateral hearing loss.

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• 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
appropriate 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) administered 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 T-Mic and M Earhooks are accessories 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 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

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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 T-Mic and M Earhooks are intended for use with
the Advanced Bionics Naída CI M and Sky CI M Sound
Processors. The M T-Mic isintended to pick up sound at the
natural opening of the ear canal when the sound processor
is worn in a behind-the-ear configuration. TheM Earhook is
intended to hold the sound processor on theear when the
sound processor is worn inabehind-the-ear configuration.
Intended Users
The intended users of the M T-Mics and M Earhooks are
users 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 T-Mic and M
Earhooks are healthcare and daily living environments.
The M T-Mic and M Earhooks are designed to be worn
daily during the user’s normal waking hours.
Compatibility
The M T-Mic and M Earhooks are compatible with
only Naída CI M and Sky CI M sound processors from
Advanced Bionics.
Operating Instructions
Connecting the M T-Mic or M Earhook to
thesoundprocessor
Beginning with the M T-Mic or M Earhook disconnected
and the earhook pin uninstalled, align the M T-Mic or M
Earhook flush with the sound processor. Hold the M T-Mic
or M Earhook firmly at the top and push towards the sound
processor until it meets flush with the sound processor.

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Using the provided pin removal tool, place one of the pins
in the small hole on the side of the tool. This will help to
steady the pin as you line it up with the pin hole on the
MT-Mic or M Earhook.
Line up the pin with the hole in the M T-Mic or M Earhook
and gently push it through the hole. The pin will move
from one side of the sound processor, through the M T-Mic
or MEarhook to the other side of the sound processor,
holding the M T-Mic or M Earhook in place. The pin should
not come out the other side.

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If a small portion of the pin extends beyond the sound
processor, use the side of the tool to push the pin inwards
so it lies flush with the sound processor.
.
Pull the tool away from the sound processor, leaving the
pin inside the sound processor.

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Removing the M T-Mic or M Earhook
Align the pointed end of the tool with the hole on the
sound processor that contains the pin holding the M T-Mic
or M Earhook on the sound processor.
Gently press the tool in the hole, pushing the pin out the
other side.
The pin does not need to be removed from the sound
processor. As long as the tool is pushed in flush on one
side of the sound processor, the pin should be displaced
enough to adequately remove the M T-Mic or M Earhook.
Remove the tool from the sound processor. Gently

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grasp the M T-Mic or M Earhook at the top near where it
connects with the sound processor and pull forward until
itis separated from the sound processor.
Attaching the T-Mic cover
Hold the T-Mic cover. In the other hand, hold the M T-Mic
at the end that houses the microphone. Align the bottom of
the T-Mic with the T-Mic cover. Gently turn the M T-Mic into
the T-Mic cover. Screw until they are flush with one another.

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Removing the M T-Mic cover
Grasp the end of the M T-Mic where the T-Mic cover is
located, in one hand. Firmly hold the M T-Mic microphone
portion in the other hand. Turn the hand holding the T-Mic
cover to slowly unscrew the T-Mic cover from the M T-Mic.
Continue turning until the T-Mic cover separates from
theM T-Mic.

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CARE AND MAINTENANCE
Storing the M T-Mics and M-Earhooks
Store any unused M T-Mic or M Earhooks in the box or
case provided.
Cleaning and Maintenance
Wipe the outside of the M T-Mic or M Earhook with a soft,
dry cloth. Do not insert foreign objects into the M T-Mic
inan attempt to clean it. If the M T-Mic is exposed to
humidity or moisture, it may be necessary to dry it with
a drying system. The T-Mic cover should be replaced at
regular intervals to maintain sound quality.

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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 T-Mic is 5 years.
The expected life of the M Earhooks is 1 year.
Ingress Protection (IP) Ratings
The following product configurations have an IP rating of
54 (protection against dust; protection against failure due
to water splashes from all directions):
• The Naída CI M90 sound processor with an
MBattery or M Zn-Air Battery Pak, an M T-Mic or
MAcoustic Earhook, and a Slim HP, Slim HP Mic,
orSlim HP Standard.
• The Naída CI M90 sound processor with an M Zn-Air
Battery Pak, an M Earhook, and a Slim HP, Slim HP
Mic, or Slim HP Standard.