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.