Advanced Bionics CI-5851 User manual

M ACOUSTIC EARHOOK
CI-5851
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 7
PRODUCT DESCRIPTION 7
INDICATIONS FOR USE 8
INTENDED PURPOSE 10
Intended Users 10
Intended Use Environment 11
COMPATIBILITY 11
OPERATING INSTRUCTIONS 11
Removing and Attaching the Dome 12
Exchanging the Earwax Protection 13
Connecting the M Acoustic Earhook 16
Removing the M Acoustic Earhook 18
Inserting and Removing the
M Acoustic Earhook onthe Ear 21
CARE AND MAINTENANCE 22
Storing the M Acoustic Earhook 22
Cleaning and Maintenance 22
Recommended Operating, Storage Temperature,
and Humidity Ranges 23
Expected Life 24
Ingress Protection (IP) Ratings 24

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DISPOSAL AND HAZARDOUS MATERIALS 24
AVAILABLE PRODUCT OPTIONS AND MODEL
NUMBERS 24
CLINICAL BENEFITS 25
SUMMARY OF SAFETY AND CLINICAL
PERFORMANCE 25

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SYMBOLS TABLE
Labeling symbols and their meanings
European Community Mark of Conformity.
Authorized to ax the CE Mark in 2021
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 Acoustic Earhook. 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 Acoustic Earhook.
Limitations and Contraindications
As the M Acoustic Earhook is a component of the
HiResolution™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 Acoustic Earhook.
• Do not allow children to place the M Acoustic Earhook
in the mouth.
• The M Acoustic Earhook should only be used by the
intended recipient and not by any other individual.

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• Exposure of the M Acoustic Earhook to high humidity,
sweat, or water could damage the speaker unit.
• Placing the M Acoustic Earhook within close proximity
to the headpiece magnet may damage the M Acoustic
Earhook.
• Remove your sound processor and consult your
cochlear implant professional if uncomfortable sounds
are heard or in case of discomfort, pain or skin irritation.
• Do not use the M Acoustic Earhook unless the earwax
protection is properly seated and the appropriate dome
is attached.
• In the unlikely event that the dome or earwax protection
becomes dislodged in the ear canal, contact your
cochlear implant professional. Do not try to remove the
dome or earwax protection from your ear canal yourself.
• If you observe any changes in sound quality with the M
Acoustic Earhook, please contact Advanced Bionics or
your cochlear implant professional.
• 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 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 Acoustic Earhook is an attachment to the
AdvancedBionics Naída™ CI M90 and Sky CI™ M90
sound processors. The M Acoustic Earhook allows for the
addition of acoustic amplification to the electrical stimulation
traditionally produced by a cochlear implant. From the sound
processor connector, a cable extends to the speaker unit that
transfers sound inputs through the sound outlet into the ear
canal. There are 5 sizes of the M Acoustic Earhook for right
and left ears to accommodate dierent ear sizes and shapes.
Domes attach to the speaker unit of the acoustic earhook to
provide a comfortable fit in the ear canal.
Sound
Processor
Connector
Speaker
Power DomeVented Dome

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The connector pins and pin removal tool are also included.
Conector Pin
Pin Removal
Tool
INDICATIONS FOR USE
The M Acoustic Earhook 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).
Children
• 12 months through 17 years of age.

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• 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
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).
The M Acoustic Earhook coupled with the Naída CI M90
or Sky CI M90 sound processor is indicated for unilateral
or bilateral use in patients with aidable low frequency
hearing sensitivity and severe-to-profound sensorineural
hearing loss.

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Intended Purpose
The M Acoustic Earhook is an external component 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 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 Acoustic
Earhook provides acoustic amplification for patients with
aidable low frequency hearing.
The M Acoustic Earhook coupled with the Naída CI M90
or Sky CI M90 sound processor is intended to provide
acoustic amplification and electrical stimulation to
Advance Bionics cochlear implant recipients.
Intended Users
The intended users of the M Acoustic Earhook 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

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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.
Intended Use Environment
The intended use environments of the M Acoustic
Earhook are healthcare and daily living environments.
TheMAcoustic Earhook is designed to be worn daily
during the user’s normal waking hours.
Compatibility
The M Acoustic Earhook is compatible with Naída CI M90
and Sky CI M90 sound processors from AdvancedBionics.
Operating Instructions
Before using the M Acoustic Earhook, you must ensure:
• A dome is attached to the sound outlet over top of
the earwax protection.
• The M Acoustic Earhook is connected to your sound
processor.
• Your cochlear implant professional has programmed
your sound processor for use with your M Acoustic
Earhook.
• The M Acoustic Earhook is not placed within close
proximity to the headpiece magnet, as the magnet
may damage the M Acoustic Earhook.

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Removing and Attaching the Dome
Remove the dome from the speaker unit by holding the
speaker unit in one hand and the dome in the other.
Pullo the dome to remove.
Attach the dome by holding the speaker unit in one hand
and the dome in the other.
Slide the dome over the speaker unit sound outlet. The
speaker unit and the dome should fit perfectly together.

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For a more custom fit, the Phonak SlimTip is an optional
earpiece that may be used in place of the provided
dome. The SlimTip must be ordered from Phonak; it is
not provided with the M Acoustic Earhook. Contact your
cochlear implant professional for more details.
Exchanging the Earwax Protection
The M Acoustic Earhook is equipped with an earwax
protection (CeruShield) to protect the speaker unit from
earwax damage. Check the earwax protection regularly
and exchange it if it looks dirty or if volume or sound
quality is reduced. The earwax protection should be
replaced every four to eight weeks. The earwax protection
should be discarded after use.
Remove the dome from the speaker unit and clean the
speaker unit with a lint-free cloth.
Gently rotate the CeruShield Disk in the direction indicated
by the arrows until a free opening appears under the trash
icon.

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To remove used earwax protection, carefully insert the
speaker unit into the free opening (under trash icon) until
it clicks.
After the click you will see the removed earwax protection
in the opening below the trash icon.

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To insert new earwax protection carefully insert the speaker
unit into the opening where the new earwax protection
isvisible (opposite the trash icon) until it clicks.
After the click you will see the opening below is empty and
the new earwax protection sits in the speaker unit.

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Connecting the M Acoustic Earhook
Remove the power source from the Naída CI M90 or
SkyCI M90 sound processor and remove the M T-Mic or
MEarhook if necessary.
Align the M Acoustic Earhook flush with the sound
processor. Hold the M Acoustic 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 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 Acoustic
Earhook.
Line up the pin with the hole in the M Acoustic Earhook
and gently push it through the hole. The pin will move from
one side of the sound processor, through the M Acoustic
Earhook to the other side of the sound processor, holding
the M Acoustic 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.
Removing the M Acoustic Earhook
Align the pointed end of the tool with the hole on the sound
processor that contains the pin holding the MAcoustic
Earhook on the sound processor.