Advanced Bionics Slim HP User manual

Slim HP, Slim HP Mic, Slim HP AquaMic™
CI-5320, CI-5322, CI-5321
Slim HP Color Caps
CI-7131, CI-7132
instructions for use
English, Français, Español, Deutsch, Nederlands, Italiano

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Contents
PURPOSE AND SCOPE OF IFU 4
LIMITATIONS AND CONTRAINDICATIONS 5
PRECAUTIONS, CAUTIONS, AND WARNINGS 5
UNDESIRABLE SIDE EFFECTS 7
PRODUCT DESCRIPTION 7
INDICATIONS FOR USE 10
INTENDED PURPOSE 11
Intended Users 13
Intended Use Environment 14
COMPATIBILITY 14
OPERATING INSTRUCTIONS 14
Assembly Instructions 14
Cables 15
Color Caps 17
Magnets 18
For use of Slim HP AquaMic in water 18
CARE AND MAINTENANCE 18
Storing the Slim HPs 18
Cleaning and Maintenance 18
Recommended Operating and
Storage Temperature Ranges 19
Expected Life 19
Ingress Protection (IP) Ratings 19

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DISPOSAL AND HAZARDOUS MATERIALS 20
AVAILABLE PRODUCT OPTIONS
AND MODEL NUMBERS 20
Slim HP 20
Slim HP Mic 21
Slim HP AquaMic 21
Slim HP Color Caps 22
CLINICAL BENEFITS 24
SUMMARY OF SAFETY AND
CLINICALPERFORMANCE 24

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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
MD Medical Device
Unique Device Identifier
European authorized representative
Type of Protection: BF
Suitable temperature range for transport
and storage
See Instructions for Use
XXXX-XX-XX

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Fragile
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
IPxx Ingress Protection Rating
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 Slim HP, Slim HP Mic, Slim HP AquaMic,
and Slim HP Color Caps. 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 SlimHP,
Slim HP Mic, Slim HP AquaMic, and Slim HP Color Caps.

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Limitations and Contraindications
As the Slim HP, Slim HP Mic, Slim HP AquaMic, and
SlimHP Color Caps are components 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.
• Do not remove or replace the Slim HP cable from the
sound processor or waterproof wearing solution while
underwater. If the cable becomes accidently detached
during water use, remove the headpiece and sound
processor from the water and dry both devices prior to
re-connecting the cable to the sound processor.
• 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 Slim HPs or Slim HP Magnets.
• Do not allow children to place the Slim HPs or Slim HP
Magnets in the mouth.
• The large Slim HP Color Cap is for use by recipients older
than 3 years of age, as this color cap and the Slim HP
magnet may become displaced upon dropping.

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• Due to increased risk of strangulation, do not use
cables longer than 81cm (32”) with young children.
• Remove your sound processor and consult your
cochlear implant professional if uncomfortable sounds
are heard or in case of discomfort, pain or skin irritation.
• Be sure to choose a cable length that does not require
looping or bundling of the cable due to excess length.
• The headpiece must only be used by the intended
person and not by others.
• Do not use a headpiece, magnet, or any associated
part, that is broken, damaged, or cracked.
• The color cap must be attached when the headpiece
is in use.
• Store spare magnets safely and away from cards that
may have a magnetic strip (e.g. credit cards) and from
other spare magnets or headpieces.
• High levels of static electricity may damage electronic
components of your sound processor or implant.
Careshould be taken to avoid exposure of the system
to static electricity.
• Use the lowest strength magnet required to ensure
sucient magnetic attraction of the headpiece.
• Contact your cochlear implant professional to adjust
the magnet strength if the magnetic attraction of
theheadpiece is insucient.
• If the headpiece magnet is too strong, pressure sores
may develop at the headpiece site. If this happens,

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orif you experience any discomfort, irritation, pressure,
or redness in this area, contact your cochlear implant
professional.
• Although electromagnetic emissions of the Slim HPs
have been confirmed within safe limits, some other
devices could be sensitive to such emissions. If you
notice other devices do not behave as expected when
your Slim HPs are nearby, separate the devices.
• The magnetic field created by the headpiece magnet
may alter the programming of magnetic shunts. Users
of magnetic shunts should consider o-the-shelf
retention methods.
• 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 Slim HPs. 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 Slim HPs may include skin
irritation and discomfort from pressure on the ear or head,
device overheating, or overly loud sounds.
Product Description
The Slim HP is a headpiece with an integrated cable
designed for use with a sound processor worn on
theear. The Slim HP is available with cable lengths of
3.5inches/9cm, 4.25 inches/11cm, and 5.5 inches/14cm.

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Slim HP with Color Cap
Sound Processor
Connector
Integrated
Cable
The Slim HP Mic is a headpiece with an integrated
12inch/30cm cable and a microphone designed for use with
a sound processor worn o the ear (for example, in a clip).
Sound Processor
Connector
Integrated Cable
Microphone
Slim HP Mic with
Color Cap
The Slim HP AquaMic™ headpiece is a waterproof
headpiece with an integrated cable and a microphone
designed for use with waterproof solutions (e.g., Neptune,
AquaCase, or M Waterproof Battery). The Slim HP
AquaMic is available with cable lengths of 12 inches/30cm,
18inches/46cm, 24 inches/61cm, and 42 inches/107cm.

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Sound Processor
Connector
Integrated Cable
Microphone
Slim HP AquaMic
with Color Cap
Cable Clip
The Slim HPs are compatible with the following accessory
products: Slim HP Magnets, Slim HP Color Caps, and
theSlim HP Color Cap Removal Tool.
The Slim HPs contain a magnet well designed to
accommodate the appropriate Slim HP magnet with
appropriate strength to ensure retention between the
cochlear implant and the headpiece. The Standard
Magnets are for use by recipients of CII, HiRes 90k,
HiRes90k Advantage, and HiRes Ultra implants. The 3D
Magnets arefor use by recipients of HiRes Ultra 3D implants.
The Slim HP Color Cap snaps in place on top of the
headpiece securely covering the magnet well and the
microphone. There are two sizes of Slim HP Color Caps:
Standard and Large. The Standard Color Cap is for use with
the smallest Slim HP Magnets: Standard Magnet sizes 1

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through 5 and 3D Magnet sizes 1 through 4. The Large Color
Cap is for use with the largest Slim HP Magnets: Standard
Magnet sizes 6 and 7 and 3D Magnet sizes 5, 6, and 7.
INDICATIONS FOR USE
The Slim HP, Slim HP Mic, Slim HP AquaMic, and Slim HP
Color Caps are external components 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.
• 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.

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• 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 Slim HP headpieces are part of the external components
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.

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The Slim HP is a headpiece with an integrated cable
designed for use with a sound processor on the ear and
is intended to transfer sound signals and power between
Advanced Bionics’ cochlear implant and sound processor.
The Slim HP Mic headpieces are part of the external
components 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 Slim HP Mic is a headpiece with an integrated cable and
a microphone designed for use with a sound processor worn
o the ear. It is intended to transfer sound signals and power
between Advanced Bionics’ cochlear implant and sound
processor. The embedded microphone, if enabled, allows
the headpiece to also function as a sound input source.
The Slim HP AquaMicTM headpieces are part of the external
components 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

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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 Slim HP AquaMicTM is a headpiece with an integrated
cable and a microphone designed for use in water
environments. It is intended to transfer sound signals and
power between Advanced Bionics’ cochlear implant and
sound processor. The embedded microphone, if enabled,
allows the headpiece to also function as a sound input source.
Intended Users
The intended users of the Slim HPs are recipients of the
Neptune, Naída™ CI Q, 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 Slim HPs are
healthcare and daily living environments. The Slim HP,
Slim HP Mic, Slim HP AquaMic, and Slim HP Color Caps
are designed to be worn daily on the skin over the implant
during the user’s normal waking hours.
Compatibility
The Slim HPs are compatible with Neptune, NaídaCIQ,
Naída CI M, or Sky CI M sound processors from
AdvancedBionics.
Operating Instructions
Assembly Instructions
To operate your headpiece with your cochlear implant
system you will need to install a Slim HP Magnet and
attach a Slim HP Color Cap, as follows:
1. Insert the Slim HP Magnet into the magnet well of
theheadpiece.
a. For recipients using the Standard Magnet, no specific
magnet orientation is required.
b.For recipients using the 3D Magnet, the magnet
should be inserted so that the arrow on the magnet
points up when the headpiece is on the head.
2. Attach a color cap (See “Color Caps” section).
3. Attach the headpiece and cable to your sound
processor (See “Cables” section).

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4. Then place the bottom side of the headpiece over
theinternal magnet of your cochlear implant.
NOTE: For recipients of HiRes Ultra 3D implants, if the
headpiece repels or pushes away when brought over
the internal device, rotate the headpiece back and forth
as you move the headpiece closer towards the implant.
Once attraction is felt, adjust the headpiece to the
original orientation and place on head.
NOTE: For recipients of HiRes Ultra 3D implants, when
in a magnetic field or when the headpiece is removed,
you may feel the internal components of the magnet
vibrate and/or rotate.This movement is expected as
the magnets are designed to rotate in the presence
of strong magnetic fields.This movement may be
noticeable and is not expected to be uncomfortable.
Cables
Slim HP, Slim HP Mic, and Slim HP AquaMic have cables
that are integrated into the headpiece.
Attaching the Slim HP cable to the sound processor
To attach the Slim HP cable to the sound processor, hold
the headpiece cable by the cable’s strain relief. Align the
connector on the cable with the connector on the sound
processor and gently push the cable into the sound
processor until it snaps into place.

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Removing the Slim HP cable from the sound processor
Remove the battery from the processor before removing
the cable from the processor. To remove the cable from
the sound processor, always hold the cable’s strain relief
and gently pull it away.
NOTE:To maximize cable life, the cable should only be
unplugged from the sound processor when changing
wearing configuration or when replacing the cable.

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Color Caps
Attaching the Slim HP Color Cap
Align the Color Cap over the Slim HP and snap it into place.
Removing the Slim HP Color Cap
The arrow on the underside of the Slim HPs indicates where
the Slim HP Color Cap removal tool can be inserted to remove
the Color Cap from the Slim HP. Insert the tool as indicated
by the arrow to pop the Color Cap o of theSlim HP.

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Magnets
It is important for your headpiece to have the correct
magnet strength and orientation to avoid discomfort or
retention issues. Contact your cochlear implant professional
if there are any concerns regarding magnet retention.
Ifdeemed appropriate, your cochlear implant professional
may replace the headpiece magnet with a stronger or
weaker magnet or adjust magnet orientation. If needed,
youmay use o-the-shelf solutions to improve retention.
For use of Slim HP AquaMic in water
If a swim cap, headband, or other device used in water
environments is placed over the headpiece microphone,
some degradation in sound quality may be perceived. If
the headpiece is worn following submersion in water, sound
quality may be aected. Dry the headpiece fully to restore
typical system sound quality. It is recommended that you
replace your headpiece after water use with a dry headpiece
to ensure restoration of typical system sound quality.
CARE AND MAINTENANCE
Storing the Slim HPs
When not in use, store Slim HPs in the equipment case
provided.
Cleaning and Maintenance
Periodically, clean your headpiece using a soft cloth.
Donot use solvents. Replace the color cap every 90 days,
or sooner, if a change in sound quality is noted.
Following use of the Slim HP AquaMic in Water:
• Rinse Slim HP AquaMic with clean water.