Advanced Bionics CI-5851 Manuale utente
M ACOUSTIC EARHOOK
CI-5851
instructions for use
English, Français, Español, Deutsch, Nederlands, Italiano
1
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 onthe 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
2
DISPOSAL AND HAZARDOUS MATERIALS 24
AVAILABLE PRODUCT OPTIONS AND MODEL
NUMBERS 24
CLINICAL BENEFITS 25
SUMMARY OF SAFETY AND CLINICAL
PERFORMANCE 25
3
SYMBOLS TABLE
Labeling symbols and their meanings
European Community Mark of Conformity.
Authorized to ax 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
4
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
5
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.
6
• 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.
7
Undesirable Side Effects
Undesirable side eects 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
AdvancedBionics 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 dierent 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
8
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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