Advanced Bionics HiResolution Bionic Ear System Instructions For Use Manual

EN
INSTRUCTIONS FOR USE
HiResolution™ Bionic Ear System, HiRes™ Ultra 3D cochlear implant
For more information contact:
Advanced Bionics AG
Laubisrütistrasse 28
8712 Stäfa, Switzerland
+41.58.928.78.00
DEVICE DESCRIPTION: The HiResolution Bionic Ear System consists of internal
and external components. The internal components include the HiRes™ Ultra 3D
receiver and either the HiFocus™ SlimJ electrode or the HiFocus™ Mid-Scala (MS)
electrode array that are implanted surgically under the skin behind the ear. Both
the HiFocus SlimJ and the HiFocus Mid-Scala electrode arrays have 16 contacts
and are connected to the implant through the electrode lead. The receiver stimula-
tor encapsulates the electronics into a titanium casing, the antenna coil allows for
forward and backward telemetry between the implant and the external parts. The
antenna coil also includes a magnet in order to retain the external headpiece.
The external components include a sound processor (body-worn or ear-level),
a headpiece, and a cable. The system converts sound into electrical energy
that activates the auditory nerve. The auditory nerve then sends information to
the brain, where it is interpreted as sound.
INTENDED USE: The HiResolution Bionic Ear System is a cochlear implant
designed to provide useful hearing to individuals with severe-to-profound
hearing loss via electrical stimulation of the auditory nerve. The HiResolution
Bionic Ear System is intended to restore a level of auditory sensation.
INDICATIONS FOR USE: The HiResolution Bionic Ear System 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.
•
Postlingual 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.
•
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 difficult
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 soundfield (70 dB SPL).
CONTRAINDICATIONS: Deafness due to lesions of the acoustic nerve or central
auditory pathway; active external or middle ear infections; cochlear ossification
that prevents electrode insertion; absence of cochlear development; tympanic
membrane perforations associated with recurrent middle ear infections.
WARNINGS:
• Bacterial meningitis has been reported in users of the system and other
cochlear implants, especially in children under the age of 5. The cause of
meningitis in these cases has not been established. A small percentage of deaf
patients may have congenital abnormalities of the cochlea (inner ear) which
predispose them to meningitis even prior to implantation. Patients who become
deaf as a result of meningitis are also at increased risk of subsequent episodes
of meningitis compared to the general population. Other predisposing factors
may include young age (<5 years), otitis media, immunodeficiency, or surgical
technique. The cochlear implant, because it is a foreign body, may act as
a nidus for infection when patients have bacterial illnesses.
Manufactured by:
Advanced Bionics, LLC
California, USA
+1.661.362.1400
The incidence rate, although low, appears to be higher than the age-adjusted
rate for the general population. The fatality rate as a result of meningitis also
appears to be higher. Adequate epidemiological data are not available to
determine whether the incidence and fatality rates are, in fact, definitively
different from the general population, whether there are special risk factors
in the cochlear implant population, or whether different cochlear implant
models pose different risks.
Adults and parents of children who are considering a cochlear implant
or who have received cochlear implants should be advised of the risk of
meningitis. They should also be informed of the availability of vaccines
that have been shown to substantially reduce the incidence of meningitis
in the general population resulting from the organisms that commonly
cause bacterial meningitis (Streptococcus pneumoniae, Haemophilus
influenzae, Meningococcus). National health agencies frequently provide
updated information on the safety and utility of specific vaccines and offer
recommendations reflecting local or regional conditions. Physicians or
patients should refer to the applicable authorities for this information. These
vaccines can be administered by pediatricians, primary care/family physicians,
and infectious disease specialists.
Adults and parents of children who have received cochlear implants should
be counseled on the symptoms of meningitis, the need to seek immediate
medical care if any symptoms appear, and the need to advise the treating
physicians of the presence of the cochlear implant and of the possibility of
increased risk of meningitis associated with implant. They should also be
counseled to obtain medical care at the first signs of otitis media.
• Extreme direct pressure on the implanted device, up, down, left or right may
cause the implant to move and possibly dislodge the electrode array.
• A direct impact to the implant site may damage the implant and result in its
failure to function. There have been instances of Advanced B ionics device
failure as a result of a child hitting his/her head at the site of the implanted
device. None of these reported incidents have resulted in a concussion or
fracture of the skull. In all cases, the failed device was explanted and a new
device reimplanted with no further complications.
• The long term effects of chronic electrical stimulation are unknown. Clinical
experience with the system since 1991 has shown no adverse effects of
chronic electrical stimulation on recipient performance, electrical thresholds,
or dynamic range.
• Electrode displacement can occur if the electrode is not inserted properly.
Surgeons should be proficient in the use of the electrode insertion tool.
Failure to follow the recommended surgical procedure for placement and
stabilization of the HiRes Ultra 3D cochlear implant increases the risk of
device migration or extrusion, and of damage resulting from impact trauma,
including breakage of the electrode lead wires. Creating a recessed bed for
the implant and securely stabilizing the device in place are critical elements
of the surgical procedure.
• Insertion of a cochlear implant electrode will likely result in the loss of any
residual hearing in the implanted ear.
In general, external components (e.g. sound processor and headpiece) should
be removed or deactivated before undergoing the following medical proce-
dures, where the implant may be exposed to electric fields or electrical current.
If unexpected sounds or interruptions are experienced during or after medical
procedures notify the physician.
• Electrosurgery: Electrosurgical instruments and RF Ablation instruments
are capable of producing radio-frequency voltages of such magnitude that
a direct coupling might occur between the cautery tip and the electrode.
Induced currents may cause damage to the cochlear tissues or permanent
damage to implants. Monopolar electrosurgery and RF Ablation must
only be used outside the head or neck region. For the use of bipolar
electrosurgical equipment, the probe tips must not contact the implant and
should be kept more than 1 mm (0.04 in) from the implant.
• Extracorporeal Electrical Stimulation: Electrodes or probe tips used in
extracorporeal electrical stimulation instruments such as TENS, TEMS, etc.
must not be placed over the implant.
2018
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