Description

High Resolution

• The only device with 16 independent current sources that facilitate current steering.
• Ability to stimulate 120 distinct spectral bands leading to unsurpassed temporal resolution and better pitch differentiation.²
• The fastest stimulation rate combined with the widest input dynamic range allows for the most natural hearing possible.^3,4,5
• Circuitry provides nearly unlimited ways to deliver stimulation – for future technology not invented yet.

Low Profile

• Minimal drilling required, with a shallow 1mm ramped recess.
• The thin 4.5mm profile and small footprint make it suitable for all implant recipients — adults and very young children.

 

 

 

MRI Compatible

• FDA and TÜV approved for 1.5T with the magnet in place – an MRI Antenna Coil Cover and a simple head-bandage procedure is all that is required, no surgical procedure is necessary
• FDA and TÜV approved for 3T MRI with the magnet removed – the magnet can be taken out easily and replaced through a small incision, without the inconvenience of removing the implant

 

 

HiFocus Mid-Scala Electrode

The HiFocus Mid-Scala electrode has been designed for ideal positioning in the Scala Tympani and full spectrum coverage for maximum performance⁶, while protecting the delicate cochlear structure.

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Single Sided Deafness

The HiRes Ultra cochlear implant and HiFocus Mid-Scala electrode have been approved by TÜV, a European Notified Body, to be implanted in patients with unilateral (asymmetric)hearing loss, also known as single-sided deafness (SSD).

The HiResolution Bionic Ear System is a cochlear implant designed to provide
useful hearing to individuals with severe-to-profound hearing loss. It consists
of internal and external components. The internal components include the
HiRes™ Ultra 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. The external components include a sound processor (bodyworn 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.
INDICATIONS: 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 (≥ 70 dB HL).
• 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.
• Profound, bilateral sensorineural deafness (≥ 90 dB HL).
• 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.
The incidence rate, although low, appears to be higher than the ageadjusted 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,
definitivelydifferent 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 Bionics 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 patient 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 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.
• Electrosurgical instruments must not be used. Electrosurgical 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 could cause damage to the cochlear tissues or permanent
damage to the implant.
• Diathermy must never be applied. High currents induced into the electrode
can cause tissue damage to the cochlea or permanent damage to the
implant.
• Diagnostic Ultrasound Energy must not be used.
• Electroconvulsive therapy must never be used on a cochlear implant patient.
Electroconvulsive therapy may cause tissue damage to the cochlea or
permanent damage to the implant.
• Ionizing Radiation Therapy cannot be used as it may damage the device.
• The effects of cobalt treatment and linear acceleration techniques on the
implant are unknown.
• Insertion of a cochlear implant electrode will likely result in the loss of any
residual hearing in the implanted ear.
• MRI Safety Information:
Testing has demonstrated that the HiRes Ultra cochlear implant is MR
Conditional. Unilateral and bilateral recipients with this device can be safely
scanned in an MR system meeting the following conditions:
3.0T with the magnet removed
– The internal magnet must be removed. See the “Surgeon Manual for the
HiRes Ultra Cochlear Implant” for removal instructions.
– The external sound processor and headpiece are MR Unsafe and must be
removed before entering a room containing an MR scanner.
– Horizontal closed bore scanners with a static magnetic field of 3.0T
– Maximum spatial field gradient of 2,000 Gauss/cm (20 T/m)
– Maximum MR system reported, whole body averaged specific absorption
rate (SAR) of ≤ 2 W/kg at 3.0T (Normal Operating Mode) for quadrature
transmit RF body coils
– Maximum MR system reported, head averaged SAR of ≤ 2.6 W/kg at 3.0T
(Normal Operating Mode) for quadrature transmit RF head coils
– RMS gradient field of 30 T/s and peak gradient field of 150 T/s
Under the scan conditions defined above the HiRes Ultra implant is expected
to produce a maximum temperature rise of <3°C after 15 minutes of
continuous 3.0T scanning.