Clinical Studies; Performance Data - Advanced Bionics HiResolution Bionic Ear System Instructions For Use Manual

EN
• Neurostimulation: Do not use neurostimulation directly over the implant.
High currents induced into the electrode lead can cause tissue damage or
permanent damage to the implant.
• Therapeutic Diathermy: Therapeutic diathermy may induce currents in
the electrode, which could cause injury to cochlear tissues. The HiRes Ultra 3D
cochlear implant is safe to use during exposure to shortwave (f = 27.12 MHz
and E-field = 1.16 kV/m; M-field = 8.5 A/m) and longwave (f = 1 MHz and
E-field = 750 V/m; M-field = 2.0 A/m) diathermy.
• Ultrasound: Diagnostic ultrasound can be used anywhere within the
following parameters: Intensity (ISPTA): 1500 mW/cm
3.325 - 3.675 MHz, Duty Cycle: 20%. Therapeutic ultrasound energy must
not be used over the implant since it may cause permanent damage to the
implant by inadvertently concentrating the ultrasonic field and may cause
injury in tissue surrounding the implant.
• Electroconvulsive Therapy: 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: The implant remained functional after being
exposed to a total dosage of 250 Gray using a 15 MeV beam strength
and 3 cm depth. Ionizing radiation therapy may damage the device. Long
term effects of ionizing radiation on the implant may not be immediately
detectable. The implant should not be placed directly in the ionizing
radiation beam to minimize the risk of tissue necrosis. Diagnostic radiation
imaging such as, CT, X-Ray, Mammography, etc. are safe to use.
MRI WARNINGS
Do not allow patients with a HiRes™ cochlear implant to be in the area of an
MRI scanner unless the following conditions have been met:
•
The external sound processor and headpiece must be removed before
entering a room containing an MRI scanner.
•
Verify that the implant, or both implants if bilaterally implanted, are compat-
ible for conducting an MRI before proceeding. Failure to do so can lead to
device movement, device damage, magnet movement, patient discomfort,
or trauma and pain to the patient.
Note: MRI procedures are contraindicated for CLARION (C1 and CII) cochlear
implant recipients. For information regarding MRI use with HiRes 90K,
HiRes 90K Advantage, and HiRes Ultra cochlear implants, please contact
Advanced Bionics Technical Support.
Note: MRI safety was evaluated only for the HiRes Ultra 3D. Interactions
between non-Advanced Bionics implants and the HiRes Ultra 3D during
MRI are unknown.
•
The recommended minimum duration of time post implant surgery prior to
undergoing an MRI scan is 2 to 4 weeks in order to allow any inflammation
to subside.
•
An MRI scan is not recommended if the patient has a fever.
Caution:
•
During the MRI procedure, you may experience pain, pressure or discomfort.
If this occurs, please notify your physician.
•
Please consult with your physician prior to MRI to determine if the benefits
of MRI are worthwhile over other imaging techniques.
•
Removal of the implant magnet is contraindicated for the HiRes Ultra 3D
cochlear implant.
MRI Safety Information: Testing has demonstrated that the HiRes Ultra
3D cochlear implant is MR Conditional. Unilateral and bilateral recipients with
this device can be safely scanned in a horizontal closed bore quadrature coil
MR system meeting the following conditions:
MRI Field Strength
Maximum Spatial Field Gradient
RMS Gradient Field
Peak Slew Rate
Maximum whole body averaged SAR
Maximum head averaged SAR
When tested under the scan conditions defined above the HiRes Ultra 3D
cochlear implant produced a maximum temperature rise of <3°C after 15
minutes of continuous scanning.
Note: During the scan, patients might perceive auditory sensations. Adequate
counseling of the patient is advised prior to performing the MRI. The likelihood
2
2 , Frequency Range:
1.5T 3.0T
20 T/m
34.4 T/s
200 T/m/s
2.0 W/kg 2.0 W/kg
3.2 W/kg 2.6 W/kg
and intensity of the auditory sensations can be reduced by selecting sequences
with a lower Specific Absorption Rate (SAR) and slower gradient slew rates.
The largest artifact at 3.0T is >15 cm when imaged under spin echo and gra-
dient echo sequences. Smaller artifacts are possible using different scanning
parameters, only.
For additional information regarding the use of an MRI scanner with
a HiRes Ultra 3D cochlear implant, please contact Advanced Bionics
Technical Support at technicalservices@advancedbionics.com or visit
www.advancedbionics.com/mri.
PRECAUTIONS:
• Electrostatic Discharge (ESD): It is known that static electricity can
potentially damage sensitive electronic components such as the ones used
in the cochlear implant system. Care should be taken to avoid situations
in which high levels of static electricity are generated. More information is
provided in the instructions for use provided with the external components
of the system. If static electricity is present, static electrical potential of the
cochlear implant recipients can safely be reduced by the recipients touching
any person or object with their fingers prior to that person or object
contacting the implant system.
• Digital Cellular Phones: Using or being in close vicinity to someone using
some digital cellular phones may cause interference with the system. If such
interference occurs, recipients can turn off the sound processor or move a
greater distance from the phone. Before purchasing a digital cellular phone,
recipients should evaluate whether it will interfere with their system. No such
interference has been noted with cellular phones using analog technology.
• Ingestion of Small Parts: The external components of the implant system
contain small parts that may be harmful if swallowed.
• Airport/Security Metal Detectors: Metal detectors, x-ray machines, and
security scanners will not damage the implant or sound processor. However,
individuals with a cochlear implant should be advised that passing through
security metal detectors may activate the detector alarm. It is advised that
recipients carry their "Medical Device Identification Card" with them at all
times. Cochlear implant users also might hear a distorted sound caused by
the magnetic field around the security scanner door or hand-held scanning
wand. Turning the sound-processor volume down before passing through
security screening will ensure that those sounds, if they occur, are not too
loud or uncomfortable.
• Electromagnetic Interference: RF workers may be exposed to higher interfer-
ence. In the presence of high intensity EMI you may experience loss of sound.
If this occurs, move from the area or temporarily discontinue use of the system
by removing the headpiece.
• Electromagnetic Sources: It is advised to maintain a minimum distance of
30 cm (12 in) from electromagnetic emitters such as RFID, and metal detectors.
It is advised to maintain a minimum distance of 50 cm (20 in) from an electronic
article surveillance emitter.
• Use of Another Person's Sound Processor: Implant recipients should use
only the sound processor that has been specifically programmed for them
by their clinician. Use of a different sound processor may be ineffective
in providing sound information and may cause physical discomfort.
• Physical Activity: When engaging in physical activities that include the
possibility of trauma or impact, precautions should be taken, such as wearing
a p rotective helmet, to reduce the risk of damage to the internal device.

CLINICAL STUDIES:

PERFORMANCE DATA

The HiRes Ultra 3D cochlear implant supports the HiResolution family of sound
processing strategies including HiRes, HiRes with Fidelity 120 (HiRes 120), and
ClearVoice.
HiRes and HiRes 120 Sound Processing
A clinical study was conducted in 50 adults implanted with a CII/HiRes 90K
device who used a Harmony processor to document the benefits of HiRes 120
and HiRes sound processing. Performance with HiRes was assessed at the
baseline visit and compared with HiRes 120 performance after three months
of listening experience. Subsequently, subjects were refit and retested with
HiRes. Results showed equivalent mean CNC word recognition scores for the
two strategies. The mean HINT sentence perception scores in quiet and noise
were significantly higher for HiRes 120 compared to baseline with HiRes. For
HINT sentences in noise, the mean scores for HiRes 120 were significantly
higher than scores after subjects were refit with HiRes.