Medel Mi1000 CONCERTO PIN Series Instruction Manual

Cochlear Implants
CONCERTO PIN Surgical Guideline
Mi1000
MED‑EL Elektromedizinische Geräte GmbH
Worldwide Headquarters
Fürstenweg 77a
6020 Innsbruck, Austria
ofc[email protected]om
medel.com
AW7694_6.0 (English EU)

The MED‑EL Cochlear Implant System serves to restore hearing sensations through electrical stimulation of the auditory
nerve. It is the result of many years of research at leading technical institutions throughout the world.
MED‑EL cochlear implants are manufactured to the highest quality standards in order to ensure long term reliability.
All materials used in the implant have been rigorously tested for biocompatibility, durability and reliability. MED‑EL
applies a quality management system that meets all EN ISO 13485:2003 requirements and complies with US Quality
System Regulations and Canadian Medical Device regulations (CAN/CSA ISO 13485‑2003). Components of the MED‑EL
Cochlear Implant System meet the requirements for AIMD 90/385/EEC and MDD 93/42/EEC.
This Surgical Guideline describes proper techniques for implanting the Mi1000 CONCERTO PIN Cochlear Implant
(hereafter referred to as the CONCERTO PIN). It serves as additional information for professionals and should not be
used as an “Instructions for Use”.
The information in this brochure is believed to be true and correct. However, specications are subject to change without
notice.
Not all products represented on these materials are currently approved or available in all markets. For country specic
information please see the applicable “Instruction for Use” delivered with the implant system.
Introduction

3
Table of contents
I. Patient selection and evaluation 2
Indication 2
Selection and Evaluation 2
II. Technical description of the implant 3
Performance Characteristics 4
Implant Variants 4
III. Surgical tools 9
Surgical Kit for the CONCERTO PIN Cochlear Implant 9
Insertion Test Tools 14
IV. General remarks about the surgery 15
V. Surgical procedure 16
STEP 1: Prepare Patient 16
STEP 2: Mark Implant Position 17
STEP 3: Plan Incision 18
STEP 4-A: Open Skin Flap 19
STEP 4-B: Skin Flap Thickness 20
STEP 5: Check Position of Implant and Electrode Lead 21
STEP 6: Drill Mastoidectomy and Posterior Tympanotomy 22
STEP 7: Drill Stimulator Bed and Electrode Channel 24
STEP 8 – VARIANT 1: Preparation for a Round Window opening 27
STEP 8 – VARIANT 2: Preparation for a Cochleostomy 29
STEP 9: Select Appropriate Electrode Variant 31
STEP 10: Immobilise the Implant 33
STEP 11: Opening the Cochlea 34
STEP 12: Insert the Electrode Array 35
STEP 13-A: Seal Cochlear Opening 38
STEP 13-B: Secure Electrode Lead 39
STEP 14: Intra-operative Recordings 41
STEP 15: Close Wound 42
Appendix 43
MRI Caution 43
X-rays 45
Explanting the Device 45
Hearing Preservation Surgical Technique 46
Literature 48
MED-EL Surgical Videos 52
MED-EL Contacts 52

4
Patient selection and evaluation
I. Patient selection and evaluation
Indication
The MED-EL Cochlear Implant System is intended to evoke
auditory sensations via electrical stimulation of the auditory
pathways. It is designed for severely to profoundly hearing
impaired individuals who obtain little or no benet from
acoustic amplication in the best aided condition.
Additionally the MED-EL Cochlear Implant System used in
combination with the implant variant +FLEX24 or +FLEX20
is intended to evoke auditory sensations via electrical
stimulation or via combined electric-acoustic stimulation
(EAS) of the auditory pathways for partially deaf individuals,
who obtain benet from acoustic amplication in the lower
frequencies only.
The MED-EL Cochlear Implant System is also intended to
evoke auditory sensations via electrical stimulation of the
auditory pathways for individuals with single–sided
deafness, which is dened as severe to profound hearing
impairment in one ear and normal hearing or mild to
moderate hearing impairment in the other ear.
Selection and Evaluation
Patients should full the audiological criteria of their
respective country for open-set sentence testing and
open-set monosyllabic words when tested with hearing
aids. MED-EL strongly recommends the use of optimally
tted hearing aids for a minimum of three months before
deciding to pursue a cochlear implant. In cases of
ossication or deafness due to infectious disease, there
may be no need to try a hearing aid, and implantation
should generally not be delayed.
A complete cochlear implant evaluation protocol should
include an audiologic assessment, a medical/surgical
evaluation, counselling sessions and, when possible, a
psychological assessment. To obtain the optimal benet
from the implant, candidates should be sufciently
motivated and understand the importance of returning to
the implant centre for regular audio processor programming,
training, and assessment sessions.
The medical evaluation prior to cochlear implant surgery
serves to:
• assess the candidate’s health status and ability to
undergo surgery
• verify the absence of disease and infection of the outer
and middle ear
• screen for cochlear obliteration and other obstacles to
electrode insertion
• rule out central auditory lesions and verify a functional
auditory nerve
The above evaluations usually involve an otologic/otoscopic
examination and a CT scan and/or MRI. If there are concerns
about the integrity of the upper auditory pathways and
auditory lesions, an MRI is necessary.
It is important to realise that there are a variety of
conditions that predispose a person to contracting bacterial
meningitis irrespective of cochlear implantation, such as:
malformations of the inner ear, history of recurrent
meningitis, the presence of CSF leaks, etc. There is no
evidence that implantation of a MED-EL device increases
the risk for postoperative meningitis. MED-EL encourages
all cochlear implant candidates and recipients, especially
individuals with cochlear malformations and other risk
factors, to discuss with their physician whether vaccination
may be appropriate for them. The immunisation status of
all cochlear implant candidates should be determined prior
to surgery. Vaccination may reduce the risk of infection.

5
Technical description of the implant
The CONCERTO PIN is the implantable part of the MED-EL
Cochlear Implant System and can only be used together
with compatible MED-EL external components.
The device consists of a stimulator, a coil with a magnet
within its centre, a reference electrode, an EAP reference
electrode and an active electrode permanently attached
to the stimulator. The active electrode can be of different
types, thus resulting in different implant variants (implant
family CONCERTO PIN). This device is intended to be
implanted by adequately trained and experienced surgeons
only.
The CONCERTO PIN has been designed according to the
highest safety and reliability standards. All materials used
in the construction of the CONCERTO PIN have been
extensively tested for biological compatibility and durability.
The power required by the implant is transmitted from the
external audio processor through the intact skin via an
inductive link. The implant therefore contains no batteries
or other components that require replacement.
The implant offers a stimulation mode and a telemetry
mode. Stimulation sequences of biphasic and triphasic
pulses can be delivered sequentially or simultaneously on
two or more channels. In telemetry mode the device allows
a functional check about the technical status of the implant
including communication over the transcutaneous link as
well as the assessment of the electrode impedances and
recording of the electrically evoked compound action
potential of the hearing nerve.
The electronics of the CONCERTO PIN contain a powerful
custom-made circuit that is capable of processing large
amounts of information at a very rapid rate. It can stimulate
at 50,704 pulses per second. This capability makes the
implant compatible with a wide range of pulsatile processing
strategies and future developments in speech processing.
A telemetry feature enables the clinic to verify the
functional status of the implant within a matter of seconds.
For added safety, each output has a capacitor to prevent
any possible leakage of DC current to the auditory nerve.
II. Technical description of the implant
Figure 1 CONCERTO PIN Cochlear Implant (~ dimensions
in mm, typical values)

6
Technical description of the implant
Performance Characteristics
• Output characteristics of a stimulation signal on a 1
kOhm resistor:
Maximum current amplitude:
Median value = 1250µA, range = 500µA
Maximum pulse width:
Median value = 203.8 µs, range = 8.2 µs
• The impedance measurement accuracy is typically
better than 5%.
• When keeping to the safety guidelines the implant is
conditionally MRI safe for MR scanner field strengths
of 0.2 Tesla, 1.0 Tesla and 1.5 Tesla.
• There are no default factory settings of the implant
system.
• Proper functioning of the implantable part of the CI
system can be checked by performing telemetry (refer
to MED-EL application software user manual).
• The implant has 24 independent current sources
stimulating 12 independent electrode channels in
monopolar mode.
• The implant has a mass of 7.6g (typical value).
• The volume of the implant without electrode is 3.7 cm³.
• The electrode is made of medical grade silicone,
platinum (electrode contacts) and platinum/iridium
(90/10) wires and nitinol.
• All electrode variants have a straight and flexible design.
The electrode does not deliver any medicinal
substances.
• Geometric surface area of the stimulation reference
electrode = 50 mm².
• Following materials are in direct contact with human
tissue: medical grade silicone, platinum, iridium and
titanium.
Implant Variants
Cochleae may differ signicantly in size and shape from
one another as can individual cochlear duct lengths.
MED-EL offers the largest selection of electrode arrays for
each implant variant. Please see Section V, Step 9, “Select
Appropriate electrode Variant” for the circumstances in
which each variant should be used.
FLEXSOFT Electrode Array
Order number: 07680
The FLEXSOFT Electrode Array (see Figure 2) is 31.5 mm
long featuring FLEX tip technology for increased mechanical
exibility and enabling CCC (Complete Cochlear Coverage).
The contacts for the 12 channels are arranged as 5 single
contacts at the apical array end and 7 contact pairs at the
base with a 2.4mm spacing between each channel. The
specially designed electrode tip offers increased mechanical
exibility for reduced insertion force. The marker ring is
located 31.5mm from the electrode tip and indicates the
deepest insertion. Near the marker ring, the electrode lead
features an additional marker dot on the same side of the
array as the single apical contacts. The marker allows the
surgeon to ensure appropriate alignment of the single
contacts toward the modiolus.
Ø 1.3mm
Active Stimulation Range: 26.4mm
FLEX-Tip
31.5mm
23
1
0.5 x 0.4mm
119 platinum electrode contacts
Optimal spacing over a 26.4 mm stimulation range
2Diameter at basal end: 1.3m
3FLEX-Tip for minimal insertion trauma
Dimensions at apical end: 0.5 x 0.4mm
Figure 2 FLEXSOFT Electrode Array
* Implant variants availability is subject to regulatory approval
*

7
Technical description of the implant
FLEX28 Electrode Array
Order number: 08841
The FLEX28 Electrode Array (see Figure 3) is 28 mm long
featuring FLEX tip technology suitable for 96% of all normal
cochlear duct lengths. The contacts for the 12 channels
are arranged as 5 single contacts at the apical array end
and 7 contact pairs at the base with a 2.1mm spacing
between each channel. The specially designed electrode
tip offers increased mechanical exibility for reduced
insertion force. The marker ring is located 28mm from the
electrode tip and indicates the deepest insertion. Near the
marker ring, the electrode lead features an additional
marker dot on the same side of the array as the single
apical contacts. The marker allows the surgeon to ensure
appropriate alignment of the single contacts toward the
modiolus.
0.5 x 0.4mm
Ø 0.8mm
Active Stimulation Range: 23.1mm
FLEX-Tip
28mm
23
1
119 platinum electrode contacts
Optimal spacing over a 23.1 mm stimulation range
2Diameter at basal end: 0.8mm
3FLEX-Tip for minimal insertion trauma
Dimensions at apical end: 0.5 x 0.4mm
Figure 3 FLEX28 Electrode Array
FLEX24 Electrode Array
Order number: 07679
The FLEX24 Electrode Array (see Figure 4) is 24 mm long
featuring FLEX tip technology and designed for combined
Electric Acoustic Stimulation (EAS) less than 1.5 turns. The
contacts for the 12 channels are arranged as 5 single
contacts at the apical array end and 7 contact pairs at the
base with a 1.9mm spacing between each channel. The
specially designed electrode tip offers increased mechanical
exibility for reduced insertion force. The marker ring is
located 24mm from the electrode tip and indicates the
deepest insertion. Near the marker ring, the electrode lead
features an additional marker dot on the same side of the
array as the single apical contacts. The marker allows the
surgeon to ensure appropriate alignment of the single
contacts toward the modiolus.
0.5 x 0.3mm
Ø 0.8mm
Active Stimulation Range: 20.9mm
FLEX-Tip
24mm
23
1
119 platinum electrode contacts
Optimal spacing over a 20.9 mm stimulation range
2Diameter at basal end: 0.8mm
3FLEX-Tip for minimal insertion trauma
Dimensions at apical end: 0.5 x 0.3mm
Figure 4 FLEX24 Electrode Array
EAS SURGICAL TRAINING RECOMMENDED
EAS

8
Technical description of the implant
FLEX20 Electrode Array
Order number: 30969
The FLEX20 Electrode Array (see Figure 5) is 20 mm long
featuring FLEX tip technology and designed for combined
Electric Acoustic Stimulation (EAS). The contacts for the 12
channels are arranged as 5 single contacts at the apical
array end and 7 contact pairs at the base with a 1.4mm
spacing between each channel. The specially designed
electrode tip offers increased mechanical exibility for
reduced insertion force. The marker ring is located 20mm
from the electrode tip and indicates the deepest insertion.
Near the marker ring, the electrode lead features an
additional marker dot on the same side of the array as the
single apical contacts. The marker allows the surgeon to
ensure appropriate alignment of the single contacts toward
the modiolus.
0.5 x 0.3mm
Ø 0.8mm
ASR: 15.4mm
FLEX-Tip
20mm
23
1
119 platinum electrode contacts
Optimal spacing over a 15.4mm stimulation range
2Diameter at basal end: 0.8mm
3FLEX-Tip for minimal insaertion trauma
Dimensions at apical end: 0.5 x 0.3mm
Figure 5 FLEX20 Electrode Array
EAS SURGICAL TRAINING RECOMMENDED
FORM24™
Order Number: 30660
The FORM24 Electrode Array*(see Figure 6) is 24 mm long
electrode array designed for open (no obliteration or
ossication) or malformed cochleae, especially Type II
malformations. It features 12 evenly spaced electrode pairs
spaced over 18.7 mm, with 1.7 mm spacing between each
contact pair. The FORM24 electrode array features an
integrated SEAL function designed to close off the cochlear
opening. SEAL is a 2.4 mm conical thickening located at
the basal end of the array designed to control the leakage
of cerebrospinal uid (CSF), also known as ‘gusher’.
24mm
Ø 0.5mm 4
Active Stimulation Range (ASR): 18.7mm
1
Ø 1.9mm
2.4mm
Ø 0.8mm
2
CSF SEAL3
124 platinum electrode contacts
Optimal spacing over a 18.7mm stimulation range
2Diameter at basal end: 0.8mm
3CSF SEAL
4Diameter at apical end: 0.5mm
Figure 6 FORM24™
* Electrode development was in close collaboration with Prof. Levent Sennaroglu, Department of Otolaryngology, Hacettepe University Medical
Faculty, Turkey
EAS

9
Technical description of the implant
FORM19™
Order Number: 30661
The FORM19 Electrode Array*(see Figure 7) is 19 mm long
electrode array designed intended to be used in cochleae
with malformation, especially Type I andType III, obliteration,
or ossication. It features 12 evenly spaced electrode pairs
spaced over 14.3 mm, with 1.3 mm spacing between each
contact pair. The FORM19 electrode array features an
integrated SEAL function designed to close off the cochlear
opening. SEAL is a 2.4 mm conical thickening located at
the basal end of the array designed to control the leakage
of cerebrospinal uid (CSF), also known as ‘gusher’.
Ø 1.9mm
2.4mm
Ø 0.8mm
2
19mm
Ø 0.5mm
CSF SEAL
4
3
ASR: 14.3mm
1
124 platinum electrode contacts
Optimal spacing over a 14.3mm stimulation range
2Diameter at basal end: 0.8mm
3CSF SEAL
4Diameter at apical end: 0.5mm
Figure 7 FORM19™
Standard Electrode Array
Order number: 07676
The Standard Electrode Array (see Figure 8) is 31.5mm long
and designed for long cochlear duct lengths. Contacts are
spaced over 26.4mm with 2.4mm spacing between each
contact pair. The electrode’s length allows insertion into
the scala tympani and stimulation of the cochlear canal to
the fullest extent possible. The array features a marker ring
31.5mm from the apex that is used to seal and to indicate
maximum electrode insertion. The diameter of the array
increases to 1.3mm at the proximal thicker part of the
array just before the marker ring.
Ø 1.3mm Ø 0.5mm
Active Stimulation Range (ASR): 26.4mm
31.5mm
2
1
3
124 platinum electrode contacts
Optimal spacing over a 26.4 mm stimulation range
2Diameter at basal end: 1.3mm
3Diameter at apical end: 0.5mm
Figure 8 Standard Electrode Array
* Electrode development was in close collaboration with Prof. Levent Sennaroglu, Department of Otolaryngology, Hacettepe University Medical
Faculty, Turkey

10
Technical description of the implant
Medium Electrode Array
Order number: 07678
The Medium Electrode Array (see Figure 9) is 24mm long
and designed for cases where deep insertion is not desired
or is not possible due to anatomic restrictions. It features
12 evenly spaced electrode pairs spaced over 20.9mm, with
1.9mm spacing between each contact pair. Note that the
Medium Electrode Array is not inserted to the marker ring.
Ø 0.8mm
2
24mm
Ø 0.5mm 3
Active Stimulation Range (ASR): 20.9mm
1
124 platinum electrode contacts
Optimal spacing over a 20.9 mm stimulation range
2Diameter at basal end: 0.8mm
3Diameter at apical end: 0.5mm
Figure 9 Medium Electrode Array
Compressed Electrode Array
Order number: 07677
The Compressed Electrode Array (see Figure 10) is 15mm
long and designed for partial ossication or malformation
of the cochlea. It features 12 pairs of contacts spaced
closer together in the apical end of the array. The contacts
are spaced over 12.1mm, with 1.1 mm between each
contact pair. Note that the Compressed Electrode Array is
not inserted to the marker ring.
Ø 0.7mm
2
15mm
Ø 0.5mm 3
ASR: 12.1mm
1
124 platinum electrode contacts
Optimal spacing over a 12.1 mm stimulation range
2Diameter at basal end: 0.7mm
3Diameter at apical end: 0.5mm
Figure 10 Compressed Electrode Array