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AW 7846 Rev. 1.0
8
surGicAL prEcAutiOns AnD WArninGs – risks rELAtED tO surGErY
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Cochlear implant surgery is comparable to middle ear surgery with additional access to the inner ear. The
normal risks of surgery and general anaesthesia are applicable. primary surgical risks include the following:
infection, inflammation, necrosis, haematoma, leakage of CsF, damage to the facial nerve, pain, scarring of
the wound, swallowing difficulties and complications related to general anaesthesia. Additionally, meningitis
4
can be a rare post-operative complication, but has the potential to be serious. The risk of meningitis may be
reduced, for example by vaccination, antibiotic cover, and surgical technique.
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If available, facial nerve monitoring is recommended and if carried out, neural muscular blockade should be
avoided.
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prophylactic use of antibiotics is recommended for all patients unless medically contraindicated.
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Clear identification of the anatomical landmarks is required. When drilling, care should be taken to avoid
exposing the dura inadvertently. If the dura is exposed as a landmark, exposure shall be kept to an absolute
minimum. Inadequate large exposure or injury to the dura may reduce the barrier to future infection and
may increase the potential risk for future meningitis. For example, neuro-radiological follow-up in cases of
fractures of the anterior skull base have shown that foudroyantly progressing meningitis may occur, even
years later. similar mechanisms may also exist in respect of ear and mastoid surgery.
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All sharp edges of bone must be removed and drilling should be completed before the cochlea is opened to
prevent any bone dust from entering.
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In order to achieve good magnetic holding power and optimal coupling the distance between the lateral side
of the implant and the surface of the skin (with hair) shall not exceed 6 mm.
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The serial number of the implant must be visible on the implant before fixing it in place.
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The implant must be immobilized in a flat stimulator bed drilled in the temporal bone and the electrode
lead should be protected in a ramp-like bony channel without sharp edges. The anterior stimulator edge
should not be recessed to a depth more than 2 mm. Both should be done in such a way that there will be no
postoperative movement. Continuous movement may result in mechanical fatigue and subsequent premature
failure of electrical connections.
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Additional immobilization of the implant needs to be done (e.g. with sutures). It should be done in such a way
that there will be no postoperative movement. Continuous movement may result in mechanical fatigue and
subsequent premature failure of electrical connections.
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To minimize the risk of postoperative infection, care should be taken that the round window and its membrane
remain intact during drilling the cochleostomy.
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The recommended diameter of the cochleostomy is 1.3 mm for the Cochlear Implant ConCeRTo standard
and 0.8 mm for the Cochlear Implants ConCeRTo medium and ConCeRTo Compressed.
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The recommended diameter of the cochleostomy is 1.3 mm for the Cochlear Implant ConCeRTo FleX
soFT
and 0.8 mm for the Cochlear Implant ConCeRTo FleX
eAs
.
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To ensure proper electrical stimulation, it is important to insert the electrode array with the apical single
contacts facing towards the modiolus. Using a higher magnification to focus on the electrode tip can facilitate
finding the correct contact orientation. When the electrode array is inserted, the small marker on the
electrode lead indicates the contact orientation at the electrode array base.
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Insertion of the electrode array into the cochlea will probably destroy any remaining hearing that may have
been present in that ear pre-surgically.
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only meD-el approved surgical instruments must be used during the electrode array insertion process.
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The implant contains a strong magnet. never use magnetic surgical tools.
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The electrode array should be inserted into the cochlea up to the recommended depth without compressing
the array or touching the electrode contacts. To minimize the risk of postoperative infection rinsed fascia or
similar tissue (muscle is not recommended) should be used. Create a seal around the electrode array at the
entrance into the cochlea to secure the electrode array and to seal the cochlea opening.
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After insertion, the electrode lead shall be fixed so that no postoperative movement will occur. The excess
electrode lead must be looped in the mastoid cavity well below the surface of the bone, using the cortical
overhang to hold it in place, so that the electrode array will not move out of the cochlea or be subject to
external pressure that could cause movement and subsequent damage of electrical connections.
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Do not place the sutures directly over the electrode lead.
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Inaccurate placement of the electrode array may impair acoustic perception with the device and may
necessitate additional surgery. Improper fixation or placement of the electrode lead may also result in
premature failure of the implant.
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other risks after surgery may be avoided by following the instructions in the applicable meD-el processor
User manual and the mAesTRo application software User manual.
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Cochlear implantation in partially deaf patients with low frequency hearing carries the risk of partial or total
hearing loss which should be clearly explained to the patient by the surgeon prior to implantation. However,
studies have shown benefits using electrical stimulation solely in this group of patients even if residual hearing
is lost. etiology, duration of partial deafness, and hearing aid benefit should be taken into consideration and
hearing preservation surgical technique should be applied.