12
12
English
• When the electrode array is inserted, the small marker on the electrode lead
indicates the contact orientation at the electrode array base. For FLEX electrode
variants the marker is coloured.
• Insertion of the electrode array into the cochlea will probably destroy any remain‑
ing hearing that may have been present in that ear pre‑surgically.
• Only MED‑EL approved surgical instruments must be used during the electrode array
insertion process.
• The implant contains a strong magnet. Never use magnetic surgical tools.
• The electrode array should be inserted into the cochlea up to the recommended
depth without squeezing the electrode array or the electrode lead and without
touching the electrode contacts. To minimise 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.
• After insertion, the electrode lead shall be fi xed so that no postoperative movement
will occur. The excess electrode lead must be looped in the mastoid cavity well be‑
low 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 pres‑
sure that could cause movement and subsequent damage of electrical connections.
• Do not place the sutures directly over the electrode lead.
• Inaccurate placement of the electrode array may impair acoustic perception with
the device and may necessitate additional surgery. Improper fi xation or placement
of the electrode lead may also result in premature failure of the implant.
• Good physical and thus stable electrical contact between stimulation reference
electrode and surrounding tissue is essential for electrical stimulation. Therefore
do not place any fi xation sutures directly over the reference electrode and do not
recess the stimulator too deeply to avoid any air gap over the reference electrode.
• Other risks after surgery may be avoided by following the instructions in the ap‑
plicable MED‑EL audio processor user manual and the MED‑EL application software
user manual.
• Cochlear implantation in partially deaf individuals with low frequency hearing car‑
ries the risk of partial or total hearing loss which should be clearly explained to
the individual by the surgeon prior to implantation. However, studies have shown
benefi ts using electrical stimulation solely in this group of recipients even if residual
hearing is lost. Aetiology, duration of partial deafness and hearing aid benefi t
should be taken into consideration and hearing preservation surgical technique
should be applied.
• In case of a magnet exchange surgery MED‑EL recommends the use of the fol‑
lowing tools: The Magnet Removal Tool Ms050206 or the Magnet Insertion Tool
Ms050205 can be used in combination with the Non‑Magnetic Spacer Ms010107 or
the Replacement Magnet Ms010108. Please refer to the applicable Instructions for
Use of these devices for further surgical precautions and warnings.