Inner Ear Malformations Clinical Trial
Official title:
A New Cochlear Implant Electrode With A "Cork" Type Stopper For Inner Ear Malformations
The custom made device was produced by Med-El Company. It has a "cork" like stopper instead
of the usual silicon ring to prevent gusher. There are two types of electrodes consisting of
different length. Standard one is 25 mm (contact space 1.7 mm) and the short one is 20 mm
(contact space 1.3 mm). It was used in 50 patients with different inner ear malformations.
Thirteen patients had gusher, and 11 patients oozing during cochleostomy. One patient with
initial prototype of the cork electrode had to be revised because of persistent oozing around
the electrode. Another patient had slow extrusion of the electrode most probably due to CSF
(cerebrospinal fluid) pulsation and had to be revised. Both patients had no more CSF fistula.
CSF fistula in inner ear malformations is a serious situation which may lead to recurrent
meningitis. The new cochlear implant electrode with "cork" stopper looks promising in
preventing the postoperative CSF leak around the electrode.
Gusher in inner ear malformations is common in patients with incomplete partition type-I, and
III. It is also common in less severe form as oozing in incomplete partition type II and
large vestibular aqueduct. It is important to prevent CSF escape around the cochlear implant
electrode to prevent meningitis.
The custom made device was produced by Med-El Company. It has a "cork" like stopper instead
of the usual silicon ring to prevent gusher. There are two types of electrodes consisting of
different length. Standard one is 25 mm (contact space 1.7 mm) and the short one is 20 mm
(contact space 1.3 mm). It was used in 50 patients with different inner ear malformations.
Thirteen patients had gusher, and 11 patients oozing during cochleostomy. One patient with
initial prototype of the cork electrode had to be revised because of persistent oozing around
the electrode. Another patient had slow extrusion of the electrode most probably due to CSF
pulsation and had to be revised. Both patients had no more CSF fistula.
CSF fistula in inner ear malformations is a serious situation which may lead to recurrent
meningitis. The new cochlear implant electrode with "cork" stopper looks promising in
preventing the postoperative CSF leak around the electrode.
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