A New Cochlear Implant Electrode For Inner Ear Malformations

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A New Cochlear Implant Electrode With A Cork Type Stopper For Inner Ear Malformations

Conditions
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Inner Ear Malformations

Intervention / Treatment
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* Device: Cork Electrode


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Must have an inner ear malformation Must meet the criteria for cochlear implantation Exclusion Criteria: Prior cochlear implantation surgery
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cork Electrode<br>Using Cork Electrode for CSF leak prevention for inner ear malformations. | Device: Cork Electrode<br> <br> * Other names: MedEl Cork Electrode;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CSF leak | Occurrence of CSF leak after the surgery. | Up to 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Meningitis | Having meningitis due to CSF leak or connection to the middle ear after surgery. | Up to 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Inner Ear Malformations, Gusher, Cochlear Implantation