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A New Cochlear Implant Electrode For Inner Ear Malformations

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02011867
Enrollment
50
Registered
2013-12-13
Start date
2013-05-31
Completion date
2013-11-30
Last updated
2013-12-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inner Ear Malformations

Keywords

Inner Ear Malformations, Gusher, Cochlear Implantation

Brief summary

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

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.

Interventions

DEVICECork Electrode

Sponsors

Hacettepe University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* Must have an inner ear malformation * Must meet the criteria for cochlear implantation

Exclusion criteria

* Prior cochlear implantation surgery

Design outcomes

Primary

MeasureTime frameDescription
CSF leakUp to 1 yearOccurrence of CSF leak after the surgery.

Secondary

MeasureTime frameDescription
MeningitisUp to 1 yearHaving meningitis due to CSF leak or connection to the middle ear after surgery.

Other

MeasureTime frameDescription
HearingUntil deathImprovement in hearing after cochlear implantation.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026