Simultaneous Cochlear Implantation During Translabyrinthine Resection of Vestibular Schwannoma

Study Overview
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Brief Summary
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This study will address the feasibility of simultaneous cochlear implantation during resection of a vestibular schwannoma.

Detailed Description
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This is prospective study patients undergoing a translabyrinthine resection for a vestibular schwannoma with intact hearing in the contralateral ear. During surgery, simultaneous cochlear implantation will be performed if the cochlear nerve can be identified and preserved during the resection. Relevant data to be collected will include patient demographics, details related to the vestibular schwannoma including side, size, symptoms (specifically pre-operative hearing loss, degree of tinnitus), and status of hearing in the contralateral ear. Surgical details to be recorded will include date of surgery, surgical time, and whether the cochlear nerve was identified and preserved. Details related to the post-operative course to be recorded include length of stay in the hospital, post-operative complications such as wound infection or cerebral spinal fluid (CSF) leak, and need for revision or additional procedures.

Official Title
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Simultaneous Cochlear Implantation During Translabyrinthine Resection of Vestibular Schwannoma

Conditions
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Vestibular Schwannoma, Cochlear Implantation

Intervention / Treatment
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* Device: Cochlear implant


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with a vestibular schwannoma undergoing a translabyrinthine resection with intact hearing in the contralateral ear Exclusion Criteria: -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cochlear implantation<br>Simultaneous cochlear implantation with tumor resection | Device: Cochlear implant<br>* Tumor resection with cochlear implant<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of Hearing Parameters | Audiologist assesses changes in understanding of the AzBio test (words in quiet and words in background noise) post cochlear implantation. | 1 month, 3 months and 6 months postoperatively. | 
| Measurement of Hearing Parameters | Audiologist assesses changes in understanding of 50 random consonant-nucleus-consonant sounds. | 1 month, 3 months and 6 months postoperatively. | 
| Measurement of Hearing Parameters | Audiologist assesses changes in understanding changes in understanding of Speech, Spatial and Qualities of Hearing. | 1 month, 3 months and 6 months postoperatively. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of Change of Physical Symptoms Associated with Hearing Loss | Patients will complete the Dizziness Handicap Inventory | 1, 3 and 6 months postoperatively | 
| Assessment of Change of Physical Symptoms Associated with Hearing Loss | Patients will complete the Tinnitus Handicap Inventory | 1, 3 and 6 months postoperatively | 
| Assessment of incision site healing | Surgeon evaluates wound hearing over 3 months | 1 week, and 1 and 3 months postoperatively |