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Maintaining Cochlear Patency After VIIIth Nerve Surgery

NCT ID: NCT03261726

Last Updated: 2025-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-04

Study Completion Date

2021-03-04

Brief Summary

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Tumors arising from the VIIIth Nerve (vestibulo-cochlear nerve) typically present with progressive unilateral hearing loss and tinnitus. VIIIth Nerve tumors with documented growth on serial MRI scans typically lead to deafness in the affected ear over time. Radiation (Gamma Knife® or stereotactic radiosurgery) may preserve hearing in \~80% while surgery (middle cranial fossa or retrosigmoid approach) may preserve hearing in 16 - 40% of small tumors, although initial hearing preservation by both modalities may fail over time. Surgical resection via the translabyrinthine approach is the safest way to remove many of these tumors, but involves loss of all hearing. In all treatment modalities, the vascular supply (the labyrinthine artery, a terminal branch of AICA with no collaterals) to the cochlea is at risk. After devascularization, the cochlea frequently fills with fibrous tissue or ossifies (labyrinthitis ossificans), making it impossible to place a cochlear implant should it be required later. The incidence of this is 46% in our patients. This study seeks to determine the feasibility of preserving the cochlear duct with an obdurator so that patients undergoing translabyrinthine removal of VIIIth nerve tumors may retain the option of a cochlear implant at a later time.

Detailed Description

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Conditions

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Acoustic Neuroma Labyrinthitis Ossificans Profound Hearing Impairment

Keywords

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unilateral deafness acoustic neuroma cochlear implant

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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MedEl Test Electrode Placer

MedEl Test Electrode Placed at VIIIth nerve tumor resection

Group Type EXPERIMENTAL

MedEl Test Electrode Placer

Intervention Type DEVICE

This study uses a sterile dummy (i.e., not working) cochlear implant electrode inserted at the time of tumor removal to keep the inner ear from scarring or filling with bone. The significance of this to you is that if you ever become eligible for a cochlear implant sometime after surgery, it may be possible to remove the dummy and insert a functioning cochlear implant.

Interventions

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MedEl Test Electrode Placer

This study uses a sterile dummy (i.e., not working) cochlear implant electrode inserted at the time of tumor removal to keep the inner ear from scarring or filling with bone. The significance of this to you is that if you ever become eligible for a cochlear implant sometime after surgery, it may be possible to remove the dummy and insert a functioning cochlear implant.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* patients of all ages with unilateral or bilateral acoustic neuromas who face loss of hearing in 1 ear from surgical removal via a translabyrinthine approach.
* patients do not meet criteria for conventional cochlear implantation or auditory brainstem implantation.
* tumor removal must allow preservation of the auditory division of the VIIIth cranial nerve.
* the patient must be willing to undergo preoperative S pneumococcus immunization protocol recommended by the US CDC immunization recommendations for cochlear implant patients.

Exclusion Criteria

* inability to preserve the auditory division of the VIIIth cranial nerve during tumor removal ossification or fibrosis of the cochlea found on preoperative imaging (CT or MRI) that precludes cochlear implantation.
* active middle ear disease.
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Med-El Corporation

INDUSTRY

Sponsor Role collaborator

Henry Ford Health System

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Eric W Sargent, MD

Role: PRINCIPAL_INVESTIGATOR

Ascension Providence Hospital

Locations

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The Michigan Ear Institute

Farmington Hills, Michigan, United States

Site Status

Countries

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United States

Other Identifiers

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IRB# 1040241

Identifier Type: -

Identifier Source: org_study_id