Status:
WITHDRAWN
Maintaining Cochlear Patency After VIIIth Nerve Surgery
Lead Sponsor:
Henry Ford Health System
Collaborating Sponsors:
Med-El Corporation
Conditions:
Acoustic Neuroma
Labyrinthitis Ossificans
Eligibility:
All Genders
Phase:
NA
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 4 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 4 2021
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03261726
Start Date
August 4 2017
End Date
March 4 2021
Last Update
December 19 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
The Michigan Ear Institute
Farmington Hills, Michigan, United States, 48334