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Simultaneous Cochlear Implantation During Translabyrinthine Resection of Vestibular Schwannoma

Simultaneous Cochlear Implantation During Translabyrinthine Resection of Vestibular Schwannoma

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03958006
Enrollment
6
Registered
2019-05-21
Start date
2018-12-05
Completion date
2023-01-30
Last updated
2023-04-20

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

Conditions

Cochlear Implantation, Vestibular Schwannoma

Brief summary

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

Detailed description

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.

Interventions

DEVICECochlear implant

Tumor resection with cochlear implant

Sponsors

Henry Ford Health System
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No

Inclusion criteria

* Patients with a vestibular schwannoma undergoing a translabyrinthine resection with intact hearing in the contralateral ear

Exclusion criteria

\-

Design outcomes

Primary

MeasureTime frameDescription
Measurement of Hearing Parameters1 month, 3 months and 6 months postoperatively.Audiologist assesses changes in understanding of the AzBio test (words in quiet and words in background noise) post cochlear implantation.

Secondary

MeasureTime frameDescription
Measurement of Change of Physical Symptoms Associated with Hearing Loss1, 3 and 6 months postoperativelyPatients will complete the Dizziness Handicap Inventory
Assessment of Change of Physical Symptoms Associated with Hearing Loss1, 3 and 6 months postoperativelyPatients will complete the Tinnitus Handicap Inventory
Assessment of incision site healing1 week, and 1 and 3 months postoperativelySurgeon evaluates wound hearing over 3 months

Countries

United States

Outcome results

None listed

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