Percutaneous Cochlear Implantation: Implementation of Technique



Status:Recruiting
Conditions:Other Indications
Therapuetic Areas:Other
Healthy:No
Age Range:Any
Updated:10/21/2012
Start Date:October 2011
End Date:April 2017
Contact:Wendy W. Lipscomb, BSN
Email:wendy.lipscomb@vanderbilt.edu
Phone:615-936-2491

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The investigators are studying a new way of doing cochlear implant surgery called
"Percutaneous Cochlear Implantation". In this surgery, instead of doing a mastoidectomy
where about 30ml of bone is removed, the investigators use image-guided technology (similar
to GPS systems used to guide automobile travel) to drill directly from the surface of the
skull to the cochlea, removing less than 2ml of bone. To use this technique, three markers
(or anchor screws) are screwed into the bone around the ear. Next, an x-ray of the head
(called a CT scan) is taken. Using this CT scan, a path to the inner ear (cochlea) is
planned and a drill guide (Microtable) is made that mounts on the anchor screws. A drill
will be attached to the guide and used to drill a path from the surface of the skull to the
inner ear (cochlea). The implant electrode will be threaded through this path. All of
these procedures take place under general anesthesia.


Inclusion Criteria:

- 18-80 year old patients undergoing cochlear implantation who are able to participate
in the informed consent process.

- Pre-operative CT scan of head performed as standard of care for cochlear implant
work-up.

Exclusion Criteria:

- Patients with co-morbidities so severe that the potential additional operating room
time is deemed to be too significant of an operative risk. This assessment is made
by the local institutions pre-operative work-up.

- History of allergic reaction/intolerance of local anesthesia and/or epinephrine.

- History of allergic reaction to titanium.

- Patients with severe anatomical abnormality of the temporal bone.

- Patients with severe chronic ear disease for whom traditional mastoidectomy might
offer benefit.

- Females who are pregnant.
We found this trial at
1
site
1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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from
Nashville, TN
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