The Microtable® Microstereotactic Frame and Drill Press and Associated Method for Cochlear Implantation consists of a patient-customized microstereotactic frame which targets the cochlea. The intended use of the device in this early feasibility study is to surgically access the cochlea, allowing placement of an intra-cochlear electrode array for cochlear implantation, thereby providing a less invasive surgical option than currently performed. Compared to traditional cochlear implantation (CI) surgery, the investigators hypothesize that the minimally invasive, image-guided approach may offer the following benefits: (1) shorter procedure time including shorter general anesthesia time, (2) less tissue removal potentially eliminating post-operative mastoid bone depression, decreased post-operative patient discomfort, and quicker wound healing, (3) better chance of preservation of taste secondary to preservation of the chorda tympani nerve, and (4) standardization of electrode placement potentially allowing more consistent placement within the scala tympani sub-compartment of the cochlea which has been shown to be associated with improved post-operative audiological performance. This early feasibility study will focus on the advantages of the new technology to the patient. Advantages to the healthcare delivery system will be examined during the pivotal study phase.
Male or female 22 to 80 years of age.
Able to complete study related procedures.
Able to provide written informed consent.
Eligible for cochlear implant surgery as per routine pre-operative CI evaluation/workup. If patient is a candidate for bilateral CI, the research technique will be performed unilaterally on the side with the most favorable anatomy and/or worst residual hearing.
Females who are pregnant. As part of routine pre-operative care, all females of childbearing potential will undergo either urine or blood pregnancy testing.
ASA (American Society of Anesthesiologists) Physical Status classification of 4 or above or determined by surgeon to be too great of a health risk.
Previous mastoidectomy on the ear undergoing research procedures.
Severe anatomical abnormality of the temporal bone including but not limited to: 1) Mondini malformation 2) common cavity malformation 3) enlarged vestibular aqueducts (EVA) and/or 4) cochlea ossification.
Single group
The Microtable® Stereotactic System
Devicex
Successful insertion of the CI electrode array into the cochlea.
Assessed by CT confirmation of intra-cochlear placement of the electrode array.
Time in minutes of cochlear implant surgery.
Assessed by physical exam immediately after surgical intervention.
Amount of tissue removed scanning
Volume assessed by comparison of pre-operative CT scan to the post-operative CT scan
Preservation of taste scanning
Assessed by postoperative survey
Optimal electrode position within the cochlea's scala tympani scanning
Assessed by intraoperative CT scan
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
