Microtable® Method for Cochlear Implantation Investigational Device Exemption (IDE)
Key facts
- Where
- Charleston, United StatesSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 22 and 80 years old?
Source: NCT03101917, who can take part
Where in United States
- Medical University of South CarolinaCharleston, United StatesContact: Robert F. Labadie, MD, PhDNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Medical University of South Carolina
- Trial code
- NCT03101917
- Record updated
- 18 June 2026
- Original description
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.Read full original descriptionShow less
Microtable® Microstereotactic Frame and Drill Press and Associated Method for Cochlear Implantation
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.
Inclusion: 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; Pre-operative CT scan of head/temporal bone as part of routine care showing normal temporal bone and intra-cochlear anatomy; Scheduled to receive either a Cochlear CI522 with the slim straight electrode or a MED-EL Synchrony with standard, Flex 24, or Flex 28 electrode.
Exclusion: Previous mastoidectomy on the ear undergoing research procedures; Severe chronic ear disease; Active middle ear infection; 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; 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; Subjects without a favorable trajectory based on pre-operative imaging, analysis and planning with favorable trajectory defined as a linear track extending from the surface of the mastoid cortex, through the facial recess, and targeting the basal turn of the cochlea without violation of the external auditory canal, sigmoid sinus, tegmen, and/or facial nerve.