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Microtable® Method for Cochlear Implantation Investigational Device Exemption (IDE)
Sponsor: Medical University of South Carolina
Summary
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.
Official title: Microtable® Microstereotactic Frame and Drill Press and Associated Method for Cochlear Implantation
Key Details
Gender
All
Age Range
22 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
12
Start Date
2026-07-01
Completion Date
2028-07-31
Last Updated
2025-03-05
Healthy Volunteers
No
Conditions
Interventions
The Microtable® Stereotactic System
x
Locations (1)
Medical University of South Carolina
Charleston, South Carolina, United States