Microtable® Method for Cochlear Implantation Investigational Device Exemption (IDE)

Conditions

• Hearing Loss, Cochlear

Eligibility Criteria

Sex

ALL

Age

22 Years - 80 Years

Healthy Volunteers

Not accepted

Interventions

• The Microtable® Stereotactic System — DEVICE
  x

Study Details

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.

Key Dates

Start date

Jul 1, 2026

Status verified

Mar 2025

Primary completion

Jul 5, 2028

Completion

Jul 31, 2028

Study Design

Enrollment

12 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Visual assessment of electrode insertion
  This arm will include the first 6 participants. In this group, a cut will be made near the eardrum and it will be lifted up so the surgeon can see the electrode as it goes into the cochlea.
• Experimental: Camera assessment of electrode insertion
  This arm will include the next 6 participants. In this group, a tube with a camera will be inserted past the ear drum, by making a small hole in the ear drum, to see the electrode as it goes into the cochlea.

Primary Outcome Measure

Successful insertion of the CI electrode array into the cochlea. [ Time Frame: Intraoperative ]

Central Contacts

• Robert F. Labadie, MD, PhD
  843-792-7161
  [email protected]

Locations (1)

Find similar trials in Charleston, SC

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