Microtable® Method for Cochlear Implantation

This study is testing a new, less invasive way to perform cochlear implantation surgery using the Microtable® Stereotactic System. This system uses a custom-made frame to precisely target the cochlea (the inner ear structure responsible for hearing). Researchers hope this new method will lead to shorter surgery times, less tissue removal, quicker healing, and potentially better hearing outcomes compared to traditional surgery. You may be able to join if you are 22 to 80 years old, eligible for a cochlear implant, and can complete study procedures. The main goal is to see if the cochlear implant electrode array can be successfully inserted into the cochlea using this new method. The current status of this study is unclear.

Study design: This is an interventional study planning to enroll 12 participants. It is testing a new surgical device and method.
What's involved: Not specified in the trial record.
Compensation: Not stated in the trial record.
Follow-up: The primary outcome of successful electrode array insertion is measured during the surgery itself.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

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

Not Yet Recruiting

NAAges 22–80InterventionalTreatment

Medical University of South Carolina

~12 participants

Updated 2026-06-18 on ClinicalTrials.gov

What's tested:The Microtable® Stereotactic System

At a glance

Recruiting sites

0 of 1 listed site is recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Successful insertion of the CI electrode array into the cochlea.

Measured over Intraoperative

Conditions

Hearing Loss, Cochlear

Where it's being run

1 sites across 1 states

South Carolina1

Study leadership

Robert F. Labadie, MD, PhD · PRINCIPAL_INVESTIGATOR · Medical University of South Carolina

Who to contact

Robert F. Labadie, MD, PhD

[email protected]

843-792-7161

Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

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

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.

Severe chronic ear disease.

Active middle ear infection.

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.

What this trial measures

Successful insertion of the CI electrode array into the cochlea.Intraoperative
Assessed by CT confirmation of intra-cochlear placement of the electrode array.

Trialytics