Microtable® Cochlear Implantation for Hearing Loss

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen byRobert F. Labadie, MD, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Medical University of South Carolina

No Placebo Group

Trial Summary

What is the purpose of this trial?This trial tests a custom-made device that helps doctors perform more precise and less invasive cochlear implant surgeries. It targets patients who need cochlear implants and may benefit from quicker recovery and fewer complications. The device uses imaging to guide a drill for accurate surgery.

Eligibility Criteria

This trial is for adults aged 22 to 80 who need cochlear implant surgery and have normal temporal bone anatomy as shown by a CT scan. It's not for pregnant women, those with severe health risks or ear abnormalities like Mondini malformation, or if the surgical path isn't clear on imaging.

Inclusion Criteria

I am approved for cochlear implant surgery after a standard evaluation.

I am between 22 and 80 years old.

Able to complete study related procedures.

+9 more

Exclusion Criteria

I have had a mastoidectomy on the ear being studied.

My pre-surgery scans show a safe path for ear surgery without risking important structures.

I currently have a middle ear infection.

+4 more

Participant Groups

The Microtable® System is being tested to see if it can make cochlear implant surgeries less invasive. The system uses a custom frame and drill press guided by images to place an electrode in the ear, which may lead to quicker procedures and better outcomes.

2Treatment groups

Experimental Treatment

Group I: Visual assessment of electrode insertionExperimental Treatment1 Intervention

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.

Group II: Camera assessment of electrode insertionExperimental Treatment1 Intervention

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.