Robotic Assisted Cochlear Implantation Feasibility Study

Insel Gruppe AG, University Hospital Bern9 enrolled

Overview

A first in man clinical trial to asses the the use of am image guided robotic system to safely and effectively create a minimally invasive access tunnel to the middle ear cavity to allow access to the round window for cochlear implant electrode insertion.

A first in man feasibility study of an image guided robotic system for performing a key-hole approach to the middle ear cavity.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Sensory Hearing Loss

Interventions

Minimally invasive robotic cochlear implantationDEVICE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Geographically and physically able to attend scheduled evaluations and follow-up appointments * Indicated for cochlear implantation * Age 18 years or older * Fluent in German or French * Sufficient facial recess size ( \> 2.5 mm between the facial nerve and chorda tympani) Exclusion Criteria: * Pregnancy * Anatomical malformation of the middle or inner ear or unusual facial nerve course * Lack of compliance with any inclusion criteria

Locations (1)

Inselspital University Hospital Bern

Bern, Switzerland

Outcomes

Primary Outcomes

Drilling accuracy

The lateral distance between the center lines of the planned and drilled tunnel positions at the level of the facial nerve measured from medical image data

Time frame: Image data acquired during the procedure