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Study of a Minimally Invasive Cochlear Access for Cochlear Implantation Via a Robotic Procedure

Sensorineural Hearing Loss, Bilateral Clinical Trial

Official title:
The Efficacy of a Minimally Invasive Direct Cochlear Access Via the HEARO Procedure

Clinical Trial Summary

The objectives of this study are to explore the efficacy and safety of a robotic procedure for a minimally invasive cochlear implantation.

Clinical Trial Description

The cochlear implant (CI) is a neural prothesis and has been the gold standard treatment for severe to profound sensorineural hearing loss over several decades. The surgical procedure for cochlear implantation surgery aims to atraumatically insert the electrode array of the cochlear implant into the cochlea. However, due to the location of the cochlea inside the skull, the surgeon is required to initially create an access from the surface of the temporal bone to the cochlea (inner ear). In conventional methods, this access is acquired by removal of large portions of the mastoid bone through a wide mastoidectomy and posterior tympanotomy. The outcome and success of the conventional procedure varies due to mainly two factors: surgeon skill and subject anatomical variation. To overcome these variables toward a more consistent and less invasive cochlear implantation surgery, the development of robotic and image guided cochlear implantation has taken place. This study primarily aims to explore the efficacy of the HEARO robotic cochlear implantation surgery. Primary Objective The primary objective of this study is to: • explore the efficacy of a minimally invasive direct cochlear access via the HEARO procedure. Secondary Objectives The secondary objectives of this study are to: - explore the safety of a minimally invasive direct cochlear access via the HEARO procedure. - exploratively evaluate the electrode array insertion outcomes through the direct tunnel access. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04777565
Study type Interventional
Source MED-EL Elektromedizinische Geräte GesmbH
Contact
Status Completed
Phase N/A
Start date September 15, 2021
Completion date January 1, 2023
View Details
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