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

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

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

Study Overview

• Status: Completed
• Conditions: Sensorineural Hearing Loss, Bilateral
• Intervention / Treatment: Other: Robotic surgery

Detailed 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 Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Vincent Péan, PhD; Phone Number: (+33)603592974; Email: vincent.pean@medel.com

Study Locations

• France
  • Montpellier, France, 34295
    • CHU Montpellier

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subjects scheduled for CI surgery according to clinical routine
• Subjects who will receive a cochlear implant of the MED-EL portfolio
• Signed and dated informed consent form

Exclusion Criteria:

• Lack of compliance with any inclusion criteria
• Age under 18 years
• Pregnancy
• Distance of the planned trajectory to the facial nerve is < 0.4 mm as per screening CT scan
• Distance of the planned trajectory to the chorda tympani is < 0.3 mm as per screening CT scan
• A safe inner ear access cannot be planned for preservation of RW membrane and cochlear structures
• Individuals where image guidance or robotic procedures are not indicated
• Individuals who have known allergy to components of the cochlear implant

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CI surgery; cochlear implant surgery	Other: Robotic surgery; Cochlear implant surgery with HEARO procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Electrode array insertion	• Relative ratio of successful electrode array insertions through the drilled direct cochlear access with the HEARO procedure to the total HEARO procedures (i.e. proportion of successful insertions with the procedure out of the total number of patients included in the study).	During surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Electrode array insertion outcome (efficacy)	• The angular insertion depth will be evaluated.	During surgery
Electrode array insertion outcome (efficacy)	• The number of contacts inserted will be evaluated.	During surgery
Electrode array insertion outcome (efficacy)	• The tip-fold over will be evaluated.	During surgery
Electrode array insertion outcome (efficacy)	• The scalar deviation will be evaluated.	During surgery
Insertion depth prediction accuracy (efficacy)	• The insertion depth prediction accuracy as the difference between the estimated insertion depth of the electrode at the planning and the actual insertion depth.	During surgery
Absolute angular accuracy of the drilled tunnel access (safety)	• The absolute lateral accuracy of the drilled tunnel to the facial nerve and chorda tympani is measured as the difference between the planned trajectory and the actual drilled trajectory distance.	During surgery
Absolute lateral accuracy of the drilled tunnel at the target (safety)	• The absolute lateral accuracy of the drilled tunnel is measured as the distance between the planned target trajectory position and actual target of the drilled trajectory position.	During surgery
Ratio of the round window membrane preservation during the inner ear access (safety)	• The ratio of the preserved round window (RW) membrane at the robotic inner ear access by visual inspection. This will be assessed as subjective evaluation by the surgeon.	During surgery
Timing of the HEARO procedure	• The timing of the different steps of the HEARO procedure will be recorded.	During surgery
Adverse events (safety)	• Adverse events will be recorded	During surgery

Collaborators and Investigators

• Sponsor: MED-EL Elektromedizinische Geräte GesmbH

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2021
• Primary Completion (Actual): January 1, 2023
• Study Completion (Actual): January 1, 2023

Study Registration Dates

• First Submitted: February 10, 2021
• First Submitted That Met QC Criteria: March 1, 2021
• First Posted (Actual): March 2, 2021

Study Record Updates

• Last Update Posted (Estimate): February 21, 2023
• Last Update Submitted That Met QC Criteria: February 20, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: cochlear implant; robotic surgery; electrode insertion
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Hearing Loss; Hearing Loss, Sensorineural; Hearing Loss, Bilateral
• Other Study ID Numbers: MED-EL_HEARO_french_study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No