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Sensorineural Hearing Loss, BilateralNCT04777565

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

A study testing Robotic surgery in people with Sensorineural Hearing Loss, Bilateral, run by MED-EL Elektromedizinische Geräte GmbH at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 years and older
Conditions the study is for
Sensorineural Hearing Loss, Bilateral
What is being tested?
Robotic surgery
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteFrance
Study dates
15 Sep 2021to 1 Jan 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

France1 site

  • CHU Montpellier

    Montpellier, 34295

Other trials in France

About this study

Official title: 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.

Read the 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.
Being tested
Robotic surgery
Keywords
cochlear implant, robotic surgery, electrode insertion
Medical subject headings
Hearing Loss, Sensorineural

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Robotic surgeryOther

    Cochlear implant surgery with HEARO procedure

Study groups in NCT04777565
Study groupRoleWhat they receive
CI surgeryExperimentalcochlear implant surgery
Receives: Other: Robotic surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: During surgery

Secondary outcomes (10)

  1. Electrode array insertion outcome (efficacy)

    • The angular insertion depth will be evaluated.

    Measured: During surgery

  2. Electrode array insertion outcome (efficacy)

    • The number of contacts inserted will be evaluated.

    Measured: During surgery

  3. Electrode array insertion outcome (efficacy)

    • The tip-fold over will be evaluated.

    Measured: During surgery

  4. Electrode array insertion outcome (efficacy)

    • The scalar deviation will be evaluated.

    Measured: During surgery

  5. 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.

    Measured: During surgery

  6. 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.

    Measured: During surgery

  7. 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.

    Measured: During surgery

  8. 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.

    Measured: During surgery

  9. Timing of the HEARO procedure

    • The timing of the different steps of the HEARO procedure will be recorded.

    Measured: During surgery

  10. Adverse events (safety)

    • Adverse events will be recorded

    Measured: During surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Mar 2021
  2. Study start15 Sep 2021
  3. Primary completion1 Jan 2023
  4. Study completion1 Jan 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04777565
Sponsor's protocol ID
MED-EL_HEARO_french_study
Status last verified
Feb 2023
First submitted
10 Feb 2021
Last updated
21 Feb 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Fourez AL, Kaderbay A, Villerabel C, Korchagina J, Pean V, Mondain M, Venail F. Implementation of Robot-Assisted Minimally Invasive Cochlear Implantation: A Feasibility Study. Otol Neurotol. 2025 Aug 1;46(7):809-815. doi: 10.1097/MAO.0000000000004531. Epub 2025 May 23.

    PubMed 40423721

Questions about this trial

What is this clinical trial studying?

A study testing Robotic surgery in people with Sensorineural Hearing Loss, Bilateral, run by MED-EL Elektromedizinische Geräte GmbH at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Electrode array insertion (time frame: During surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04777565, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2023.

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