Evaluation of Electrode-modiolus Distance and Cochlear Fibrosis Using Depth Sounding and Spectroscopy Tools

Related Clinical Trial
Anatomy-Based Fitting in Unexperienced Cochlear Implant Users Effect of Modulated Auditory Stimulation on Interaural Auditory Perception Effect of Donepezil on Speech Recognition in Cochlear Implant Users Analysis of Risk Factors of Neurodevelopmental Disorder in Deaf Infants Under Ten Months of Age. Natural History in Children up to 10 Years With Moderate to Profound Hearing Loss Due to Mutations in GJB2/OTOF Genes Evaluation of Electrode-modiolus Distance and Cochlear Fibrosis Using Depth Sounding and Spectroscopy Tools Audiological and Quality of Life Outcomes of Anatomy Based Fitting in Patients Implanted by Robot Assisted Cochlear Implant Surgery (RACIS) Pupillometry Techniques Usage to Quantify the Programming Parameters Effect in the Auditory Effort in Zti Opticon Cochlear Implant Adult Users Factors Affecting Early Progress of Cochlear Implant Outcomes in Adults Study of Sound and Speech Perception in New Cochlear Implanted Subjects Using or Not an Anatomy-based Fitting Post Approval Study to Assure the ContInued saFety and effectIveness of Neuro Cochlear Implant System in Adult Users Quantification of Visually Evoked Cortical Potentials in Individuals With Hearing Loss A Trial of LY3056480 in Patients With SNLH Fundamental Asynchronous Stimulus Timing Sound Coding Study Phase I Clinical Study of HY01 in Patients Genotype-phenotype Correlation of SLC26A4 in CI Patients With EVA Study of Music and Speech Perception in New Cochlear Implanted Subjects Using or Not a Tonotopy Based Fitting Oral Statins and Protection From Hearing Loss Study of a Minimally Invasive Cochlear Access for Cochlear Implantation Via a Robotic Procedure Cochlear Implant With Dexamethasone Eluting Electrode Array Hearing Implant Performance in Adults With Low-Frequency Residual Hearing Perimodiolar Implant Performance in Adults With Low-Frequency Residual Hearing Cochlear Implanted Listening Effort and Hearing Attention The Performance of a Robot-assisted Minimally Invasive Direct Cochlear Access for Cochlear Implantation Auditory Performances With Different Stimulation Depths in Cochlear Implanted Subjects Using a Fine Structure Strategy Feasibility of the Mi2000 Totally Implantable Cochlear Implant in Severely to Profoundly Deaf Adults. Hearing Aid Noise Reduction in Pediatric Users Pilot Study (Oticon Pilot Study) Phase I/IIa Study Evaluating Safety and Efficacy of an Intratympanic Dose of PIPE-505 in Subjects With Hearing Loss Dexamethasone-Eluting Cochlear Implant Electrode Artificial Intelligence in Diagnosis of DFNA9 Randomized Controlled Trial of Valganciclovir for Cytomegalovirus Infected Hearing Impaired Infants Study to Determine the Safety, Tolerability, and Pharmacokinetic Profile of HPN-07 and HPN-07 Plus NAC Cochlear Implant and Vestibular Function. Quality Control of CE-Certified Phonak Hearing Aids – 2018_42 Quality Control of CE-Certified Phonak Hearing Aids – 2018_28 Enlarged Vestibular Aqueduct Registry Evaluation of the High Frequency Digit Triplet Test in Cystic Fibrosis Effectiveness of P02 Digital Hearing Aids ABR Characteristics and Salivary Cortisone Concentration in Noise-exposed Workers Clinical Investigation of New CI Delivery Models in an Adult Nucleus CI Population Genetic Analysis of Hereditary Disorders of Hearing and Balance Compassionate Use Arm – ABI541 ABI for 10 NF2 Patients Evaluation of a Binaural Beamformer (StereoZoom) in a Virtual Acoustic Environment and in Real Life Evaluation of N6 Sound Processor in Group of Freedom Users Robotic Assisted Cochlear Implantation Feasibility Study Auditory Nerve Test System During Vestibular Schwannoma Resection Cochlear Electrical Impedance and the Effect of Topical Dexamethasone on Cochlear Implant Surgery Comparison Between Neuro 1 and Neuro 2 Cochlear Implant Speech Processors Listening Effort in Cochlear Implant Users Quality Control of CE-Certified Phonak Hearing Aids – 2019_19 Esteem Totally Implantable Hearing System A Clinical Trial of Anakinra for Steroid-Resistant Autoimmune Inner Ear Disease Study of Quality Perception on Music in New Cochlear Implanted Subjects Using or Not a Fine Structure Strategy An Evidence Based Delivery Model of Care for Newly Implanted Adult CI Recipients Study of Auditory Performance on Prosodic Tests in Cochlear Implanted Subjects Using a Fine Structure Strategy CI532 – Early Experience Study Clinical Applications of Round Window Imaging Anatomy in Cochlear Implant Surgery Single-sided Deafness and Cochlear Implants Cochlear Implantation Among Adults and Older Children With Unilateral or Asymmetric Hearing Loss Clinal Evaluation of Navigation Based Functional Ear Surgery Using Image Guided and Robotically Assisted Techniques OTO-413 in Subjects With Speech-in-Noise Hearing Impairment The Efficacy of a Minimally Invasive Direct Cochlear Access Via the HEARO Procedure Clinical Evaluation of a Cochlear Implant System Objective Measures in Cochlear Implant Evaluation of a Binaural Spatialization Method for Hearing Aids Esteem New Subject Enrollment Post Approval Study Safety of Autologous Stem Cell Infusion for Children With Acquired Hearing Loss Investigation of Anatomical Correlates of Speech Discrimination Efficacy of Digital Noise Reduction Strategies: A Hearing Aid Trial Evaluation of Revised Indicatons (ERID) for Cochlear Implant Candidacy for the Adult CMS Population Clinical and Genetic Analysis of Enlarged Vestibular Aqueducts Balance in Children With Cochlear Implants Congenital Cytomegalovirus: Efficacy of Antiviral Treatment Nucleus Freedom Cochlear Implant System Pediatric Post-approval Study Evaluation of the Nucleus Hybrid™ L24 Cochlear Implant System Radiological Classification of the Facial Nerve Congenital Cytomegalovirus: Efficacy of Antiviral Treatment in a Randomized Controlled Trial The Effect of Sound Stimulation on Hearing Ability The Effect of Sound Stimulation on Pure-tone Hearing Threshold Efficacy of SENS 401 in Subjects With Severe or Profound Sudden Sensorineural Hearing Loss The SeaSHeL National Prospective Cohort Study Non-linear Frequency Compared to Conventional Processing in Patients With and Without Cochlear Dead Regions. Study of Low Level Laser Therapy and Word Recognition in Hearing Impaired Individuals Electrode Placement and Audiologic Outcomes With the Advanced Bionics HiFocus L23 Electrode Video HIT in Sudden Sensorineural Hearing Loss Determine the Incidence of Long QT Amongst a Large Cohort of Subjects Diagnosed With Unilateral or Bilateral Sensorineural Hearing Loss. FX-322 in Sensorineural Hearing Loss Autologous Bone Marrow Harvest and Transplant for Sensorineural Hearing Loss FX-322 in Adults With Stable Sensorineural Hearing Loss

Brief Title

Evaluation of Electrode-modiolus Distance and Cochlear Fibrosis Using Depth Sounding and Spectroscopy Tools

Official Title

Evaluation of Electrode-modiolus Distance and Cochlear Fibrosis Using Depth Sounding and Spectroscopy Tools: Comparison With Postoperative Cone Beam CT

Brief Summary

      Cochlear fibrosis development can compromise the success and the outcomes of the cochlear
      implantation (CI) thus affecting the quality of life of the implanted patient. Correlating
      the results of the Transimpedance Matrix (TIM) measurements to the implant electrode location
      determined by the Cone Beam Computer Tomography (CBCT), this study aims to identify a range
      of TIM profiles within the implanted population, certain profiles suggesting the growth of
      the fibrosis tissue in cochlea

Detailed Description

      Fibrosis tissue growth after the CI is an inflammatory reaction to a foreign body occurring
      around the electrode array. It is considered responsible for a larger current diffusion, less
      precise stimulation of auditory nerve fibres and elevated electrical impedances thus
      affecting the functioning and the battery life of an implant. Fibrosis has been also proposed
      as a factor reducing residual hearing. Hence, its early detection and prevention can
      significantly improve the outcomes of CI.

      To date, no reliable technique to visualise cochlear fibrosis in vivo exists. However, the
      TIM measurement developed by Cochlear® including depth sounding and spectroscopy tools could
      possibly provide a better "view" of the fibrosis apparition after CI. This approach has been
      already successfully applied in the University Hospital of Montpellier, France, to the
      patients-users of the Advanced Bionics cochlear implants.

      One of the factors provoking the fibrosis tissue development is an electrode positioning into
      the scala vestibule (SV) versus scala tympani (ST). CBCT will be used to visualise the
      electrode location as well as possible damages of the inner ear caused by CI. The imaging
      data will be then linked to the TIM measurements results.

      Potential participants will be recruited from the French population of the Cochlear® implant
      users either coming for their regular checks-up at the ENT service of the University Hospital
      of Montpellier and implanted for more than 6 month (time necessary for the fibrosis tissue to
      develop) or recently implanted at the same hospital.

      For the patients with long-term implantation (160 participants planned) the TIM measurements
      will be performed only once whereas the newly implanted group (20 participants planned) will
      require these measurements to be repeated several times: on the day of the surgery as well as
      15 days, 1 month, 2 months, 3 months and 6 months after it. For the first group the post
      operational CBCT imaging file will be extracted from the patient medical record; for the
      second group CBCT will be performed during the surgery.

      The main objective of this study is:

      For the group with long-term implantation - to show the difference in TIM profiles according
      to the electrode scala position (ST or SV) determined by CBCT 6 months or more after the
      implantation For the group with recent implantation - to evaluate the changes in TIM profiles
      with time according to the electrode scala position (ST or SV) determined by CBCT

      The secondary objectives are common for both groups:

        -  To analyse various patient subgroups defined by the electrode type (Contour Advanced -
           only for long-term implantation, Slim Straight, Slim Modiolar) and the inner ear access
           (round window, enlarged round window or cochleostomy)

        -  To identify the TIM profile threshold values, potential indicators of the cochlear
           fibrosis apparition, depending on the electrode type

        -  To evaluate the depth sounding tool accuracy for the measurement of the distance between
           the electrode and the spiral ganglion in comparison to CBCT depending on the type of the
           electrode array.

        -  To evaluate the spectroscopy tool accuracy for fibrosis detection in specific cochlear
           areas (around electrodes dislocated to SV or basal electrodes in case of cohleostomy)

Study Type


Primary Outcome

TIM profiles in patients with long-term implantation

Secondary Outcome

 TIM profiles depending on electrode array and inner ear access


Sensorineural Hearing Loss


Transimedance Matrix measurements

Study Arms / Comparison Groups

 Patients with long-term implantation
Description:  Patients undergone CI more than 6 months ago. After the study is presented to the patient and the egligibility criterias are verified, the patient is proposed to sign a consent form (visit 0). Once the consent form is signed, the visit 1 is scheduled (0 to 90 days after the visit 0). During the visit 1 TIM measurements are performed, including depth sounding and spectroscopy, and adversed affects if any are collected.


* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status


Estimated Enrollment


Start Date

June 2022

Completion Date

June 2024

Primary Completion Date

December 2023

Eligibility Criteria

        Inclusion Criteria:

        Group with long-term implantation:

          -  Age18 years or older

          -  Affiliation to the French social security

          -  Signed and dated informed consent form

          -  Users of uni or bilateral cochlear implants for more than 6 months (CI24CA, CI422,
             CI512, CI522, CI532, CI612; CI622; CI632), in primo-implantation or reimplantation,
             with more than 18 electrodes active

          -  Postoperation CBCT imaging results available

        Recently-implanted group:

          -  Age18 years or older

          -  Affiliation to the French social security

          -  Signed and dated informed consent form

          -  Indication for CI622 or CI632 cochlear implants

          -  Postoperation CBCT imaging results available

        Exclusion Criteria:

          -  Vulnerable individuals (minors, adults protected in accordance to the French Public
             Health code, patients deprived of liberty by court decision)

          -  Daily usage of the cochlear implant for less than 4 hours or weekly usage for less
             than 5 days

          -  Failure or disfunction of the cochlear implant




18 Years - 120 Years

Accepts Healthy Volunteers



, +33467336890, [email protected]

Administrative Informations



Organization ID


Responsible Party


Study Sponsor

University Hospital, Montpellier

Study Sponsor

, , 

Verification Date

May 2022