Electrode Placement and Audiologic Outcomes With the Advanced Bionics HiFocus L23 Electrode

Related Clinical Trial
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

Electrode Placement and Audiologic Outcomes With the Advanced Bionics HiFocus L23 Electrode

Official Title

Multi-Center Assessment of Electrode Placement and Audiologic Outcomes in Cochlear Implantation With the Advanced Bionics HiFocus L23 Electrode

Brief Summary

      The goal of this study is to measure patient performance after cochlear implantation with the
      Food and Drug Administration (FDA) approved Advanced Bionics HiFocus L23 device.

      The specific aims of the project are as follows:

        1. To measure implant audiologic performance as defined by speech performance in standard
           cochlear implant speech test batteries.

        2. To determine scalar location after insertion through either intraoperative or
           postoperative imaging and correlate this with audiologic outcomes.

        3. To assess the rates of preservation of residual acoustic hearing and correlate those
           with scalar location as determined in specific aim 2 and audiologic performance as
           determined in specific aim 1.

        4. To correlate speech outcomes with quality of life measures, as defined by validated
           questionnaires including the Tinnitus Handicap Index (THI), Speech and Spatial Qualities
           (SSQ) Questionnaire, and Nijmegen Questionnaire.

        5. To evaluate intraoperative ease of insertion from the surgeon's perspective and
           correlate this with postoperative electrode location and audiologic performance.
    

Detailed Description

      Cochlear implants (CI) are biomechanical sense prostheses approved by the FDA for the
      treatment of sensorineural hearing loss. CI's function by bypassing the absent or
      dysfunctional cochlear end organs to directly electrically stimulate the spiral ganglion and
      cochlear nerve. A variety of commercially available FDA-approved implants exist for the
      treatment of severe to profound deafness. Implants are typically designed in two broad
      categories: lateral wall electrodes and perimodiolar. Perimodiolar electrodes are precurved
      electrodes that are designed to hug the center of the cochlea (modiolus) after insertion.
      Lateral wall electrodes are slim and straight, hugging the lateral wall on insertion.

      Recent studies have shown that electrode design and location within the cochlea impact
      patient performance. Specifically, electrodes located completely within the scala tympani are
      associated with better outcomes than those that cross over from the scala tympani to the
      scala vestibuli during insertion. The same study has shown that lateral wall electrodes are
      less likely than perimodiolar electrodes to have scalar excursion to the scala vestibuli.
      Location matters with these implants because electrode position completely within the scala
      tympani is associated with higher rates of preservation of residual hearing. Minimizing
      cochlear trauma allows for preservation of residual acoustic hearing particularly in low
      frequencies. While this low frequency hearing is of little benefit independently, when
      combined with the electrical stimulation from the cochlear implant patients have improved
      performance.

      The HiFocus L23 electrode is manufactured by Advanced Bionics (Valencia, California), and is
      FDA approved for the treatment of sensorineural hearing loss in adult and pediatric patients.
      It is designed as a slim and straight lateral wall electrode that can be inserted with low
      force to minimize intracochlear trauma. While pre-market studies were performed by Advanced
      Bionics as a part of its approval for use by the FDA, no post-market studies have been
      performed to assess the audiologic outcomes, electrode location after insertion, and hearing
      preservation rates when using this electrode. These aims will be accomplished through several
      means. Audiologic speech performance will be assessed through a standardized
      clinical/audiometric protocol currently followed by the Vanderbilt University Medical Center
      cochlear implant team. Electrode location for all participants will be determined using novel
      software created by Vanderbilt engineering faculty and graduate students that uses
      computerized tomography (CT) images obtained as a part of practice postoperatively or
      intraoperatively using an FDA approved Xoran xCAT® device, a portable flat panel volume
      computerized tomography (fpVCT) machine (Vanderbilt) or regular CT scan at participating
      institutions as applicable. These images can be registered to existing pre-operative
      conventional CT scans and used to produce 3-dimensional models of electrode placement within
      each patient's cochlea. This software is investigational and used in other research studies
      for the same purpose.

      The extent to which the electrode remains in the desired location (scala tympani) will then
      be correlated with audiologic outcomes as obtained above. Residual hearing rates and quality
      of life measures will be obtained as a part of audiologic testing.

      If a fine resolution, high quality conventional head CT has been previously obtained, or is
      obtained as part of routine care this scan may be used in place of the fpVCT or in addition
      to the fpVCT scan. The option of having a conventional head CT performed in radiology for
      research purposes in place of the fpVCT head CT scan will also be available.

      Surgeons will complete surveys after each case concludes to evaluate the ease of insertion
      and will record the insertion via standard recording techniques in the operating room that
      are available for any microscopic case. These videos for all surgeries will be blinded and
      reviewed at Vanderbilt for ease and speed of insertion.
    


Study Type

Observational


Primary Outcome

Treatment Effectiveness-Consonant Nucleus Consonant (CNC) word test

Secondary Outcome

 Treatment Effectiveness

Condition

Sensorineural Hearing Loss


Study Arms / Comparison Groups

 Sensorineural hearing loss patients post cochlear implant
Description:  Patients who have documented sensorineural hearing loss and have received cochlear implantation (per standard of care).

Publications

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

Recruitment Information



Estimated Enrollment

100

Start Date

February 21, 2019

Completion Date

December 2022

Primary Completion Date

December 2021

Eligibility Criteria

        Inclusion Criteria:

          -  Male or female 18 years of age and above.

          -  Sensorineural hearing loss meeting criteria for cochlear implants, assessed no greater
             than three months prior to cochlear implant surgery

          -  Patient schedule to undergo CI surgery using Advanced Bionics SlimJ/L23 device.

          -  Ability to undergo adequate audiology follow-up or planned follow up for those
             participants undergoing scanning in the OR.

          -  Competent in decision making process and able to read and sign a written informed
             consent form.

          -  English language proficiency.

          -  If the patient has already had a fine resolution CT or a fpVCT of the head (more than
             likely as a participant of another research study) the scan will not be repeated, the
             images from the previous scan will be used for the purposes of this study.

          -  If the patient has undergone a conventional CT scan of the head after cochlear
             implantation as part of their routine care, this scan may be used in place of the
             research scan or in addition to the research scan.

        Exclusion Criteria:

          -  Patients who weigh over 300 lbs (when Xoran xCAT headboard is being used). Otherwise,
             weight is not exclusionary.

          -  Females who are pregnant. All females of child-bearing age in the study will undergo a
             pregnancy test.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Alejandro Rivas, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT03858647

Organization ID

181904


Responsible Party

Principal Investigator

Study Sponsor

Vanderbilt University Medical Center


Study Sponsor

Alejandro Rivas, MD, Principal Investigator, Vanderbilt University Medical Center


Verification Date

August 2020