Cochlear Implant With Dexamethasone Eluting Electrode Array

checkorphan
Learn more about:
Sensorineural hearing loss
Related Clinical Trial
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

Cochlear Implant With Dexamethasone Eluting Electrode Array

Official Title

Cochlear Implant With Dexamethasone Eluting Electrode Array (The CI-DEX Study): Pivotal Study

Brief Summary

      An evaluation of Cochlear's cochlear implant electrode array which passively elutes
      dexamethasone for a defined period of time to help reduce inflammatory responses.

Detailed Description

      The primary objectives of the pivotal evaluation is to show the efficacy of the dexamethasone
      eluting electrode through reduction in electrode impedances as compared to a standard
      electrode and the improvement of speech recognition from preoperative baseline. The secondary
      objectives are to assess the benefit-risk balance of a dexamethasone eluting electrode as
      similar to a standard electrode by comparison of adverse events and speech outcomes.

Study Type

Interventional

Primary Outcome

Comparison of Monopolar (MP1+2) impedance measurement (kOhms) between randomisation groups measured through Custom Sound software during clinical visits.

Secondary Outcome

 Comparison of rate and type of device related adverse events between randomisation groups.

Condition

Sensorineural Hearing Loss

Intervention

CI632D

Study Arms / Comparison Groups

 CI632D Investigational Medical Device (IMD)
Description:

Publications

* 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

Device

Estimated Enrollment

120

Start Date

October 4, 2021

Completion Date

July 2024

Primary Completion Date

July 2023

Eligibility Criteria

        Inclusion Criteria:

          -  Post-lingual, bilateral, moderate (≥ 40 dB HL) to profound sensorineural hearing loss
             at 250, 500and 1000 Hz and profound high-frequency hearing loss, defined by a
             pure-tone average (PTA) threshold, 2000 through 8000 Hz, ≥ 90 dB HL.

          -  18 years or older at time of consent.

        Exclusion Criteria:

          -  Abnormal cochlear and middle ear anatomy

          -  History with cochlear implant surgery

          -  Allergy to dexamethasone

          -  Women who are pregnant or plan to become pregnant

          -  Unable/unwilling to comply to study requirements

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Melanie Moylan, +61459377289, [email protected]

Location Countries

Australia

Location Countries

Australia

Administrative Informations

NCT ID

NCT04750642

Organization ID

CLTD5759

Responsible Party

Sponsor

Study Sponsor

Cochlear

Collaborators

 NAMSA

Study Sponsor

Melanie Moylan, Study Director, Cochlear

Verification Date

March 2022