Clinical Evaluation of a Cochlear Implant System

Related Clinical Trial
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

Clinical Evaluation of a Cochlear Implant System

Official Title

Clinical Evaluation of a Cochlear Implant System

Brief Summary

      The primary objective of this study is to assess the usability of a Cochlear implant system.
    

Detailed Description

      Measure participant ratings on satisfaction of a Cochlear implant system via use of validated
      and non-validated questionnaires.
    


Study Type

Interventional


Primary Outcome

Cochlear implant subjects' ratings on hearing performance, connectivity, streaming, phone use, comfort, retention, ease of use and controls obtained with their own Sound Processor and the CP1000 Sound Processor.

Secondary Outcome

 Speech perception performance of the CP1000 Sound Processor in quiet and in noise.

Condition

Sensorineural Hearing Loss

Intervention

Nucleus 7 Cochlear Implant System

Study Arms / Comparison Groups

 Cochlear implant users
Description:  This is a within-subject, repeated measures study. There was one arm in this study, each subject served as their own control. All subjects received all interventions.

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

46

Start Date

July 1, 2016

Completion Date

September 7, 2017

Primary Completion Date

September 7, 2017

Eligibility Criteria

        Inclusion Criteria:

          1. Eighteen years of age or older

          2. At least 6 months experience with a Nucleus 24 series or later implant in at least one
             implanted ear

          3. At least 3 months experience with the CP810,CP920 or CP910 sound processor

          4. Fluent speaker in the language used to assess speech perception performance

          5. Willingness to participate in and to comply with all requirements of the protocol

          6. Able to score 30% or more at +15 SNR with CI alone on a sentence in babble test

        Exclusion Criteria:

          1. Unrealistic expectations on the part of the subject, regarding the possible benefits,
             risks and limitations that are inherent to the procedure and prosthetic device

          2. Additional disabilities that would prevent participation in evaluations

          3. Nucleus 22 Implant
      

Gender

All

Ages

18 Years - 100 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Mary Beth Brinson, , 

Location Countries

Australia

Location Countries

Australia

Administrative Informations


NCT ID

NCT03467399

Organization ID

CLTD5620


Responsible Party

Sponsor

Study Sponsor

Cochlear


Study Sponsor

Mary Beth Brinson, Principal Investigator, Cochlear Ltd


Verification Date

March 2018