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CI532 - Early Experience Study

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ClinicalTrials.gov Identifier: NCT02755935
Recruitment Status : Completed
First Posted : April 29, 2016
Results First Posted : February 21, 2018
Last Update Posted : March 20, 2018
Sponsor:
Information provided by (Responsible Party):
Cochlear

Brief Summary:
To evaluate performance outcomes in patients implanted with the Cochlear Nucleus CI532 electrode array.

Condition or disease Intervention/treatment Phase
Sensorineural Hearing Loss, Bilateral Device: Cochlear Nucleus CI532 Not Applicable

Detailed Description:
To compare speech perception and audiometric outcomes in patients implanted with the Cochlear Nucleus CI532 electrode array at 3 months postactivation with their best preoperative hearing status.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Implantation With the Cochlear Nucleus® CI532 Implant - Early Experience Study
Actual Study Start Date : May 2016
Actual Primary Completion Date : June 2017
Actual Study Completion Date : September 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Implanted
Subjects who meet the specified inclusion criteria and are implanted with the CI532 cochlear implant
Device: Cochlear Nucleus CI532
cochlear implantation




Primary Outcome Measures :
  1. Speech Understanding (% Correct) on AzBio Sentences in Quiet in the Implanted Ear [ Time Frame: 3 months postactivation of the sound processor ]
    Unilateral listening performance at 3 months post activation with the CI532 compared to the best aided unilateral preoperative condition for sentence perception in quiet.

  2. Speech Understanding (% Correct) on AzBio Sentences in Noise in the Implanted Ear [ Time Frame: 3 months post-activation ]
    unilateral listening performance at 3 months post activation with the CI532 compared to the best aided unilateral preoperative condition for sentence perception in noise



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Ages Eligible for Study:   12 Months and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Medical and audiological candidate for a CI532 cochlear implant per commercially approved, age appropriate, FDA indications
  • Post-linguistically deafened
  • Ability to complete age appropriate testing

Exclusion Criteria:

  • Previous cochlear implantation in the ear to be implanted
  • Pre-linguistically deafened (onset of hearing loss at less than two years of age)
  • Ossification or any other cochlear anomaly that might prevent complete insertion of the electrode array
  • Diagnosis of retro-cochlear pathology
  • Diagnosis of auditory neuropathy
  • Unrealistic expectations on the part of the subject regarding the possible benefits, risks, and limitations that are inherent to the surgical procedure and use of the prosthetic device
  • Unwillingness or inability to comply with all investigational requirements
  • Additional cognitive handicaps that would prevent participation on all study requirements

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02755935


Locations
United States, Illinois
NorthShore University
Skokie, Illinois, United States, 60201
United States, Iowa
University of Iowa
Iowa City, Iowa, United States, 52242
United States, Michigan
The University of Michigan
Ann Arbor, Michigan, United States, 48108
United States, Missouri
Center for Hearing and Balance
Chesterfield, Missouri, United States, 63017
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37203
United States, Texas
Dallas Ear Institute
Dallas, Texas, United States, 75230
Sponsors and Collaborators
Cochlear
  Study Documents (Full-Text)

Documents provided by Cochlear:
Study Protocol  [PDF] March 31, 2016
Statistical Analysis Plan  [PDF] January 23, 2018


Responsible Party: Cochlear
ClinicalTrials.gov Identifier: NCT02755935     History of Changes
Other Study ID Numbers: CAM5660
First Posted: April 29, 2016    Key Record Dates
Results First Posted: February 21, 2018
Last Update Posted: March 20, 2018
Last Verified: January 2018

Additional relevant MeSH terms:
Hearing Loss
Hearing Loss, Sensorineural
Hearing Loss, Bilateral
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms