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Clinical Evaluation of the Cochlear Nucleus CI532 Cochlear Implant in Adults (SME)

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ClinicalTrials.gov Identifier: NCT03007472
Recruitment Status : Active, not recruiting
First Posted : January 2, 2017
Last Update Posted : April 13, 2018
Sponsor:
Information provided by (Responsible Party):
Cochlear

Brief Summary:
The purpose of this study is to gather long-term data on the FDA approved CI532 cochlear implant, and CP1000 (Nucleus 7) sound processor

Condition or disease Intervention/treatment Phase
Hearing Loss, Sensorineural Device: CI532 Device: Nucleus 7 Not Applicable

Detailed Description:
Appropriate candidates will receive a CI532 cochlear implant and be fit with the CP1000 sound processor. Imaging will be completed pre-op, intra-op, and post-op to assess implant location. Speech perception testing as well as subjective questionnaires will be administered over 12 months.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Evaluation of the Cochlear Nucleus(R) CI532 Cochlear Implant in Adults
Study Start Date : December 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: CI532/N7 study group
All subjects will receive a CI532 cochlear implant (intervention) and be fit with the CP1000 sound processor
Device: CI532
Cochlear implant
Other Names:
  • Slim Modiolar Electrode
  • 532
Device: Nucleus 7
Sound processor
Other Names:
  • N7
  • CP1000



Primary Outcome Measures :
  1. To Evaluate change from pre- to 6months post-implantation speech recognition in quiet in the implanted ear alone [ Time Frame: Pre-operatively and 6 months post sound processor activation ]
    Improved group mean CNC word recognition in quiet measured pre-operatively and again at 6 month post sound processor activation compared to the group mean score in the preoperative, best unilateral condition



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Adults 18 years or older who have a bilateral postlinguistic sensorineural hearing loss.
  2. Limited benefit from amplification as defined by test scores of 40% correct or less in the ear to be implanted and 50% or less in the contralateral ear on a recorded monosyllabic word test I. Consistent with the Minimum Speech Test Battery (2011), it is required that all subjects be evaluated at 60 dBA presentation level.
  3. Bilateral moderate sloping to profound hearing loss
  4. Minimum of 30 days experience with appropriately fit bilateral amplification, fit using the standardized NAL fitting method
  5. Proficient in English
  6. Ability to complete testing -

Exclusion Criteria:

  1. Previous cochlear implantation
  2. Pre-linguistically deafened (onset of hearing loss at less than two years of age)
  3. Ossification or any other cochlear anomaly that might prevent complete insertion of the electrode array
  4. Duration of severe to profound hearing loss greater than 20 years
  5. Diagnosis of retro-cochlear pathology
  6. Diagnosis of auditory neuropathy
  7. 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
  8. Unwillingness or inability to comply with all investigational requirements
  9. Additional cognitive, medical or social handicaps that would prevent completion of 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): NCT03007472


Locations
United States, California
University of California, San Francisco
San Francisco, California, United States, 94115
United States, Colorado
Rocky Mountain Ear Center
Englewood, Colorado, United States, 80113
United States, Iowa
University of Iowa
Iowa City, Iowa, United States, 52242
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48108
United States, Missouri
The Center for Hearing and Balance Disorders
Chesterfield, Missouri, United States, 63017
Midwest Ear Institute
Kansas City, Missouri, United States, 64111
Washington University
Saint Louis, Missouri, United States, 63110
United States, New York
New York University
New York, New York, United States, 10016
United States, Ohio
The Ohio State University
Columbus, Ohio, United States, 13212
United States, Oklahoma
Hearts for Hearing
Oklahoma City, Oklahoma, United States, 73120
United States, Texas
Dallas Ear Institute
Dallas, Texas, United States, 75230
Ear Medical Group
San Antonio, Texas, United States, 78240
United States, Washington
Spokane ENT
Spokane, Washington, United States, 99201
Sponsors and Collaborators
Cochlear
Investigators
Study Director: Jillian Crosson, PhD Senior Manager of Clinical Services
Study Director: Megan Mears, AuD Clinical Project Manager

Publications:
Responsible Party: Cochlear
ClinicalTrials.gov Identifier: NCT03007472     History of Changes
Other Study ID Numbers: CLTD5685
First Posted: January 2, 2017    Key Record Dates
Last Update Posted: April 13, 2018
Last Verified: April 2018

Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No

Keywords provided by Cochlear:
cochlear implant, sound processor

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