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

December 4, 2020 updated by: Cochlear

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

96

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Englewood, Colorado, United States, 80113
        • Rocky Mountain Ear Center
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa
    • Michigan
      • Ann Arbor, Michigan, United States, 48108
        • University of Michigan
    • Missouri
      • Chesterfield, Missouri, United States, 63017
        • The Center for Hearing and Balance Disorders
      • Kansas City, Missouri, United States, 64111
        • Midwest Ear Institute
      • Saint Louis, Missouri, United States, 63110
        • Washington University
    • New York
      • New York, New York, United States, 10016
        • New York University
    • Ohio
      • Columbus, Ohio, United States, 13212
        • The Ohio State University
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73120
        • Hearts for Hearing
    • Texas
      • Dallas, Texas, United States, 75230
        • Dallas Ear Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 National Acoustics Laboratory (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-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Pre- to 6 Months Post-implantation Speech Recognition in Quiet in the Implanted Ear Alone
Time Frame: Preoperatively and 6 months post sound processor activation
Group mean Consonant Nucleus Consonant (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. The CNC word test has a score range of 0-100% with higher values indicating better scores.
Preoperatively and 6 months post sound processor activation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of Change in Pre and Post Implantation Speech Recognition in Noise Scores in the Implanted Ear Alone
Time Frame: Preoperatively and 6 months post sound processor activation
Group mean AzBio sentence in noise score in the best unilateral condition compared to the group mean score in the preoperative, unilateral aided condition. The AzBio sentence test has a score range of 0-100% with higher values indicating better scores.
Preoperatively and 6 months post sound processor activation
Change in Pre and Post Implantation Score on the Health Utility Index-3 (HUI3)
Time Frame: Preoperatively and 6 months post sound processor activaton
Group mean HUI3 score post sound processor activation compared to the scores measured preoperatively. The HUI3 consists of eight attributes of general health (vision, hearing, speech, mobility, dexterity, emotion, cognition, and pain) with five or six levels per attribute. For each respondent, health status is described as a vector that combines the levels of each attribute. This information is then converted into a utility score of HRQL on a scale from perfect health (1.0) to death (0).
Preoperatively and 6 months post sound processor activaton

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequency Specific Thresholds and Speech Recognition in Noise or Quiet
Time Frame: 12 months post-activation
Frequency-specific thresholds at standard audiometric frequencies for each ear, and speech recognition in quiet (CNC words) or noise (AzBio sentences) in best unilateral and/or electric alone.
12 months post-activation
Speech Perception in Quiet and Noise With Change in Cochlear Implant Programming
Time Frame: Following 12-month study visit but prior to 36-month interval.
Two optional study visits to evaluate whether a change in cochlear implant programming, specifically an increase in the number of channels will improve subject speech perception in quiet and noise.
Following 12-month study visit but prior to 36-month interval.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cochlear

Investigators

  • Study Director: Jillian Crosson, PhD, Senior Manager of Clinical Services
  • Study Director: Megan Mears, AuD, Clinical Project Manager

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 15, 2017

Primary Completion (Actual)

December 3, 2018

Study Completion (Actual)

March 6, 2020

Study Registration Dates

First Submitted

December 27, 2016

First Submitted That Met QC Criteria

December 30, 2016

First Posted (Estimate)

January 2, 2017

Study Record Updates

Last Update Posted (Actual)

December 30, 2020

Last Update Submitted That Met QC Criteria

December 4, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLTD5685

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hearing Loss, Sensorineural

Clinical Trials on CI532

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kenya

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe