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Safety and Efficacy of the Cochlear Nucleus CI422 Cochlear Implant in Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01867008
Recruitment Status : Completed
First Posted : June 3, 2013
Results First Posted : January 25, 2021
Last Update Posted : January 25, 2021
Sponsor:
Information provided by (Responsible Party):
Cochlear

Tracking Information
First Submitted Date  ICMJE May 29, 2013
First Posted Date  ICMJE June 3, 2013
Results First Submitted Date  ICMJE November 5, 2020
Results First Posted Date  ICMJE January 25, 2021
Last Update Posted Date January 25, 2021
Study Start Date  ICMJE August 2013
Actual Primary Completion Date November 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 5, 2021)
Change in Open Set Monosyllabic Word Recognition Score as Measured on a Consonant Nucleus Consonant (CNC) Word Test [ Time Frame: Preoperative baseline to 6 months postactivation ]
Performance at 6 months postactivation compared to pre-operative word recognition score (percent correct: 0-100%, where a 0% is the lowest score and a 100% is the highest score)
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy of the Cochlear Nucleus CI422 Cochlear Implant in Adults
Official Title  ICMJE Safety and Efficacy of the Cochlear Nucleus CI422 Cochlear Implant in Adults
Brief Summary Clinical study to evaluate the safety and efficacy of the Cochlear™ Nucleus® CI422 cochlear implant for new cochlear implant adult recipients with broader requirements to be considered an eligible candidate.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hearing Loss
Intervention  ICMJE Device: Nucleus CI422 Cochlear Implant with N6 Sound Processor
Study Arms  ICMJE Experimental: Nucleus CI422 Cochlear Implant with Nucleus 6 (N6) Sound Processor
Intervention: Device: Nucleus CI422 Cochlear Implant with N6 Sound Processor
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 5, 2021)
55
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE November 2016
Actual Primary Completion Date November 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Eighteen years of age or older at the time of implantation
  2. Moderate low frequency thresholds up to and including 1000 Hz, severe to profound high frequency (above 3000 Hz) sensorineural hearing loss
  3. Minimum of 30 days experience with appropriately fit bilateral amplification, fit using the standardized National Acoustics Laboratory (NAL) fitting method described in the Fitting and Use of Hearing Aids section below
  4. Aided Consonant Nucleus Consonant (CNC) word recognition score (mean of two lists) between 10% and 50%, inclusive in the ear to be implanted
  5. Aided CNC word recognition score (mean of two lists) in the contralateral ear equal to, or better than, the ear to be implanted but not more than 70%
  6. Willingness to use bimodal stimulation (i.e., a cochlear implant on one ear and a hearing aid on the contralateral ear) through at least 6-months postactivation
  7. English spoken as a primary language

Exclusion Criteria:

  1. Duration of severe-to-profound hearing loss greater than 30 years
  2. Congenital hearing loss (for the purpose of this study, onset prior to 2 years-of-age)
  3. Medical or psychological conditions that contraindicate undergoing surgery as determined by the Investigator
  4. Ossification or any other cochlear anomaly that might prevent complete insertion of the electrode array
  5. Conductive overlay of 15 decibels (dB) or greater at two or more frequencies, in the range 500 to 1000 Hz
  6. Deafness due to lesions of the acoustic nerve or central auditory pathway
  7. Absence of cochlear development
  8. Diagnosis of auditory neuropathy
  9. Active middle-ear infection
  10. Tympanic membrane perforation in the presence of active middle ear disease
  11. Unrealistic expectations on the part of the subject, regarding the possible benefits, risks, and limitations that are inherent to the surgical procedure(s) and prosthetic devices as determined by the Investigator
  12. Unwillingness or inability of the candidate to comply with all investigational requirements as determined by the Investigator
  13. Additional handicaps that would prevent or restrict participation in the audiological evaluations as determined by the Investigator
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01867008
Other Study ID Numbers  ICMJE CAM-CI422-2012
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Cochlear
Study Sponsor  ICMJE Cochlear
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Cochlear
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP