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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

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.

Condition or disease Intervention/treatment Phase
Hearing Loss Device: Nucleus CI422 Cochlear Implant with N6 Sound Processor Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 55 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of the Cochlear Nucleus CI422 Cochlear Implant in Adults
Study Start Date : August 2013
Actual Primary Completion Date : November 2016
Actual Study Completion Date : November 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Nucleus CI422 Cochlear Implant with Nucleus 6 (N6) Sound Processor Device: Nucleus CI422 Cochlear Implant with N6 Sound Processor



Primary Outcome Measures :
  1. 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT01867008


Locations
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United States, Maryland
Greater Baltimore Medical Center
Baltimore, Maryland, United States, 21204
United States, North Carolina
University of North Carolina
Chapel Hill, North Carolina, United States, 27517
Sponsors and Collaborators
Cochlear
  Study Documents (Full-Text)

Documents provided by Cochlear:
Statistical Analysis Plan  [PDF] April 3, 2014

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Responsible Party: Cochlear
ClinicalTrials.gov Identifier: NCT01867008    
Other Study ID Numbers: CAM-CI422-2012
First Posted: June 3, 2013    Key Record Dates
Results First Posted: January 25, 2021
Last Update Posted: January 25, 2021
Last Verified: January 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Hearing Loss
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases