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

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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

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Hearing Loss
Intervention Device: Nucleus CI422 Cochlear Implant with N6 Sound Processor
Enrollment 55
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Nucleus CI422 Cochlear Implant With N6 Sound Processor
Hide Arm/Group Description Newly implanted patient population seeking cochlear implantation as standard of care
Period Title: Overall Study
Started 55
Completed 54
Not Completed 1
Reason Not Completed
Withdrawal by Subject             1
Arm/Group Title Nucleus CI422 Cochlear Implant With N6 Sound Processor
Hide Arm/Group Description Newly implanted adults with moderate to severe sensorineural hearing loss, seeking cochlear implantation as a standard of care
Overall Number of Baseline Participants 55
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 55 participants
<=18 years
0
   0.0%
Between 18 and 65 years
14
  25.5%
>=65 years
41
  74.5%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 55 participants
70.3  (10.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 55 participants
Female
16
  29.1%
Male
39
  70.9%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 55 participants
55
1.Primary Outcome
Title Change in Open Set Monosyllabic Word Recognition Score as Measured on a Consonant Nucleus Consonant (CNC) Word Test
Hide Description 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)
Time Frame Preoperative baseline to 6 months postactivation
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Nucleus CI422 Cochlear Implant With N6 Sound Processor
Hide Arm/Group Description:
Newly implanted adults with moderate to severe sensorineural hearing loss, seeking cochlear implantation as a standard of care
Overall Number of Participants Analyzed 54
Mean (Standard Deviation)
Unit of Measure: percentage correct
54.7  (21.3)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Nucleus CI422 Cochlear Implant With N6 Sound Processor
Hide Arm/Group Description Newly implanted adults with moderate to severe sensorineural hearing loss, seeking cochlear implantation as a standard of care
All-Cause Mortality
Nucleus CI422 Cochlear Implant With N6 Sound Processor
Affected / at Risk (%)
Total   0/55 (0.00%)    
Hide Serious Adverse Events
Nucleus CI422 Cochlear Implant With N6 Sound Processor
Affected / at Risk (%) # Events
Total   5/55 (9.09%)    
Cardiac disorders   
Irregular heartbeat  [1]  1/55 (1.82%)  1
Atrial fibrillation [2]  1/55 (1.82%)  1
Ear and labyrinth disorders   
Vertigo or dizziness [3]  1/55 (1.82%)  1
Revision surgery  1/55 (1.82%)  1
Musculoskeletal and connective tissue disorders   
Broken hip  1/55 (1.82%)  1
Indicates events were collected by systematic assessment
[1]
Admitted overnight for irregular heartbeat
[2]
Admitted to hospital for atrial fibrillation. Discharged without further episodes.
[3]
Vertigo started 1 day post-op after discharged from surgery. Admitted for observation and provided steroids.
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Nucleus CI422 Cochlear Implant With N6 Sound Processor
Affected / at Risk (%) # Events
Total   34/55 (61.82%)    
Ear and labyrinth disorders   
New or worsened tinnitus   3/55 (5.45%)  3
Vertigo or dizziness  7/55 (12.73%)  7
Skin flap  1/55 (1.82%)  1
Device related/programming problems  5/55 (9.09%)  5
Hearing loss  9/55 (16.36%)  9
Earmold or acoustic component sores  14/55 (25.45%)  14
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Clinical Project Manager
Organization: Cochlear Americas
Phone: 303-264-2340
EMail: knix@cochlear.com
Layout table for additonal information
Responsible Party: Cochlear
ClinicalTrials.gov Identifier: NCT01867008    
Other Study ID Numbers: CAM-CI422-2012
First Submitted: May 29, 2013
First Posted: June 3, 2013
Results First Submitted: November 5, 2020
Results First Posted: January 25, 2021
Last Update Posted: January 25, 2021