Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Observation of Benefits for Patients Implanted With a Hearing Implant of the Company Cochlear (IROS)

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: NCT02004353
Recruitment Status : Terminated (Original study purpose accomplished)
First Posted : December 9, 2013
Results First Posted : November 8, 2021
Last Update Posted : November 8, 2021
Sponsor:
Information provided by (Responsible Party):
Cochlear

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Hearing Loss
Intervention Device: Cochlear® Hearing Implants
Enrollment 1518
Recruitment Details 1518 participants were recruited in 77 centers from July 2011 to 31 July 2020
Pre-assignment Details  
Arm/Group Title Cochlear® Hearing Implants
Hide Arm/Group Description Nucleus Cochlear implants, Cochlear Baha implants, Cochlear Acoustic Implants
Period Title: Overall Study
Started 1518
Completed 184
Not Completed 1334
Reason Not Completed
Voluntary participation             1334
Arm/Group Title Cochlear® Hearing Implants
Hide Arm/Group Description Nucleus Cochlear implants, Cochlear Baha implants, Cochlear Acoustic Implants
Overall Number of Baseline Participants 1506
Hide Baseline Analysis Population Description
Participants with baseline data recorded in the database.
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
<18 Number Analyzed 1506 participants
48
   3.2%
18-34 Number Analyzed 1506 participants
351
  23.3%
35-44 Number Analyzed 1506 participants
194
  12.9%
45-54 Number Analyzed 1506 participants
268
  17.8%
55-64 Number Analyzed 1506 participants
293
  19.5%
>64 Number Analyzed 1506 participants
348
  23.1%
Unknown Number Analyzed 1506 participants
4
   0.3%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1506 participants
Female
789
  52.4%
Male
717
  47.6%
Race (NIH/OMB)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants
American Indian or Alaska Native
Asian
Native Hawaiian or Other Pacific Islander
Black or African American
White
More than one race
Unknown or Not Reported
[1]
Measure Analysis Population Description: Data not collected.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Colombia Number Analyzed 1506 participants
396
Argentina Number Analyzed 1506 participants
62
Hungary Number Analyzed 1506 participants
47
Portugal Number Analyzed 1506 participants
20
Spain Number Analyzed 1506 participants
197
Austria Number Analyzed 1506 participants
2
Netherlands Number Analyzed 1506 participants
2
Sweden Number Analyzed 1506 participants
3
Turkey Number Analyzed 1506 participants
31
Belgium Number Analyzed 1506 participants
7
Poland Number Analyzed 1506 participants
193
Brazil Number Analyzed 1506 participants
2
South Africa Number Analyzed 1506 participants
200
Slovenia Number Analyzed 1506 participants
16
France Number Analyzed 1506 participants
36
Germany Number Analyzed 1506 participants
292
1.Primary Outcome
Title Change in Hearing Ability Assessed Via Speech Spatial Hearing Qualities Questionnaire
Hide Description A scale from 0 to 10 is used, where 0 represents "can not hear at all" and 10 "hear perfectly". The change from baseline to post-implant at 1 year is presented. A positive value indicates improved hearing, a negative value indicates impaired hearing.
Time Frame Baseline (i.e. pre-implanted status, prior to 1st switch-on) and post-implant at 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
For all devices with 50 or more participants with baseline data, analysis of the SSQ data was performed.
Arm/Group Title Cochlear® Hearing Implants
Hide Arm/Group Description:
Nucleus Cochlear implants, Cochlear Baha implants, Cochlear Acoustic Implants
Overall Number of Participants Analyzed 327
Mean (Standard Error)
Unit of Measure: Score on a scale
CI512 cochlear implant Number Analyzed 133 participants
2.73  (0.148)
CI522 cochlear implant Number Analyzed 58 participants
2.1  (0.24)
CI532 cochlear implant Number Analyzed 60 participants
2.1  (0.27)
Baha bone conduction hearing implant Number Analyzed 76 participants
2.2  (0.21)
2.Primary Outcome
Title Change in Hearing Ability Assessed Via Speech Spatial Hearing Qualities Questionnaire
Hide Description A scale from 0 to 10 is used, where 0 represents "can not hear at all" and 10 "hear perfectly". The change from baseline to post-implant at 2 years is presented. A positive value indicates improved hearing, a negative value indicates impaired hearing.
Time Frame Baseline (i.e. pre-implanted status, prior to 1st switch-on) and post-implant at 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
For all devices with 50 or more participants with baseline data, analysis of the SSQ data was performed.
Arm/Group Title Cochlear® Hearing Implants
Hide Arm/Group Description:
Nucleus Cochlear implants, Cochlear Baha implants, Cochlear Acoustic Implants
Overall Number of Participants Analyzed 160
Mean (Standard Error)
Unit of Measure: Score on a scale
CI512 cochlear implant Number Analyzed 79 participants
2.95  (0.179)
CI522 cochlear implant Number Analyzed 32 participants
2.4  (0.31)
CI532 cochlear implant Number Analyzed 40 participants
2.5  (0.33)
Baha bone conduction hearing implant Number Analyzed 9 participants
1.9  (0.65)
3.Primary Outcome
Title Change in Hearing Ability Assessed Via Speech Spatial Hearing Qualities Questionnaire
Hide Description A scale from 0 to 10 is used, where 0 represents "can not hear at all" and 10 "hear perfectly". The change from baseline to post-implant at 3 years is presented. A positive value indicates improved hearing, a negative value indicates impaired hearing.
Time Frame Baseline (i.e. pre-implanted status, prior to 1st switch-on) and post-implant at 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
For all devices with 50 or more participants with baseline data, analysis of the SSQ data was performed.There were too few Baha participants at years 3 to conduct a statistical analysis.
Arm/Group Title Cochlear® Hearing Implants
Hide Arm/Group Description:
Nucleus Cochlear implants, Cochlear Baha implants, Cochlear Acoustic Implants
Overall Number of Participants Analyzed 69
Mean (Standard Error)
Unit of Measure: Score on a scale
CI512 cochlear implant Number Analyzed 46 participants
2.74  (0.217)
CI522 cochlear implant Number Analyzed 17 participants
2.4  (0.39)
CI532 cochlear implant Number Analyzed 6 participants
2.6  (0.67)
4.Primary Outcome
Title Change in General Quality of Life Assessed Via Health Utility Index Mark III Questionnaire
Hide Description A health utility value of 1.00 indicates perfect health while a score of 0.00 indicates death. The change from baseline to post-implant at 1 year is presented. A positive value indicates an improved quality of life, a negative value indicates impaired quality of life.
Time Frame Baseline (i.e. pre-implanted status, prior to 1st switch-on) and post-implant at 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
For all devices with 50 or more participants with baseline data, analysis of the HUI3 data was performed.
Arm/Group Title Cochlear® Hearing Implants
Hide Arm/Group Description:
Nucleus Cochlear implants, Cochlear Baha implants, Cochlear Acoustic Implants
Overall Number of Participants Analyzed 327
Mean (Standard Error)
Unit of Measure: Score on a scale
CI512 cochlear implant Number Analyzed 133 participants
0.166  (0.0212)
CI522 cochlear implant Number Analyzed 58 participants
0.22  (0.032)
CI532 cochlear implant Number Analyzed 60 participants
0.15  (0.034)
Baha bone conduction hearing implant Number Analyzed 76 participants
0.12  (0.03)
5.Primary Outcome
Title Change in General Quality of Life Assessed Via Health Utility Index Mark III Questionnaire
Hide Description A health utility value of 1.00 indicates perfect health while a score of 0.00 indicates death. The change from baseline to post-implant at 2 years is presented. A positive value indicates an improved quality of life, a negative value indicates impaired quality of life.
Time Frame Baseline (i.e. pre-implanted status, prior to 1st switch-on) and post-implant at 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
For all devices with 50 or more participants with baseline data, analysis of the HUI3 data was performed.There were too few Baha participants at 2 years to conduct a statistical analysis.
Arm/Group Title Cochlear® Hearing Implants
Hide Arm/Group Description:
Nucleus Cochlear implants, Cochlear Baha implants, Cochlear Acoustic Implants
Overall Number of Participants Analyzed 151
Mean (Standard Error)
Unit of Measure: Score on a scale
CI512 cochlear implant Number Analyzed 79 participants
0.175  (0.0255)
CI522 cochlear implant Number Analyzed 32 participants
0.28  (0.04)
CI532 cochlear implant Number Analyzed 40 participants
0.15  (0.042)
6.Primary Outcome
Title Change in General Quality of Life Assessed Via Health Utility Index Mark III Questionnaire
Hide Description A health utility value of 1.00 indicates perfect health while a score of 0.00 indicates death. The change from baseline to post-implant at 3 years is presented. A positive value indicates an improved quality of life, a negative value indicates impaired quality of life.
Time Frame Baseline (i.e. pre-implanted status, prior to 1st switch-on) and post-implant at 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
For all devices with 50 or more participants with baseline data, analysis of the HUI3 data was performed.There were too few Baha participants at 3 years to conduct a statistical analysis.
Arm/Group Title Cochlear® Hearing Implants
Hide Arm/Group Description:
Nucleus Cochlear implants, Cochlear Baha implants, Cochlear Acoustic Implants
Overall Number of Participants Analyzed 71
Mean (Standard Error)
Unit of Measure: Score on a scale
CI512 cochlear implant Number Analyzed 48 participants
0.123  (0.0311)
CI522 cochlear implant Number Analyzed 17 participants
0.22  (0.051)
CI532 cochlear implant Number Analyzed 6 participants
0.27  (0.087)
7.Secondary Outcome
Title Unaided Hearing Thresholds
Hide Description Unaided hearing thresholds for bone and air conduction for the implanted and non-implanted ear to monitor clinically significant changes over time for frequencies between 500 Hz and 4000 Hz
Time Frame Baseline (i.e. pre-implant status) assessed prior to 1st switch-on
Hide Outcome Measure Data
Hide Analysis Population Description
Results are for Baha participants. For the contra-lateral ear, data not received for all participants.
Arm/Group Title Cochlear® Hearing Implants
Hide Arm/Group Description:
Nucleus Cochlear implants, Cochlear Baha implants, Cochlear Acoustic Implants
Overall Number of Participants Analyzed 173
Mean (Standard Deviation)
Unit of Measure: Decibel
Air conduction-implanted ear Number Analyzed 173 participants
71.7  (21.6)
Bone conduction-implanted ear Number Analyzed 173 participants
34.1  (24.4)
Air conduction-contralateral year Number Analyzed 168 participants
36.7  (26.5)
Bone conduction-contralateral ear Number Analyzed 168 participants
18.1  (15.7)
8.Secondary Outcome
Title Unaided Hearing Thresholds
Hide Description Unaided hearing thresholds for bone and air conduction for the implanted and non-implanted ear to monitor clinically significant changes over time for frequencies between 500 and 4000 Hz
Time Frame post-implant at 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
Results are for Baha participants. For the contra-lateral ear, data not received for all participants.
Arm/Group Title Cochlear® Hearing Implants
Hide Arm/Group Description:
Nucleus Cochlear implants, Cochlear Baha implants, Cochlear Acoustic Implants
Overall Number of Participants Analyzed 173
Mean (Standard Deviation)
Unit of Measure: Decibel
Air conduction-Implanted ear Number Analyzed 173 participants
60.2  (24.2)
Bone conduction-implanted ear Number Analyzed 173 participants
29.4  (20.0)
Air conduction- Contralateral ear Number Analyzed 168 participants
37.5  (24.5)
Bone conduction-Contralateral ear Number Analyzed 168 participants
18.1  (13.8)
9.Secondary Outcome
Title Unaided Hearing Thresholds
Hide Description Unaided hearing thresholds for bone and air conduction for the implanted and non-implanted ear to monitor clinically significant changes over time for frequencies between 125Hz and 8000 Hz
Time Frame immediately post-implant
Hide Outcome Measure Data
Hide Analysis Population Description
Data not received due to voluntary participation of participants.
Arm/Group Title Cochlear® Hearing Implants
Hide Arm/Group Description:
Nucleus Cochlear implants, Cochlear Baha implants, Cochlear Acoustic Implants
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
10.Secondary Outcome
Title Unaided Hearing Thresholds
Hide Description Unaided hearing thresholds for bone and air conduction for the implanted and non-implanted ear to monitor clinically significant changes over time for frequencies between 125Hz and 8000 Hz
Time Frame post-implant at 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Data not received due to voluntary participation of participants.
Arm/Group Title Cochlear® Hearing Implants
Hide Arm/Group Description:
Nucleus Cochlear implants, Cochlear Baha implants, Cochlear Acoustic Implants
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description Deaths, serious adverse events and non-serious adverse events were not assessed.
 
Arm/Group Title Cochlear® Hearing Implants
Hide Arm/Group Description Nucleus Cochlear implants, Cochlear Baha implants, Cochlear Acoustic Implants
All-Cause Mortality
Cochlear® Hearing Implants
Affected / at Risk (%)
Total   0/0 
Hide Serious Adverse Events
Cochlear® Hearing Implants
Affected / at Risk (%)
Total   0/0 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Cochlear® Hearing Implants
Affected / at Risk (%)
Total   0/0 
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: Jasmin Kaur
Organization: Cochlear
Phone: +41612058238
EMail: jakaur@cochlear.com
Layout table for additonal information
Responsible Party: Cochlear
ClinicalTrials.gov Identifier: NCT02004353    
Other Study ID Numbers: CEL 5277
First Submitted: November 26, 2013
First Posted: December 9, 2013
Results First Submitted: September 2, 2021
Results First Posted: November 8, 2021
Last Update Posted: November 8, 2021