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Trial Outcomes & Findings for Observation of Benefits for Patients Implanted With a Hearing Implant of the Company Cochlear (NCT NCT02004353)

NCT ID: NCT02004353

Last Updated: 2021-11-08

Results Overview

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.

Recruitment status

TERMINATED

Target enrollment

1518 participants

Primary outcome timeframe

Baseline (i.e. pre-implanted status, prior to 1st switch-on) and post-implant at 1 year

Results posted on

2021-11-08

Participant Flow

1518 participants were recruited in 77 centers from July 2011 to 31 July 2020

Participant milestones

Participant milestones
Measure
Cochlear® Hearing Implants
Nucleus Cochlear implants, Cochlear Baha implants, Cochlear Acoustic Implants
Overall Study
STARTED
1518
Overall Study
COMPLETED
184
Overall Study
NOT COMPLETED
1334

Reasons for withdrawal

Reasons for withdrawal
Measure
Cochlear® Hearing Implants
Nucleus Cochlear implants, Cochlear Baha implants, Cochlear Acoustic Implants
Overall Study
Voluntary participation
1334

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Cochlear® Hearing Implants
n=1506 Participants
Nucleus Cochlear implants, Cochlear Baha implants, Cochlear Acoustic Implants
Age, Customized
<18
48 Participants
n=1506 Participants
Age, Customized
18-34
351 Participants
n=1506 Participants
Age, Customized
35-44
194 Participants
n=1506 Participants
Age, Customized
45-54
268 Participants
n=1506 Participants
Age, Customized
55-64
293 Participants
n=1506 Participants
Age, Customized
>64
348 Participants
n=1506 Participants
Age, Customized
Unknown
4 Participants
n=1506 Participants
Sex: Female, Male
Female
789 Participants
n=1506 Participants
Sex: Female, Male
Male
717 Participants
n=1506 Participants
Region of Enrollment
Colombia
396 participants
n=1506 Participants
Region of Enrollment
Argentina
62 participants
n=1506 Participants
Region of Enrollment
Hungary
47 participants
n=1506 Participants
Region of Enrollment
Portugal
20 participants
n=1506 Participants
Region of Enrollment
Spain
197 participants
n=1506 Participants
Region of Enrollment
Austria
2 participants
n=1506 Participants
Region of Enrollment
Netherlands
2 participants
n=1506 Participants
Region of Enrollment
Sweden
3 participants
n=1506 Participants
Region of Enrollment
Turkey
31 participants
n=1506 Participants
Region of Enrollment
Belgium
7 participants
n=1506 Participants
Region of Enrollment
Poland
193 participants
n=1506 Participants
Region of Enrollment
Brazil
2 participants
n=1506 Participants
Region of Enrollment
South Africa
200 participants
n=1506 Participants
Region of Enrollment
Slovenia
16 participants
n=1506 Participants
Region of Enrollment
France
36 participants
n=1506 Participants
Region of Enrollment
Germany
292 participants
n=1506 Participants

PRIMARY outcome

Timeframe: Baseline (i.e. pre-implanted status, prior to 1st switch-on) and post-implant at 1 year

Population: For all devices with 50 or more participants with baseline data, analysis of the SSQ data was performed.

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.

Outcome measures

Outcome measures
Measure
Cochlear® Hearing Implants
n=327 Participants
Nucleus Cochlear implants, Cochlear Baha implants, Cochlear Acoustic Implants
Change in Hearing Ability Assessed Via Speech Spatial Hearing Qualities Questionnaire
CI522 cochlear implant
2.1 Score on a scale
Standard Error 0.24
Change in Hearing Ability Assessed Via Speech Spatial Hearing Qualities Questionnaire
CI532 cochlear implant
2.1 Score on a scale
Standard Error 0.27
Change in Hearing Ability Assessed Via Speech Spatial Hearing Qualities Questionnaire
Baha bone conduction hearing implant
2.2 Score on a scale
Standard Error 0.21
Change in Hearing Ability Assessed Via Speech Spatial Hearing Qualities Questionnaire
CI512 cochlear implant
2.73 Score on a scale
Standard Error 0.148

PRIMARY outcome

Timeframe: Baseline (i.e. pre-implanted status, prior to 1st switch-on) and post-implant at 2 years

Population: For all devices with 50 or more participants with baseline data, analysis of the SSQ data was performed.

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.

Outcome measures

Outcome measures
Measure
Cochlear® Hearing Implants
n=160 Participants
Nucleus Cochlear implants, Cochlear Baha implants, Cochlear Acoustic Implants
Change in Hearing Ability Assessed Via Speech Spatial Hearing Qualities Questionnaire
CI512 cochlear implant
2.95 Score on a scale
Standard Error 0.179
Change in Hearing Ability Assessed Via Speech Spatial Hearing Qualities Questionnaire
CI522 cochlear implant
2.4 Score on a scale
Standard Error 0.31
Change in Hearing Ability Assessed Via Speech Spatial Hearing Qualities Questionnaire
CI532 cochlear implant
2.5 Score on a scale
Standard Error 0.33
Change in Hearing Ability Assessed Via Speech Spatial Hearing Qualities Questionnaire
Baha bone conduction hearing implant
1.9 Score on a scale
Standard Error 0.65

PRIMARY outcome

Timeframe: Baseline (i.e. pre-implanted status, prior to 1st switch-on) and post-implant at 3 years

Population: 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.

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.

Outcome measures

Outcome measures
Measure
Cochlear® Hearing Implants
n=69 Participants
Nucleus Cochlear implants, Cochlear Baha implants, Cochlear Acoustic Implants
Change in Hearing Ability Assessed Via Speech Spatial Hearing Qualities Questionnaire
CI512 cochlear implant
2.74 Score on a scale
Standard Error 0.217
Change in Hearing Ability Assessed Via Speech Spatial Hearing Qualities Questionnaire
CI522 cochlear implant
2.4 Score on a scale
Standard Error 0.39
Change in Hearing Ability Assessed Via Speech Spatial Hearing Qualities Questionnaire
CI532 cochlear implant
2.6 Score on a scale
Standard Error 0.67

PRIMARY outcome

Timeframe: Baseline (i.e. pre-implanted status, prior to 1st switch-on) and post-implant at 1 year

Population: For all devices with 50 or more participants with baseline data, analysis of the HUI3 data was performed.

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.

Outcome measures

Outcome measures
Measure
Cochlear® Hearing Implants
n=327 Participants
Nucleus Cochlear implants, Cochlear Baha implants, Cochlear Acoustic Implants
Change in General Quality of Life Assessed Via Health Utility Index Mark III Questionnaire
CI512 cochlear implant
0.166 Score on a scale
Standard Error 0.0212
Change in General Quality of Life Assessed Via Health Utility Index Mark III Questionnaire
CI522 cochlear implant
0.22 Score on a scale
Standard Error 0.032
Change in General Quality of Life Assessed Via Health Utility Index Mark III Questionnaire
CI532 cochlear implant
0.15 Score on a scale
Standard Error 0.034
Change in General Quality of Life Assessed Via Health Utility Index Mark III Questionnaire
Baha bone conduction hearing implant
0.12 Score on a scale
Standard Error 0.03

PRIMARY outcome

Timeframe: Baseline (i.e. pre-implanted status, prior to 1st switch-on) and post-implant at 2 years

Population: 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.

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.

Outcome measures

Outcome measures
Measure
Cochlear® Hearing Implants
n=151 Participants
Nucleus Cochlear implants, Cochlear Baha implants, Cochlear Acoustic Implants
Change in General Quality of Life Assessed Via Health Utility Index Mark III Questionnaire
CI512 cochlear implant
0.175 Score on a scale
Standard Error 0.0255
Change in General Quality of Life Assessed Via Health Utility Index Mark III Questionnaire
CI522 cochlear implant
0.28 Score on a scale
Standard Error 0.04
Change in General Quality of Life Assessed Via Health Utility Index Mark III Questionnaire
CI532 cochlear implant
0.15 Score on a scale
Standard Error 0.042

PRIMARY outcome

Timeframe: Baseline (i.e. pre-implanted status, prior to 1st switch-on) and post-implant at 3 years

Population: 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.

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.

Outcome measures

Outcome measures
Measure
Cochlear® Hearing Implants
n=71 Participants
Nucleus Cochlear implants, Cochlear Baha implants, Cochlear Acoustic Implants
Change in General Quality of Life Assessed Via Health Utility Index Mark III Questionnaire
CI522 cochlear implant
0.22 Score on a scale
Standard Error 0.051
Change in General Quality of Life Assessed Via Health Utility Index Mark III Questionnaire
CI532 cochlear implant
0.27 Score on a scale
Standard Error 0.087
Change in General Quality of Life Assessed Via Health Utility Index Mark III Questionnaire
CI512 cochlear implant
0.123 Score on a scale
Standard Error 0.0311

SECONDARY outcome

Timeframe: Baseline (i.e. pre-implant status) assessed prior to 1st switch-on

Population: Results are for Baha participants. For the contra-lateral ear, data not received for all participants.

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

Outcome measures

Outcome measures
Measure
Cochlear® Hearing Implants
n=173 Participants
Nucleus Cochlear implants, Cochlear Baha implants, Cochlear Acoustic Implants
Unaided Hearing Thresholds
Air conduction-implanted ear
71.7 Decibel
Standard Deviation 21.6
Unaided Hearing Thresholds
Bone conduction-implanted ear
34.1 Decibel
Standard Deviation 24.4
Unaided Hearing Thresholds
Air conduction-contralateral year
36.7 Decibel
Standard Deviation 26.5
Unaided Hearing Thresholds
Bone conduction-contralateral ear
18.1 Decibel
Standard Deviation 15.7

SECONDARY outcome

Timeframe: post-implant at 1 year

Population: Results are for Baha participants. For the contra-lateral ear, data not received for all participants.

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

Outcome measures

Outcome measures
Measure
Cochlear® Hearing Implants
n=173 Participants
Nucleus Cochlear implants, Cochlear Baha implants, Cochlear Acoustic Implants
Unaided Hearing Thresholds
Air conduction-Implanted ear
60.2 Decibel
Standard Deviation 24.2
Unaided Hearing Thresholds
Bone conduction-implanted ear
29.4 Decibel
Standard Deviation 20.0
Unaided Hearing Thresholds
Air conduction- Contralateral ear
37.5 Decibel
Standard Deviation 24.5
Unaided Hearing Thresholds
Bone conduction-Contralateral ear
18.1 Decibel
Standard Deviation 13.8

SECONDARY outcome

Timeframe: immediately post-implant

Population: Data not received due to voluntary participation of participants.

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: post-implant at 2 years

Population: Data not received due to voluntary participation of participants.

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

Outcome measures

Outcome data not reported

Adverse Events

Cochlear® Hearing Implants

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jasmin Kaur

Cochlear

Phone: +41612058238

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place