Trial Outcomes & Findings for Nucleus Hybrid L24 Extended Duration Post Approval Study (NCT NCT02379273)
NCT ID: NCT02379273
Last Updated: 2021-11-30
Results Overview
The CNC Words test consists of 10 recorded lists of 50 monosyllabic words in compact disk format. For this study, two lists were administered in quiet at a level equal to 60 dBA (decibels A-weighted) in the sound field and scored as total number of words correct, which will be expressed as a percentage correct. Minimum score is 0/100 words or 0% (worse), maximum score is 100/100 or 100% (best possible).
COMPLETED
NA
35 participants
5 years postactivation.
2021-11-30
Participant Flow
Eight of 10 pivotal study sites agreed to participate. All subjects who remained enrolled under the pivotal Investigational Device Exemption (IDE) study (G070191) or under a continued access study (G070191/S024) were eligible to participate in this post-approval study. Subject enrollment for this study was completed in the period, January 14, 2015 through September 12, 2016.
Of 53 subjects implanted prior to this study: 6 no longer used the Hybrid L24 implant, 8 subjects were not available to enroll, and 4 subjects declined participation. Thirty-five subjects enrolled in this postapproval study. First subject enrolled January 14, 2015; last subject enrolled September 12, 2016.
Participant milestones
| Measure |
Hybrid L24 Pivotal Study Subjects.
Available subjects implanted under the pivotal IDE study (G070191) or under a continued access study (G070191/S024) were followed for 5 years postactivation.
|
|---|---|
|
Overall Study
STARTED
|
35
|
|
Overall Study
COMPLETED
|
35
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Hybrid L24 Pivotal Study Subjects.
n=35 Participants
Available subjects implanted under the pivotal IDE study (G070191) or under a continued access study (G070191/S024) were followed for 5 years postactivation.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=35 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
18 Participants
n=35 Participants
|
|
Age, Categorical
>=65 years
|
17 Participants
n=35 Participants
|
|
Age, Continuous
|
61.3 years
STANDARD_DEVIATION 16.1 • n=35 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=35 Participants
|
|
Region of Enrollment
United States
|
35 participants
n=35 Participants
|
|
Aided Speech Recognition
CNC Words Implanted Ear: Percentage of total words correctly recognized.
|
27 Percentage of total words correctly re
STANDARD_DEVIATION 14.6 • n=35 Participants
|
|
Aided Speech Recognition
CNC Words Bilateral: Percentage of total words correctly recognized.
|
44.4 Percentage of total words correctly re
STANDARD_DEVIATION 17.3 • n=35 Participants
|
|
Aided Speech Recognition
CNC Words Contralateral: Percentage of total words correctly recognized.
|
39 Percentage of total words correctly re
STANDARD_DEVIATION 17.9 • n=35 Participants
|
|
Aided Speech Recognition
AzBio+5 dB SNR Implant Ear: Percentage of total words correctly recognized.
|
15.7 Percentage of total words correctly re
STANDARD_DEVIATION 13.7 • n=35 Participants
|
|
Aided Speech Recognition
AzBio+5 dB SNR Bilateral: Percentage of total words correctly recognized.
|
28.8 Percentage of total words correctly re
STANDARD_DEVIATION 20.6 • n=35 Participants
|
PRIMARY outcome
Timeframe: 5 years postactivation.Population: All subjects completing the 5-year postactivation evaluation interval.
The CNC Words test consists of 10 recorded lists of 50 monosyllabic words in compact disk format. For this study, two lists were administered in quiet at a level equal to 60 dBA (decibels A-weighted) in the sound field and scored as total number of words correct, which will be expressed as a percentage correct. Minimum score is 0/100 words or 0% (worse), maximum score is 100/100 or 100% (best possible).
Outcome measures
| Measure |
Hybrid L24 Pivotal Study Subjects.
n=35 Participants
Available subjects implanted under the pivotal IDE study (G070191) or under a continued access study (G070191/S024) were followed for 5 years postactivation.
|
|---|---|
|
Consonant-Nucleus-Consonant (CNC) Word Recognition in Quiet: Percentage of Total Words Correctly Recognized.
Implanted Ear
|
71.2 percentage of total words correct
Standard Deviation 20.4
|
|
Consonant-Nucleus-Consonant (CNC) Word Recognition in Quiet: Percentage of Total Words Correctly Recognized.
Bilateral Condition
|
81 percentage of total words correct
Standard Deviation 12.7
|
PRIMARY outcome
Timeframe: 5 years postactivation.Population: All subjects completing the 5-year postactivation evaluation interval.
The AzBio Sentence Test consists of 15 lists of 20 sentences each. AzBio sentences are spoken by different talkers in a conversational style with limited contextual cues that the listener can use to predict or 'fill in' unintelligible words. Each list includes 5 sentences from 4 different male and female speakers. Each word in the sentence counts towards the overall score. Minimum score is 0 out the total number of words in a given list (varies list to list, with an average length of 141 words) words or 0% (worse), maximum score is all words correctly repeated or 100% (best possible).
Outcome measures
| Measure |
Hybrid L24 Pivotal Study Subjects.
n=35 Participants
Available subjects implanted under the pivotal IDE study (G070191) or under a continued access study (G070191/S024) were followed for 5 years postactivation.
|
|---|---|
|
AzBio (Arizona Biomedical Institute) Sentence Recognition in Noise: Percentage of Total Words Correctly Recognized.
Implanted Ear
|
49.6 percentage of total words correct
Standard Deviation 27.5
|
|
AzBio (Arizona Biomedical Institute) Sentence Recognition in Noise: Percentage of Total Words Correctly Recognized.
Bilateral Condition
|
61.4 percentage of total words correct
Standard Deviation 24.5
|
POST_HOC outcome
Timeframe: Preoperative through 5 years postactivation.Population: All subjects completing the 5-year postactivation evaluation interval.
The Speech, Spatial, and Qualities of Hearing Scale or SSQ (Gatehouse \& Noble, 2004) was administered as a self-assessment of hearing (dis)abilities across a range of listening situations that fall within three hearing domains: Speech Hearing, Spatial Hearing, and Qualities of Hearing. Within each domain or subscale, each question is scored by the reader indicating on a line marked from 0 through 10. The score for each subscale represents the average of the responses made to each question within the subscale. A score of zero is the minimum and corresponds to minimal ability (i.e., poorer) and 10 corresponds to complete ability (i.e., better) for each subscale.
Outcome measures
| Measure |
Hybrid L24 Pivotal Study Subjects.
n=35 Participants
Available subjects implanted under the pivotal IDE study (G070191) or under a continued access study (G070191/S024) were followed for 5 years postactivation.
|
|---|---|
|
Speech, Spatial and Qualities of Hearing Scale (SSQ): Speech Hearing Subscale
Preoperative
|
3.3 score on a scale
Standard Deviation 1.4
|
|
Speech, Spatial and Qualities of Hearing Scale (SSQ): Speech Hearing Subscale
1 Year Postactivation
|
5.9 score on a scale
Standard Deviation 1.7
|
|
Speech, Spatial and Qualities of Hearing Scale (SSQ): Speech Hearing Subscale
5 Years Postactivation
|
5.4 score on a scale
Standard Deviation 1.6
|
POST_HOC outcome
Timeframe: Preoperative through 5 years postactivation.Population: All subjects completing the 5-year postactivation evaluation interval.
The Speech, Spatial, and Qualities of Hearing Scale or SSQ (Gatehouse \& Noble, 2004) was administered as a self-assessment of hearing (dis)abilities across a range of listening situations that fall within three hearing domains: Speech Hearing, Spatial Hearing, and Qualities of Hearing. Within each domain or subscale, each question is scored by the reader indicating on a line marked from 0 through 10. The score for each subscale represents the average of the responses made to each question within the subscale. A score of zero is the minimum and corresponds to minimal ability (i.e., poorer) and 10 corresponds to complete ability (i.e., better) for each subscale.
Outcome measures
| Measure |
Hybrid L24 Pivotal Study Subjects.
n=35 Participants
Available subjects implanted under the pivotal IDE study (G070191) or under a continued access study (G070191/S024) were followed for 5 years postactivation.
|
|---|---|
|
Speech, Spatial and Qualities of Hearing Scale: Spatial Hearing Subscale
Preoperative
|
4.2 score on a scale
Standard Deviation 1.8
|
|
Speech, Spatial and Qualities of Hearing Scale: Spatial Hearing Subscale
1 Year Postactivation
|
5.6 score on a scale
Standard Deviation 2.0
|
|
Speech, Spatial and Qualities of Hearing Scale: Spatial Hearing Subscale
5 Years Postactivation
|
5.01 score on a scale
Standard Deviation 1.7
|
POST_HOC outcome
Timeframe: Preoperative through 5 years postactivation.Population: All subjects completing the 5-year postactivation evaluation interval.
The Speech, Spatial, and Qualities of Hearing Scale or SSQ (Gatehouse \& Noble, 2004) was administered as a self-assessment of hearing (dis)abilities across a range of listening situations that fall within three hearing domains: Speech Hearing, Spatial Hearing, and Qualities of Hearing. Within each domain or subscale, each question is scored by the reader indicating on a line marked from 0 through 10. The score for each subscale represents the average of the responses made to each question within the subscale. A score of zero is the minimum and corresponds to minimal ability (i.e., poorer) and 10 corresponds to complete ability (i.e., better) for each subscale.
Outcome measures
| Measure |
Hybrid L24 Pivotal Study Subjects.
n=35 Participants
Available subjects implanted under the pivotal IDE study (G070191) or under a continued access study (G070191/S024) were followed for 5 years postactivation.
|
|---|---|
|
Speech, Spatial and Qualities of Hearing Scale: Qualities of Hearing Subscale
Preoperative
|
4.8 score on a scale
Standard Deviation 1.5
|
|
Speech, Spatial and Qualities of Hearing Scale: Qualities of Hearing Subscale
1 Year Postactivation
|
6.7 score on a scale
Standard Deviation 1.7
|
|
Speech, Spatial and Qualities of Hearing Scale: Qualities of Hearing Subscale
5 Years Postactivation
|
6.4 score on a scale
Standard Deviation 1.4
|
Adverse Events
Hybrid L24 Pivotal Study Subjects.
Serious adverse events
| Measure |
Hybrid L24 Pivotal Study Subjects.
n=35 participants at risk
Available subjects implanted under the pivotal IDE study (G070191) or under a continued access study (G070191/S024) were followed for 5 years postactivation.
|
|---|---|
|
Cardiac disorders
Heart Attack
|
2.9%
1/35 • Number of events 1 • Adverse event (AE) data were captured from baseline for this study through 5 years postactivation. Since subjects were recruited following their completion of the pivotal study baseline was anywhere from 2 years through 5 years postactivation.
|
|
Ear and labyrinth disorders
Cochlear implant revision
|
2.9%
1/35 • Number of events 1 • Adverse event (AE) data were captured from baseline for this study through 5 years postactivation. Since subjects were recruited following their completion of the pivotal study baseline was anywhere from 2 years through 5 years postactivation.
|
Other adverse events
| Measure |
Hybrid L24 Pivotal Study Subjects.
n=35 participants at risk
Available subjects implanted under the pivotal IDE study (G070191) or under a continued access study (G070191/S024) were followed for 5 years postactivation.
|
|---|---|
|
General disorders
Teeth cracking and pain associated with Bruxism
|
2.9%
1/35 • Number of events 1 • Adverse event (AE) data were captured from baseline for this study through 5 years postactivation. Since subjects were recruited following their completion of the pivotal study baseline was anywhere from 2 years through 5 years postactivation.
|
|
Ear and labyrinth disorders
Ear pain
|
2.9%
1/35 • Number of events 1 • Adverse event (AE) data were captured from baseline for this study through 5 years postactivation. Since subjects were recruited following their completion of the pivotal study baseline was anywhere from 2 years through 5 years postactivation.
|
|
Ear and labyrinth disorders
Tinnitus
|
2.9%
1/35 • Number of events 1 • Adverse event (AE) data were captured from baseline for this study through 5 years postactivation. Since subjects were recruited following their completion of the pivotal study baseline was anywhere from 2 years through 5 years postactivation.
|
|
Ear and labyrinth disorders
Perceived change in hearing due to wax occlusion
|
2.9%
1/35 • Number of events 1 • Adverse event (AE) data were captured from baseline for this study through 5 years postactivation. Since subjects were recruited following their completion of the pivotal study baseline was anywhere from 2 years through 5 years postactivation.
|
Additional Information
Aaron J Parkinson, PhD, Principal Clinical Project Manager
Cochlear Americas
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place