Trial Outcomes & Findings for Evaluation of the Nucleus Hybrid™ L24 Cochlear Implant System (NCT NCT00678899)

Last Updated: 2015-07-15

Results Overview

The co-primary study endpoints will be statistically significant differences between the mean, preoperative monosyllabic CNC word score (unilateral acoustic, ear to be implanted) and the postoperative monosyllabic CNC word scores (Hybrid mode) for the activated, Hybrid L24 cochlear implant subjects. The CNC Words test consists of 10 recorded lists of 50 monosyllabic words in CD format. For this study, two lists will be administered in quiet at a level equal to 60 dBA in the sound field and scored as a total number of words correct, which will be expressed as a percentage correct for this study.

Recruitment status

COMPLETED

Study phase

Target enrollment

50 participants

Primary outcome timeframe

6 Months Postactivation

Results posted on

2015-07-15

Participant Flow

Participant milestones

Participant milestones
Measure	6 Months Post Activation Subjects implanted with the Hybrid L implant who completed the primary endpoint of 6 months postactivation
Overall Study STARTED	50
Overall Study COMPLETED	49
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	6 Months Post Activation Subjects implanted with the Hybrid L implant who completed the primary endpoint of 6 months postactivation
Overall Study Adverse Event	1

Baseline Characteristics

Evaluation of the Nucleus Hybrid™ L24 Cochlear Implant System

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Surgery n=50 Participants Implantation with the Nucleus Hybrid L24 Cochlear Implant
Age, Continuous	64.1 years STANDARD_DEVIATION 14.7 • n=5 Participants
Sex: Female, Male Female	25 Participants n=5 Participants
Sex: Female, Male Male	25 Participants n=5 Participants
Duration of hearing loss	28.1 years STANDARD_DEVIATION 14.9 • n=5 Participants
Duration of severe to profound high frequency hearing loss	13.1 years STANDARD_DEVIATION 7.2 • n=5 Participants
Monosyllabic words	28.4 percent correct STANDARD_DEVIATION 14.7 • n=5 Participants
AzBio sentences	16.3 percent correct STANDARD_DEVIATION 14.4 • n=5 Participants

PRIMARY outcome

Timeframe: 6 Months Postactivation

Outcome measures

Outcome measures
Measure	6 Months Postactivation n=49 Participants Subjects implanted with the Hybrid L implant who completed the primary endpoint of 6 months postactivation
Consonant Nucleus Consonant (CNC) Monosyllabic Word Score-Treated Ear (CO-PRIMARY)	65.4 percentage of words correct Standard Deviation 25.4

PRIMARY outcome

Timeframe: 6 Months Postactivation

The co-primary study endpoints will be statistically significant differences between the mean, preoperative AzBio Sentences score in noise (unilateral acoustic, ear to be implanted) and postoperative AzBio Sentences score in noise (Hybrid mode) for the activated, Hybrid L24 cochlear implant subjects. 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.

Outcome measures

Outcome measures
Measure	6 Months Postactivation n=49 Participants Subjects implanted with the Hybrid L implant who completed the primary endpoint of 6 months postactivation
AzBio Sentence Score in Noise - Treated Ear (Co-Primary)	49.2 percentage of words correct Standard Deviation 30.8

SECONDARY outcome

Timeframe: 6 Months Postactivation

Secondary efficacy endpoints using binomial comparisons (based on the postoperative Hybrid condition) are as follows: The CNC Words test consists of 10 recorded lists of 50 monosyllabic words in CD format. For this study, two lists will be administered in quiet at a level equal to 60 dBA in the sound field. The percentage of subjects that scored equal to or better than they did in the pre-operative unilateral acoustic-only condition will be reported.

Outcome measures

Outcome measures
Measure	6 Months Postactivation n=49 Participants Subjects implanted with the Hybrid L implant who completed the primary endpoint of 6 months postactivation
Consonant Nucleus Consonant (CNC) Monosyllabic Words - Treated Ear	96 percentage of subjects

SECONDARY outcome

Timeframe: 6 Months Postactivation

Secondary efficacy endpoints using binomial comparisons (based on the postoperative Hybrid condition) are as follows: 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 toward the overall score. The percentage of subjects that scored equal to or better than they did in the pre-operative acoustic only condition will be reported.

Outcome measures

Outcome measures
Measure	6 Months Postactivation n=49 Participants Subjects implanted with the Hybrid L implant who completed the primary endpoint of 6 months postactivation
AzBio Sentence Score-Treated Ear	89.9 percentage of subjects

Adverse Events

Surgery

Serious events: 0 serious events

Other events: 34 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Surgery n=50 participants at risk Implantation with the Nucleus Hybrid L24 Cochlear Implant
Ear and labyrinth disorders hearing loss	44.0% 22/50 • Number of events 22
Ear and labyrinth disorders Open/short circuited electrodes	22.0% 11/50 • Number of events 11
Ear and labyrinth disorders Increased Tinnitus	12.0% 6/50 • Number of events 6
Ear and labyrinth disorders Tinnitus not present preoperatively	12.0% 6/50 • Number of events 6
Ear and labyrinth disorders Dizziness	6.0% 3/50 • Number of events 3
Ear and labyrinth disorders Dizziness with change in hearing	4.0% 2/50 • Number of events 2
Ear and labyrinth disorders Increased tinnitus with change in hearing	4.0% 2/50 • Number of events 2
Ear and labyrinth disorders Skin irritation due to externals	4.0% 2/50 • Number of events 2
Ear and labyrinth disorders Sound quality issue	4.0% 2/50 • Number of events 2
Ear and labyrinth disorders Decrease in performance	2.0% 1/50 • Number of events 1
Ear and labyrinth disorders Imbalance	2.0% 1/50 • Number of events 1
Ear and labyrinth disorders Imbalance with change in hearing	2.0% 1/50 • Number of events 1
Ear and labyrinth disorders Increased impedances with change in hearing	2.0% 1/50 • Number of events 1
Ear and labyrinth disorders Local stitch infection	2.0% 1/50 • Number of events 1
Ear and labyrinth disorders Overstimulation	2.0% 1/50 • Number of events 1
Ear and labyrinth disorders Pain in implant ear	2.0% 1/50 • Number of events 1
Ear and labyrinth disorders Vertiginous symptoms with change in hearing	2.0% 1/50 • Number of events 1
Ear and labyrinth disorders Vertigo	2.0% 1/50 • Number of events 1

Additional Information

Ginger Grant/Clinical Project Manager

Cochlear Americas

Phone: 410-375-0883

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place