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Trial Outcomes & Findings for Clinical Evaluation of the Cochlear Nucleus CI532 Cochlear Implant in Adults (NCT NCT03007472)

NCT ID: NCT03007472

Last Updated: 2020-12-30

Results Overview

Group mean Consonant Nucleus Consonant (CNC) word recognition in quiet measured pre-operatively and again at 6 month post sound processor activation compared to the group mean score in the preoperative, best unilateral condition. The CNC word test has a score range of 0-100% with higher values indicating better scores.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

96 participants

Primary outcome timeframe

Preoperatively and 6 months post sound processor activation

Results posted on

2020-12-30

Participant Flow

Participant milestones

Participant milestones
Measure
CI532/N7 Study Group
All subjects will receive a CI532 cochlear implant (intervention) and be fit with the CP1000 sound processor CI532: Cochlear implant Nucleus 7: Sound processor
Overall Study
STARTED
96
Overall Study
COMPLETED
91
Overall Study
NOT COMPLETED
5

Reasons for withdrawal

Reasons for withdrawal
Measure
CI532/N7 Study Group
All subjects will receive a CI532 cochlear implant (intervention) and be fit with the CP1000 sound processor CI532: Cochlear implant Nucleus 7: Sound processor
Overall Study
Did not have aidable contralateral thresholds at the time
2
Overall Study
Death
2
Overall Study
Loss to Follow Up
1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
CI532/N7 Study Group
n=96 Participants
All subjects will receive a CI532 cochlear implant (intervention) and be fit with the CP1000 sound processor CI532: Cochlear implant Nucleus 7: Sound processor
Age, Continuous
67.39 years
n=96 Participants
Sex: Female, Male
Female
34 Participants
n=96 Participants
Sex: Female, Male
Male
62 Participants
n=96 Participants
Region of Enrollment
United States
96 participants
n=96 Participants
Ipsilateral Ear Mean - Duration of Hearing Loss
21.7 years
STANDARD_DEVIATION 14 • n=96 Participants
Contralateral Ear Mean - Duration of Hearing Loss
26.7 years
STANDARD_DEVIATION 14 • n=96 Participants

PRIMARY outcome

Timeframe: Preoperatively and 6 months post sound processor activation

Group mean Consonant Nucleus Consonant (CNC) word recognition in quiet measured pre-operatively and again at 6 month post sound processor activation compared to the group mean score in the preoperative, best unilateral condition. The CNC word test has a score range of 0-100% with higher values indicating better scores.

Outcome measures

Outcome measures
Measure
CI532/N7 Study Group
n=96 Participants
All subjects will receive a CI532 cochlear implant (intervention) and be fit with the CP1000 sound processor CI532: Cochlear implant Nucleus 7: Sound processor
Change From Pre- to 6 Months Post-implantation Speech Recognition in Quiet in the Implanted Ear Alone
Baseline Ipsilateral Aided
14.6 percentage of correct words
Standard Deviation 11.6
Change From Pre- to 6 Months Post-implantation Speech Recognition in Quiet in the Implanted Ear Alone
6 Month CI/Best Unilateral
60.9 percentage of correct words
Standard Deviation 21.09

SECONDARY outcome

Timeframe: Preoperatively and 6 months post sound processor activation

Group mean AzBio sentence in noise score in the best unilateral condition compared to the group mean score in the preoperative, unilateral aided condition. The AzBio sentence test has a score range of 0-100% with higher values indicating better scores.

Outcome measures

Outcome measures
Measure
CI532/N7 Study Group
n=96 Participants
All subjects will receive a CI532 cochlear implant (intervention) and be fit with the CP1000 sound processor CI532: Cochlear implant Nucleus 7: Sound processor
Evaluation of Change in Pre and Post Implantation Speech Recognition in Noise Scores in the Implanted Ear Alone
Baseline Ipsilateral Aided +10 SNR
14.8 percentage of correct AzBio sentences
Standard Deviation 17.24
Evaluation of Change in Pre and Post Implantation Speech Recognition in Noise Scores in the Implanted Ear Alone
6 Month CI/Best Unilateral +10 SNR
42.7 percentage of correct AzBio sentences
Standard Deviation 26.21

SECONDARY outcome

Timeframe: Preoperatively and 6 months post sound processor activaton

Group mean HUI3 score post sound processor activation compared to the scores measured preoperatively. The HUI3 consists of eight attributes of general health (vision, hearing, speech, mobility, dexterity, emotion, cognition, and pain) with five or six levels per attribute. For each respondent, health status is described as a vector that combines the levels of each attribute. This information is then converted into a utility score of HRQL on a scale from perfect health (1.0) to death (0).

Outcome measures

Outcome measures
Measure
CI532/N7 Study Group
n=94 Participants
All subjects will receive a CI532 cochlear implant (intervention) and be fit with the CP1000 sound processor CI532: Cochlear implant Nucleus 7: Sound processor
Change in Pre and Post Implantation Score on the Health Utility Index-3 (HUI3)
Baseline
0.46 score on a scale
Standard Deviation 0.2
Change in Pre and Post Implantation Score on the Health Utility Index-3 (HUI3)
6 Month
0.64 score on a scale
Standard Deviation 0.197

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months post-activation

Frequency-specific thresholds at standard audiometric frequencies for each ear, and speech recognition in quiet (CNC words) or noise (AzBio sentences) in best unilateral and/or electric alone.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Following 12-month study visit but prior to 36-month interval.

Two optional study visits to evaluate whether a change in cochlear implant programming, specifically an increase in the number of channels will improve subject speech perception in quiet and noise.

Outcome measures

Outcome data not reported

Adverse Events

CI532/N7 Study Group

Serious events: 16 serious events
Other events: 26 other events
Deaths: 2 deaths

Serious adverse events

Serious adverse events
Measure
CI532/N7 Study Group
n=96 participants at risk
All subjects will receive a CI532 cochlear implant (intervention) and be fit with the CP1000 sound processor CI532: Cochlear implant Nucleus 7: Sound processor
Gastrointestinal disorders
Acid Reflux
1.0%
1/96 • Number of events 1 • 12 months
Ear and labyrinth disorders
Active Meniere's Disease/Vertigo
1.0%
1/96 • Number of events 1 • 12 months
Blood and lymphatic system disorders
Anemia
1.0%
1/96 • Number of events 1 • 12 months
Cardiac disorders
Atrial Fibrillation requiring Ablation Procedure
1.0%
1/96 • Number of events 1 • 12 months
Product Issues
CI Explanted Due to Non-Auditory Stimulation
1.0%
1/96 • Number of events 1 • 12 months
Ear and labyrinth disorders
Coxsackievirus, subsequent labyrinthitis/vestibular neuritis
1.0%
1/96 • Number of events 1 • 12 months
Vascular disorders
CVA (cerebrovascular accident)
1.0%
1/96 • Number of events 1 • 12 months
Cardiac disorders
Cardio-respiratory failure
1.0%
1/96 • Number of events 1 • 12 months
Hepatobiliary disorders
Alcoholic cirrhosis of the liver
1.0%
1/96 • Number of events 1 • 12 months
Ear and labyrinth disorders
Decreased Hearing in Non-Implanted Ear
1.0%
1/96 • Number of events 1 • 12 months
General disorders
Dehydration
1.0%
1/96 • Number of events 1 • 12 months
Reproductive system and breast disorders
Diagnosed with prostate cancer
1.0%
1/96 • Number of events 1 • 12 months
Injury, poisoning and procedural complications
Electrode Tip Foldover
1.0%
1/96 • Number of events 1 • 12 months
Cardiac disorders
Heart Attack
1.0%
1/96 • Number of events 2 • 12 months
Nervous system disorders
Seizure
1.0%
1/96 • Number of events 1 • 12 months
Vascular disorders
TIA/Stroke
1.0%
1/96 • Number of events 1 • 12 months
Injury, poisoning and procedural complications
Tip Rollover
1.0%
1/96 • Number of events 1 • 12 months

Other adverse events

Other adverse events
Measure
CI532/N7 Study Group
n=96 participants at risk
All subjects will receive a CI532 cochlear implant (intervention) and be fit with the CP1000 sound processor CI532: Cochlear implant Nucleus 7: Sound processor
General disorders
Dizziness
14.6%
14/96 • Number of events 14 • 12 months
Ear and labyrinth disorders
Vertigo
13.5%
13/96 • Number of events 13 • 12 months

Additional Information

Cochlear Clinical Studies

Cochlear

Phone: (303) 790-9010

Results disclosure agreements

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