Trial Outcomes & Findings for CI532 - Early Experience Study (NCT NCT02755935)

NCT ID: NCT02755935

Last Updated: 2018-03-20

Results Overview

Unilateral listening performance at 3 months post activation with the CI532 compared to the best aided unilateral preoperative condition for sentence perception in quiet.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 24 participants
• Primary outcome timeframe: 3 months postactivation of the sound processor
• Results posted on: 2018-03-20

Participant Flow

Participant milestones

Measure	Implanted Subjects who meet the specified inclusion criteria and are implanted with the CI532 cochlear implant Cochlear Nucleus CI532: cochlear implantation
Overall Study STARTED	24
Overall Study COMPLETED	22
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Implanted n=24 Participants Subjects who meet the specified inclusion criteria and are implanted with the CI532 cochlear implant Cochlear Nucleus CI532: cochlear implantation
Age, Categorical <=18 years	0 Participants n=24 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=24 Participants
Age, Categorical >=65 years	17 Participants n=24 Participants
Sex: Female, Male Female	8 Participants n=24 Participants
Sex: Female, Male Male	16 Participants n=24 Participants
Speech understanding (% correct) on AzBio sentences in quiet in the ear to be implanted	11.2 percent correct STANDARD_DEVIATION 16.6 • n=24 Participants
Speech understanding (% correct) on AzBio sentences in noise in the ear to be implanted	5.3 percent correct STANDARD_DEVIATION 12.8 • n=24 Participants

PRIMARY outcome

Timeframe: 3 months postactivation of the sound processor

Population: implanted and enrolled

Unilateral listening performance at 3 months post activation with the CI532 compared to the best aided unilateral preoperative condition for sentence perception in quiet.

Outcome measures

Measure	Implanted n=22 Participants Subjects who meet the specified inclusion criteria and are implanted with the CI532 cochlear implant Cochlear Nucleus CI532: cochlear implantation
Speech Understanding (% Correct) on AzBio Sentences in Quiet in the Implanted Ear	53.5 percent correct Standard Deviation 28.2

PRIMARY outcome

Timeframe: 3 months post-activation

Population: implanted and enrolled

unilateral listening performance at 3 months post activation with the CI532 compared to the best aided unilateral preoperative condition for sentence perception in noise

Outcome measures

Measure	Implanted n=22 Participants Subjects who meet the specified inclusion criteria and are implanted with the CI532 cochlear implant Cochlear Nucleus CI532: cochlear implantation
Speech Understanding (% Correct) on AzBio Sentences in Noise in the Implanted Ear	25.3 percent correct Standard Deviation 24.5

Adverse Events

Implanted

Serious events: 2 serious events

Other events: 6 other events

Deaths: 1 deaths

Serious adverse events

Measure	Implanted n=24 participants at risk Subjects who meet the specified inclusion criteria and are implanted with the CI532 cochlear implant Cochlear Nucleus CI532: cochlear implantation
General disorders death	4.2% 1/24 • Number of events 1 • 4 months
Infections and infestations skin flap	4.2% 1/24 • Number of events 1 • 4 months

Other adverse events

Measure	Implanted n=24 participants at risk Subjects who meet the specified inclusion criteria and are implanted with the CI532 cochlear implant Cochlear Nucleus CI532: cochlear implantation
Ear and labyrinth disorders Facial nerve	4.2% 1/24 • Number of events 1 • 4 months
Ear and labyrinth disorders Vertigo or dizziness	4.2% 1/24 • Number of events 1 • 4 months
Ear and labyrinth disorders Tingling sensation	4.2% 1/24 • Number of events 1 • 4 months
Product Issues Device related/programming problems	12.5% 3/24 • Number of events 3 • 4 months

Additional Information

Ginger Grant, AuD

Cochlear Americas

Phone: 410-375-0883

Email: ggrant@cochlear.com

Results disclosure agreements

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