Trial Outcomes & Findings for Clinical Evaluation of the Nucleus 5 Cochlear Implant (CI) System (NCT NCT01072409)

NCT ID: NCT01072409

Last Updated: 2016-10-27

Results Overview

CNC Word Test is a validated test of open-set word recognition. The test consists of 10 lists with 50 monosyllabic words in each list. Subject responses are scored for both words and phonemes correct in the correct sequence. Subjects will be tested using a configuration of speech at 0º azimuth in quiet.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 49 participants
• Primary outcome timeframe: 12 months
• Results posted on: 2016-10-27

Participant Flow

Participant milestones

Measure	Implanted Subjects who met study inclusion and completed the primary endpoint.
Overall Study STARTED	45
Overall Study COMPLETED	38
Overall Study NOT COMPLETED	7

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Clinical Evaluation of the Nucleus 5 Cochlear Implant (CI) System

Baseline characteristics by cohort

Measure	Implanted n=38 Participants Subjects who met study inclusion and completed the primary endpoint.
Age, Continuous	63.6 years n=93 Participants
Sex: Female, Male Female	18 Participants n=93 Participants
Sex: Female, Male Male	20 Participants n=93 Participants
Age at onset of hearing loss	40.8 years n=93 Participants
Preoperative CNC word score - Treated ear	5.6 percent correct STANDARD_DEVIATION 1.4 • n=93 Participants

PRIMARY outcome

Timeframe: 12 months

CNC Word Test is a validated test of open-set word recognition. The test consists of 10 lists with 50 monosyllabic words in each list. Subject responses are scored for both words and phonemes correct in the correct sequence. Subjects will be tested using a configuration of speech at 0º azimuth in quiet.

Outcome measures

Measure	Implanted n=38 Participants Subjects who met study inclusion and completed the primary endpoint.
CNC Monosyllabic Word Performance - Treated Ear	56.8 percent correct Standard Error 3.9

Adverse Events

Implanted

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

Teresa Zwolan, Ph.D.

University of Michigan

Phone: (313) 618-9669

Email: zwolan@umich.edu

Results disclosure agreements

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