Trial Outcomes & Findings for Evaluation of a Revised Indication for Determining Adult Cochlear Implant Candidacy (NCT NCT01337076)

NCT ID: NCT01337076

Last Updated: 2016-10-27

Results Overview

The primary study endpoint was to test whether a statistically significant difference could be obtained between the mean, preoperative Consonant Nucleus Consonant (CNC) monosyllabic word score in the ear to be implanted compared to the postoperative CNC word score in the cochlear implant alone condition at 6 months postimplant activation for candidates who currently perform outside the approved Nucleus® cochlear implant candidacy requirements. 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: 21 participants
• Primary outcome timeframe: Six months
• Results posted on: 2016-10-27

Participant Flow

Participant milestones

Measure	Implanted Subjects who met study inclusion and completed the primary endpoint of 6 months postimplant activation
Overall Study STARTED	21
Overall Study COMPLETED	19
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluation of a Revised Indication for Determining Adult Cochlear Implant Candidacy

Baseline characteristics by cohort

Measure	Implanted n=21 Participants Subjects who met study inclusion and completed the primary endpoint of 6 months postimplant activation
Age, Continuous	77 years n=93 Participants
Sex: Female, Male Female	4 Participants n=93 Participants
Sex: Female, Male Male	17 Participants n=93 Participants
Preoperative CNC word score - Treated Ear	23.6 percent correct n=93 Participants
Preoperative HINT Quiet score - Treated Ear	62.3 percent correct n=93 Participants
Preoperative AzBio Sentence Noise score - Treated Ear	9.9 percent correct n=93 Participants

PRIMARY outcome

Timeframe: Six months

The primary study endpoint was to test whether a statistically significant difference could be obtained between the mean, preoperative Consonant Nucleus Consonant (CNC) monosyllabic word score in the ear to be implanted compared to the postoperative CNC word score in the cochlear implant alone condition at 6 months postimplant activation for candidates who currently perform outside the approved Nucleus® cochlear implant candidacy requirements.

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=19 Participants Subjects who met study inclusion and completed the primary endpoint of 6 months postimplant activation
CNC Monosyllabic Word Score - Treated Ear	57.1 percent correct Interval 16.0 to 95.0

Adverse Events

Implanted

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Implanted n=21 participants at risk Subjects who met study inclusion and completed the primary endpoint of 6 months postimplant activation
Ear and labyrinth disorders Postoperative Pain	4.8% 1/21
Ear and labyrinth disorders Decrement in CNC word score performance postimplantation	4.8% 1/21

Additional Information

Dr. Colin Driscoll

Mayo Clinic, Rochester

Phone: 507 266 1965

Email: driscoll.colin@mayo.edu

Results disclosure agreements

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