Trial Outcomes & Findings for Safety and Efficacy of the Cochlear Nucleus CI422 Cochlear Implant in Adults (NCT NCT01867008)

NCT ID: NCT01867008

Last Updated: 2021-01-25

Results Overview

Performance at 6 months postactivation compared to pre-operative word recognition score (percent correct: 0-100%, where a 0% is the lowest score and a 100% is the highest score)

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 55 participants
• Primary outcome timeframe: Preoperative baseline to 6 months postactivation
• Results posted on: 2021-01-25

Participant Flow

Participant milestones

Measure	Nucleus CI422 Cochlear Implant With N6 Sound Processor Newly implanted patient population seeking cochlear implantation as standard of care
Overall Study STARTED	55
Overall Study COMPLETED	54
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure	Nucleus CI422 Cochlear Implant With N6 Sound Processor Newly implanted patient population seeking cochlear implantation as standard of care
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Nucleus CI422 Cochlear Implant With N6 Sound Processor n=55 Participants Newly implanted adults with moderate to severe sensorineural hearing loss, seeking cochlear implantation as a standard of care
Age, Categorical <=18 years	0 Participants n=55 Participants
Age, Categorical Between 18 and 65 years	14 Participants n=55 Participants
Age, Categorical >=65 years	41 Participants n=55 Participants
Age, Continuous	70.3 years STANDARD_DEVIATION 10.5 • n=55 Participants
Sex: Female, Male Female	16 Participants n=55 Participants
Sex: Female, Male Male	39 Participants n=55 Participants
Region of Enrollment United States	55 participants n=55 Participants

PRIMARY outcome

Timeframe: Preoperative baseline to 6 months postactivation

Performance at 6 months postactivation compared to pre-operative word recognition score (percent correct: 0-100%, where a 0% is the lowest score and a 100% is the highest score)

Outcome measures

Measure	Nucleus CI422 Cochlear Implant With N6 Sound Processor n=54 Participants Newly implanted adults with moderate to severe sensorineural hearing loss, seeking cochlear implantation as a standard of care
Change in Open Set Monosyllabic Word Recognition Score as Measured on a Consonant Nucleus Consonant (CNC) Word Test	54.7 percentage correct Standard Deviation 21.3

Adverse Events

Nucleus CI422 Cochlear Implant With N6 Sound Processor

Serious events: 5 serious events

Other events: 34 other events

Deaths: 0 deaths

Serious adverse events

Measure	Nucleus CI422 Cochlear Implant With N6 Sound Processor n=55 participants at risk Newly implanted adults with moderate to severe sensorineural hearing loss, seeking cochlear implantation as a standard of care
Cardiac disorders Irregular heartbeat	1.8% 1/55 • Number of events 1
Musculoskeletal and connective tissue disorders Broken hip	1.8% 1/55 • Number of events 1
Ear and labyrinth disorders Vertigo or dizziness	1.8% 1/55 • Number of events 1
Cardiac disorders Atrial fibrillation	1.8% 1/55 • Number of events 1
Ear and labyrinth disorders Revision surgery	1.8% 1/55 • Number of events 1

Other adverse events

Measure	Nucleus CI422 Cochlear Implant With N6 Sound Processor n=55 participants at risk Newly implanted adults with moderate to severe sensorineural hearing loss, seeking cochlear implantation as a standard of care
Ear and labyrinth disorders New or worsened tinnitus	5.5% 3/55 • Number of events 3
Ear and labyrinth disorders Vertigo or dizziness	12.7% 7/55 • Number of events 7
Ear and labyrinth disorders Skin flap	1.8% 1/55 • Number of events 1
Ear and labyrinth disorders Device related/programming problems	9.1% 5/55 • Number of events 5
Ear and labyrinth disorders Hearing loss	16.4% 9/55 • Number of events 9
Ear and labyrinth disorders Earmold or acoustic component sores	25.5% 14/55 • Number of events 14

Additional Information

Clinical Project Manager

Cochlear Americas

Phone: 303-264-2340

Email: knix@cochlear.com

Results disclosure agreements

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