Trial Outcomes & Findings for Implantation of the Cochlear® Nucleus® System in Adults With Single-Sided Deafness (NCT NCT01670006)

NCT ID: NCT01670006

Last Updated: 2022-09-22

Results Overview

Device and procedure-related anticipated and unanticipated aderse events.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 10 participants
• Primary outcome timeframe: 12 months
• Results posted on: 2022-09-22

Participant Flow

Participant milestones

Measure	Subjects With Single-Sided Deafness and a Cochlear Implant Ten subjects with Single-Sided Deafness (SSD) were implanted with a Cochlear Nucleus Cochlear Implant System and followed for 12 months after device activation.
Overall Study STARTED	10
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Subjects With Single-Sided Deafness and a Cochlear Implant n=10 Participants Ten subjects with Single-Sided Deafness (SSD) were implanted with a Cochlear Nucleus Cochlear Implant System and followed for 12 months after device activation.
Age, Continuous	52.8 years STANDARD_DEVIATION 11.3 • n=10 Participants
Sex: Female, Male Female	7 Participants n=10 Participants
Sex: Female, Male Male	3 Participants n=10 Participants
Region of Enrollment United States	10 participants n=10 Participants

PRIMARY outcome

Timeframe: 12 months

Device and procedure-related anticipated and unanticipated aderse events.

Outcome measures

Measure	Subjects With Single-Sided Deafness and a Cochlear Implant n=10 Participants Ten subjects with Single-Sided Deafness (SSD) were implanted with a Cochlear Nucleus Cochlear Implant System and followed for 12 months after device activation.
Number of Subjects With Adverse Events	1 participants

SECONDARY outcome

Timeframe: 12 months

To access speech perception performance using Hearing in noise test sentences in noise was measured at 12 months post activation. Recorded HINT sentences were presented to participants at 60dBA pre-operatively and 12 months post activation. Resultant score is percentage of words repeated correctly. Possible scores ranges from 0% to 100% correctly repeated. Higher percentage score means better outcome.

Outcome measures

Measure	Subjects With Single-Sided Deafness and a Cochlear Implant n=10 Participants Ten subjects with Single-Sided Deafness (SSD) were implanted with a Cochlear Nucleus Cochlear Implant System and followed for 12 months after device activation.
Hearing in Noise Test (HINT)Score	10.9 percentage of correct words. Standard Deviation 3.8

Adverse Events

Subjects With Single-Sided Deafness and a Cochlear Implant

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Subjects With Single-Sided Deafness and a Cochlear Implant n=10 participants at risk Ten subjects with Single-Sided Deafness (SSD) were implanted with a Cochlear Nucleus Cochlear Implant System and followed for 12 months after device activation.
Surgical and medical procedures Sudden ventilation restriction upon induction of anesthesia	10.0% 1/10 • Number of events 1 • 12 months Suspected allergic response to a drug used during the anesthesia procedure.

Additional Information

PRS Specialist, Clinical Affairs

Cochlear

Phone: +612 9428 6555

Email: cltd-prs-admin@cochlear.com

Results disclosure agreements

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

Restriction type: OTHER