Trial Outcomes & Findings for Bilateral Cochlear Implantation in Children With the MED-EL Cochlear Implant (NCT NCT00784043)

NCT ID: NCT00784043

Last Updated: 2018-05-25

Results Overview

Speech perception scores will be compared pre-operatively and postoperatively.

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 37 participants
• Primary outcome timeframe: 60 months post initial stimulation
• Results posted on: 2018-05-25

Participant Flow

Participant milestones

Measure	Bilateral Bilaterally implanted simultaneously Cochlear Implant: Bilateral Implantation in children	Unilateral Unilaterally implanted Cochlear Implant: Bilateral Implantation in children
Overall Study STARTED	31	6
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	31	6

Reasons for withdrawal

Measure	Bilateral Bilaterally implanted simultaneously Cochlear Implant: Bilateral Implantation in children	Unilateral Unilaterally implanted Cochlear Implant: Bilateral Implantation in children
Overall Study Withdrawal by Subject	8	5
Overall Study Protocol Terminated	23	1

Baseline Characteristics

Sex information not available for 3 participants.

Baseline characteristics by cohort

Measure	Bilateral n=31 Participants Bilaterally implanted simultaneously Cochlear Implant: Bilateral Implantation in children	Unilateral n=6 Participants Unilaterally implanted Cochlear Implant: Bilateral Implantation in children	Total n=37 Participants Total of all reporting groups
Age, Categorical <=18 years	31 Participants n=31 Participants	6 Participants n=6 Participants	37 Participants n=37 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=31 Participants	0 Participants n=6 Participants	0 Participants n=37 Participants
Age, Categorical >=65 years	0 Participants n=31 Participants	0 Participants n=6 Participants	0 Participants n=37 Participants
Sex: Female, Male Female	12 Participants n=28 Participants • Sex information not available for 3 participants.	0 Participants n=6 Participants • Sex information not available for 3 participants.	12 Participants n=34 Participants • Sex information not available for 3 participants.
Sex: Female, Male Male	16 Participants n=28 Participants • Sex information not available for 3 participants.	6 Participants n=6 Participants • Sex information not available for 3 participants.	22 Participants n=34 Participants • Sex information not available for 3 participants.
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Canada	5 participants n=31 Participants	0 participants n=6 Participants	5 participants n=37 Participants
Region of Enrollment United States	26 participants n=31 Participants	6 participants n=6 Participants	32 participants n=37 Participants

PRIMARY outcome

Timeframe: 60 months post initial stimulation

Population: Pre- and post-operative data were not collected for this outcome measure and thus no data is reported here

Speech perception scores will be compared pre-operatively and postoperatively.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 60 months post initial activation

Population: Pre- and post-operative data were not collected for this outcome measure and thus no data is reported here

Scores over time on the MacArthur communicative development inventory.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 5 years

Population: Pre- and post-operative data were not collected for this outcome measure and thus no data is reported here.

Speech production scores over time on the Goldman-Fristoe test of articulation and the Kaufman speech praxis test for children.

Outcome measures

Outcome data not reported

Adverse Events

Bilateral

Serious events: 6 serious events

Other events: 4 other events

Deaths: 0 deaths

Unilateral

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Bilateral n=31 participants at risk Bilaterally implanted simultaneously Cochlear Implant: Bilateral Implantation in children	Unilateral n=6 participants at risk Unilaterally implanted Cochlear Implant: Bilateral Implantation in children
Surgical and medical procedures high fever during surgery	3.2% 1/31 • Number of events 1 • Adverse events were collected from the time of enrollment through the study endpoint ( 5 years postoperatively) for each subject. However, due to early termination of the study the endpoint was not reached, and participants were followed for an average of 3 years postoperatively. Definitions do not differ	0.00% 0/6 • Adverse events were collected from the time of enrollment through the study endpoint ( 5 years postoperatively) for each subject. However, due to early termination of the study the endpoint was not reached, and participants were followed for an average of 3 years postoperatively. Definitions do not differ
Ear and labyrinth disorders Device failure due to impact	3.2% 1/31 • Number of events 1 • Adverse events were collected from the time of enrollment through the study endpoint ( 5 years postoperatively) for each subject. However, due to early termination of the study the endpoint was not reached, and participants were followed for an average of 3 years postoperatively. Definitions do not differ	0.00% 0/6 • Adverse events were collected from the time of enrollment through the study endpoint ( 5 years postoperatively) for each subject. However, due to early termination of the study the endpoint was not reached, and participants were followed for an average of 3 years postoperatively. Definitions do not differ
Ear and labyrinth disorders Device failure	12.9% 4/31 • Number of events 4 • Adverse events were collected from the time of enrollment through the study endpoint ( 5 years postoperatively) for each subject. However, due to early termination of the study the endpoint was not reached, and participants were followed for an average of 3 years postoperatively. Definitions do not differ	0.00% 0/6 • Adverse events were collected from the time of enrollment through the study endpoint ( 5 years postoperatively) for each subject. However, due to early termination of the study the endpoint was not reached, and participants were followed for an average of 3 years postoperatively. Definitions do not differ

Other adverse events

Measure	Bilateral n=31 participants at risk Bilaterally implanted simultaneously Cochlear Implant: Bilateral Implantation in children	Unilateral n=6 participants at risk Unilaterally implanted Cochlear Implant: Bilateral Implantation in children
Ear and labyrinth disorders Changes in device telemetry	6.5% 2/31 • Number of events 2 • Adverse events were collected from the time of enrollment through the study endpoint ( 5 years postoperatively) for each subject. However, due to early termination of the study the endpoint was not reached, and participants were followed for an average of 3 years postoperatively. Definitions do not differ	0.00% 0/6 • Adverse events were collected from the time of enrollment through the study endpoint ( 5 years postoperatively) for each subject. However, due to early termination of the study the endpoint was not reached, and participants were followed for an average of 3 years postoperatively. Definitions do not differ
Ear and labyrinth disorders Otitis media	6.5% 2/31 • Number of events 2 • Adverse events were collected from the time of enrollment through the study endpoint ( 5 years postoperatively) for each subject. However, due to early termination of the study the endpoint was not reached, and participants were followed for an average of 3 years postoperatively. Definitions do not differ	0.00% 0/6 • Adverse events were collected from the time of enrollment through the study endpoint ( 5 years postoperatively) for each subject. However, due to early termination of the study the endpoint was not reached, and participants were followed for an average of 3 years postoperatively. Definitions do not differ

Additional Information

Jennifer Bulls

MED-EL Corporation

Phone: 1-888-633-3524

Email: research.us@medel.com

Results disclosure agreements

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

Restriction type: LTE60