Trial Outcomes & Findings for A Safety Study of the Auditory Brainstem Implant for Pediatric Profoundly Deaf Patients (NCT NCT02102256)

NCT ID: NCT02102256

Last Updated: 2025-09-15

Results Overview

Surgical Safety The number of subjects successfully implanted.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

10 participants

Primary outcome timeframe

12-months post-device (auditory brainstem implant) successful activation

Results posted on

2025-09-15

Participant Flow

Of the 10 subjects enrolled, 4 subjects did not proceed to auditory brainstem implant surgery because (1) the parents chose not to proceed, and/or (2) the child did not meet one or more of the inclusion criteria.

Participant milestones

Participant milestones
Measure	Auditory Brainstem Implant Visit # 1 2 3 4 5 6 7 8 9 10 11-12 Day 0 Day 1-4 Wk 1 Wk 4-6 M 1 M 3 M 6 M 9 M 12 Yr 2-3 Activity Screen Implant In-hospital Activate device Device Fitting/Evaluation Early Efficacy Informed consent X Medical History X Audiological tests X Psychological tests X Vital signs X X X X Physical examination X Chest x-ray, EKG X Vaccinations X CT and MRI X Laboratory tests X Neurotology exam X X X X EABR X X Soundfield Thresholds X X X X X X Monitor vital signs X X X X X X X Device Fitting ("Mapping") X X X X X X X IT-MAIS/MAIS X X X X X X X Adverse Events X X X X X X X X X X Communication Battery X X
Overall Study STARTED	6
Overall Study Auditory Brainstem Implant Surgery	6
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Safety Study of the Auditory Brainstem Implant for Pediatric Profoundly Deaf Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Experimental n=10 Participants Device Implantation Auditory Brainstem Implant
Age, Categorical <=18 years	10 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	3 Years n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	8 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants

PRIMARY outcome

Timeframe: 12-months post-device (auditory brainstem implant) successful activation

Population: Deaf children receiving the auditory brainstem implant

Surgical Safety The number of subjects successfully implanted.

Outcome measures

Outcome measures
Measure	Auditory Brainstem Implant n=6 Participants Visit # 1 2 3 4 5 6 7 8 9 10 11-12 Day 0 Day 1-4 Wk 1 Wk 4-6 M 1 M 3 M 6 M 9 M 12 Yr 2-3 Activity Screen Implant In-hospital Activate device Device Fitting/Evaluation Early Efficacy Informed consent X Medical History X Audiological tests X Psychological tests X Vital signs X X X X Physical examination X Chest x-ray, EKG X Vaccinations X CT and MRI X Laboratory tests X Neurotology exam X X X X EABR X X Soundfield Thresholds X X X X X X Monitor vital signs X X X X X X X Device Fitting ("Mapping") X X X X X X X IT-MAIS/MAIS X X X X X X X Adverse Events X X X X X X X X X X Communication Battery X X
Primary Endpoint	6 Participants

SECONDARY outcome

Timeframe: 3 years post-device activation

Access to sound at a level (dB HL) and with the frequency range (500-4000Hz), known to be associated with speech.

Outcome measures

Outcome measures
Measure	Auditory Brainstem Implant n=6 Participants Visit # 1 2 3 4 5 6 7 8 9 10 11-12 Day 0 Day 1-4 Wk 1 Wk 4-6 M 1 M 3 M 6 M 9 M 12 Yr 2-3 Activity Screen Implant In-hospital Activate device Device Fitting/Evaluation Early Efficacy Informed consent X Medical History X Audiological tests X Psychological tests X Vital signs X X X X Physical examination X Chest x-ray, EKG X Vaccinations X CT and MRI X Laboratory tests X Neurotology exam X X X X EABR X X Soundfield Thresholds X X X X X X Monitor vital signs X X X X X X X Device Fitting ("Mapping") X X X X X X X IT-MAIS/MAIS X X X X X X X Adverse Events X X X X X X X X X X Communication Battery X X
Secondary Endpoint: Preliminary Efficacy 250 Hz	5 Participants
Secondary Endpoint: Preliminary Efficacy 500 Hz	5 Participants
Secondary Endpoint: Preliminary Efficacy 1000 Hz	5 Participants
Secondary Endpoint: Preliminary Efficacy 2000 Hz	5 Participants
Secondary Endpoint: Preliminary Efficacy 4000 Hz	5 Participants

Adverse Events

Experimental

Serious events: 1 serious events

Other events: 1 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Experimental n=10 participants at risk Device Implantation Auditory Brainstem Implant
Ear and labyrinth disorders CSF leak following surgery resolved with lumbar drain	10.0% 1/10 • Number of events 1 • 3 years

Other adverse events

Other adverse events
Measure	Experimental n=10 participants at risk Device Implantation Auditory Brainstem Implant
Ear and labyrinth disorders Vestibular effects during electricial stimulation. Resolved by deprogramming affected electrode.	10.0% 1/10 • 3 years

Additional Information

Dr. Laurie Eisenberg

University of Southern California

Phone: 213-764-2826

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place