Trial Outcomes & Findings for Auditory Brainstem Implant (ABI) in Adult Non-Neurofibromatosis Type 2 Subjects (NCT NCT01736267)

Last Updated: 2020-05-06

Results Overview

Average pure tone threshold measured 12 months post-operatively. Measured in dB HL, where a lower threshold indicates more sensitive hearing and a higher threshold indicates less sensitive hearing. We only included data from subjects that had auditory percept of any magnitude following ABI surgery (1/3 subjects).

Recruitment status

TERMINATED

Study phase

Target enrollment

3 participants

Primary outcome timeframe

12 months post-operative

Results posted on

2020-05-06

Participant Flow

Participant milestones

Participant milestones
Measure	Non-NF2 ABI Surgery Placement of an Auditory Brainstem Implant (ABI) device
Overall Study STARTED	3
Overall Study COMPLETED	3
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

Baseline characteristics by cohort
Measure	Non-NF2 ABI Surgery n=3 Participants Placement of an Auditory Brainstem Implant (ABI) device
Age, Categorical <=18 years	0 Participants n=3 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=3 Participants
Age, Categorical >=65 years	0 Participants n=3 Participants
Age, Continuous	40 years n=3 Participants
Sex: Female, Male Female	1 Participants n=3 Participants
Sex: Female, Male Male	2 Participants n=3 Participants
Region of Enrollment United States	3 participants n=3 Participants
Pure Tone Threshold Average (dB)	120 dB HL n=3 Participants

PRIMARY outcome

Timeframe: 12 months post-operative

Population: We only included data from subjects that had auditory percept of any magnitude following ABI surgery (1/3 subjects).

Outcome measures

Outcome measures
Measure	Non-NF2 ABI Surgery n=1 Participants Placement of an Auditory Brainstem Implant (ABI) device
Audiologic Performance	87 dB HL

Adverse Events

Non-NF2 ABI Surgery

Serious events: 2 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Non-NF2 ABI Surgery n=3 participants at risk Placement of an Auditory Brainstem Implant (ABI) device
General disorders Headache, photophobia, stiff neck	33.3% 1/3 • Number of events 1 • All reported events occurred within one year of when the participant had surgery. Participants were followed through the end of their participation in the study for safety and continue to receive routine medical monitoring for safety as part of their standard care.
Ear and labyrinth disorders clear AD drainage	33.3% 1/3 • Number of events 1 • All reported events occurred within one year of when the participant had surgery. Participants were followed through the end of their participation in the study for safety and continue to receive routine medical monitoring for safety as part of their standard care.

Other adverse events

Other adverse events
Measure	Non-NF2 ABI Surgery n=3 participants at risk Placement of an Auditory Brainstem Implant (ABI) device
General disorders CSF collection	33.3% 1/3 • Number of events 1 • All reported events occurred within one year of when the participant had surgery. Participants were followed through the end of their participation in the study for safety and continue to receive routine medical monitoring for safety as part of their standard care.
Nervous system disorders non-auditory side effects	33.3% 1/3 • Number of events 1 • All reported events occurred within one year of when the participant had surgery. Participants were followed through the end of their participation in the study for safety and continue to receive routine medical monitoring for safety as part of their standard care.

Additional Information

Dr. Daniel Lee

Massachusetts Eye & Ear Infirmary

Phone: 6175736391

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place