A Feasibility Study of the Placement, Use, and Safety of the Nucleus 24 Auditory Brainstem Implant in Non-Neurofibromatosis Type 2 (NF2) Pediatric Patients
Trial Snapshot
- Phase
- Phase 1
- Status
- Withdrawn
- Sponsor
- House Research Institute
- Locations
- 2
- Primary Endpoint
- Number of Serious Adverse Events
Study Overview
Brief Summary
Current treatment options for bilateral profoundly deaf children, diagnosed with inner ear anatomical abnormalities are limited, and in the case of absent cochleas, non-existent. An auditory brainstem implant (ABI) places an electrode close to the auditory nucleus in the brainstem. Children aged 2 - 5 who are not candidates for a cochlear implant, or who did not demonstrate benefit from a cochlear implant, will be implanted with an ABI and followed for 1 year for safety and a total of 3 years for preliminary efficacy. This is a feasibility study to determine the safety of the ABI.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 2 Years to 5 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Bilateral profound deafness due to cochlear aplasia, cochlear nerve deficiency, or ossification secondary to meningitis
- •If previously received a cochlear implant, must demonstrate lack of benefit from that device
Exclusion Criteria
- •Medical contraindication to craniotomy/intracranial surgery
- •Severe cognitive or developmental delays
Outcomes
Primary Outcomes
Number of Serious Adverse Events
Time Frame: 12-month post-activation
Count of the number of expected serious adverse events must not exceed that known to occur in pediatric retrosigmoid craniotomy and Count of the number of unexpected serious adverse events must not exceed 2 in the first 5 children.
Secondary Outcomes
- Access to sound at a level (dB) and within the frequency range (500-4000 Hz), known to be associated with speech(3 years post-activation)