Phase 1
Completed N=6
A Safety Study of the Auditory Brainstem Implant for Pediatric Profoundly Deaf Patients
Profound Bilateral Deafness Due to · Bilateral Cochlear Aplasia · Bilateral Cochlear Nerve Deficiency · Bilateral Cochlear Ossification Secondary to Meningitis
Source: ClinicalTrials.gov NCT02102256 ↗
Enrolled (actual)
6
Serious AEs
10.0%
Results posted
Sep 2025
Primary outcomePrimary: Primary Endpoint — 6 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Primary Endpoint |
6 | — |
| SECONDARY Secondary Endpoint: Preliminary Efficacy |
5; 5; 5; 5; 5 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02102256). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.