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Phase 1 N=6 Device Feasibility

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

Bottom Line

View on ClinicalTrials.gov: NCT02102256 ↗
Enrolled (actual)
6
Serious AEs
10.0%
Results posted
Sep 2025
Primary outcome: Primary: Primary Endpoint — 6 Participants

Study Design & Population

Study type
Interventional
Phase
Phase 1
Interventions
Auditory Brainstem Implant (Device)
Age
Pediatric · 2+ yrs
Sex
All
Sponsor
Laurie Eisenberg
Primary completion
Apr 2021

Outcome Measures

OutcomeResultp-value
PRIMARY
Primary Endpoint		 6 —
SECONDARY
Secondary Endpoint: Preliminary Efficacy		 5; 5; 5; 5; 5 —

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.

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
View full record on ClinicalTrials.gov →

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.

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