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

Bilateral Cochlear Aplasia Clinical Trial

Official title: A Feasibility Study of the Placement, Use, and Safety of the Nucleus 24 Auditory Brainstem Implant in Non-Neurofibromatosis Type 2 (NF2) Pediatric Patients

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Bilateral Cochlear Aplasia
• Bilateral Cochlear Nerve Deficiency
• Bilateral Cochlear Ossification Secondary to Meningitis
• Deafness
• Hearing Loss
• Meningitis
• Profound Bilateral Deafness Due to

• NCT number: NCT02102256
• Study type: Interventional
• Source: University of Southern California
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: March 2014