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

Status:	Active, not recruiting
Conditions:	Other Indications, Other Indications, Infectious Disease
Therapuetic Areas:	Immunology / Infectious Diseases, Other
Healthy:	No
Age Range:	2 - 6
Updated:	2/17/2019
Start Date:	March 2014

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

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.

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

We found this trial at

sites

Childrens Hospital Los Angeles

4650 Sunset Blvd
Los Angeles, California 90027

(323) 660-2450