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

Phase 1

• Conditions: Profound Bilateral Deafness Due to; Bilateral Cochlear Aplasia; Bilateral Cochlear Nerve Deficiency; Bilateral Cochlear Ossification Secondary to Meningitis
• Interventions: Device: Auditory Brainstem Implant

• Registration Number: NCT02102256
• Lead Sponsor: Laurie Eisenberg

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-03
• Study First Submitted: 2014-03-19
• Study First Submitted QC: 2014-03-28
• Study First Posted: 2014-04-02
• Primary Completion: 2019-01
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-13
• Last Update Posted: 2019-02-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental	Auditory Brainstem Implant	Device Implantation

Primary Outcome Measures

Name	Time	Method
Primary endpoint	12-months post-device activation	Serious adverse event (count) per subject. Count of expected serious adverse events per subject.

Secondary Outcome Measures

Name	Time	Method
Secondary endpoint: Preliminary efficacy	3 years post-device activation	Access to sound at a level (dB) and with the frequency range (500-4000Hz), known to be associated with speech.
Unexpected Serious Adverse Events	12-months post-activation	Unexpected adverse events (count).

Trial Locations

Locations (2)

Keck School of Medicine of USC; 🇺🇸 Los Angeles, California, United States

Children's Hospital Los Angeles; 🇺🇸 Los Angeles, California, United States