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

Phase 1

Completed

Conditions: Profound Bilateral Deafness Due to
Bilateral Cochlear Aplasia
Bilateral Cochlear Nerve Deficiency
Bilateral Cochlear Ossification Secondary to Meningitis

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: The multichannel auditory brainstem implant (ABI) has now been used with some benefit in more than 1000 deaf patients worldwide who were not candidates for a cochlear implant (CI). For many years, the ABI was used primarily in adults deafened by Neurofibromatosis-Type 2 (NF2). During the past decade, ABI surgery has been safely performed on non-NF2 children outside of the United States, and results have shown great promise. The overall objective of this Phase I Clinical Trial grant is to evaluate safety in ten pediatric subjects who are not candidates for traditional cochlear implants due to cochlear nerve deficiency, cochlear aplasia, or cochlear ossification. These types of pathologies prevent normal transmission of auditory information between the cochlea and the brainstem. The University of Southern California, House Clinic, and Children's Hospital of Los Angeles are conducting a pediatric, non-NF2 ABI clinical with the Nucleus ABI device.

The Primary Aim is to describe the safety aspects of device implant surgery and 12-month use of an ABI in 10 pediatric patients (ages 2-6 years) with profound bilateral hearing loss not amenable to other treatments, such as hearing aids or cochlear implants. Surgical safety analysis is defined as no greater number of serious surgery-related adverse events than is commonly observed in non-NF2 adults undergoing craniotomy with or without an ABI and no more than four unexpected serious device-related adverse events for the 10 subjects during 12 months of follow-up. A Secondary Aim will determine whether or not the device provides patients with access to sound (thresholds of 50 dB HL) during a critical period for communication skills development. Efficacy is here defined as access to sound at a level and within the frequency range, known to be associated with speech.

Recruitment & Eligibility

Status: COMPLETED

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

Primary Outcome Measures

Name	Time	Method
Primary Endpoint	12-months post-device (auditory brainstem implant) successful activation	Surgical Safety The number of subjects successfully implanted.

Secondary Outcome Measures

Name	Time	Method
Secondary Endpoint: Preliminary Efficacy	3 years post-device activation	Access to sound at a level (dB HL) and with the frequency range (500-4000Hz), known to be associated with speech.

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