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

Laurie Eisenberg

Status and phase: Unknown; Phase 1

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

Treatments: Device: Auditory Brainstem Implant

Study type: Interventional

Funder types: Other

Identifiers

NCT02102256

KSOM-ABI 001

Details and patient eligibility

About

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.

Enrollment: 10 estimated patients

Sex: All

Ages: 2 to 6 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Experimental

Experimental group

Description:

Device Implantation

Treatment:

Device: Auditory Brainstem Implant