Feasibility Study of Auditory Brainstem Implant in Young Children

Withdrawn before enrolling · Phase 1

Conditions studied: Bilateral Cochlear Aplasia, Bilateral Cochlear Nerve Deficiency, Bilateral Cochlear Ossification Secondary to Meningitis

In brief

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.

Key facts

Study ID

NCT01850225

Run by

House Research Institute

People needed

0

Starts

2013-10-01

Expected to finish

2017-09-01

Last updated by the study team

2015-03-18

Who can join

Age: 2 and older, up to 5. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Medical contraindication to craniotomy/intracranial surgery
• Severe cognitive or developmental delays

Where it is running

• House Research Institute CARE Center — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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