Acquired Cochlear Nerve Deficiency Clinical Trial
Official title:
An Early Feasibility Study of the Safety and Efficacy of the Nucleus 24 Auditory Brainstem Implant in Children With Cochlear or Cochlear Nerve Disorders Not Resulting From Neurofibromatosis Type II
To purpose of this feasibility study is to demonstrate the safety and efficacy of the Nucleus
24 Multichannel Auditory Brainstem Implant (ABI, Cochlear Corp, Sydney, AUS) in children
without the diagnosis of neurofibromatosis type II (NFII) that have either experienced failed
cochlear implantation (CI) or have been unable to receive a CI secondary to cochlear or
cochlear nerve disorders. These conditions can include: developmental or acquired cochlear
nerve deficiency (CND), cochlear aplasia (Michel), post-meningitic cochlear ossification or
cochlear malformation.
This study proposes to implant up to 10 young children (<5 yrs. of age) with the Nucleus 24
Multichannel ABI (Sydney, AUS) in an attempt to demonstrate safety of the surgical procedure,
tolerance of device stimulation, and the potential for auditory benefit beyond that
experienced with their CI. This study will provide the preliminary experience for a larger
scale clinical trial.
Aim 1: Demonstrate the safety of ABI surgery in children. Aim 2: Demonstrate the development
of sound awareness and improved speech understanding among children implanted with the ABI
when compared to their baseline skills. Aim 3: Demonstrate the development of oral language
skills following the use of the ABI that were not evident prior to its use.
n/a