Research with Human Subjects

Our researchers from the Wilson Auditory Brainstem Implant Program are currently conducting the only FDA-regulated clinical trial in the US for adult deaf patients who do not have NF2 to receive the ABI. This is a joint effort between Mass. Eye and Ear and Harvard Medical School.

Ten patients will be recruited. Patients in this trial have jury to the hearing nerves or inner ear from skull fracture, infection, meningitis, otosclerosis, or have auditory neuropathy or auditory dyssynchrony. Three candidates have already been identified for this study and successful surgery has been performed in one subject with a history of skull base fractures, deafness, and cochlear implant failure in both ears.

This FDA-regulated study was given clearance by the Human Studies Committee of Massachusetts Eye and Ear and Harvard Medical School in 2012.

A second study for pediatric patients who are deaf but do not have NF2 to receive the ABI was approved in May 2013.