Research with Human Subjects
Researchers from the Wilson Auditory Brainstem Implant Program at the Massachusetts Eye and Ear Infirmary are currently conducting the only FDA approved clinical trial in the U.S. for adult deaf patients who do not have NF2 to receive the ABI. This is a joint effort between Massachusetts Eye and Ear Infirmary 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 approved study was given clearance by the Human Studies Committee of the Massachusetts Eye and Ear Infirmary 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 FDA approved in May 2013.