The Massachusetts Eye and Ear Infirmary, a Harvard Medical School teaching affiliate, is now enrolling a select group of deaf infants and children in a new FDA-approved clinical trial of an Auditory Brainstem Implant (ABI).
This study will evaluate how the Nucleus 24 ABI improves the hearing and quality of life of deaf infants and children who do not have neurofibromatosis type 2 (NF2) and are not cochlear implant candidates. Outcomes will include subjective and objective measures of hearing before and after ABI surgery. The Food and Drug Administration has issued an Investigational Device Exemption for this new clinical trial.
The ABI is the world's first successful prosthetic hearing device to stimulate auditory neurons directly at the human brainstem, bypassing the inner ear and hearing nerve entirely. More than 1,000 children and adults worldwide have received the ABI.
This device is currently approved by the FDA for adults and children 12 and older who are diagnosed with NF2.
The multidisciplinary Pediatric ABI team is led by Daniel Lee, M.D., Director of Mass. Eye and Ear's Pediatric Ear, Hearing and Balance Center and the Helene and Grant Wilson ABI Program.
"The ABI provides hearing sensations to patients who have deafness from conditions that do not allow for successful cochlear implant surgery. These conditions include severe congenital malformation of the inner ear (no hearing nerve or no cochlea), scarring of both inner ears due to infection / meningitis, otosclerosis, or injury, injury to the hearing nerve or inner ear from a severe skull fracture or auditory neuropathy/dyssynchrony (AN/AD)," Dr. Lee explained. "With the FDA's approval of our new clinical trial, we have the opportunity to study the hearing benefits of the ABI in deaf infants and children who cannot receive the cochlear implant due to conditions not related to NF2."
Dr. Lee and his team are closely collaborating with Professor Vittorio Colletti from Verona, Italy, and Professor Levent Sennaroglu, from Ankara, Turkey, both international experts on pediatric ABI surgery, to ensure that patients who are enrolled in this clinical trial receive the very best possible care at Mass. Eye and Ear.
An adult FDA-approved clinical trial (NCT01736267) at Mass. Eye and Ear began in November 2012 and is actively recruiting deaf patients for the ABI who do not have NF2 and are not cochlear implant candidates (or are failed cochlear implant candidates).
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