Mass. Eye and Ear Beginning New FDA Clinical Trial for Auditory Brainstem Implants for Children

June 11, 2013

Contact: Mary Leach

BOSTON (June 11, 2013) – Massachusetts Eye and Ear, a Harvard Medical School teaching affiliate, is now enrolling a select group of deaf infants and children in a new FDA-regulated 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. 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 regulated by the FDA for adults and children 12 and older who are diagnosed with NF2.

Dan 20Lee 20webThe multidisciplinary Pediatric ABI team is led by Daniel Lee, MD, director of Mass. Eye and Ear’s Pediatric Ear, Hearing and Balance Center (photo left) 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 regulation 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-regulated clinical trial (NCT01736267) at Mass. Eye and Ear was approved 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). For more details about this adult ABI study please refer to the Mass. Eye and Ear website or

Information on the pediatric FDA-regulated clinical trial (NCT01864291) and the study criteria is available on the Mass. Eye and Ear website or

If you are a patient, parent, referring physician or audiologist who is interested in our pediatric or adult ABI clinical trial, please contact us at 617-573-3130 or email us at:

About Massachusetts Eye and Ear
Mass. Eye and Ear clinicians and scientists are driven by a mission to find cures for blindness, deafness and diseases of the head and neck. After uniting with Schepens Eye Research Institute Mass. Eye and Ear in Boston became the world's largest vision and hearing research center, offering hope and healing to patients everywhere through discovery and innovation. Mass. Eye and Ear is a Harvard Medical School teaching hospital and trains future medical leaders in ophthalmology and otolaryngology, through residency as well as clinical and research fellowships. Internationally acclaimed since its founding in 1824, Mass. Eye and Ear employs full-time, board-certified physicians who offer high-quality and affordable specialty care that ranges from the routine to the very complex. U.S. News & World Report’s “Best Hospitals Survey” has consistently ranked the Mass. Eye and Ear Departments of Otolaryngology and Ophthalmology as top five in the nation.