Pediatric auditory brainstem implant clinical trial awarded NIH grant
House Research Institute (HRI) and Los Angeles Children’s Hospital have announced final approval of grant funding by the NIH National Institute on Deafness and Communications Disorders (NIDCD) for a five-year, FDA-approved clinical trial of the auditory brainstem implant (ABI) in children.
Children considered for the clinical trial must have congenital bilateral deafness resulting from a malformed or non-existent cochlea or hearing nerve. Such patients cannot receive hearing benefits from a hearing aid or cochlear implant. Children with cochlear implants that have not provided benefit are also suitable candidates for the study. Ten U.S. children will have their surgical and audiological care provided by the trial grant.
The ABI was developed at HRI in the late 1970s and is the world’s first successful prosthetic hearing device to stimulate neurons directly at the human brainstem, bypassing the inner ear and hearing nerve entirely. More than 1,000 adults worldwide have received the ABI, led by physicians of the House Clinic.
The goal of the study is to establish the safety of both the ABI and the delicate brain surgery procedures required for its successful implantation for children. To date, children who have been implanted with ABIs outside the U.S. have demonstrated potential to understand speech, and five U.S. children who were implanted in Europe in recent years receive regular follow-up by the pediatric audiology staff at HRI’s CARE (Children’s Auditory Research and Evaluation) Center in Los Angeles.
“For the children we have been evaluating in the CARE Center, communication outcomes have been shown to vary. However, we are impressed by the rate at which some of these children are learning to recognize speech without visual cues,” said Laurie Eisenberg, Ph.D., co-director, House Research Institute’s CARE Center, and audiologist and Co-Principal Investigator on the grant.