![]() ![]() ![]() ![]() “We’re excited to have reached this milestone and look forward to being able to offer this amazing technology to children in the United States who currently have no other option for hearing rehabilitation,” said Eric Wilkinson, MD, co-principal investigator and lead physician for the clinical trial, HRI, and associate of House Clinic. The Pediatric ABI team includes physicians and researchers from the House Research Institute, including Eric Wilkinson, MD, Laurie Eisenberg, PhD, Robert Shannon, PhD, Marc Schwartz, MD, Laurel Fisher, PhD, Steve Otto, MA, and Margaret Winter, MS Children’s Hospital’s Mark Krieger, MD, and Gordon McComb, MD and Verona Hospital’s Vittorio Colletti, MD, Marco Carner, MD, and Liliana Colletti, PhD. This study has the potential to expand the use of this device, which represents the only effective sensory prosthetic for direct brain stimulation in use today.” However, it has never been approved by the FDA for treating deafness in children. “Since its development at the House Research Institute in 1979 by Drs William House and William Hitselberger, the ABI has been successful in providing a sense of sound to many adults in the US. “This will be the first FDA-approved trial of its kind, and represents a major step forward to bring a sense of hearing to deaf children in the US who are born without a hearing nerve or cochlea (hearing organ) and therefore are unable to benefit from hearing aids or cochlear implants,” said Neil Segil, PhD, executive vice president for research, House Research Institute. Since the procedure began, more than 1,000 adults worldwide have received the ABI, according to House Clinic. The ABI was developed at the House Research Institute and is the world’s first prosthetic hearing device to stimulate neurons directly at the human brainstem, bypassing the inner ear and hearing nerve entirely. The trial is a surgical collaboration sponsored by the House Research Institute in partnership with Children’s Hospital Los Angeles and Vittorio Colletti, MD, of the University of Verona Hospital, Verona, Italy. The House Research Institute (HRI) and Children’s Hospital in Los Angeles announced today that the United States Food and Drug Administration (FDA) has given final approval to begin a clinical trial of an Auditory Brainstem Implant (ABI) procedure for children. ![]()
0 Comments
Leave a Reply. |
AuthorWrite something about yourself. No need to be fancy, just an overview. ArchivesCategories |