A Los Angeles team of scientists and surgeons from Keck Medicine of USC, Children’s Hospital Los Angeles and Huntington Medical Research Institutes (HMRI) reported that sound registered in the brain of a deaf Canadian boyfor the first time after doctors activated a hearing device that had been surgically implanted in his brainstem.
Auguste Majkowski, 3, is the first child in the United States to undergo an auditory brainstem implant (ABI) surgery in a U.S. Food and Drug Administration-approved trial supported by a National Institutes of Health clinical trial grant. On June 12, six weeks after surgery at CHLA, the device was activated with positive results at the Department of Otolaryngology – Head & Neck Surgery clinic at Keck Medicine of USC.“It was magical,” said Sophie Gareau, the child’s mother. “He’s a tough kid.”
Breaking the ‘sound barrier’
The surgery, device activation and future behavioral study are part of a five-year clinical trial in which 10 devices will be implanted in deaf children under the age of 5 and studied over the course of three years. The Los Angeles study, co-led by audiologist Laurie Eisenberg and surgeon Eric Wilkinson is the only in the United States to be supported by the NIH.
“Our Los Angeles-based team has been at the forefront of ABI technology development since it came into use in the late 1970s for adults, so it is especially gratifying to help break the ‘sound barrier’ once again; this time, for children who previously could not hear,” said Eisenberg, a professor of otolaryngology at the Keck School of Medicine of USC. “Surgeons outside the United States have been doing ABI surgeries in children for 10 years, but there has never been a formal safety or feasibility study under regulatory oversight. Our team is writing the manuals for all the procedures for this technology, and we have a top-notch multidisciplinary team in place to carry out the research.”
The surgical team that performed the operation at CHLA included Wilkinson, HMRI research scientist and neurotologist at the House Clinic; HMRI research scientist and House Clinic neurosurgeon Marc Schwartz and pediatric neurosurgeon Mark Krieger of Division of Neurosurgery at CHLA. Attending the surgery was Vittorio Colletti of the University of Verona Hospital in Italy, who has performed the most ABI surgeries on children overseas and is a collaborator on the study.
The study’s goal is to establish safety and efficacy protocols for the surgery and subsequent behavioral mapping procedures that doctors in the United States can then later use once the surgery is approved for children in the United States.
“Hundreds of children in the U.S. can benefit from ABI surgery,” said Krieger, who also is associate professor of clinical neurological surgery at the Keck School of Medicine. “These children would otherwise never hear or develop verbal speech in their lives.”