Medical Device Daily Staff Writer

A five-year-grant from the National Institutes of Health (NIH) National Institute on Deafness and Communications Disorders (NIDCD) could pave the way to help treat children suffering from congenital bilateral deafness resulting from a malformed or non-existent cochlea or hearing nerve.

House Research Institute (HRI; Los Angeles) and Children's Hospital Los Angeles reported final approval of grant funding by the agencies for a major five-year, FDA-approved clinical trial of the auditory brainstem implant (ABI) in children.

"This is ground-breaking because the NIH budget as a whole has been cut due to Sequestration," Eric Wilkinson, MD, principal investigator, House Research Institute, lead physician on the study, and associate, House Clinic, told Medical Device Daily. "Their budget numbers are down but they still have decided to fund us."

Researchers say this represents the first time the NIDCD has funded a pediatric ABI clinical trial.

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.

Wilkinson said that of every 1,000 births in the U.S. and worldwide, there will be two children who will be born suffering from congenital bilateral deafness resulting from a malformed or non-existent cochlea or hearing nerve.

"The clinical trial grant provides us with vital funding to begin phase one of our surgical trial of the pediatric ABI in the U.S," said Marc Schwartz, MD, ABI neurosurgeon and investigator, and neurosurgeon at House Neurosurgical Associates at the House Clinic.

Wilkinson pointed out that while the ABI has been used in adults, it hasn't received regulatory approval to treat younger children in the U.S. yet and that's the purpose of this trial. He noted that the device has been used for children outside of the U.S. – specifically Europe.

Ten U.S. children will have their surgical and audiological care provided by the trial grant. 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.

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 American 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, PhD, co-director, House Research Institute's CARE Center, and audiologist and co-principal investigator on the grant.

The HRI pointed out the example of Nathan Goss, who was implanted in Italy in 2008 at the age of three, Nathan was one of the first U.S. children to receive an ABI. According to his parents and HRI's CARE Center clinical team, Nathan, who is now 7- years- old, is communicating well enough to be successful in 2nd grade in at mainstream elementary school.

Mark Krieger, MD, pediatric neurosurgeon and chief of medical staff, Children's Hospital Los Angeles, and Billy and Audrey Wilder Endowed Chair in Neurosurgery, who completes the surgical team said, "We are especially looking forward to offering this innovative procedure to provide sound to deaf children in the U.S.," Krieger said.

Omar Ford; 404-262-5546;

omar.ford@thomsonreuters.com

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