|[July 22, 2014]
Los Angeles Medical Team Performs California's First Auditory Brainstem Implant Surgery on Toddler at Children's Hospital Los Angeles, Part of Only NIH-funded Study of Device's Safety and Use In Young Children
LOS ANGELES --(Business Wire)--
A Los Angeles team of scientists and surgeons from Keck Medicine of the
University of Southern California (USC), Children's
Hospital Los Angeles (CHLA) and Huntington Medical Research
Institutes (HMRI) reported that sound registered in the brain of a deaf
Canadian boy for the first time after doctors activated a hearing device
that had been surgically implanted in his brainstem.
A Los Angeles medical team performed California's first auditory brainstem Implant surgery on a toddler at Children's Hospital Los Angeles. Auguste Majkowski, 3, with his mom Sophie, six weeks after surgery. (Photo: Business Wire)
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 (FDA)-approved trial supported by a National Institutes
of Health (NIH) 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, Auguste's mother. "He's a tough
Auguste's 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,
Ph.D., and surgeon Eric Wilkinson, M.D., 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 Keck School of Medicine of USC otolaryngology professor. "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 Children's Hospital
included Wilkinson, HMRI research scientist and neurotologist at House
Clinic; HMRI research scientist and House Clinic neurosurgeon Marc
Schwartz, M.D., and pediatric neurosurgeon Mark
D. Krieger, M.D., Billy and Audrey Wilder chair, Division
of Neurosurgery at CHLA. Attending the surgery was also Vittorio
Colletti, M.D., of the University of Verona Hospital, Verona, 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 utilize once the surgery is approved for
children in the U.S.
"Hundreds of children in the U.S. can benefit from ABI surgery," said
Krieger, who also is associate professor of clinical neurosurgery at the
Keck School of Medicine of USC. "These children would otherwise never
hear or develop verbal speech in their lives."
Auguste was the first child accepted into the Los Angeles study.
Thirty-six days after the May 6 surgery at CHLA, his parents watched as
audiologists Margaret Winter, M.S. and Jamie Glater, Au.D., from the USC
Center for Childhood Communication activated the device implanted in
Auguste's brainstem. When Winter delivered tiny pulses of electic
current to the electrodes in his brain, the toddler lifted his head
indicating he heard a sound.
Auguste has been deaf since birth. At 22 months, he underwent a
bilateral cochlear implant, which uses electrodes to stimulate auditory
nerves, but the device didn't help him hear because he doesn't have a
cochlear, or hearing, nerve. Auguste traveled with his parents, Sophie
and Christophe, from Montreal to Los Angeles to participate in the
clinical trial. The NIH grant covers the costs of the device, procedure
and subsequent testing. To qualify for participation, patients must show
that standard treatment such as hearing aids and cochlear implants have
During the six-hour surgery in May, doctors made an incision by
Auguste's right ear and removed his right cochlear implant before
implanting the ABI device on his brainstem. The ABI device has external
and internal parts. The external parts, which consist of a processor
with a microphone and transmitter, transform sound into electrical
signals and transmit the signals to an internal receiver that is part of
the electrode array. The electrode array is placed on the cochlear
nucleus of the brainstem. The procedure is considered revolutionary
because it stimulates neurons directly at the human brainstem, bypassing
the inner ear entirely.
The young children who had ABIs implanted outside the United States now
have the potential to understand speech, but, in the United States, the
device is FDA-approved for use only in patients 12 years or older with
neurofibromatosis type II, an inherited disease that causes a
non-malignant brain tumor on the hearing nerve. It has shown limited
effectiveness in adults, however, and scientists believe that the device
would be more effective in young children, when their brains are more
adaptable. The clinical trial will attempt to prove that this surgery is
safe in young children and allow researchers to study how the brain
develops over time and how it learns to hear sound and develop speech.
"The children in this study are under 5 years of age," says Keck School
of Medicine of USC Professor Robert V. Shannon, Ph.D., an investigator
for the trial and leading scientist in the development of ABI technology
since 1989. "When a child is born, their ear is hard-wired for sound but
the brain has to learn how to perceive sound and speech from the
information coming up the hearing pathway. If the ear is not providing
sound information to the brain, the hearing part of the brain doesn't
develop properly. The ABI provides sound to these pathways so they grow
and develop with the child."
After the devices are implanted, the Los Angeles-based researchers will
study how the brain develops over time as it incorporates sound and
speech. If the clinical trial is successful, children across the United
States will be able to benefit from surgical and audiology techniques
and safety and efficacy protocols developed in the study.
About Children's Hospital Los Angeles
Children's Hospital Los Angeles has been named the best children's
hospital on the West Coast and among the top five in the nation for
clinical excellence with its selection to the prestigious U.S. News &
World Report Honor Roll. Children's Hospital is home to The Saban
Research Institute, one of the largest and most productive pediatric
research facilities in the United States. Children's Hospital is also
one of America's premier teaching hospitals through its affiliation
since 1932 with the Keck School of Medicine of the University of
Southern California. For more information, visit�CHLA.org.
Follow us on Twitter,
or visit our blog: WeTreatKidsBetter.org.
About Keck Medicine Of USC
Keck Medicine of USC is the University of Southern California's medical
enterprise, one of only two university-based medical systems in the Los
Angeles area. Encompassing academic, research and clinical excellence,
the medical system attracts internationally renowned experts who teach
and practice at the Keck School of Medicine of USC, the region's first
medical school; includes the renowned USC Norris Comprehensive Cancer
Center, one of the first comprehensive cancer centers established by the
National Institutes of Health (NIH) in the United States; has a medical
faculty practice, the USC Care Medical Group; operates the Keck Medical
Center of USC, which includes two acute care hospitals: 401-licensed bed
Keck Hospital of USC and 60-licensed bed USC Norris Cancer Hospital; and
owns USC Verdugo Hills Hospital, a 158-licensed bed community hospital.
It also includes more than 40 outpatient facilities, some at affiliated
hospitals, in Los Angeles, Orange (News - Alert), Kern, Tulare and Ventura counties.
For more information, go to www.keckmedicine.org/beyond.
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