January 24, 2013 9:59 — 1 Comment

FDA Approves Clinical Trial of Auditory Brainstem Implant Procedure for Children in the U.S.

On Jan. 22, 2013, the Los Angeles-based House Research Institute and Children’s Hospital Los Angeles announced that the United States Food and Drug Administration (FDA) gave final approval to begin a clinical trial of an Auditory Brainstem Implant (ABI) procedure for children. 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 ABI was developed at the House Research Institute 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. Since the procedure began, more than 1,000 adults worldwide have received the ABI.

“Children’s Hospital Los Angeles is thrilled that the FDA has approved the Auditory Brainstem Implant clinical trial for children,” says pediatric neurosurgeon Mark Krieger, MD, FAANS, who serves as both chief of Medical Staff and chief of the division of pediatric neurosurgery at Children’s Hospital Los Angeles. “We are looking forward to offering this innovative procedure to provide sound to deaf children in the United States. This prosthetic device has shown great success in providing hearing to children and adults and we look forward to contributing to research on advancing the ABI and to the training of physicians on the surgical implantation techniques.” For more information on this story, please click here.

 

One Comment

  1. K.K.Choudhary says:

    It is indeed a good news, We have been doing this ABI for the last two years in Delhi,India. Now, as there is a FDA approval, this procedure will now have wide acceptance.

    Dr. K.K.Choudhary
    Consultant Neurosurgeon
    Columbia Asia Hospital , Gurgaon, Delhi-NCR. INDIA

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