FDA Approves Auditory Brainstem Implant

For those who are born without a hearing nerve or cochlea, there is now a solution approved by the FDA — Auditory Brainstem Implant (ABI).

Basically, the ABI is a prosthetic hearing device that stimulate neurons inside the human brainstem, and it was developed by House Research Institute in Los Angeles, CA. The United States Food and Drug Administration recently gave them final approval to begin a clinical trial of the procedure for treating deafness in children.

“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 U.S. 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, Ph.D of House Research Institute.

The ABI was first developed in 1979 by Dr. William House and William Hitselberger, and has since offered the technology to more than 1,000 adults worldwide, but it was never approved by the FDA for treating deaf children until now.

“Children’s Hospital Los Angeles is thrilled that the FDA has approved the Auditory Brainstem Implant clinical trial for children. 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,” said pediatric neurosurgeon Mark Krieger, MD, Children’s Hospital Los Angeles.

The evaluation of patients for potential enrollment beings in the next several months.