• SKIP TO CONTENT
  • SKIP NAVIGATION
  • Patient Resources
    • Clinical Trial Listings
    • What is Clinical Research?
    • Volunteering for a Clinical Trial
    • Understanding Informed Consent
    • Useful Resources
    • FDA Approved Drugs
  • Professional Resources
    • Research Center Profiles
    • Market Research
    • Benchmark Reports
    • FDA Approved Drugs
    • Training Guides
    • Books
    • eLearning
    • Events
    • Newsletters
    • White Papers
    • SOPs
  • White Papers
  • Clinical Trial Listings
  • Advertise
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » Pediatric auditory brainstem implant clinical trial awarded NIH grant

Pediatric auditory brainstem implant clinical trial awarded NIH grant

August 23, 2013
CenterWatch Staff

House Research Institute (HRI) and Los Angeles Children’s Hospital have announced final approval of grant funding by the NIH National Institute on Deafness and Communications Disorders (NIDCD) for a five-year, FDA-approved clinical trial of the auditory brainstem implant (ABI) in children.

Children considered for the clinical trial must have congenital bilateral deafness resulting from a malformed or non-existent cochlea or hearing nerve.  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. Ten U.S. children will have their surgical and audiological care provided by the trial grant.

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.

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 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, Ph.D., co-director, House Research Institute’s CARE Center, and audiologist and Co-Principal Investigator on the grant. 

    Upcoming Events

    • 16Oct

      MAGI@home Clinical Research Conference 2023

    • 25Oct

      2023 WCG Patient Forum

    • 26Oct

      FDA in 2024: What to Expect in an Election Year

    Featured Products

    • Surviving an FDA GCP Inspection

      Surviving an FDA GCP Inspection: Resources for Investigators, Sponsors, CROs and IRBs

    • Best Practices for Clinical Trial Site Management

      Best Practices for Clinical Trial Site Management

    Featured Stories

    • Donna Snyder

      New WCG Executive Physician Outlines Goals for Clinical Research

    • Hand Shake at Meeting

      Partnership to Bolster Trials in Low Resource Regions Kicks Off

    • Guidelines-360x240.png

      Major Industry Groups Offer Feedback on ICH’s E6(R3) Guidelines

    • AsktheExpertsBadge-360x240.png

      Ask the Experts: Monitoring

    Standard Operating Procedures for Risk-Based Monitoring of Clinical Trials

    The information you need to adapt your monitoring plan to changing times.

    Learn More Here
    • About Us
    • Contact Us
    • Privacy Policy
    • Do Not Sell or Share My Data

    Footer Logo

    300 N. Washington St., Suite 200, Falls Church, VA 22046, USA

    Phone 703.538.7600 – Toll free 888.838.5578

    Copyright © 2023. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing