Surgeons at Washington University School of Medicine in St. Louis made history on July 15 when they completed the first case in a clinical trial to restore hearing in patients with vestibular schwannomas, also known as acoustic neuromas.
The July operation at Barnes-Jewish Hospital marked the first use of the MED-EL Auditory Nerve Test System (ANTS) in North America, allowing simultaneous removal of a vestibular schwannoma and placement of a cochlear implant. Conceived by Department of Otolaryngology Chair Craig Buchman, MD, and neurotologist Cameron Wick, MD, the clinical trial received FDA-approval for use of the ANTS under an investigator-initiated investigational device exemption (IDE) from the United States Food and Drug Administration (FDA).
The MED-EL system allows monitoring of the auditory nerve during tumor removal, opening the door to preserving that nerve and potential hearing rehabilitation with a cochlear implant for these patients. Since that historic case, the department’s skull base team has completed two more successful operations and has two more patients awaiting the procedure.
“Identifying the auditory nerve during vestibular schwannoma surgery can be challenging because part of the nerve is distorted by the tumor,” said Wick, principal investigator on the trial. Wick, together with Neurotology Chief Jacques Herzog, MD, and neurosurgeon and Department of Neurosurgery Chair Greg Zipfel, MD, participated in the novel surgery.
“Using the ANTS gives us feedback that helps ensure the auditory nerve is healthy during tumor resection and hopefully will be able to carry the cochlear implant signal,” said Wick. “This has the potential to cure the single-sided deafness (SSD) caused by vestibular schwannomas and their treatment.”
For the vast majority of patients with a vestibular schwannoma, hearing gradually declines regardless of whether their benign tumor is observed, radiated, or surgically removed. Current hearing rehabilitation options, like CROS hearing aids or osseointegrated implants, fail to restore hearing in the affected ear. The new procedure offers hope that hearing can be restored through the preservation of the auditory nerve and the use of cochlear implants.
Washington University is the only site for this clinical trial (NCT04241679). For more information about the clinical trial, please contact Cameron Wick, MD, at 314-273-1589 or firstname.lastname@example.org.