Evaluating a Device for Mild Therapeutic Cooling During Cochlear Implant Surgery to Preserve Hearing

What this Trial Is About

Researchers are evaluating the use of mild therapeutic hypothermia during cochlear implant surgery to preserve residual hearing in adults with severe to profound sensorineural hearing loss. This interventional clinical trial aims to determine whether this therapy is safe and effective compared to the standard of care, which includes steroids without cooling. The study addresses the common issue of hearing loss deterioration after cochlear implantation that limits broader application of combined acoustic and electrical stimulation. Participants will receive mild therapeutic hypothermia delivered through a device inserted into the ear canal during cochlear implant surgery. The study compares patients receiving this cooling therapy to a control group receiving standard care without cooling. The device delivers localized, controlled mild hypothermia without altering current surgical methods or cochlear implant devices. The trial will assess safety and efficacy, with half the participants receiving the hypothermia therapy and half receiving no cooling during surgery. Participants will undergo standard cochlear implant surgery and follow-up care, including activation and programming of the implant. Hearing will be assessed using pure tone audiometry at cochlear implant activation or one month post-operation, and again at three and twelve months. Additional measures include electrophysiological impedance and electrically evoked compound action potential evaluated during surgery and follow-up visits. The study will monitor hearing preservation and device function over a year, with participation lasting up to 12 months post-surgery.

Investigation of a Device to Deliver Intra-Operative Therapeutic Hypothermia for Hearing Preservation in Cochlear Implantation