Investigation of a Device to Deliver Intra-Operative Therapeutic Hypot

A new study titled “Investigation of a Device to Deliver Intra-Operative Therapeutic Hypothermia for Hearing Preservation in Cochlear Implantation” is now live on clinicaltrials.gov!

This will be a first-in-humans study examining the safety and efficacy of mild therapeutic hypothermia during cochlear implant (CI) surgery. The study team of audiologists, biomedical engineers, and neurotologists will be using a brand-new hypothermia device from RestorEar called ReSurg to carry out the investigation.

Here is a brief description of the study (from clinicaltrials.gov):

The goal of this interventional clinical study is to investigate the use of mild therapeutic hypothermia for preservation of residual hearing in cochlear implant surgery. The main questions the trial aims to answer are:

Is mild therapeutic hypothermia safe for use during cochlear implantation?

Is mild therapeutic hypothermia effective at preserving residual hearing after cochlear implantation?

Participants will receive mild therapeutic hypothermia therapy during cochlear implant surgery. Researchers will compare results from those receiving the therapy to those from a control group (individuals receiving no therapy).

You can read about the preclinical research that contributed to the development of Resurg here:

As always, check out our Clinical Page to stay up to date on clinical trials and publications. And keep an eye on clinicaltrials.gov as recruitment begins for this study.

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