This study is looking into a new way to protect your hearing during cochlear implant surgery. It's testing a device called an Intra-Ear Canal Cooling Catheter, which applies mild cooling inside your ear canal during the operation. The goal is to see if this cooling method is safe and if it can help preserve any remaining hearing you have after getting a cochlear implant. You could be eligible if you have severe to profound hearing loss and are planning to have cochlear implant surgery at the University of Miami. Researchers will measure your hearing at different times after surgery to see if the cooling treatment made a difference. The study is currently unclear on its recruitment status.

Study design

This study is an interventional study planning to enroll 54 participants. It will compare results from those receiving the cooling therapy to a control group who do not receive the therapy.

What's involved

Participants will receive mild therapeutic hypothermia therapy during their cochlear implant surgery. Your hearing will be tested at initial cochlear implant activation (or 1 month post-operatively), and again at 3 and 12 months after surgery.

Compensation

Not stated in the trial record.

Follow-up

Participants will be followed for 12 months after their cochlear implant surgery, with hearing tests at specific intervals.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.