RecruitingNot ApplicableNCT06375278

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

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

Sponsor

Restorear Devices LLC

Enrollment

54 participants

Start Date

Sep 23, 2024

Study Type

INTERVENTIONAL

Conditions

Cochlear Implantation Hearing Loss Cochlear Implants

Summary

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: 1. Is mild therapeutic hypothermia safe for use during cochlear implantation? 2. 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).

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Intra-Ear Canal Cooling Catheter for people with cochlear implantation, cochlear implants, and other related conditions. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEIntra-Ear Canal Cooling Catheter

Mild therapeutic hypothermia will be applied via the catheter device installed inside the ear canal by an experienced surgeon during cochlear implantation (CI) surgery.