NCT06375278View on ClinicalTrials.gov

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

NARecruitingINTERVENTIONAL
Enrollment

54

Participants

Timeline

Start Date

September 23, 2024

Primary Completion Date

April 30, 2026

Study Completion Date

July 31, 2026

Conditions
Cochlear ImplantsCochlear ImplantationHearing Loss
Interventions
DEVICE

Intra-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.

Trial Locations (1)

33136

RECRUITING

University of Miami, Miami

All Listed Sponsors
collaborator

University of Miami

OTHER

collaborator

National Institute on Deafness and Other Communication Disorders (NIDCD)

NIH

lead

Restorear Devices LLC

INDUSTRY