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

Exclusion Criteria17

Subjects under 18 years of age. Subjects not meeting functional hearing requirements.
Types of CI devices:
The study will enroll patients receiving CI devices from all three manufactures.
Advanced Bionics (FDA indications - severe to profound sensorineural hearing loss (greater than or equal to 70 dB HL)
HiRes Ultra 3D slim J
HiRes Ultra 3D midScala
Cochlear Corporation (FDA indications - moderate to profound sensorineural hearing loss; sentence recognition less than or equal to 50% in the ear to be implanted AND less than or equal to 60% in the contralateral ear
CI632
CI622
CI612
Med-EL (moderately-severe to severe sensorineural hearing loss (greater than or equal to 65 db HL).
Synchrony 2 Flex soft
Synchrony 2 Flex28
Synchrony 2 Flex 24
Synchrony 2 Compressed
Synchrony 2 Medium
Additional patients receiving devices not listed here may be eligible as the criteria by manufacturer change.

Print for Your Doctor

Interested in this trial?

Get notified about updates and connect with the research team.

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.