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

Recruiting now · Not applicable

Conditions studied: Cochlear Implants, Cochlear Implantation, Hearing Loss

In brief

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).

Key facts

Study ID

NCT06375278

Run by

Restorear Devices LLC

People needed

54

Starts

2024-09-23

Expected to finish

2027-09-30

Last updated by the study team

2026-07-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Potential participants for the study are patients who have been diagnosed with severe to profound hearing loss (HL) and plan to undergo cochlear implantation (CI) at the University of Miami. The cochlear implant surgery, pre and post-surgical care, and activation and programming of the implant are part of the participants' standard of care. If the inclusion criteria are met (age 18 years and older, equal number of men and women, profound sensorineural hearing loss (for safety study n=6) and residual hearing (see criteria below) from pre-surgical auditory brainstem response (ABR) (for efficacy study n=48), equal numbers of CI devices from all 3 manufactures and English or Spanish speakers the patient will be approached by the study personnel and will be asked to participate in the study.

You may not qualify if…

• 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.

Where it is running

• University of Miami — Miami, Florida, United States (enrolling)

Full record on ClinicalTrials.gov

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