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

Launched by RESTOREAR DEVICES LLC · Apr 16, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring a new method to help preserve hearing during cochlear implant surgery by using a technique called mild therapeutic hypothermia, which involves cooling the body slightly. The main goals of the study are to find out if this cooling method is safe to use during the surgery and whether it effectively helps patients keep some of their natural hearing after getting a cochlear implant.

To be eligible for the study, participants should be 18 years or older and must have been diagnosed with severe to profound hearing loss. They also need to be planning to have cochlear implant surgery at the University of Miami. If they qualify, they will receive the mild cooling treatment during their surgery, and researchers will compare their results with a control group that does not receive this treatment. The trial is currently recruiting participants, and everyone, regardless of gender, can join if they meet the criteria. This study aims to improve outcomes for patients undergoing cochlear implant surgeries and could lead to better hearing preservation techniques in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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.
• Exclusion Criteria:
• • 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.
• • 1. Advanced Bionics (FDA indications - severe to profound sensorineural hearing loss (greater than or equal to 70 dB HL)
• • 1. HiRes Ultra 3D slim J
• • 2. HiRes Ultra 3D midScala
• • 2. 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
• • 1. CI632
• • 2. CI622
• • 3. CI612
• • 3. Med-EL (moderately-severe to severe sensorineural hearing loss (greater than or equal to 65 db HL).
• • 1. Synchrony 2 Flex soft
• • 2. Synchrony 2 Flex28
• • 3. Synchrony 2 Flex 24
• • 4. Synchrony 2 Compressed
• • 5. Synchrony 2 Medium
• • Additional patients receiving devices not listed here may be eligible as the criteria by manufacturer change.