Investigation of a Device to Deliver Intra-Operative Therapeutic Hypothermia for Hearing Preservation in Cochlear Implantation
Restorear Devices LLC · with University of Miami, National Institute on Deafness and Other Communication Disorders (NIDCD) · NCT06375278
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 18+ · All sexes
- Healthy volunteers
- Not accepted (a condition is required)
- Study type
- Interventional · Not applicable
- Target enrollment
- 54
- US sites recruiting
- 1
- Study start
- September 23, 2024
- Record last updated
- July 23, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
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:
- Is mild therapeutic hypothermia safe for use during cochlear implantation?
- 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).
Being studied: Intra-Ear Canal Cooling Catheter
Conditions: Cochlear Implants; Cochlear Implantation; Hearing Loss
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full 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.
- 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.
Recruiting US locations
University of Miami
Miami, FL 33136
Site contact: Suhrud M Rajguru, Ph.D. · 8016418180 · srajguru@restorear.com
Study contacts (from the official record)
- Suhrud M Rajguru, Ph.D. · 801-641-8180 · srajguru@restorear.com
- Curtis S King · 406-414-6278 · cking@restorear.com