Clinical trial for Cochlear Implants
Official title Investigation of a Device to Deliver Intra-Operative Therapeutic Hypothermia for Hearing Preservation in Cochlear Implantation
ClinicalTrials.gov ID: NCT06375278
What this study is testing
- What it's testing
- The study wants to find out if mild therapeutic hypothermia (cooling) is safe during cochlear implant surgery and whether it helps preserve the patient's residual hearing.
- Who it's for
- People who are having a cochlear implant placed and still have some natural hearing left.
- What's involved
- During the implant operation, a cooling device will be applied to the ear; some participants will receive the cooling and others will not, and hearing will be measured before and after surgery.
- Time commitment
- The cooling is done during the surgery, with follow‑up visits for hearing tests after the operation.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Potential participants for the study are patients who have been diagnosed with severe to profound hearing loss (HL) and plan to undergo cochlear...
You likely can't join if
- people under 18 years of age. people not meeting functional hearing requirements.
- 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
- CI632
See the full eligibility 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.
- people under 18 years of age. people 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.
The study team makes the final eligibility decision.
Where it is enrolling
- Miami, Florida, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Miami, Florida, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.