Using mild cooling during cochlear implant surgery to preserve hearing

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the use of mild therapeutic hypothermia during cochlear implant surgery to preserve residual hearing in patients with severe to profound hearing loss. Participants will receive localized cooling therapy while undergoing the procedure, and their outcomes will be compared to a control group that does not receive the therapy. The study aims to determine both the safety and effectiveness of this approach, which has shown promise in preclinical studies. The goal is to reduce the loss of residual hearing that often occurs after cochlear implantation.

Why it matters

Who can join: the full rules

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.

Where it's running

• University of Miami
  Miami, Florida, United States Recruiting

Study contacts

• Study coordinator: Suhrud M Rajguru, Ph.D.
• Email: srajguru@restorear.com
• Phone: 801-641-8180

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Long-term hearing and speech outcomes after cochlear implants

  This project will see if cochlear implants improve hearing, speech understanding, and quality of life in Mandarin-speaking patients of all ages before and after surgery.

  Recruiting Eye & ENT Hospital of Fudan University · Shanghai · NCT07380269

• Improving music and speech perception for cochlear implant users

  This study is testing a new way to help cochlear implant users hear music and speech better by improving how they perceive sound details that are usually missed.

  Recruiting University of Southern California · Los Angeles, California · NCT04708717

• Long-term outcomes of MED-EL SONATA 2 Cochlear Implants in real life

  This study looks at long-term results from people who received a SONATA 2 cochlear implant to see how well it works in everyday life.

  Recruiting MED-EL Elektromedizinische Geräte GmbH · Madrid and 1 other locations · NCT07697911

• New software to help guide electrode insertion during cochlear implant surgery

  A new software tool called OTOGUIDE is being tested to see if it can help surgeons place cochlear implant electrodes more accurately during surgery.

  Recruiting at 2 sites MED-EL Elektromedizinische Geräte GmbH · Innsbruck, Tyrol and 1 other locations · NCT07690995

• WhatsApp AI support vs paper support for first-time hearing aid users

  This study tests whether a WhatsApp-based AI support program helps adults with new hearing aids in LMIC communities use and feel confident about their devices better than a paper pamphlet.

  Recruiting at 2 sites University of Pretoria · Pretoria, Province and 1 other locations · NCT07690670

• Hearing and Brain Development in Children and Teens

  This observational study tests how hearing care paths (like hearing aids, cochlear implants, brainstem implants, gene therapy, or no intervention) relate to hearing, speech, language, and brain development in kids and teens, with a normal-hearing group for comparison.

  Recruiting Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University · Shanghai · NCT07625462

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.