Device to Deliver Intra-Operative Therapeutic Hypothermia for Hearing Preservation in Cochlear Implantation
Restorear Devices LLC
Summary
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).
Description
Cochlear implants (CI) have dramatically changed the treatment and prognosis for patients with severe to profound sensorineural hearing loss. With the recent advent of electro-acoustic stimulation (EAS), the combined acoustic amplification at low frequencies with electrical stimulation of high frequency cochlear regions promises to benefit patients with even partial residual hearing by improving difficult listening situations like speech-in-noise and music appreciation. Unfortunately, trauma associated with the implant surgery results in inflammation, mechanical and vascular damage, and loss o…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- DeviceIntra-Ear Canal Cooling Catheter
Mild therapeutic hypothermia will be applied via the catheter device installed inside the ear canal by an experienced surgeon during cochlear implantation (CI) surgery.
Location
- University of MiamiMiami, Florida