Cochlear ImplantsNCT06375278
Investigation of a Device to Deliver Intra-Operative Therapeutic Hypothermia for Hearing Preservation in Cochlear Implantation
A study testing Intra-Ear Canal Cooling Catheter in people with Cochlear Implants and Cochlear Implantation, run by Restorear Devices LLC at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cochlear Implants, Cochlear Implantation, Hearing Loss
- What is being tested?
- Intra-Ear Canal Cooling Catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Sep 2024to 30 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 17Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Miami
Miami, Florida, 33136
Suhrud M Rajguru, Ph.D., 8016418180, srajguru@restorear.com
Sandra Prentiss, Ph.D., CCC-A, 305-890-6059, S.Prentiss@med.miami.edu
About this study
Official title: Device to Deliver Intra-Operative Therapeutic Hypothermia for Hearing Preservation in Cochlear Implantation
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).
Read the detailed 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 of remaining sensory hair cells (HC) and neurons. As a result, more than 44% of EAS patients lose residual hearing post-CI surgery and the residual hearing deteriorates by more than 30 dB over time in a majority of patients. This loss of residual hearing post-CI surgery has been the primary barrier for an extended application of CI/EAS.
This clinical trial will evaluate a novel mild therapeutic hypothermia device as an effective therapy to preserve residual hearing post-CI. This system does not require modification of the current surgery or CI devices and will deliver localized, controlled mild hypothermia to the sensitive inner ear structures. With preclinical published results, the investigators have already shown that localized hypothermia during CI surgery is highly effective and safe for residual hearing preservation. Here, the investigators will investigate the implementation of a therapy that benefits patients undergoing CI by improving post-surgical audiological outcomes. Extensive prior commercialization and development experience, intellectual property and engineering expertise coupled with the investigators' collaborators' clinical expertise in Otolaryngology and Audiology will ensure the successful clinical and commercial outcome of this therapy.
Overall, the aim of this clinical trial is:
Validate the clinical applicability, safety and efficacy of the system and device assembly for preservation of residual hearing after CI surgery. The device and hypothermia delivery system will be tested on adult patients undergoing CI surgery at the University of Miami. For clinical translation, the investigators aim to demonstrate that the application of hypothermia combined with the current standard of care for cochlear implantation for residual hearing preservation (steroids) is effective. The investigators hypothesize that the hypothermia application will not negatively impact CI function in patients (safety) and will improve early audiologic outcomes (efficacy) compared to the current standard of care in CI surgeries. The investigators will utilize clinically relevant pre-surgical, intra-operative and post-surgical measures in groups of patients receiving the standard of care and hypothermia therapy.
Preliminary and published preclinical data, and an existing system and device have been constructed for this clinical trial. The proposed therapy and device design for CI surgeries represent a non-pharmaceutical therapeutic strategy to preserve residual hearing.
- Conditions
- Cochlear Implants, Cochlear Implantation, Hearing Loss
- Being tested
- Intra-Ear Canal Cooling Catheter
- Keywords
- Cochlear Implant, Residual Hearing, Hearing Preservation
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intra-Ear Canal Cooling CatheterDevice
Mild therapeutic hypothermia will be applied via the catheter device installed inside the ear canal by an experienced surgeon during cochlear implantation (CI) surgery.
| Study group | Role | What they receive |
|---|---|---|
| Safety Study | Experimental | Aim 1: Ascertain the safety of the system and device in patients undergoing cochlear implantation (CI). Mild therapeutic hypothermia will be delivered to the subjects during CI surgery via the ear canal. Receives: Device: Intra-Ear Canal Cooling Catheter |
| Efficacy Study Cooling | Experimental | Aim 2: Ascertain the applicability and efficacy of the device and system in patients undergoing cochlear implantation (CI). Half of the candidates will receive mild therapeutic hypothermia via the ear canal during cochlear implant surgery. Receives: Device: Intra-Ear Canal Cooling Catheter |
| Efficacy Study Control | No intervention | Aim 2: Ascertain the applicability and efficacy of the device and system in patients undergoing cochlear implantation (CI). Half of the candidates will receive standard of care (no cooling) during cochlear implant surgery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pure Tone Audiometry
Pure-tone average (PTA) of 125, 250 and 500 Hz which will be tested post-operatively in the safety and efficacy arms to measure residual hearing. A clinically significant change in hearing is greater than 10 dB HL (decibels hearing level) shift.
Measured: At initial cochlear implant activation or 1 month post-operatively; 3 and 12 months post-operatively
Secondary outcomes (2)
Electrophysiological Impedance
Per standard of care, electrophysiological impedances will be compared between groups intra- and post-operatively to measure CI device and electrode function. Impedances will be measured in the safety and efficacy arms.
Measured: Immediately post-operatively/during surgery; at initial cochlear implant activation/1 month post-operatively; 3 and 12 months post-operatively
Electrically Evoked Compound Action Potential (ECAP)
Per standard of care, ECAP will be compared between groups intra- and post-operatively to test CI device function. ECAP will be measured in the safety and efficacy arms.
Measured: Immediately post-operatively/during surgery; at initial cochlear implant activation/1 month post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2024
- Study start23 Sep 2024
- Primary completion31 Mar 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (111)Papers the sponsor has linked to this study.
- Other trials for Cochlear ImplantsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- For the safety study (aim 1), a single group (n=6) will receive the cooling treatment. For the efficacy study (aim 2) patients will be randomized to either a treatment or control arm in a 1:1 ratio (n=24 per group) in a parallel model.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Restorear Devices LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Miami, National Institute on Deafness and Other Communication Disorders (NIDCD)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06375278
- Sponsor's protocol ID
- DC019586
- Other IDs
- 5R44DC019586
- Status last verified
- Jul 2026
- First submitted
- 11 Apr 2024
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Lotocki G, de Rivero Vaccari JP, Perez ER, Sanchez-Molano J, Furones-Alonso O, Bramlett HM, Dietrich WD. Alterations in blood-brain barrier permeability to large and small molecules and leukocyte accumulation after traumatic brain injury: effects of post-traumatic hypothermia. J Neurotrauma. 2009 Jul;26(7):1123-34. doi: 10.1089/neu.2008.0802.
PubMed 19558276Khan AM, Handzel O, Damian D, Eddington DK, Nadol JB Jr. Effect of cochlear implantation on residual spiral ganglion cell count as determined by comparison with the contralateral nonimplanted inner ear in humans. Ann Otol Rhinol Laryngol. 2005 May;114(5):381-5. doi: 10.1177/000348940511400508.
PubMed 15966525Ye Q, Tillein J, Hartmann R, Gstoettner W, Kiefer J. Application of a corticosteroid (Triamcinolon) protects inner ear function after surgical intervention. Ear Hear. 2007 Jun;28(3):361-9. doi: 10.1097/01.aud.0000261655.30652.62.
PubMed 17485985Perez E, Viziano A, Al-Zaghal Z, Telischi FF, Sangaletti R, Jiang W, Dietrich WD, King C, Hoffer ME, Rajguru SM. Anatomical Correlates and Surgical Considerations for Localized Therapeutic Hypothermia Application in Cochlear Implantation Surgery. Otol Neurotol. 2019 Oct;40(9):1167-1177. doi: 10.1097/MAO.0000000000002373.
PubMed 31318786Kurz M, Lyden P, Lundbye J, Rajguru S. Local to Systemic Use of Hypothermia. Ther Hypothermia Temp Manag. 2018 Mar;8(1):4-8. doi: 10.1089/ther.2018.29041.mjk. Epub 2018 Jan 23. No abstract available.
PubMed 29360005Dugan EA, Bennett C, Tamames I, Dietrich WD, King CS, Prasad A, Rajguru SM. Therapeutic hypothermia reduces cortical inflammation associated with utah array implants. J Neural Eng. 2020 Apr 29;17(2):026035. doi: 10.1088/1741-2552/ab85d2.
PubMed 32240985Bennett C, Samikkannu M, Mohammed F, Dietrich WD, Rajguru SM, Prasad A. Blood brain barrier (BBB)-disruption in intracortical silicon microelectrode implants. Biomaterials. 2018 May;164:1-10. doi: 10.1016/j.biomaterials.2018.02.036. Epub 2018 Feb 20.
PubMed 29477707Bennett C, Mohammed F, Alvarez-Ciara A, Nguyen MA, Dietrich WD, Rajguru SM, Streit WJ, Prasad A. Neuroinflammation, oxidative stress, and blood-brain barrier (BBB) disruption in acute Utah electrode array implants and the effect of deferoxamine as an iron chelator on acute foreign body response. Biomaterials. 2019 Jan;188:144-159. doi: 10.1016/j.biomaterials.2018.09.040. Epub 2018 Oct 18.
PubMed 30343257Tzen YT, Brienza DM, Karg PE, Loughlin PJ. Effectiveness of local cooling for enhancing tissue ischemia tolerance in people with spinal cord injury. J Spinal Cord Med. 2013 Jul;36(4):357-64. doi: 10.1179/2045772312Y.0000000085.
PubMed 23820151Purdy PD, Novakovic RL, Giles BP, Miller SL, Riegel MS. Spinal cord hypothermia without systemic hypothermia. AJNR Am J Neuroradiol. 2013 Jan;34(1):252-6. doi: 10.3174/ajnr.A3175. Epub 2012 Jul 5.
PubMed 22766669Dietrich WD, Levi AD, Wang M, Green BA. Hypothermic treatment for acute spinal cord injury. Neurotherapeutics. 2011 Apr;8(2):229-39. doi: 10.1007/s13311-011-0035-3.
PubMed 21416406Yokobori S, Bullock R, Gajavelli S, Burks S, Mondello S, Mo J, Wang KK, Hayes RL, Bramlett H, Dietrich D. Preoperative-induced mild hypothermia attenuates neuronal damage in a rat subdural hematoma model. Acta Neurochir Suppl. 2013;118:77-81. doi: 10.1007/978-3-7091-1434-6_13.
PubMed 23564108Matsui T, Ishikawa T, Takeuchi H, Okabayashi K, Maekawa T. Mild hypothermia promotes pro-inflammatory cytokine production in monocytes. J Neurosurg Anesthesiol. 2006 Jul;18(3):189-93. doi: 10.1097/01.ana.0000188639.39844.f6.
PubMed 16799346Levi AD, Casella G, Green BA, Dietrich WD, Vanni S, Jagid J, Wang MY. Clinical outcomes using modest intravascular hypothermia after acute cervical spinal cord injury. Neurosurgery. 2010 Apr;66(4):670-7. doi: 10.1227/01.NEU.0000367557.77973.5F.
PubMed 20190669Kawai N, Okauchi M, Morisaki K, Nagao S. Effects of delayed intraischemic and postischemic hypothermia on a focal model of transient cerebral ischemia in rats. Stroke. 2000 Aug;31(8):1982-9; discussion 1989. doi: 10.1161/01.str.31.8.1982.
PubMed 10926967
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Device to Deliver Intra-Operative Therapeutic Hypothermia for Hearing Preservation in Cochlear Implantation
- ClinicalTrials.gov ID
- NCT06375278
- Acronym / sponsor ID
- DC019586
- Conditions
- Cochlear Implants, Cochlear Implantation, Hearing Loss
- Keywords
- Cochlear Implant, Residual Hearing, Hearing Preservation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Restorear Devices LLCIndustry (pharma, biotech, devices)
- Collaborators
- University of Miami, National Institute on Deafness and Other Communication Disorders (NIDCD)
- Study start
- 23 Sep 2024 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 19 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed 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 of remaining sensory hair cells (HC) and neurons. As a result, more than 44% of EAS patients lose residual hearing post-CI surgery and the residual hearing deteriorates by more than 30 dB over time in a majority of patients. This loss of residual hearing post-CI surgery has been the primary barrier for an extended application of CI/EAS.
This clinical trial will evaluate a novel mild therapeutic hypothermia device as an effective therapy to preserve residual hearing post-CI. This system does not require modification of the current surgery or CI devices and will deliver localized, controlled mild hypothermia to the sensitive inner ear structures. With preclinical published results, the investigators have already shown that localized hypothermia during CI surgery is highly effective and safe for residual hearing preservation. Here, the investigators will investigate the implementation of a therapy that benefits patients undergoing CI by improving post-surgical audiological outcomes. Extensive prior commercialization and development experience, intellectual property and engineering expertise coupled with the investigators' collaborators' clinical expertise in Otolaryngology and Audiology will ensure the successful clinical and commercial outcome of this therapy.
Overall, the aim of this clinical trial is:
Validate the clinical applicability, safety and efficacy of the system and device assembly for preservation of residual hearing after CI surgery. The device and hypothermia delivery system will be tested on adult patients undergoing CI surgery at the University of Miami. For clinical translation, the investigators aim to demonstrate that the application of hypothermia combined with the current standard of care for cochlear implantation for residual hearing preservation (steroids) is effective. The investigators hypothesize that the hypothermia application will not negatively impact CI function in patients (safety) and will improve early audiologic outcomes (efficacy) compared to the current standard of care in CI surgeries. The investigators will utilize clinically relevant pre-surgical, intra-operative and post-surgical measures in groups of patients receiving the standard of care and hypothermia therapy.
Preliminary and published preclinical data, and an existing system and device have been constructed for this clinical trial. The proposed therapy and device design for CI surgeries represent a non-pharmaceutical therapeutic strategy to preserve residual hearing.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- For the safety study (aim 1), a single group (n=6) will receive the cooling treatment. For the efficacy study (aim 2) patients will be randomized to either a treatment or control arm in a 1:1 ratio (n=24 per group) in a parallel model.
| Arm | Type | Receives |
|---|---|---|
| Safety Study | Experimental | Device: Intra-Ear Canal Cooling CatheterAim 1: Ascertain the safety of the system and device in patients undergoing cochlear implantation (CI). Mild therapeutic hypothermia will be delivered to the subjects during CI surgery via the ear canal. |
| Efficacy Study Cooling | Experimental | Device: Intra-Ear Canal Cooling CatheterAim 2: Ascertain the applicability and efficacy of the device and system in patients undergoing cochlear implantation (CI). Half of the candidates will receive mild therapeutic hypothermia via the ear canal during cochlear implant surgery. |
| Efficacy Study Control | No intervention | –Aim 2: Ascertain the applicability and efficacy of the device and system in patients undergoing cochlear implantation (CI). Half of the candidates will receive standard of care (no cooling) during cochlear implant surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (17 listed)
- Subjects under 18 years of age. Subjects not meeting functional hearing requirements.
- 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)
- 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
- Med-EL (moderately-severe to severe sensorineural hearing loss (greater than or equal to 65 db HL).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intra-Ear Canal Cooling CatheterMild therapeutic hypothermia will be applied via the catheter device installed inside the ear canal by an experienced surgeon during cochlear implantation (CI) surgery. | Device | Efficacy Study Cooling, Safety Study |
Primary outcome
Pure Tone Audiometry
Time frame: At initial cochlear implant activation or 1 month post-operatively; 3 and 12 months post-operatively
Pure-tone average (PTA) of 125, 250 and 500 Hz which will be tested post-operatively in the safety and efficacy arms to measure residual hearing. A clinically significant change in hearing is greater than 10 dB HL (decibels hearing level) shift.
2 secondary outcomes
Electrophysiological Impedance
Time frame: Immediately post-operatively/during surgery; at initial cochlear implant activation/1 month post-operatively; 3 and 12 months post-operatively
Electrically Evoked Compound Action Potential (ECAP)
Time frame: Immediately post-operatively/during surgery; at initial cochlear implant activation/1 month post-operatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2026.
- Background: PubMed 19558276Lotocki G, de Rivero Vaccari JP, Perez ER, Sanchez-Molano J, Furones-Alonso O, Bramlett HM, Dietrich WD. Alterations in blood-brain barrier permeability to large and small molecules and leukocyte accumulation after traumatic brain injury: effects of post-traumatic hypothermia. J Neurotrauma. 2009 Jul;26(7):1123-34. doi: 10.1089/neu.2008.0802.
- Background: PubMed 15966525Khan AM, Handzel O, Damian D, Eddington DK, Nadol JB Jr. Effect of cochlear implantation on residual spiral ganglion cell count as determined by comparison with the contralateral nonimplanted inner ear in humans. Ann Otol Rhinol Laryngol. 2005 May;114(5):381-5. doi: 10.1177/000348940511400508.
- Background: PubMed 17485985Ye Q, Tillein J, Hartmann R, Gstoettner W, Kiefer J. Application of a corticosteroid (Triamcinolon) protects inner ear function after surgical intervention. Ear Hear. 2007 Jun;28(3):361-9. doi: 10.1097/01.aud.0000261655.30652.62.
- Background: PubMed 31318786Perez E, Viziano A, Al-Zaghal Z, Telischi FF, Sangaletti R, Jiang W, Dietrich WD, King C, Hoffer ME, Rajguru SM. Anatomical Correlates and Surgical Considerations for Localized Therapeutic Hypothermia Application in Cochlear Implantation Surgery. Otol Neurotol. 2019 Oct;40(9):1167-1177. doi: 10.1097/MAO.0000000000002373.
- Background: PubMed 29360005Kurz M, Lyden P, Lundbye J, Rajguru S. Local to Systemic Use of Hypothermia. Ther Hypothermia Temp Manag. 2018 Mar;8(1):4-8. doi: 10.1089/ther.2018.29041.mjk. Epub 2018 Jan 23. No abstract available.
- Background: PubMed 32240985Dugan EA, Bennett C, Tamames I, Dietrich WD, King CS, Prasad A, Rajguru SM. Therapeutic hypothermia reduces cortical inflammation associated with utah array implants. J Neural Eng. 2020 Apr 29;17(2):026035. doi: 10.1088/1741-2552/ab85d2.
- Background: PubMed 29477707Bennett C, Samikkannu M, Mohammed F, Dietrich WD, Rajguru SM, Prasad A. Blood brain barrier (BBB)-disruption in intracortical silicon microelectrode implants. Biomaterials. 2018 May;164:1-10. doi: 10.1016/j.biomaterials.2018.02.036. Epub 2018 Feb 20.
- Background: PubMed 30343257Bennett C, Mohammed F, Alvarez-Ciara A, Nguyen MA, Dietrich WD, Rajguru SM, Streit WJ, Prasad A. Neuroinflammation, oxidative stress, and blood-brain barrier (BBB) disruption in acute Utah electrode array implants and the effect of deferoxamine as an iron chelator on acute foreign body response. Biomaterials. 2019 Jan;188:144-159. doi: 10.1016/j.biomaterials.2018.09.040. Epub 2018 Oct 18.
- Background: PubMed 23820151Tzen YT, Brienza DM, Karg PE, Loughlin PJ. Effectiveness of local cooling for enhancing tissue ischemia tolerance in people with spinal cord injury. J Spinal Cord Med. 2013 Jul;36(4):357-64. doi: 10.1179/2045772312Y.0000000085.
- Background: PubMed 22766669Purdy PD, Novakovic RL, Giles BP, Miller SL, Riegel MS. Spinal cord hypothermia without systemic hypothermia. AJNR Am J Neuroradiol. 2013 Jan;34(1):252-6. doi: 10.3174/ajnr.A3175. Epub 2012 Jul 5.
- Background: PubMed 21416406Dietrich WD, Levi AD, Wang M, Green BA. Hypothermic treatment for acute spinal cord injury. Neurotherapeutics. 2011 Apr;8(2):229-39. doi: 10.1007/s13311-011-0035-3.
- Background: PubMed 23564108Yokobori S, Bullock R, Gajavelli S, Burks S, Mondello S, Mo J, Wang KK, Hayes RL, Bramlett H, Dietrich D. Preoperative-induced mild hypothermia attenuates neuronal damage in a rat subdural hematoma model. Acta Neurochir Suppl. 2013;118:77-81. doi: 10.1007/978-3-7091-1434-6_13.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intra-Ear Canal Cooling Catheter in people with Cochlear Implants and Cochlear Implantation, run by Restorear Devices LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Suhrud M Rajguru, Ph.D. (801-641-8180, srajguru@restorear.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pure Tone Audiometry (time frame: At initial cochlear implant activation or 1 month post-operatively; 3 and 12 months post-operatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06375278, which also lists 111 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2026.