Evidence map›Paper›PMID 29240567›Full record

ArticleEar and hearing

Theoretical Evaluation and Experimental Validation of Localized Therapeutic Hypothermia Application to Preserve Residual Hearing After Cochlear Implantation.

Ilmar Tamames, Curtis King, Chin-Yuh Huang, Fred F Telischi, Michael E Hoffer, Suhrud M Rajguru

4 registry-linked trialsAbstract readValidation Study
In one paragraph

Article in Ear and hearing. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 4 registered trials, which are not on this map. Cited by 12 papers.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed
0.9field-weighted citation impact, top 25% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT06375278 narecruitingnot on this map

Device to Deliver Intra-Operative Therapeutic Hypothermia for Hearing Preservation in Cochlear Implantation

TypeinterventionalSponsorRestorear Devices LLCRan2024 to 2027Enrolled54ConditionsCochlear Implants, Cochlear Implantation, Hearing LossArmsIntra-Ear Canal Cooling Catheter
NCT06729632 narecruitingnot on this map

Non-Invasive System to Deliver Therapeutic Hypothermia for Protection Against Noise-Induced Hearing Loss

TypeinterventionalSponsorRestorear Devices LLCRan2024 to 2027Enrolled116ConditionsNoise Exposure, Noise-induced Hearing Loss, Noise, Adverse EffectArmsCold pack-delivered mild therapeutic hypothermia
NCT07017998 narecruitingnot on this map

Mild Therapeutic Hypothermia for Tinnitus Management

TypeinterventionalSponsorRestorear Devices LLCRan2025 to 2027Enrolled80ConditionsTinnitus, Tinnitus, SubjectiveArmsCold pack-delivered mild therapeutic hypothermia, Sham (No Treatment)
NCT07071480 narecruitingnot on this map

Noninvasive Therapeutic Hypothermia for Tinnitus

TypeinterventionalSponsorRestorear Devices LLCRan2025 to 2027Enrolled40ConditionsTinnitus, Tinnitus, SubjectiveArmsCold pack-delivered mild therapeutic hypothermia, Sham device
3 · Its place in the literature

Who cites it

12 citing papers in PubMed, 20 citations in OpenAlex.

  1. Article
  2. Development and Evaluation of a Novel Transcanal Catheter for Delivery of Hypothermia to the Inner Ear.Otology & neurotology : official publication of the American Otological Society, American Neurotology Society [and] European Academy of Otology and Neurotology · 2025
    Article
  3. Article
  4. Article
  5. Article
  6. Review
  7. Article
  8. Article
  9. Article
  10. Article
  11. Anatomical Correlates and Surgical Considerations for Localized Therapeutic Hypothermia Application in Cochlear Implantation Surgery.Otology & neurotology : official publication of the American Otological Society, American Neurotology Society [and] European Academy of Otology and Neurotology · 2019
    Article
  12. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors at 1 institution in 1 country.

Ilmar TamamesDepartment of Biomedical Engineering, University of Miami, Miami, Florida, USA.
Curtis KingLucent Medical Systems, Seattle, Washington, USA.
Chin-Yuh HuangDepartment of Biomedical Engineering, University of Miami, Miami, Florida, USA.
Fred F TelischiDepartment of Otolaryngology, University of Miami, Miami, Florida, USA.
Michael E HofferDepartment of Otolaryngology, University of Miami, Miami, Florida, USA.
Suhrud M RajguruDepartment of Biomedical Engineering, University of Miami, Miami, Florida, USA.
University of Miami · US

Funding

Miami Clinical and Translational Science InstituteUL1TR000460 · NCATS · UNIVERSITY OF MIAMI SCHOOL OF MEDICINE · PI SACCO, RALPH L. · 2012 to 2016
$16.9M
Pulsed infrared excitability of inner ear: molecular mechanisms and therapeuticsR01DC013798 · NIDCD · UNIVERSITY OF MIAMI SCHOOL OF MEDICINE · PI RAJGURU, SUHRUD M. · 2015 to 2019
$1.9M
Electronic Self-Management Resource Training to Reduce Health DisparitiesRC2MD004760 · NIMHD · CASE WESTERN RESERVE UNIVERSITY · PI CLOCHESY, JOHN M · 2009 to 2010
$1.3M
Mild therapeutic hypothermia for hearing conservation during inner ear surgeryR21DC014324 · NIDCD · UNIVERSITY OF MIAMI SCHOOL OF MEDICINE · PI RAJGURU, SUHRUD M. · 2015 to 2016
$411k
NCATS NIH HHS UL1 TR000460NIDCD NIH HHS R01 DC013798NIDCD NIH HHS R21 DC014324NIMHD NIH HHS RC2 MD004760
6 · The paper itself

Abstract

objectivesCochlear implantation surgery has been shown to result in trauma to inner ear sensory structures, resulting in loss of residual hearing. Localized therapeutic hypothermia has been shown in clinical care to be a neuroprotective intervention. Previously, we have shown in an experimental model that localized hypothermia protects cochlear hair cells and residual hearing function against surgical and cochlear implantation trauma. Using experimental temperature measurements carried out in human cadaver temporal bones and a finite element model of the inner ear, the present study examined the temperature distribution of a custom-designed hypothermia delivery system in the human inner ear organs.

designThe efficacy of the hypothermia probe and resulting heat distribution across human cochlea and surrounding tissues were modeled in three-dimensional in COMSOL. The geometry and dimensions of inner ear and temporal bones were derived from computed tomographic and magnetic resonance imaging images. Model predictions were compared with experimental observations from five human temporal bones.

resultsIn both the modeling and experimental studies, the cochlear temperature was lowered by 4 to 6 °C on the round window from a baseline of 37 °C within 16 to 18 minutes. The model simulations showed uniformly distributed cooling across the cochlea. This study provides insight for design, operation, and protocols for efficacious delivery of mild therapeutic hypothermia to the human cochlea that may significantly benefit patients undergoing surgical cochlear implantation by preserving residual hearing.

conclusionThere was a close correlation between the results of the numerical simulations and experimental observations in this study. Our custom-designed system is capable of effectively providing mild therapeutic hypothermia locally to the human cochlea. When combined with results from in vivo animal experiments, the present study suggests that the application of localized therapeutic hypothermia may hold potential for patients with an aim to preserve residual hearing after cochlear implantation.

Indexed as

CochleaCochlear ImplantationHearingTemperatureCadaverEar, InnerFinite Element AnalysisHumansHypothermia, InducedImaging, Three-DimensionalModels, TheoreticalPostoperative Care

Identifiers

PMID29240567
PMCPMC5999525
OpenAlexW2774300887

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.