# Noninvasive System to Deliver Therapeutic Hypothermia for Protection Against Noise-Induced Hearing Loss

> **NIH NIH R43** · RESTOREAR DEVICES, LLC · 2020 · $218,786

## Abstract

Project Summary
Noise-induced hearing loss (NIHL) is global public health risk and is an impairment resulting from irreversible
damage caused to the sensitive structures and neural elements in the cochlea. A Center for Disease Control
and Prevention report highlights that 24% of adults and 17% of teenagers in the United States experience hearing
loss in one or both ears from exposure to occupational or recreational loud sound. NIHL has a high prevalence
among members of the armed forces and is a serious public health concern associated with loss of productivity,
and high health care costs. Globally, occupational noise exposure is responsible for 16% of disabling hearing
loss (over 600 million people); with significant lifetime costs per person in the US alone. While several
pharmacological agents have shown promising results in preclinical trials and/or entered early clinical trials, at
present there is no clinically available strategy to reduce or prevent NIHL. Preliminary and prior published results
show that controlled and localized therapeutic hypothermia provided to the inner ear post-NIHL or post-
mechanical trauma conserves significant residual hearing and preserves sensitive neural structures. The
benefits of therapeutic hypothermia have long been discussed for improved neurological outcomes following
traumatic brain injuries and cardiac arrest. This Phase I SBIR proposal will be used to design, build and test
systems and protocols to deliver mild therapeutic hypothermia non-invasively to the inner ear during the critical
time window following noise trauma. Using computational models of heat transfer and studies from cadaveric
temporal bones, this study aims to translate such devices to clinical practice. Successful completion of these
Phase I studies will enable Restor-Ear Devices LLC to submit a q-sub for an investigational device exemption
(IDE) to the Food and Drug Administration and a future Phase II SBIR application to test efficacy and safety of
therapeutic hypothermia against NIHL in human subjects. Considering that the prevalence of hearing loss is
expected to increase significantly in the next few decades, these studies will be a first step toward establishing
therapeutic hypothermia as a technique for preservation of hearing. It is likely that our systems will find further
applications for protecting auditory and vestibular functions against ototoxic insults, traumatic brain injuries, blast
exposures, and inner ear or middle ear surgeries.

## Key facts

- **NIH application ID:** 10081624
- **Project number:** 1R43DC018760-01A1
- **Recipient organization:** RESTOREAR DEVICES, LLC
- **Principal Investigator:** Curtis Scott King
- **Activity code:** R43 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $218,786
- **Award type:** 1
- **Project period:** 2020-08-05 → 2022-02-28

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10081624

## Citation

> US National Institutes of Health, RePORTER application 10081624, Noninvasive System to Deliver Therapeutic Hypothermia for Protection Against Noise-Induced Hearing Loss (1R43DC018760-01A1). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10081624. Licensed CC0.

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