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

> **NIH NIH R44** · RESTOREAR DEVICES, LLC · 2024 · $970,535

## Abstract

Project Summary
RestorEar Devices LLC aims to develop and test application of mild therapeutic hypothermia to mitigate noise-
induced hearing loss (NIHL). 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 firefighters who are occupationally at-risk. 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. Preliminary and prior published results show that controlled and localized therapeutic
hypothermia provided to the inner ear post-noise or surgical trauma conserves significant residual hearing and
preserves sensitive neural structures. Over the past 3 years, the University of Miami team has also shown noise-
induced changes in hearing and balance functions in at-risk groups of firefighters. With the prior Phase I SBIR
award, RestorEar Devices LLC designed, built and tested systems and protocols to deliver mild therapeutic
hypothermia non-invasively to the inner ear. We met all of the milestones outlined, including testing the efficacy
of our devices for human application using computational models of heat transfer and studies from cadaveric
temporal bones. We are now ready to translate one such device, ReBoundTM, to practice. This Phase II SBIR
proposal will test safety and efficacy of ReBound-delivered mild therapeutic hypothermia treatment in mitigating
noise-induced hearing loss in firefighters. In collaboration with the University of Miami and South Florida fire
services, we have designed a clinical study to test this therapy in occupationally at-risk firefighters. Subjective
and functional assessments repeated over time will enable evaluation of the protective effects of mild therapeutic
hypothermia following noise exposure. Considering that the prevalence of hearing loss is expected to increase
significantly in the next few decades, these human clinical studies will support establishing therapeutic
hypothermia for hearing protection.

## Key facts

- **NIH application ID:** 10921181
- **Project number:** 2R44DC018760-02A1
- **Recipient organization:** RESTOREAR DEVICES, LLC
- **Principal Investigator:** Curtis Scott King
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $970,535
- **Award type:** 2
- **Project period:** 2024-05-20 → 2026-04-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10921181

## Citation

> US National Institutes of Health, RePORTER application 10921181, Non-Invasive System to Deliver Therapeutic Hypothermia for Protection Against Noise-Induced Hearing Loss (2R44DC018760-02A1). Retrieved via AI Analytics 2026-05-26 from https://api.ai-analytics.org/grant/nih/10921181. Licensed CC0.

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