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

> **NIH NIH R44** · RESTOREAR DEVICES, LLC · 2022 · $767,772

## Abstract

Project Summary
The goal of our project is to finalize, validate, and prepare for regulatory approvals a device and probe for
delivering localized, controlled therapeutic hypothermia to the inner ear. The device safety and efficacy will be
tested for residual hearing preservation in cochlear implant surgeries by comparing pre- and post-operative
hearing outcomes and intra-operative electrophysiological measurements. Extensive preclinical research was
enabled by a NIDCD R21 and industry support that allowed development of a protocol for hypothermia delivery
using a device and probe suitable for a rodent model. We propose here to re-engineer the device and probe for
clinical implantation in the operating room, and prepare it for regulatory approval. We will also carry out first-in-
patient studies for the therapy by implementing localized, therapeutic hypothermia for protection of hair cells and
neural substrate during cochlear implantation. This approach brings a non-pharmaceutical therapy for residual
hearing preservation to the market. Furthermore, hypothermia localized to the inner ear avoids challenges with
systemic cooling or with delivery of drugs to the inner ear. The device and probe do not require alteration of the
surgical approach or the implant electrode. The specific aims are motivated by our preclinical studies that have
shown that hypothermia can preserve residual hearing long-term post-cochlear implantation. Ensuring the
survival of sensitive hair cells and neural structures in the cochlea will lead to improved residual hearing
preservation, which in the long-term can improve speech perception outcomes.

## Key facts

- **NIH application ID:** 10362716
- **Project number:** 5R44DC019586-02
- **Recipient organization:** RESTOREAR DEVICES, LLC
- **Principal Investigator:** Curtis Scott King
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $767,772
- **Award type:** 5
- **Project period:** 2021-04-01 → 2026-03-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10362716

## Citation

> US National Institutes of Health, RePORTER application 10362716, Device to Deliver Intra-Operative Therapeutic Hypothermia for Hearing Preservation in Cochlear Implantation (5R44DC019586-02). Retrieved via AI Analytics 2026-05-26 from https://api.ai-analytics.org/grant/nih/10362716. Licensed CC0.

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