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

Summary

The goal of this interventional clinical study is to investigate the use of mild therapeutic hypothermia devices for preservation of sensory structures in the cochlea after noise exposure. The main aims of the study are:

1. To test the safety and best duration for use for a new hypothermia device.
2. To determine if the hypothermia device helps decrease noise-induced hearing loss in a group of firefighters.

Participants will wear the mild therapeutic hypothermia therapy devices immediately after a fire service shift serially over a year. Researchers will compare results from those receiving the therapy to those from a control group (individuals receiving no therapy and a sham therapy).

Conditions

• Noise Exposure
• Noise-induced Hearing Loss
• Noise; Adverse Effect
• Mild Therapeutic Hypothermia
• Cooling
• Occupational Exposure
• Occupational Health
• Hidden Hearing Loss

Interventions

DEVICE

Cold pack-delivered mild therapeutic hypothermia

Mild therapeutic hypothermia (cooling), delivered non-invasively to the structures of the inner ear (cochlea) for 30 minutes, using headband-style proprietary device, ReBoundRx.

Sponsors & Collaborators

• University of Miami

  collaborator OTHER

• National Institute on Deafness and Other Communication Disorders (NIDCD)

  collaborator NIH

• Restorear Devices LLC

  lead INDUSTRY

Principal Investigators

• Suhrud M Rajguru, PhD · RestorEar Devices

Study Design

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

55 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2024-12-19

Primary Completion

2026-06-01

Completion

2026-12-31

FDA Device

Yes

Countries

• United States

Study Locations