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Chilling the inner ear: a cool new way to shield hearing?

NCT ID NCT06729632

Prevention Sponsor: Restorear Devices LLC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 23, 2026 · Last updated Jul 24, 2026 · Updated 1 time

Summary

This trial tests whether a non-invasive cooling device worn like a headband can protect the inner ear from noise-induced hearing loss. Firefighters will use the device for 30 minutes immediately after their shifts over a year. Researchers will compare hearing outcomes between those who receive the cooling therapy, a sham device, and no treatment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
a headband-style device that delivers mild cooling to the inner ear
What this could lead to
If it works, this could offer a simple, non-invasive way to prevent noise-induced hearing loss in people with high occupational noise exposure.
What could go wrong
This is an early-stage trial testing safety and best duration, so the cooling approach may not provide meaningful protection. The device must also be practical for real-world use.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 116 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2024

Expected to finish

Sep 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 55 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Adults aged 18-55 years old at the time of signing the consent form * Fluency in English Exclusion Criteria: * Abnormal tympanometric findings * Abnormal pure tone audiometry from 500-8,000 Hz (Non-firefighters only) * Significant history of noise exposure (Non-firefighters only) * Temporomandibular joint disorder * Otologic pathologies (including, but not limited to): acoustic neuroma/vestibular schwannoma, chronic ear disease, Meniere's disease, documented fluctuating hearing loss, or ototoxicity * Current recipients of medical, pharmacologic, or therapeutic intervention for tinnitus or other otologic conditions * Active hearing aid users * Adults unable to consent

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Conditions

The condition(s) this trial relates to.

frostbite hearing loss disorder Hearing Loss, Hidden occupational disorder noise induced hearing loss prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cooling Hidden hearing loss Mild therapeutic hypothermia Noise exposure Noise-induced hearing loss Noise; adverse effect Occupational exposure Occupational health

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • University of Miami

    RECRUITING

    Miami, Florida, 33136, United States

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