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Noninvasive Therapy for Tinnitus

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor 2 versions Re-verified since Jan 8, 2026, no change to tracked fieldsv3-v4
  2. Notable Trial status: Not Yet Recruiting to Recruitingv2 Show 4 more changesShow less
    • Start date changed from estimate of Jul 20, 2025 to Nov 24, 2025
    • Primary completion date: Jun 30, 2026 to Nov 30, 2026
    • Study completion date: Dec 31, 2026 to May 31, 2027
    • Site details revised
  3. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The goal of this interventional clinical study is to establish mild therapeutic hypothermia, delivered non-invasively to the structures of the inner ear, as a safe and repeatable therapeutic method for symptomatic relief of tinnitus. The study will assess both objective and subjective measures to address two main aims: 1. Ascertain the benefits of mild therapeutic hypothermia for symptomatic relief of chronic tinnitus in participants using the ReBound hypothermia device. 2. Ascertain the benefits of mild therapeutic hypothermia for symptom management in chronic tinnitus participants over six months using the ReBound device. Participants will wear the ReBound hypothermia device for 30 minutes in a single session. Researchers will compare results from those receiving the therapy to those from a control group (sham therapy). Participants will also use the device in-home for 6 months and monitor their symptoms with online surveys.
Trial Details
NCT Number NCT07071480
Lead Sponsor Restorear Devices LLC
Collaborators: University of Miami, National Institute on Deafness and Other Communication Disorders (NIDCD)
Conditions
(from sponsor)
Tinnitus, Tinnitus, Subjective
Related terms Tinnitus
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov