Noninvasive Therapy for Tinnitus

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.

NCT Number	NCT07071480
Lead Sponsor	Restorear Devices LLC Collaborators: University of Miami, National Institute on Deafness and Other Communication Disorders (NIDCD)
Conditions	Tinnitus, Tinnitus, Subjective
Enrollment	40 participants
Start Date	2025-11-24
Primary Completion	2026-11-30 (estimated)
Study Completion	2027-05-31 (estimated)
Updated on ClinicalTrials.gov	2026-07-09