[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Restorear Devices LLC\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":140},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,52,77,113],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":28,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":51},"100598437","noninvasive-therapy-for-tinnitus-100598437",false,"NCT07071480","Noninvasive Therapy for Tinnitus","Noninvasive Therapeutic Hypothermia for Tinnitus","Inclusion Criteria:\n\n* Adults aged 18 years or older at the time of signing the consent form\n* Fluency in English or Spanish\n* Chronic subjective tinnitus for more than 30 days defined as audible at least 75% of waking hours\n* At least mild tinnitus, score ≥18 on the Tinnitus Handicap Inventory (THI)\n\nExclusion Criteria:\n\n* Severe anxiety, score ≥ 15 on the Generalized Anxiety Disorder-7 (GAD-7)\n* Tinnitus described as non-auditory or pulsatile in nature\n* Catastrophic tinnitus, score ≥78 on the THI\n* Tinnitus that is intermittent in nature\n* Abnormal tympanometric findings\n* Presence of conductive component as characterized by air-bone gaps ≥15 dB at two or more consecutive frequencies\n* Otologic pathologies (including, but not limited to): acoustic neuroma\u002F vestibular schwannoma, chronic ear disease, Meniere's disease, documented fluctuating hearing loss, or ototoxicity\n* Temporomandibular joint disorder\n* Those who are currently receiving medical, pharmacologic, or therapeutic intervention for tinnitus or other otologic conditions.\n* Active hearing aid use\n* Dizziness at the time of signing the consent form or at the time of starting the study protocol treatment\n* Adults unable to consent\n* Individuals who are not yet adults (infants, children, teenagers)\n* Pregnant women\n* Prisoners","ALL","18 Years",{"count":19,"type":20},40,"ESTIMATED","INTERVENTIONAL",[23],"NA","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:\n\n1. Ascertain the benefits of mild therapeutic hypothermia for symptomatic relief of chronic tinnitus in participants using the ReBound hypothermia device.\n2. Ascertain the benefits of mild therapeutic hypothermia for symptom management in chronic tinnitus participants over six months using the ReBound device.\n\nParticipants 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.",[26,27],"Tinnitus","Tinnitus, Subjective",[29,30,31,32,33,34,35,36,37,38],"tinnitus","ringing","ringing in the ears","subjective tinnitus","constant tinnitus","treatment","symptom reduction","symptom management","tinnitus management","intervention","RECRUITING","2026-01-08",{"date":42,"type":43},"2026-01-12","ACTUAL",{"date":45,"type":43},"2025-11-24",{"date":47,"type":20},"2027-05-31",{"name":49,"class":50},"Restorear Devices LLC","INDUSTRY",1,{"id":53,"slug":54,"hasResults":11,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":4,"eligibilityCriteria":58,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":59,"enrollmentInfo":60,"targetDuration":4,"studyType":21,"phases":62,"briefSummary":63,"conditions":64,"keywords":65,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":51},"100594327","external-therapy-for-tinnitus-management-100594327","NCT07017998","External Therapy for Tinnitus Management","Mild Therapeutic Hypothermia for Tinnitus Management","Inclusion Criteria:\n\n* Adults 18-55 years of age at the time of signing the informed consent form with primary complaint of tinnitus;\n* Suffering from subjective tinnitus for at least 30 days;\n* Tinnitus whose level of severity is defined by Tinnitus Handicap Inventory (THI) values ≥12,\n* Tinnitus is constant in nature (defined as audible at least 75% of waking hours).\n\nExclusion Criteria:\n\n* Very mild tinnitus (THI values \\\u003C12);\n* Tinnitus that is intermittent in nature;\n* Tinnitus described as non-auditory or pulsatile in nature;\n* Individuals with a history of vertigo or fluctuating hearing loss, such as that related to Menière's disease, chronic otitis, vestibular neuritis, neuroma, otosclerosis cholesteatoma, or temporomandibular joint disorder;\n* Individuals with a history of extreme sensitivity to cold or heat, including individuals with a past history of frostbite or Raynaud's Syndrome.\n* Those who are currently receiving medical, pharmacologic, or therapeutic intervention for tinnitus or other otologic conditions, including sound therapy, cognitive behavioral therapy (CBT), Tinnitus Retraining Therapy (TRT), steroid injections, or other treatments;\n* Those who present with a mental health score indicating significant psychological component, per standard of care, based on PHQ-4 score of moderate to severe anxiety\u002Fdepression.\n* Children (under 18 years), incarcerated individuals, adults unable to consent, and psychologically vulnerable participants.","55 Years",{"count":61,"type":20},80,[23],"The goal of this remote interventional clinical study is to investigate the use of mild therapeutic hypothermia devices for the symptomatic relief of chronic tinnitus. The main aims of the study are:\n\n1. Ascertain the effects of MTH in chronic tinnitus patients using questionnaires measuring tinnitus severity and intervention-related change.\n2. Ascertain the comfort and acceptability of the hypothermia device and therapy.\n\nParticipants with chronic tinnitus will wear the mild therapeutic hypothermia therapy devices for a single 30 minute session. Researchers will compare results from those receiving therapy to those from a control group.",[26,27],[29,31,66,36,67,68],"ringing ears","cooling","red light therapy","2025-09-10",{"date":71,"type":43},"2025-09-17",{"date":73,"type":43},"2025-07-16",{"date":75,"type":20},"2026-12-01",{"name":49,"class":50},{"id":78,"slug":79,"hasResults":11,"nctId":80,"briefTitle":81,"officialTitle":81,"acronym":4,"eligibilityCriteria":82,"healthyVolunteers":83,"sex":16,"minAge":17,"maxAge":59,"enrollmentInfo":84,"targetDuration":4,"studyType":21,"phases":86,"briefSummary":87,"conditions":88,"keywords":97,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":51},"100572158","non-invasive-system-to-deliver-therapeutic-hypothermia-for-protection-against-noise-induced-hearing-loss-100572158","NCT06729632","Non-Invasive System to Deliver Therapeutic Hypothermia for Protection Against Noise-Induced Hearing Loss","Inclusion Criteria:\n\n* Adults aged 18-55 years old at the time of signing the consent form\n* Fluency in English\n\nExclusion Criteria:\n\n* Abnormal tympanometric findings\n* Abnormal pure tone audiometry from 500-8,000 Hz (Non-firefighters only)\n* Significant history of noise exposure (Non-firefighters only)\n* Temporomandibular joint disorder\n* Otologic pathologies (including, but not limited to): acoustic neuroma\u002Fvestibular schwannoma, chronic ear disease, Meniere's disease, documented fluctuating hearing loss, or ototoxicity\n* Current recipients of medical, pharmacologic, or therapeutic intervention for tinnitus or other otologic conditions\n* Active hearing aid users\n* Adults unable to consent",true,{"count":85,"type":20},116,[23],"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:\n\n1. To test the safety and best duration for use for a new hypothermia device.\n2. To determine if the hypothermia device helps decrease noise-induced hearing loss in a group of firefighters.\n\nParticipants 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).",[89,90,91,92,93,94,95,96],"Noise Exposure","Noise-induced Hearing Loss","Noise; Adverse Effect","Mild Therapeutic Hypothermia","Cooling","Occupational Exposure","Occupational Health","Hidden Hearing Loss",[98,99,100,101,102,67,103,104],"hearing preservation","hearing loss","noise-induced hearing loss","noise exposure","mild therapeutic hypothermia","post-exposure","prevention","2025-03-28",{"date":107,"type":43},"2025-04-02",{"date":109,"type":43},"2024-12-19",{"date":111,"type":20},"2026-12-31",{"name":49,"class":50},{"id":114,"slug":115,"hasResults":11,"nctId":116,"briefTitle":117,"officialTitle":118,"acronym":4,"eligibilityCriteria":119,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":120,"targetDuration":4,"studyType":21,"phases":122,"briefSummary":123,"conditions":124,"keywords":128,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":132,"lastUpdatePostDateStruct":133,"startDateStruct":135,"completionDateStruct":137,"leadSponsor":139,"locationsCount":51},"100544929","investigation-of-a-device-to-deliver-intra-operative-therapeutic-hypothermia-for-hearing-preservation-in-cochlear-implantation-100544929","NCT06375278","Investigation of a Device to Deliver Intra-Operative Therapeutic Hypothermia for Hearing Preservation in Cochlear Implantation","Device to Deliver Intra-Operative Therapeutic Hypothermia for Hearing Preservation in Cochlear Implantation","Inclusion Criteria:\n\nPotential participants for the study are patients who have been diagnosed with severe to profound hearing loss (HL) and plan to undergo cochlear implantation (CI) at the University of Miami. The cochlear implant surgery, pre and post-surgical care, and activation and programming of the implant are part of the participants' standard of care. If the inclusion criteria are met (age 18 years and older, equal number of men and women, profound sensorineural hearing loss (for safety study n=6) and residual hearing (see criteria below) from pre-surgical auditory brainstem response (ABR) (for efficacy study n=48), equal numbers of CI devices from all 3 manufactures and English or Spanish speakers the patient will be approached by the study personnel and will be asked to participate in the study.\n\nExclusion Criteria:\n\nSubjects under 18 years of age. Subjects not meeting functional hearing requirements.\n\nTypes of CI devices:\n\nThe study will enroll patients receiving CI devices from all three manufactures.\n\n1. Advanced Bionics (FDA indications - severe to profound sensorineural hearing loss (greater than or equal to 70 dB HL)\n\n   1. HiRes Ultra 3D slim J\n   2. HiRes Ultra 3D midScala\n2. Cochlear Corporation (FDA indications - moderate to profound sensorineural hearing loss; sentence recognition less than or equal to 50% in the ear to be implanted AND less than or equal to 60% in the contralateral ear\n\n   1. CI632\n   2. CI622\n   3. CI612\n3. Med-EL (moderately-severe to severe sensorineural hearing loss (greater than or equal to 65 db HL).\n\n   1. Synchrony 2 Flex soft\n   2. Synchrony 2 Flex28\n   3. Synchrony 2 Flex 24\n   4. Synchrony 2 Compressed\n   5. Synchrony 2 Medium\n\nAdditional patients receiving devices not listed here may be eligible as the criteria by manufacturer change.",{"count":121,"type":20},54,[23],"The goal of this interventional clinical study is to investigate the use of mild therapeutic hypothermia for preservation of residual hearing in cochlear implant surgery. The main questions the trial aims to answer are:\n\n1. Is mild therapeutic hypothermia safe for use during cochlear implantation?\n2. Is mild therapeutic hypothermia effective at preserving residual hearing after cochlear implantation?\n\nParticipants will receive mild therapeutic hypothermia therapy during cochlear implant surgery. Researchers will compare results from those receiving the therapy to those from a control group (individuals receiving no therapy).",[125,126,127],"Cochlear Implants","Cochlear Implantation","Hearing Loss",[129,130,131],"Cochlear Implant","Residual Hearing","Hearing Preservation","2024-11-18",{"date":134,"type":43},"2024-11-21",{"date":136,"type":43},"2024-09-23",{"date":138,"type":20},"2026-07-31",{"name":49,"class":50},""]