[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"normal-hearing\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:normal-hearing":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,42,74],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100645018","measuring-the-evolution-of-speech-perception-in-noise-in-realistic-sound-environments-according-to-age-100645018",false,"NCT07675941","Measuring the Evolution of Speech Perception in Noise, in Realistic Sound Environments According to Age","SI 360","Inclusion Criteria:\n\n* Children with normal hearing (average hearing thresholds at 250 Hz, 500 Hz, 1000 Hz, 2000 Hz, and 4000 Hz less than 20 dB)\n* Be between 7 and 15 years old\n* Be a native French speaker, without bilingualism\n* Have typical development, as assessed by a school level corresponding to their age;\n* No objection from at least one of the two legal guardians\n* Legal guardian registered with social security\n* Able to understand instructions and information provided\n\nExclusion Criteria:\n\n* Inability of the child to respond to tests\n* Abnormal hearing thresholds\n* Speech disorder treated by speech therapist\n* Inability to understand instructions \u002F to respond to tests\n* Neurological conditions\n* Multiple disabilities\n* Ongoing treatment that may affect alertness\n* Unstable ADHD\n* History of tympanic surgery for chronic otitis media\n* Legal impossibility",true,"ALL","7 Years","15 Years",{"count":21,"type":22},150,"ESTIMATED","OBSERVATIONAL","In clinical settings, hearing perception is typically assessed using audiometric tests administered in a controlled environment. To date, these tests are administered in silence or in the presence of noise from fixed sources at an arbitrarily predetermined signal-to-noise ratio. These assessment situations are not representative of the functional difficulties encountered by people with hearing loss or Auditory Processing Disorder in their daily lives. In real life, \"soundscapes\" are diverse. Hearing assessment and rehabilitation should include the child's everyday environments as well as their lifestyle habits.\n\nThe Immersion 360 System (Virtual reality system) was developed specifically to virtually reproduce complex everyday sound experiences with realistic noise types and sound presentation conditions, enabling the assessment of auditory perception under test conditions similar to those encountered in daily life. Some of the sound environments offered by this innovative system have been standardized for adults. No standards exist for children, and we have limited knowledge regarding the development of speech perception skills in noise during childhood and adolescence. It seems essential to measure the age-related development of speech perception in realistic sound environments in order to establish reference data for children and adolescents.\n\nThis work will, through functional assessments of the auditory system and linguistic tests (speech perception in noise), provide a better understanding of the functional development of the central auditory system for speech perception in noise. The results collected from normo-hearing individuals in the age groups of interest will provide a clinical baseline for comparison with patients of the same age.",[26,27,28],"Noise Exposure","Normal Hearing","Child","NOT_YET_RECRUITING","2026-06-23",{"date":32,"type":33},"2026-06-30","ACTUAL",{"date":35,"type":22},"2026-07",{"date":37,"type":22},"2027-07",{"name":39,"class":40},"University Hospital, Toulouse","OTHER",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":17,"minAge":50,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":53,"phases":54,"briefSummary":56,"conditions":57,"keywords":60,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":70,"locationsCount":73},"100565424","evaluating-how-a-tinnitus-implant-affects-tinnitus-loudness-in-adults-with-chronic-tinnitus-and-varying-levels-of-hearing-loss-100565424","NCT06641999","Evaluating How a Tinnitus Implant Affects Tinnitus Loudness in Adults With Chronic Tinnitus and Varying Levels of Hearing Loss","A Prospective, Multicentric, Feasibility Investigation to Assess the Effect of the Tinnitus Implant on Tinnitus Loudness in Adults With Moderate to Severe Chronic Tinnitus Accompanied by Normal Hearing to Moderately Severe Hearing Loss.","TINIS","Inclusion criteria\n\n* 18 years or older.\n* Normal hearing to moderately severe sensorineural hearing loss defined as a pure tone average (PTA) at 500, 1000, 2000 and 4000 Hz less than 65 dB HL in both ears (separately) and best-aided phoneme recognition score more than or equal to 80% in both ears (separately).\n* Unilateral or asymmetric subjective (no pulsatile) tinnitus. In case of asymmetric tinnitus, the worst ear must be implanted.\n* Tinnitus duration of at least 6 months.\n* Severe tinnitus loudness determined by a. VAS-L score in the severe range i.e. 50-100\u002F100 b. TFI score in the severe range i.e. 52-90\u002F100\n* Tinnitus that is intractable and has not been ameliorated satisfactorily by standard of care such as CBT or hearing aid, when such interventions are potentially clinically indicated.\n* Clinically significant reduction in VAS-L score (≥ 15\u002F100 points) in response to trans-tympanic promontory stimulation\n* Willing and able to provide written informed consent.\n* Medically able to use the device and to undergo general anaesthesia for implantation taking into account their medical condition, contraindications and surgical risks.\n* Dutch language proficiency\n\nExclusion Criteria:\n\n* Pulsatile tinnitus.\n* Any anatomical or structural abnormalities of the inner ear, cochlear nerve, or brainstem that would negatively impact response to study intervention (determined in a temporal bone CT and if necessary (e.g. possibility of vestibular\u002Facoustic schwannoma) by a MRI scan of the head (of sufficient quality at the discretion of the investigator) not more than five years old at the time of enrolment\n* Medical contraindications limiting correct placement, activation, or treatment (determined by medical history; contraindications include brain or major ear surgery, brain or temporal bone tumor(s), recurrent ear infections within the last year, otosclerosis, prior major head trauma that results in sudden injury that causes damage to the brain and results in lasting cognitive impairment).\n* Any medical condition, including mental illness or substance abuse, deemed by the Investigator to likely interfere with a patient's ability to sign informed consent, cooperate and\u002For participate in the study, or interfere with the interpretation of the results (incl. pregnant or breastfeeding women or patients with unrealistic expectations).\n* Presence of clinically diagnosed depression or anxiety determined by a psychological state evaluation (if PHQ-9 \\> 9 or GAD-7 \\> 9).\n* Active (currently or within two months prior to enrolment) use of medications (taking regularly scheduled antidepressant, anxiolytic, antipsychotic or antiepileptic medications, or other neuromodulator agents) or other tinnitus treatments.\n* It is permissible to include people who use such medications at lower doses as a sleep aid or for people who intermittently use such medications for situational anxiety (e.g., Ativan before airplane travel). A change in medication during the trial should be avoided.\n* It is permissible to include people who prefer to use a hearing aid to amplify ipsilateral hearing loss. The start of using a hearing aid during the trial should be avoided.\n* Investigator site personnel directly affiliated with this study and\u002For their immediate families; immediate family is defined as a spouse, parent, child, or sibling.\n* Cochlear employees or employees of Contract Research Organizations or contractors engaged by Cochlear for the purposes of this investigation.\n* Current participation, or participation in another interventional clinical study\u002Ftrial in the past 60 days, involving an investigational drug or device (unless the other investigation was\u002Fis a Cochlear sponsored investigation and determined by the investigator or Sponsor to not impact this investigation).","18 Years",{"count":52,"type":22},16,"INTERVENTIONAL",[55],"NA","This study will test an experimental Tinnitus Implant System that consists of a cochlear implant, sound processor and programming software. The Tinnitus implant is surgically placed under the skin just behind the ear in the mastoid bone. It has an electrode that extends from the implant into the promontory bone of the cochlea which emits electrical signals that stimulate the auditory nerve. The sound processor is worn behind the ear and powers the implant via the coil. The study will be conducted in adults with moderate to severe chronic tinnitus who have normal hearing to moderately severe hearing loss in the inner ear. The study participants will undergo a series of tests that include evaluations of tinnitus loudness and annoyance, and self-reported questionnaires on their tinnitus and general health.",[58,59,27],"Tinnitus","Hearing Loss, Bilateral or Unilateral",[61,62],"tinnitus","cochlear implant","RECRUITING","2026-06-01",{"date":66,"type":33},"2026-06-02",{"date":68,"type":33},"2025-06-16",{"date":37,"type":22},{"name":71,"class":72},"Cochlear","INDUSTRY",2,{"id":75,"slug":76,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":80,"eligibilityCriteria":81,"healthyVolunteers":11,"sex":17,"minAge":50,"maxAge":4,"enrollmentInfo":82,"targetDuration":4,"studyType":53,"phases":84,"briefSummary":85,"conditions":86,"keywords":91,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":5},"100577967","a-study-to-evaluate-the-safety-and-performance-of-a-vestibular-implant-in-adults-to-provide-balance-restoration-100577967","NCT06805175","A Study to Evaluate the Safety and Performance of a Vestibular Implant in Adults to Provide Balance Restoration","A Prospective, Multicentric, Staged Feasibility Study to Evaluate the Safety and Performance of the Second-generation Otolith Vestibular Implant in Adults With Vestibular Dysfunction to Mitigate Imbalance. BionicVEST2","BionicVEST2","Inclusion Criteria:\n\n* Adults of 18 years or older with bilateral vestibulopathy \\>1 year of evolution without benefit from conventional rehabilitation treatment. Symptoms unlikely to improve according to clinicians´ estimation.\n* Hearing impairment ranging from:\n\n  1. Early feasibility stage (first 6 subjects enrolled): moderate to severe hearing loss with PTA of 41-70 dB HL on the ear to be implanted.\n  2. Late feasibility stage (12 subjects): normal hearing to severe hearing loss with PTA ≤ 70 dB HL on the ear to be implanted.\n* Patients diagnosed with bilateral vestibulopathy or probable bilateral vestibulopathy based on the consensus document of the Barany Society on vestibular implant candidate criteria for research \\[van de Berg et al., 2020\\]:\n\n  a. Unsteadiness when walking or standing plus at least one of the following: i. Movement-induced blurred vision or ii. Oscillopsia during walking or quick head\u002Fbody movements, and\u002For iii. Worsening of unsteadiness in darkness and\u002For on uneven ground b. Symptoms greatest during head movement and not compensated after rehabilitation program. c. Bilaterally reduced or absent angular VOR function documented by at least one of the following major criteria: i. Pathological horizontal angular VOR gain ≤ 0.6 and at least one vertical angular VOR gain \\\u003C 0.7, measured by the video-HIT technique. ii. Reduced caloric response (sum of bithermal max. peak SPV on each side ≤6◦\u002Fsec for 30 sec water stimuli or \\\u003C10◦\u002Fsec for 60 sec of air stimuli). In case only one of two criteria from c. are matched, the remaining test(s) should comply with the following minor criteria: 1) Bilaterally pathological VOR gains of at least two semicircular canals \\\u003C 0.7, measured by the video- HIT or scleral-coil technique 2) Reduced caloric response (sum of bithermal max. peak SPV on each side \\\u003C10°\u002Fsec for water and air stimuli of ≥30 sec). d. Absent cVEMP and oVEMP responses in the ear to be implanted.\n* Anatomical optimal conditions for implantation evaluated by CT and MRI:\n\nvestibule permeability ascertained and present intact vestibular nerve.\n\n* Ability to use the device and follow a personalized rehabilitation program.\n* Ability to undergo the surgery.\n\nExclusion Criteria:\n\n* Dynamic Gait Index \\> 18 and Functional Gait Assessment \\> 22\n* Ossification or other inner ear anomalies that prevent full insertion of electrodes.\n* Middle ear disorders including conductive hearing loss.\n* Retro cochlear or central origins of hearing impairment.\n* Medical contraindications for surgery.\n* Chronic depression, dementia and cognitive disorders that could, at the discretion of the clinician, significantly interfere with use or evaluation of the VI.\n* Cerebellar ataxias without bilateral vestibulopathy and CANVAS.\n* Known genetical indication for ataxia.\n* Known diagnosis of DFNA9.\n* Downbeat nystagmus syndrome.\n* Persistent Postural-Perceptual Dizziness.\n* Vestibular suppressant medications.\n* Oculomotor disorders (if oscillopsia is prominent).\n* Peripheral neuropathies.\n* Central gait disorders due to normal pressure hydrocephalus, frontal gait disorders, subcortical vascular encephalopathy or multiple sclerosis.\n* Intoxications (i.e. excessive alcohol and\u002For drugs use).\n* No current psychological or psychiatric disorder that could significantly interfere with use or evaluation of the VI.\n* Unable or unwilling to comply with the requirements of the clinical investigation as determined by the Investigator.\n* Unrealistic expectations on the part of the subject, regarding the possible benefits, risks and limitations that are inherent in the procedure and prosthetic device.\n* Investigator site personnel directly affiliated with this study and\u002For their immediate families; immediate family is defined as a spouse, parent, child, or sibling.\n* Cochlear employees or employees of Contract Research Organizations or contractors engaged by Cochlear for the purposes of this investigation.\n* Pregnant or breastfeeding women.\n* Current participation, or participation in another interventional clinical study\u002Ftrial in the past 30 days, involving an investigational drug or device (unless determined by the investigator or Sponsor to not impact this investigation).",{"count":83,"type":22},18,[55],"The main aim of this study is to understand if an experimental vestibular implant system can improve balance performance. The system consists of a vestibular implant combined with a cochlear implant sound processor and programming software. The implant is designed to preserve hearing in the implanted ear. The vestibular implant is surgically placed under the skin just behind the ear in the mastoid bone and has an electrode that stimulates the vestibular nerve. A sound processor is worn behind the ear and powers the implant via the coil. The study will be conducted in adults with bilateral vestibulopathy (BVP) who have normal to severe hearing loss in the inner ear. The study participants will undergo a series of tests that include evaluations of their balance and hearing and self-reported questionnaires on their balance and general health.",[87,88,27,89,90],"Vestibulopathy","Moderate to Severe Hearing Loss","Balance Deficits","Vestibular Abnormality",[92,93,62],"vestibular implant","vestibulopathy","2025-11-23",{"date":96,"type":33},"2025-11-25",{"date":98,"type":33},"2025-09-18",{"date":100,"type":22},"2026-10",{"name":71,"class":72}]