[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"otitis-media-with-effusion\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:otitis-media-with-effusion":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,49,77,110],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":28,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":5},"100652552","earflo-a-non-invasive-treatment-for-otitis-media-with-effusion--eustachian-tube-dysfunction-in-adults-100652552",false,"NCT07777302","EarFlo: A Non-Invasive Treatment for Otitis Media With Effusion & Eustachian Tube Dysfunction in Adults","Inclusion Criteria:\n\n* Adults aged 18 years and older.\n* Adults with confirmed Otitis Media with Effusion (OME) diagnosis with clinical assessment.\n* Adults with confirmed dilatory ETD (Eustachian Tube Dysfunction) on clinical assessment.\n* Willingness to refrain from initiating new treatments for OME\u002FETD (e.g., new surgical or device treatments, tympanostomy tubes) during the study period. Standard care will not be refrained if needed.\n\nExclusion Criteria:\n\n* Presence of acute otitis media, ear infection, or otorrhea within the past 4 weeks.\n* Any medical, psychiatric, or cognitive condition that, in the opinion of the investigators, would interfere with study participation or compliance.\n* Inability to use the EarFlo device as instructed (e.g., due to severe nasal obstruction, craniofacial anomalies, or neuromuscular disorders).\n* Recent eye, ear or nose surgeries or ear trauma. (\\\u003C4 weeks)","ALL","18 Years",{"count":18,"type":19},100,"ESTIMATED","INTERVENTIONAL",[22],"NA","This study evaluates the use of the EarFlo device in adults with clinically confirmed Eustachian tube dysfunction and\u002For otitis media with effusion. The purpose of the study is to assess the safety, tolerability, and short-term effects of device use on ear pressure symptoms and middle ear function.\n\nParticipants will complete a brief symptom questionnaire, undergo routine ear examinations and testing, and use the EarFlo device once during a clinic visit. Ear examination and testing will be repeated after device use to evaluate any short-term changes. This study involves a single study visit and does not include any surgical or invasive procedures.",[25,26,27],"Otitis Media With Effusion (OME)","Eustachian Tube Dysfunction","Otitis Media With Effusion",[29,30,31,26,32,33,34,35,36],"OME","ETD","Otitis Media with Effusion","EarFlo","Noninvasive Device","Middle Ear Function","Ear Pressure symptoms","autoinflation","NOT_YET_RECRUITING","2026-08-18",{"date":40,"type":41},"2026-08-20","ACTUAL",{"date":43,"type":19},"2026-08-27",{"date":45,"type":19},"2028-05-15",{"name":47,"class":48},"Philip Perez","OTHER",{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":15,"minAge":57,"maxAge":58,"enrollmentInfo":59,"targetDuration":4,"studyType":20,"phases":61,"briefSummary":62,"conditions":63,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":76},"100466425","coherent-optical-detection-of-middle-ear-disease-100466425","NCT05353569","Coherent Optical Detection of Middle Ear Disease","Otitis Media Diagnosis and Treatment: Coherent Optical Detection of Middle Ear Disease","OCTII","Inclusion Criteria:\n\n* Parental complaint of ear infection or ear pain (Children's Wisconsin Urgent Care Clinics) OR referred for evaluation of otitis media with effusion (Children's Wisconsin ENT Clinic)\n* Speak English\n\nExclusion Criteria:\n\n* Children with craniofacial abnormalities\n* Children with diagnosed immunologic abnormalities\n* Children with congenital syndromic conditions\n* Current open and functioning ear tubes","12 Months","6 Years",{"count":60,"type":19},235,[22],"The purpose of this project is to see if optical coherence tomography (OCT), a new technology acting as an ultrasound for the ear, facilitates accurately diagnosing acute otitis media (AOM) and otitis media with effusion (OME) in children. Clinical diagnoses made using solely otoscopy will be compared to those made with the addition of OCT.",[64,27,65],"Otitis Media","Otitis Media Acute","RECRUITING","2026-01-20",{"date":69,"type":41},"2026-01-21",{"date":71,"type":41},"2022-05-24",{"date":73,"type":19},"2028-04",{"name":75,"class":48},"Medical College of Wisconsin",2,{"id":78,"slug":79,"hasResults":11,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":4,"eligibilityCriteria":83,"healthyVolunteers":11,"sex":15,"minAge":84,"maxAge":85,"enrollmentInfo":86,"targetDuration":88,"studyType":89,"phases":4,"briefSummary":90,"conditions":91,"keywords":93,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":109},"100509565","evaluation-of-outcomes-following-in-office-tympanostomy-using-the-tula-system-a-prospective-multi-center-registry-100509565","NCT05915078","Evaluation of Outcomes Following In-office Tympanostomy Using the Tula® System: a Prospective, Multi-center Registry","Evaluation of Clinical and Health Economic Outcomes Following In-office Tympanostomy Using the Tula® System: a Prospective, Multi-center Registry","Inclusion Criteria:\n\n* Patients ages 6 months through 17 years of age (inclusive) at time of tympanostomy in-office using the Tula® System\n* Patients who are candidates for in-office tube placement using the Tula System according to the System Instructions For Use\n\nExclusion Criteria:\n\n* Patients who are wards are not included","6 Months","17 Years",{"count":87,"type":19},200,"2 Years","OBSERVATIONAL","This prospective, single-arm, multicenter registry is being conducted to collect real world post-market data from patients aged from 6 months to 17 years of age who are undergoing an in-office ear tube placement procedure (tympanostomy) using the Tula® System. The Registry will include up to 20 centers in the US and up to 200 patients for the initial evaluation.\n\nThe FDA-approved Tula System includes the Tula Iontophoresis System (IPS) with TYMBION™ otic anesthetic for local anesthesia of the ear drum and the Tula Tube Delivery System (TDS) for ear tube placement. Clinical research established the safety, efficacy and tolerability of this system for in-office procedures in the pediatric population. Patients will be treated and evaluated according to standard medical care. Outcome data is collected up to 6 months following extrusion or removal of their tube(s).",[27,92,64],"Acute Otitis Media",[94,95,96,97,98],"Otitis media","pediatric","tympanostomy","office procedure","local anesthesia","2024-07-19",{"date":101,"type":41},"2024-07-23",{"date":103,"type":41},"2023-06-15",{"date":105,"type":19},"2027-06-30",{"name":107,"class":108},"Smith & Nephew, Inc.","INDUSTRY",6,{"id":111,"slug":112,"hasResults":11,"nctId":113,"briefTitle":114,"officialTitle":115,"acronym":4,"eligibilityCriteria":116,"healthyVolunteers":117,"sex":15,"minAge":118,"maxAge":119,"enrollmentInfo":120,"targetDuration":4,"studyType":89,"phases":4,"briefSummary":121,"conditions":122,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":135},"100480411","sound-ear-check-sec-in-hearing-diagnostics-in-young-children-100480411","NCT05535634","Sound Ear Check (SEC) in Hearing Diagnostics in Young Children","Sound Ear Check (SEC) in Hearing Diagnostics in Young Children Undergoing Tympanostomy Tube Insertion","Inclusion Criteria:\n\n* Finnish speaking (child and parent)\n\nExclusion Criteria:\n\n* Prior sensorineural hearing loss\n* developmental disorder\n* Prior ear surgery (except tympanostomy insertion)",true,"3 Years","10 Years",{"count":18,"type":19},"Study Sound Ear Check (SEC) hearing test among 3-10 years old otherwise healthy children referred to tympanostomy tube placement. SEC test prior surgery (with middle ear fluid) and at 1 month control visit (dry middle ear with ventilation tube). Otitis media 6 questionnaire prior surgery and at the 1 month control visit.",[123,27,124],"Hearing Loss","Tympanostomy","2022-09-07",{"date":127,"type":41},"2022-09-10",{"date":129,"type":41},"2022-08-31",{"date":131,"type":19},"2028-12-31",{"name":133,"class":134},"Vesa Lahdes","OTHER_GOV",1]