[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-OAF":3},{"classification":4,"mappedDevices":37,"similarCandidates":38,"relatedClassifications":120,"syncDates":121},{"id":5,"product_code":6,"device_name":7,"device_class":8,"regulation_number":9,"medical_specialty":9,"medical_specialty_description":10,"review_panel":11,"submission_type_id":12,"definition":13,"implant_flag":14,"life_sustain_support_flag":15,"gmp_exempt_flag":15,"raw":16,"created_at":30,"updated_at":31,"recall_count":32,"latest_recall_date":33,"k510_count":34,"pma_count":35,"event_count":36},3837,"OAF","Implant, Hearing, Active, Middle Ear, Totally Implanted","3","","Unknown","EN","2","Intended to provide useful hearing to persons with sensorineural hearing loss. Indicated for adults with mild to severe sensorineural hearing loss who have a speech discrimination score greater than or equal to 60%.",true,false,{"openfda":17,"definition":13,"device_name":7,"review_code":9,"device_class":8,"implant_flag":27,"product_code":6,"review_panel":11,"gmp_exempt_flag":28,"third_party_flag":28,"medical_specialty":9,"regulation_number":9,"submission_type_id":12,"unclassified_reason":9,"life_sustain_support_flag":28,"medical_specialty_description":10,"summary_malfunction_reporting":29},{"fei_number":18,"pma_number":23,"registration_number":25},[19,20,21,22],"3009183442","2183744","1000219637","3004007782",[24],"P090018",[26,20,19,22],"1058584","Y","N","Eligible","2026-08-18T05:52:51.341121+00:00","2026-08-18T22:05:38.961415+00:00",2,"2018-08-08",0,40,286,[],[39,48,56,63,72,80,88,96,104,112],{"medical_device_id":40,"generic_name":41,"class_classification":42,"jmdn_code":43,"name_similarity":44,"definition_similarity":45,"vector_similarity":46,"score":47},839,"人工中耳","Ⅲ","30084000",0.574468,0.107981,0.760453,0.0327869,{"medical_device_id":49,"generic_name":50,"class_classification":42,"jmdn_code":51,"name_similarity":52,"definition_similarity":53,"vector_similarity":54,"score":55},656,"中耳用植込みモールド","31934000",0.346154,0.128713,0.733989,0.031754,{"medical_device_id":57,"generic_name":58,"class_classification":42,"jmdn_code":59,"name_similarity":60,"definition_similarity":61,"vector_similarity":62,"score":55},1062,"骨固定型補聴器","34180000",0.272727,0.136364,0.738175,{"medical_device_id":64,"generic_name":65,"class_classification":66,"jmdn_code":67,"name_similarity":68,"definition_similarity":69,"vector_similarity":70,"score":71},2979,"デジタル式補聴器","Ⅱ","41207000",0.185185,0.208696,0.693295,0.0277831,{"medical_device_id":73,"generic_name":74,"class_classification":66,"jmdn_code":75,"name_similarity":76,"definition_similarity":77,"vector_similarity":78,"score":79},2970,"耳あな型補聴器","34672000",0.269231,0.171946,0.66408,0.0277778,{"medical_device_id":81,"generic_name":82,"class_classification":42,"jmdn_code":83,"name_similarity":84,"definition_similarity":85,"vector_similarity":86,"score":87},819,"植込み能動型機器用プログラマ","70586000",0.214286,0.15427,0.679759,0.0274436,{"medical_device_id":89,"generic_name":90,"class_classification":66,"jmdn_code":91,"name_similarity":92,"definition_similarity":93,"vector_similarity":94,"score":95},2968,"耳かけ型補聴器","34671000",0.22807,0.176,0.663362,0.0262001,{"medical_device_id":97,"generic_name":98,"class_classification":66,"jmdn_code":99,"name_similarity":100,"definition_similarity":101,"vector_similarity":102,"score":103},2976,"プログラム式補聴器","17666000",0.169492,0.170854,0.694728,0.0261905,{"medical_device_id":105,"generic_name":106,"class_classification":66,"jmdn_code":107,"name_similarity":108,"definition_similarity":109,"vector_similarity":110,"score":111},2973,"カナル型補聴器","41209000",0.169811,0.128079,0.663476,0.0228758,{"medical_device_id":113,"generic_name":114,"class_classification":42,"jmdn_code":115,"name_similarity":116,"definition_similarity":117,"vector_similarity":118,"score":119},646,"人工鼓膜","34410000",0.166667,0.122727,0.735653,0.015873,[],{"510k":122,"classification":123,"enforcement":124,"event":125,"pma":126,"warning_letter":127},"2026-08-18T06:35:18.347+00:00","2026-08-18T05:52:53.75+00:00","2026-08-18T08:01:54.918+00:00","2026-08-18T22:42:53.076+00:00","2026-08-18T06:36:30.549+00:00","2026-08-18T06:42:29.411+00:00"]