[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-NIX":3},{"classification":4,"mappedDevices":30,"similarCandidates":31,"relatedClassifications":114,"syncDates":115,"translation":122,"marketSummary":129,"recalls":142,"k510s":144,"pmas":158},{"id":5,"product_code":6,"device_name":7,"device_class":8,"regulation_number":9,"medical_specialty":10,"medical_specialty_description":11,"review_panel":10,"submission_type_id":12,"definition":13,"implant_flag":14,"life_sustain_support_flag":15,"gmp_exempt_flag":15,"raw":16,"created_at":25,"updated_at":26,"recall_count":27,"latest_recall_date":28,"k510_count":29,"pma_count":27,"event_count":27},6466,"NIX","Hearing Aid, Air Conduction, Transcutaneous System","2","874.3950","EN","Ear, Nose, Throat","1","The transcutaneous air conduction hearing aid system is a wearable sound-amplifying device that is intended to compensate for impaired hearing.  It consists of an air conduction hearing aid attached to a surgically fitted tube system.  The tube creates an air channel through the soft tissue between outer ear canal and the post-auricular region of the pinna (ear).  The air conduction hearing aid attaches to the post-auricular opening of the tube, thereby transmiting amplified sound to the ear canal without occluding the canal.",true,false,{"openfda":17,"definition":13,"device_name":7,"review_code":21,"device_class":8,"implant_flag":22,"product_code":6,"review_panel":10,"gmp_exempt_flag":23,"third_party_flag":23,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":21,"life_sustain_support_flag":23,"medical_specialty_description":11,"summary_malfunction_reporting":24},{"k_number":18},[19,20],"DEN020003","K040996","","Y","N","Eligible","2026-08-18T05:52:53.233452+00:00","2026-08-24T02:00:47.318533+00:00",0,null,2,[],[32,41,50,58,66,74,82,90,98,106],{"medical_device_id":33,"generic_name":34,"class_classification":35,"jmdn_code":36,"name_similarity":37,"definition_similarity":38,"vector_similarity":39,"score":40},1062,"骨固定型補聴器","Ⅲ","34180000",0.359375,0.188119,0.738589,0.0325225,{"medical_device_id":42,"generic_name":43,"class_classification":44,"jmdn_code":45,"name_similarity":46,"definition_similarity":47,"vector_similarity":48,"score":49},2978,"骨導式補聴器","Ⅱ","33993000",0.442308,0.235495,0.716115,0.0322665,{"medical_device_id":51,"generic_name":52,"class_classification":44,"jmdn_code":53,"name_similarity":54,"definition_similarity":55,"vector_similarity":56,"score":57},2970,"耳あな型補聴器","34672000",0.232143,0.255102,0.69432,0.0284045,{"medical_device_id":59,"generic_name":60,"class_classification":44,"jmdn_code":61,"name_similarity":62,"definition_similarity":63,"vector_similarity":64,"score":65},2968,"耳かけ型補聴器","34671000",0.216667,0.254658,0.712477,0.0277303,{"medical_device_id":67,"generic_name":68,"class_classification":44,"jmdn_code":69,"name_similarity":70,"definition_similarity":71,"vector_similarity":72,"score":73},2967,"ポケット型補聴器","30082000",0.224138,0.25387,0.689292,0.0272222,{"medical_device_id":75,"generic_name":76,"class_classification":44,"jmdn_code":77,"name_similarity":78,"definition_similarity":79,"vector_similarity":80,"score":81},2980,"ヘッドバンド型補聴器","41212000",0.226415,0.237113,0.679801,0.0259784,{"medical_device_id":83,"generic_name":84,"class_classification":44,"jmdn_code":85,"name_similarity":86,"definition_similarity":87,"vector_similarity":88,"score":89},1533,"経皮血液ガスモジュール","36898000",0.234375,0.169154,0.674588,0.0243506,{"medical_device_id":91,"generic_name":92,"class_classification":44,"jmdn_code":93,"name_similarity":94,"definition_similarity":95,"vector_similarity":96,"score":97},2979,"デジタル式補聴器","41207000",0.218182,0.186544,0.678215,0.0234118,{"medical_device_id":99,"generic_name":100,"class_classification":44,"jmdn_code":101,"name_similarity":102,"definition_similarity":103,"vector_similarity":104,"score":105},2516,"鼓膜按摩器","70609000",0.0147059,0.247685,0.734681,0.016129,{"medical_device_id":107,"generic_name":108,"class_classification":44,"jmdn_code":109,"name_similarity":110,"definition_similarity":111,"vector_similarity":112,"score":113},2357,"心臓保存・搬送装置","37276000",0.301587,0.215259,0.559865,0.015873,[],{"510k":116,"classification":117,"enforcement":118,"event":119,"pma":120,"warning_letter":121},"2026-08-24T02:00:50.297+00:00","2026-08-24T02:00:49.319+00:00","2026-08-24T02:00:50.059+00:00","2026-08-24T04:00:49.186+00:00","2026-08-24T02:00:50.609+00:00","2026-08-20T03:28:02.95+00:00",{"product_code":6,"device_name_ja":123,"definition_ja":124,"commentary_ja":125,"model_name":126,"source_hash":127,"reviewed_by":28,"reviewed_at":28,"created_at":128,"updated_at":128},"経皮的気導補聴システム","経皮的気導補聴システムは、聴覚障害を代償することを目的とした装着型の音響増幅装置である。外科的に装着されるチューブシステムに取り付けられた気導補聴器から構成される。このチューブは、外耳道と耳介の耳介後部領域との間の軟部組織を貫通する気道を形成する。気導補聴器はチューブの耳介後部側の開口部に取り付けられ、これにより外耳道を閉塞することなく増幅された音を外耳道に伝達する。","本機器は米国FDAによりクラスIIに分類されており、市販前届出（510(k)）の対象となります。510(k)は、既に合法的に販売されている類似機器との実質的同等性を示すことにより市販が認められる審査区分であり、クラスIII機器に適用される市販前承認（PMA）に比べて簡略化された手続きとなっています。クラスIIへの分類は、一般的な規制に加えて安全性・有効性を確保するための特別な規制（スペシャルコントロール）が課されることを意味します。","claude-sonnet-5","56243a1d7a620f71828bad5ac996ce551fdcaaac00cb88facc12e6bc7ec46a62","2026-08-24T02:18:13.311568+00:00",{"product_code":6,"summary_ja":130,"stats":131,"stats_hash":140,"model_name":126,"created_at":141,"updated_at":141},"本製品コードの510(k)累計件数は2件、参入企業数は2社ですが、直近5年間の届出実績は確認されていません。不具合報告および回収についても、これまでの累計件数は0件で、報告・回収のいずれも確認されていません。",{"pma":132,"k510":133,"as_of":135,"events":136,"recalls":137,"top_problems":139},{"latest":28,"originals":27,"supplements":27},{"total":29,"last5y":27,"latest":134,"applicants":29},"2004-08-20","2026-08",{"death":27,"other":27,"total":27,"injury":27,"last5y":27,"malfunction":27,"latest_month":28},{"total":27,"last5y":27,"latest":28,"class_i":27,"class_ii":27,"class_iii":27,"top_root_causes":138},[],[],"c7b25d527716a03ea31f2ed2cb57492fa35de8b52dc9e354af26ac8dff4c1579","2026-08-24T04:59:09.208125+00:00",{"items":143,"total":27},[],{"items":145,"total":29},[146,152],{"k_number":20,"device_name":147,"applicant":148,"decision_date":134,"clearance_type":149,"decision_code":150,"statement_or_summary":151},"RETROX TITANIUM TUBE SYSTEM FOR THE RETROX TRANSCUTANEOUS AIR CONDUCTION HEARING AID SYSTEM","Gyrus Ent LLC","Traditional","SESE","Summary",{"k_number":19,"device_name":153,"applicant":154,"decision_date":155,"clearance_type":156,"decision_code":157,"statement_or_summary":28},"RETROX","Auric Hearing Systems, Inc.","2002-08-20","Post-NSE","DENG",{"items":159,"total":27},[]]