[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-SCR":3},{"classification":4,"mappedDevices":39,"similarCandidates":40,"relatedClassifications":123,"syncDates":124,"translation":131,"marketSummary":138,"recalls":157,"k510s":159,"pmas":185},{"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":14,"gmp_exempt_flag":14,"raw":15,"created_at":33,"updated_at":34,"recall_count":35,"latest_recall_date":36,"k510_count":37,"pma_count":35,"event_count":38},4038,"SCR","Air-Conduction Hearing Aid Software","2","874.3335","EN","Ear, Nose, Throat","1","Air-conduction hearing aid software is a device that is intended to be used with a compatible wearable hardware platform to compensate for impaired hearing. The software also allows for customization to the user's hearing needs. Devices in this classification are also subject to the requirements in § 800.30 or § 801.422 of this chapter, as applicable. This classification does not include software that is used with hardware as part of a hearing-aid device system classified in other regulations, e.g., § 874.3300, § 874.3305, or § 874.3325.",false,{"openfda":16,"definition":13,"device_name":7,"review_code":30,"device_class":8,"implant_flag":31,"product_code":6,"review_panel":10,"gmp_exempt_flag":31,"third_party_flag":31,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":30,"life_sustain_support_flag":31,"medical_specialty_description":11,"summary_malfunction_reporting":32},{"k_number":17,"fei_number":23,"registration_number":28},[18,19,20,21,22],"DEN230081","K243150","K251208","K261187","K254044",[24,25,26,27],"3023339161","3011016506","3001556165","3014343954",[24,25,29,27],"9617804","","N","Ineligible","2026-08-18T05:52:51.740364+00:00","2026-08-24T02:00:47.318533+00:00",0,null,5,4,[],[41,50,59,67,75,83,91,99,107,115],{"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",0.589744,0.163462,0.725156,0.0325225,{"medical_device_id":51,"generic_name":52,"class_classification":53,"jmdn_code":54,"name_similarity":55,"definition_similarity":56,"vector_similarity":57,"score":58},1062,"骨固定型補聴器","Ⅲ","34180000",0.45098,0.175896,0.72064,0.032002,{"medical_device_id":60,"generic_name":61,"class_classification":44,"jmdn_code":62,"name_similarity":63,"definition_similarity":64,"vector_similarity":65,"score":66},2976,"プログラム式補聴器","17666000",0.255319,0.207018,0.741318,0.0300921,{"medical_device_id":68,"generic_name":69,"class_classification":44,"jmdn_code":70,"name_similarity":71,"definition_similarity":72,"vector_similarity":73,"score":74},2979,"デジタル式補聴器","41207000",0.285714,0.22327,0.706604,0.0298507,{"medical_device_id":76,"generic_name":77,"class_classification":44,"jmdn_code":78,"name_similarity":79,"definition_similarity":80,"vector_similarity":81,"score":82},2980,"ヘッドバンド型補聴器","41212000",0.3,0.138801,0.678754,0.0271997,{"medical_device_id":84,"generic_name":85,"class_classification":44,"jmdn_code":86,"name_similarity":87,"definition_similarity":88,"vector_similarity":89,"score":90},3142,"呼吸機能測定装置用プログラム","35282042",0.238806,0.160112,0.686151,0.0258161,{"medical_device_id":92,"generic_name":93,"class_classification":44,"jmdn_code":94,"name_similarity":95,"definition_similarity":96,"vector_similarity":97,"score":98},3131,"呼吸モニタ用プログラム","35194012",0.222222,0.143266,0.687372,0.024697,{"medical_device_id":100,"generic_name":101,"class_classification":44,"jmdn_code":102,"name_similarity":103,"definition_similarity":104,"vector_similarity":105,"score":106},3200,"家庭用脈波情報解析プログラム","58884002",0.216667,0.196765,0.685455,0.0246149,{"medical_device_id":108,"generic_name":109,"class_classification":53,"jmdn_code":110,"name_similarity":111,"definition_similarity":112,"vector_similarity":113,"score":114},1125,"植込み能動型機器管理用プログラム","71052003",0.215385,0.228758,0.674103,0.0235327,{"medical_device_id":116,"generic_name":117,"class_classification":44,"jmdn_code":118,"name_similarity":119,"definition_similarity":120,"vector_similarity":121,"score":122},2973,"カナル型補聴器","41209000",0.333333,0.16041,0.653122,0.015873,[],{"510k":125,"classification":126,"enforcement":127,"event":128,"pma":129,"warning_letter":130},"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":132,"definition_ja":133,"commentary_ja":134,"model_name":135,"source_hash":136,"reviewed_by":36,"reviewed_at":36,"created_at":137,"updated_at":137},"気導補聴器用ソフトウェア","気導補聴器用ソフトウェアとは、聴覚障害を補償するために互換性のある装着型ハードウェアプラットフォームと共に使用することを意図した機器である。本ソフトウェアは、使用者の聴覚上のニーズに合わせたカスタマイズも可能とする。本分類に属する機器は、該当する場合、本章第800.30条又は第801.422条の要件にも従うものとする。本分類には、他の規則、例えば第874.3300条、第874.3305条又は第874.3325条に分類される補聴器システムの一部としてハードウェアと共に使用されるソフトウェアは含まれない。","米国ではクラスIIに分類されており、市販前届出（510(k)）の対象として、市販前に安全性・有効性を裏付ける情報をFDAに届け出ることが求められます。クラスIIは中程度のリスクを有する医療機器区分であり、一般管理に加え特別管理（性能基準や表示要件など）が課されるのが特徴です。","claude-sonnet-5","a3321100c6803163190be3454ec8b474835d5380f9108cfa2465264deb2c02d1","2026-08-24T03:37:43.881155+00:00",{"product_code":6,"summary_ja":139,"stats":140,"stats_hash":155,"model_name":135,"created_at":156,"updated_at":156},"510(k)の累計件数は5件で、直近5年間も5件と参入企業数5社のすべてがこの期間に含まれています。不具合報告は累計約4件で、傷害が3件、不具合（Malfunction）が1件となっており、死亡報告は確認されていません。主な問題としては環境適合性の問題（Environmental Compatibility Problem）、患者と機器の相互作用の問題（Patient Device Interaction Problem）、機器使用の問題（Use of Device Problem）が挙げられています。回収については累計0件で、該当する事例は確認されていません。",{"pma":141,"k510":142,"as_of":144,"events":145,"recalls":149,"top_problems":151},{"latest":36,"originals":35,"supplements":35},{"total":37,"last5y":37,"latest":143,"applicants":37},"2026-07-31","2026-08",{"death":35,"other":35,"total":38,"injury":146,"last5y":38,"malfunction":147,"latest_month":148},3,1,"2025-12",{"total":35,"last5y":35,"latest":36,"class_i":35,"class_ii":35,"class_iii":35,"top_root_causes":150},[],[152,153,154],"Environmental Compatibility Problem","Patient Device Interaction Problem","Use of Device Problem","b626a9c1d42fd319e3edc03191988b421ddd03ef8cebc2e97b9f3aaf56679569","2026-08-24T05:23:16.025025+00:00",{"items":158,"total":35},[],{"items":160,"total":37},[161,167,171,175,179],{"k_number":21,"device_name":162,"applicant":163,"decision_date":143,"clearance_type":164,"decision_code":165,"statement_or_summary":166},"Hearing Aid Feature","Samsung Electronics Co., Ltd.","Traditional","SESE","Summary",{"k_number":22,"device_name":168,"applicant":169,"decision_date":170,"clearance_type":164,"decision_code":165,"statement_or_summary":166},"Hearing assist","Meta Platform Technologies, LLC","2026-07-13",{"k_number":20,"device_name":172,"applicant":173,"decision_date":174,"clearance_type":164,"decision_code":165,"statement_or_summary":166},"Tuned Self-Fitting Mobile App","Tuned , Ltd.","2025-09-26",{"k_number":19,"device_name":176,"applicant":177,"decision_date":178,"clearance_type":164,"decision_code":165,"statement_or_summary":166},"Nuance Audio Hearing Aid Software","Luxottica Group S.P.A.","2025-01-31",{"k_number":18,"device_name":180,"applicant":181,"decision_date":182,"clearance_type":183,"decision_code":184,"statement_or_summary":36},"Hearing Aid Feature (HAF)","Apple, Inc.","2024-09-12","Direct","DENG",{"items":186,"total":35},[]]