[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-ETW":3},{"classification":4,"mappedDevices":93,"similarCandidates":94,"relatedClassifications":165,"syncDates":166,"translation":173,"marketSummary":179,"recalls":200,"k510s":202,"pmas":280},{"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":87,"updated_at":88,"recall_count":89,"latest_recall_date":90,"k510_count":91,"pma_count":89,"event_count":92},5493,"ETW","Calibrator, Hearing Aid \u002F Earphone And Analysis Systems","2","874.3310","EN","Ear, Nose, Throat","4","",false,{"openfda":16,"definition":13,"device_name":7,"review_code":13,"device_class":8,"implant_flag":85,"product_code":6,"review_panel":10,"gmp_exempt_flag":85,"third_party_flag":85,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":13,"life_sustain_support_flag":85,"medical_specialty_description":11,"summary_malfunction_reporting":86},{"k_number":17,"fei_number":64,"registration_number":80},[18,19,20,21,22,23,24,25,26,27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46,47,48,49,50,51,52,53,54,55,56,57,58,59,60,61,62,63],"K970324","K943459","K884046","K853271","K895383","K872242","K861857","K041853","K884371","K872633","K854535","K896301","K902244","K862026","K012306","K853320","K943460","K850918","K861571","K844275","K821908","K110286","K884372","K935400","K022510","K870229","K050496","K061104","K896477","K870337","K113831","K801905","K943607","K934342","K071462","K980377","K952098","K941848","K093006","K862162","K902252","K960229","K122028","K862086","K861113","K896996",[65,66,67,68,69,70,71,72,73,74,75,76,77,78,79],"3008699634","3013596041","3008386587","3018639","3002807554","1000307595","3011310592","3030089857","3005019184","3715","3004052117","3005581270","3010611950","3000254565","3034880867",[65,66,67,81,82,68,83,71,72,73,75,76,77,79,84],"9612197","8022229","1058264","9710051","N","Eligible","2026-08-18T05:52:52.566809+00:00","2026-08-24T02:00:48.882786+00:00",0,null,46,19,[],[95,103,110,117,124,131,139,146,152,159],{"medical_device_id":96,"generic_name":97,"class_classification":98,"jmdn_code":99,"name_similarity":100,"definition_similarity":89,"vector_similarity":101,"score":102},2970,"耳あな型補聴器","Ⅱ","34672000",0.245614,0.68455,0.0287179,{"medical_device_id":104,"generic_name":105,"class_classification":98,"jmdn_code":106,"name_similarity":107,"definition_similarity":89,"vector_similarity":108,"score":109},2968,"耳かけ型補聴器","34671000",0.25,0.666858,0.0272529,{"medical_device_id":111,"generic_name":112,"class_classification":98,"jmdn_code":113,"name_similarity":114,"definition_similarity":89,"vector_similarity":115,"score":116},2979,"デジタル式補聴器","41207000",0.210526,0.688753,0.0268468,{"medical_device_id":118,"generic_name":119,"class_classification":98,"jmdn_code":120,"name_similarity":121,"definition_similarity":89,"vector_similarity":122,"score":123},2976,"プログラム式補聴器","17666000",0.193548,0.701374,0.0263975,{"medical_device_id":125,"generic_name":126,"class_classification":98,"jmdn_code":127,"name_similarity":128,"definition_similarity":89,"vector_similarity":129,"score":130},2967,"ポケット型補聴器","30082000",0.216667,0.674087,0.0260443,{"medical_device_id":132,"generic_name":133,"class_classification":134,"jmdn_code":135,"name_similarity":136,"definition_similarity":89,"vector_similarity":137,"score":138},1062,"骨固定型補聴器","Ⅲ","34180000",0.202703,0.662097,0.0243506,{"medical_device_id":140,"generic_name":141,"class_classification":98,"jmdn_code":142,"name_similarity":143,"definition_similarity":89,"vector_similarity":144,"score":145},2973,"カナル型補聴器","41209000",0.313726,0.635667,0.0163934,{"medical_device_id":147,"generic_name":148,"class_classification":98,"jmdn_code":149,"name_similarity":150,"definition_similarity":89,"vector_similarity":151,"score":145},3058,"耳音響放射測定機能付聴覚誘発反応測定装置用プログラム","35747042",0.0378788,0.719665,{"medical_device_id":153,"generic_name":154,"class_classification":134,"jmdn_code":155,"name_similarity":156,"definition_similarity":89,"vector_similarity":157,"score":158},1157,"遺伝子変異解析システム（がんゲノムプロファイリング検査用）","60943033",0.268293,0.545709,0.016129,{"medical_device_id":160,"generic_name":161,"class_classification":98,"jmdn_code":162,"name_similarity":163,"definition_similarity":89,"vector_similarity":164,"score":158},2593,"歯科用咬合音測定器","70696000",0.0972222,0.71142,[],{"510k":167,"classification":168,"enforcement":169,"event":170,"pma":171,"warning_letter":172},"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":174,"definition_ja":90,"commentary_ja":175,"model_name":176,"source_hash":177,"reviewed_by":90,"reviewed_at":90,"created_at":178,"updated_at":178},"補聴器・イヤホン分析システム用校正器","この機器は、補聴器やイヤホンの性能を評価する分析システムにおいて、測定精度を確保するために用いられる校正器です。米国ではクラスIIに分類されていますが、510(k)による市販前届出は免除されており、他の一般的な管理要件を満たすことで市販が可能とされています。","claude-sonnet-5","9318324dce2803ece5b238a09e5dcb505d76c896015ea031c6adb3099488a2f4","2026-08-24T01:50:05.227637+00:00",{"product_code":6,"summary_ja":180,"stats":181,"stats_hash":198,"model_name":176,"created_at":199,"updated_at":199},"本製品コードでは、510(k)の累計届出件数は約50件、申請企業数は25社ですが、直近5年間の届出はなく、最新の判定は2012年10月となっています。PMAの承認実績は確認されていません。不具合報告は累計約20件で、大半がMalfunction（不具合）であり、死亡報告は0件、傷害報告は2件です。主な問題としてはBattery Problem（バッテリー不具合）、Break（破損）、Complete Loss of Power（完全な電源喪失）が挙げられており、最新の報告月は2025年6月です。回収に関する報告は確認されていません。",{"pma":182,"k510":183,"as_of":186,"events":187,"recalls":192,"top_problems":194},{"latest":90,"originals":89,"supplements":89},{"total":91,"last5y":89,"latest":184,"applicants":185},"2012-10-23",25,"2026-08",{"death":89,"other":89,"total":92,"injury":188,"last5y":189,"malfunction":190,"latest_month":191},2,5,17,"2025-06",{"total":89,"last5y":89,"latest":90,"class_i":89,"class_ii":89,"class_iii":89,"top_root_causes":193},[],[195,196,197],"Battery Problem","Break","Complete Loss of Power","0189798c234643e1668351a34bc5bdff6f441f27c7745ac7084c996ce19b5294","2026-08-24T04:18:34.328284+00:00",{"items":201,"total":89},[],{"items":203,"total":91},[204,210,214,218,224,228,231,235,239,242,246,249,253,257,260,264,266,270,273,277],{"k_number":60,"device_name":205,"applicant":206,"decision_date":184,"clearance_type":207,"decision_code":208,"statement_or_summary":209},"AURICAL HIT","Gn Otometrics","Traditional","SESE","Summary",{"k_number":48,"device_name":211,"applicant":212,"decision_date":213,"clearance_type":207,"decision_code":208,"statement_or_summary":209},"PRIMUS HEARING INSTRUMENT TEST UNIT","Auditdata A\u002FS","2012-04-19",{"k_number":39,"device_name":215,"applicant":216,"decision_date":217,"clearance_type":207,"decision_code":208,"statement_or_summary":209},"GN OTOMETRICS TYPE 1053 FREEFIT","Gn Otometrics A\u002FS","2011-04-28",{"k_number":56,"device_name":219,"applicant":220,"decision_date":221,"clearance_type":222,"decision_code":208,"statement_or_summary":223},"FONIX ,MODEL 8000","Frye Electronics, Inc.","2009-12-30","Abbreviated","Statement",{"k_number":52,"device_name":225,"applicant":226,"decision_date":227,"clearance_type":207,"decision_code":208,"statement_or_summary":209},"UNITY 2 HIA & PROBE ( FOR USE WITH UNITY 2)","Siemens Hearing Instruments, Inc.","2007-06-05",{"k_number":45,"device_name":229,"applicant":216,"decision_date":230,"clearance_type":207,"decision_code":208,"statement_or_summary":209},"SPEECHLINK 100 TYPE 1053","2006-05-03",{"k_number":44,"device_name":232,"applicant":233,"decision_date":234,"clearance_type":207,"decision_code":208,"statement_or_summary":223},"REM440","Interacoustics A\u002FS, Assens","2005-04-29",{"k_number":25,"device_name":236,"applicant":237,"decision_date":238,"clearance_type":207,"decision_code":208,"statement_or_summary":209},"OTOGRAM","Tympany, Inc.","2004-09-03",{"k_number":42,"device_name":240,"applicant":220,"decision_date":241,"clearance_type":222,"decision_code":208,"statement_or_summary":223},"FONIX, MODEL 7000","2002-08-27",{"k_number":32,"device_name":243,"applicant":244,"decision_date":245,"clearance_type":207,"decision_code":208,"statement_or_summary":209},"AUDIOSCAN VERIFIT, MODEL VF-1","Etymonic Design, Inc.","2001-09-21",{"k_number":53,"device_name":247,"applicant":220,"decision_date":248,"clearance_type":207,"decision_code":208,"statement_or_summary":223},"FONIX FP35 HEARING AID ANALYZER","1998-03-18",{"k_number":18,"device_name":250,"applicant":251,"decision_date":252,"clearance_type":207,"decision_code":208,"statement_or_summary":209},"GSI SA60 DPOAE SYSTEM","Grason-Stadler, Inc.","1997-06-06",{"k_number":59,"device_name":254,"applicant":255,"decision_date":256,"clearance_type":207,"decision_code":208,"statement_or_summary":209},"RESOUND REAL EAR LOUDNESS MAPPING (RELM) SYSTEM","Resound Corp.","1996-03-07",{"k_number":54,"device_name":258,"applicant":226,"decision_date":259,"clearance_type":207,"decision_code":208,"statement_or_summary":223},"SIEMENS PC AUIDIOMETER MODEL SD 100 & PC PROBE MIC SYSTEM MODEL SD 110\u002FSD WITH UNITY SOPFTWARE SUITE","1995-05-25",{"k_number":34,"device_name":261,"applicant":262,"decision_date":263,"clearance_type":207,"decision_code":208,"statement_or_summary":209},"PORTAREM 2000","Starkey Laboratories, Inc.","1994-10-21",{"k_number":19,"device_name":265,"applicant":262,"decision_date":263,"clearance_type":207,"decision_code":208,"statement_or_summary":209},"DESKREM-1000",{"k_number":50,"device_name":267,"applicant":268,"decision_date":269,"clearance_type":207,"decision_code":208,"statement_or_summary":209},"INTERACOUSTICS HEARING AID ANALYZER MS 40","Precision Acoustics Ind., Inc.","1994-09-23",{"k_number":55,"device_name":271,"applicant":268,"decision_date":272,"clearance_type":207,"decision_code":208,"statement_or_summary":209},"INTERACOUSTICS.  HEARING AID ANALYZER","1994-05-23",{"k_number":51,"device_name":274,"applicant":275,"decision_date":276,"clearance_type":207,"decision_code":208,"statement_or_summary":223},"GLASER RT450 HEARING AID TEST AND ANALYSIS SYSTEM","Glaser Instruments AG","1994-01-21",{"k_number":41,"device_name":278,"applicant":220,"decision_date":279,"clearance_type":207,"decision_code":208,"statement_or_summary":223},"FONIX 3500 HEARING AID ANALYZER","1994-01-14",{"items":281,"total":89},[]]