[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-QUH":3},{"classification":4,"mappedDevices":68,"similarCandidates":69,"relatedClassifications":152,"syncDates":157,"translation":164,"marketSummary":171,"recalls":191,"k510s":193,"pmas":238},{"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":63,"updated_at":64,"recall_count":65,"latest_recall_date":66,"k510_count":67,"pma_count":65,"event_count":67},5230,"QUH","Self-Fitting Air-Conduction Hearing Aid, Over The Counter","2","874.3325","EN","Ear, Nose, Throat","1","A self-fitting air-conduction hearing aid is a wearable sound amplifying device that is intended to compensate for impaired hearing and incorporates technology, including software, that allows users to program their hearing aids. This technology integrates user input with a self-fitting strategy and enables users to independently derive and customize their hearing aid fitting and settings. This is an over the counter hearing aid.    For information on the final rule “Establishing Over-the-Counter Hearing Aids,” please see 87 FR 50698, available at https:\u002F\u002Fwww.govinfo.gov\u002Fcontent\u002Fpkg\u002FFR-2022-08-17\u002Fpdf\u002F2022-17230.pdf.",false,{"openfda":16,"definition":13,"device_name":7,"review_code":60,"device_class":8,"implant_flag":61,"product_code":6,"review_panel":10,"gmp_exempt_flag":61,"third_party_flag":61,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":60,"life_sustain_support_flag":61,"medical_specialty_description":11,"summary_malfunction_reporting":62},{"k_number":17,"fei_number":28,"registration_number":59},[18,19,20,21,22,23,24,25,26,27],"K221064","K223137","K233464","K230538","K254108","K231550","K221698","K233747","K221052","K223848",[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],"3007344957","3015651976","3041658266","3005019184","3005650109","3039409159","3014337591","3017995697","3006312495","3008941158","3030627827","3015246392","3005085999","3023339161","3010841212","3002808415","3008848788","3024991168","3018940143","3040068315","3011927597","3015527983","3013294311","2182204","3011586575","3003426343","3026048380","3006011998","3003303986","3027202846",[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],"","N","Ineligible","2026-08-18T05:52:52.566809+00:00","2026-08-24T02:00:49.169481+00:00",0,null,10,[],[70,79,87,96,104,112,120,128,136,144],{"medical_device_id":71,"generic_name":72,"class_classification":73,"jmdn_code":74,"name_similarity":75,"definition_similarity":76,"vector_similarity":77,"score":78},2978,"骨導式補聴器","Ⅱ","33993000",0.418182,0.174785,0.717334,0.0325225,{"medical_device_id":80,"generic_name":81,"class_classification":73,"jmdn_code":82,"name_similarity":83,"definition_similarity":84,"vector_similarity":85,"score":86},2968,"耳かけ型補聴器","34671000",0.266667,0.183246,0.726187,0.0320184,{"medical_device_id":88,"generic_name":89,"class_classification":90,"jmdn_code":91,"name_similarity":92,"definition_similarity":93,"vector_similarity":94,"score":95},1062,"骨固定型補聴器","Ⅲ","34180000",0.343284,0.162393,0.710029,0.032002,{"medical_device_id":97,"generic_name":98,"class_classification":73,"jmdn_code":99,"name_similarity":100,"definition_similarity":101,"vector_similarity":102,"score":103},2970,"耳あな型補聴器","34672000",0.285714,0.188034,0.700544,0.0310245,{"medical_device_id":105,"generic_name":106,"class_classification":73,"jmdn_code":107,"name_similarity":108,"definition_similarity":109,"vector_similarity":110,"score":111},2967,"ポケット型補聴器","30082000",0.213115,0.179688,0.707035,0.0295139,{"medical_device_id":113,"generic_name":114,"class_classification":73,"jmdn_code":115,"name_similarity":116,"definition_similarity":117,"vector_similarity":118,"score":119},2979,"デジタル式補聴器","41207000",0.206897,0.181572,0.701309,0.0288981,{"medical_device_id":121,"generic_name":122,"class_classification":73,"jmdn_code":123,"name_similarity":124,"definition_similarity":125,"vector_similarity":126,"score":127},2972,"オーダーメイド式耳あな型補聴器","41208000",0.253731,0.162921,0.674591,0.028665,{"medical_device_id":129,"generic_name":130,"class_classification":73,"jmdn_code":131,"name_similarity":132,"definition_similarity":133,"vector_similarity":134,"score":135},2980,"ヘッドバンド型補聴器","41212000",0.214286,0.155807,0.695331,0.028624,{"medical_device_id":137,"generic_name":138,"class_classification":73,"jmdn_code":139,"name_similarity":140,"definition_similarity":141,"vector_similarity":142,"score":143},2971,"モジュラ式耳あな型補聴器","41193000",0.253968,0.133136,0.674282,0.0280833,{"medical_device_id":145,"generic_name":146,"class_classification":73,"jmdn_code":147,"name_similarity":148,"definition_similarity":149,"vector_similarity":150,"score":151},2975,"メガネ型補聴器","34673000",0.220339,0.189655,0.670426,0.0271062,[153],{"product_code":154,"device_name":155,"device_class":8,"k510_count":156},"QDD","Self-Fitting Air-Conduction Hearing Aid, Prescription",7,{"510k":158,"classification":159,"enforcement":160,"event":161,"pma":162,"warning_letter":163},"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":165,"definition_ja":166,"commentary_ja":167,"model_name":168,"source_hash":169,"reviewed_by":66,"reviewed_at":66,"created_at":170,"updated_at":170},"自己調整型気導補聴器（OTC）","自己適合型気導補聴器とは、聴力低下を補償することを目的とした装着型の音響増幅装置であり、ソフトウェアを含む、使用者が自身の補聴器をプログラムすることを可能にする技術を組み込んだものである。この技術は、使用者の入力を自己適合戦略と統合し、使用者が独立して自身の補聴器の適合及び設定を導出し、カスタマイズすることを可能にする。これは非処方箋（OTC）補聴器である。市販用補聴器の確立に関する最終規則については、87 FR 50698（https:\u002F\u002Fwww.govinfo.gov\u002Fcontent\u002Fpkg\u002FFR-2022-08-17\u002Fpdf\u002F2022-17230.pdf）を参照のこと。","本品は米国においてクラスIIに分類されており、市販前届出（510(k)）の対象となる医療機器です。510(k)では、既存の同等な機器（既承認品）との実質的同等性を示すことにより市販が認められ、クラスIIIで要求される市販前承認（PMA）のような、より厳格な臨床データに基づく審査は求められません。","claude-sonnet-5","d17b8c9f7ec471d38c1a619a15df4acea5a98f893f358c24dc6ed3ac22cfad72","2026-08-24T03:33:38.802601+00:00",{"product_code":6,"summary_ja":172,"stats":173,"stats_hash":189,"model_name":168,"created_at":190,"updated_at":190},"本製品コードでは、510(k)の累計届出件数は約10件で、直近5年間もすべてこの期間に該当し、申請企業数は10社となっています。不具合報告（MDR）は累計約10件で、死亡報告は0件、傷害が5件、不具合（Malfunction）が4件、その他1件となっており、報告全体のうち約半数が傷害に関するものです。主な問題としては、Defective Device（不具合のある機器）、Device Markings\u002FLabelling Problem（表示・ラベルの問題）、Crack（ひび割れ）が挙げられています。回収（リコール）については、累計件数は0件で、確認されていません。",{"pma":174,"k510":175,"as_of":177,"events":178,"recalls":183,"top_problems":185},{"latest":66,"originals":65,"supplements":65},{"total":67,"last5y":67,"latest":176,"applicants":67},"2026-06-25","2026-08",{"death":65,"other":179,"total":67,"injury":180,"last5y":67,"malfunction":181,"latest_month":182},1,5,4,"2025-11",{"total":65,"last5y":65,"latest":66,"class_i":65,"class_ii":65,"class_iii":65,"top_root_causes":184},[],[186,187,188],"Defective Device","Device Markings\u002FLabelling Problem","Crack","d247b230c43bcfd684d4ade742bd88d6394000e150a70f2c118471564efe5ae0","2026-08-24T05:21:03.140427+00:00",{"items":192,"total":65},[],{"items":194,"total":67},[195,201,205,210,214,218,222,226,230,234],{"k_number":22,"device_name":196,"applicant":197,"decision_date":176,"clearance_type":198,"decision_code":199,"statement_or_summary":200},"Jabra Enhance Select Self-fit (Jabra Enhance Select 550)","GN Hearing A\u002FS","Traditional","SESE","Summary",{"k_number":25,"device_name":202,"applicant":203,"decision_date":204,"clearance_type":198,"decision_code":199,"statement_or_summary":200},"Concha Sol Hearing Aids (CL-1001)","Concha Labs","2024-03-15",{"k_number":20,"device_name":206,"applicant":207,"decision_date":208,"clearance_type":209,"decision_code":199,"statement_or_summary":200},"WSA Self-Fitting Hearing Aid Gen 2","Wsaud A\u002FS","2024-02-09","Special",{"k_number":23,"device_name":211,"applicant":212,"decision_date":213,"clearance_type":198,"decision_code":199,"statement_or_summary":200},"Sontro® OTC Hearing Aids (AI)","Soundwave Hearing, LLC","2023-10-26",{"k_number":26,"device_name":215,"applicant":216,"decision_date":217,"clearance_type":198,"decision_code":199,"statement_or_summary":200},"Self-Fitting hearing aids","Huizhou Jinghao Medical Technology Co., Ltd.","2023-09-25",{"k_number":27,"device_name":219,"applicant":220,"decision_date":221,"clearance_type":198,"decision_code":199,"statement_or_summary":200},"Intrisound™ Tuned Lumen® 155 Hearing Aids","Tuned , Ltd.","2023-09-08",{"k_number":21,"device_name":223,"applicant":224,"decision_date":225,"clearance_type":198,"decision_code":199,"statement_or_summary":200},"All-Day Clear Slim ADCS1 Hearing Aid. All-Day Clear ADC1 Hearing Aid","Sonova AG","2023-06-16",{"k_number":19,"device_name":227,"applicant":228,"decision_date":229,"clearance_type":198,"decision_code":199,"statement_or_summary":200},"Lexie Lumen Self-Fitting OTC Hearing Aids with Lexie Application","Hearx SA (Pty) , Ltd.","2023-03-14",{"k_number":24,"device_name":231,"applicant":232,"decision_date":233,"clearance_type":198,"decision_code":199,"statement_or_summary":200},"Eargo 5 , Eargo 6","Eargo, Inc.","2022-12-21",{"k_number":18,"device_name":235,"applicant":236,"decision_date":237,"clearance_type":198,"decision_code":199,"statement_or_summary":200},"Nuheara IQbuds 2 PRO Hearing Aid","Nuheara Limited","2022-10-30",{"items":239,"total":65},[]]