{"id":32513,"date":"2026-04-29T10:57:54","date_gmt":"2026-04-29T10:57:54","guid":{"rendered":"https:\/\/lifelonghearing.com\/lt\/?p=32513"},"modified":"2026-04-29T11:01:27","modified_gmt":"2026-04-29T11:01:27","slug":"oficialiai-pripazintas-klausos-issaugojimas","status":"publish","type":"post","link":"https:\/\/lifelonghearing.com\/lt\/oficialiai-pripazintas-klausos-issaugojimas\/","title":{"rendered":"Oficialiai pripa\u017eintas klausos i\u0161saugojimas"},"content":{"rendered":"

Reguliavimo institucija patvirtina: \u201eMED-EL FLEX\u201c elektrodai i\u0161saugo likutin\u0119 klaus\u0105 kochlearini\u0173 implant\u0173 naudotojams<\/h1><\/div>

D\u0117l susir\u016bpinimo i\u0161saugoti likusi\u0105 klaus\u0105 kandidatai kartais daugel\u012f met\u0173 atid\u0117lioja kochlearin\u0119 implantacij\u0105. Ta\u010diau \u201eFLEX\u201c elektrodai gali i\u0161saugoti likutin\u0119 klaus\u0105 \u2013 tai dabar patvirtinta net unikaliu FDA patvirtinimu!<\/strong><\/p>\n

Eva Kohl<\/em><\/p>\n<\/div>

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Anks\u010diau buvo manoma, kad atliekant kochlearin\u0119 implantacij\u0105 pacientas praranda bet koki\u0105 likusi\u0105 klaus\u0105. D\u0117l to \u017emon\u0117s, turintys progresuojant\u012f klausos praradim\u0105, da\u017enai vengdavo implantacijos net tada, kai \u012fprasti klausos aparatai jau nebeu\u017etikrindavo pakankamo kalbos supratimo.<\/p>\n

Ta\u010diau per 50 met\u0173 KI vystymosi technologijos ir chirurgin\u0117s technikos labai patobul\u0117jo. Jau 2006 m. \u201eMED-EL\u201c pristat\u0117 ypa\u010d plon\u0105 ir atraumatin\u0119 \u201eFLEX\u201c technologij\u0105: net naudojant vidutinio ilgio ar ilgas \u201eFLEX\u201c elektrod\u0173 sistemas galima i\u0161saugoti klaus\u0105. Net ir ilgiausias pasaulyje KI elektrodas si\u016blomas klaus\u0105 i\u0161saugan\u010dio dizaino \u2013 \u201eFLEX 34\u201c.<\/p>\n

\u201eFLEX\u201c konstrukcija taip pat padeda kandidatams, turintiems likutin\u0119 klaus\u0105, lengviau apsispr\u0119sti d\u0117l savalaik\u0117s implantacijos, kai kalbos jau nebe\u012fmanoma suprasti net su klausos aparatais.<\/p>\n

Klausos i\u0161saugojimas patvirtintas grie\u017e\u010diausios licencijas i\u0161duodan\u010dios institucijos<\/h3>\n

JAV Maisto ir vaist\u0173 administracija (FDA) laikoma viena grie\u017e\u010diausi\u0173 reguliavimo institucij\u0173 medicinos technologij\u0173 srityje. 2024 m. spal\u012f ji patvirtino \u201eMED-EL\u201c kochlearini\u0173 implant\u0173 su \u201eFLEX\u201c elektrod\u0173 sistemomis naudojim\u0105 suaugusiesiems, turintiems vidutinio sunkumo ar sunk\u0173 sensorineuralin\u012f klausos praradim\u0105, jei jie i\u0161 klausos aparat\u0173 gauna tik ribot\u0105 naud\u0105. Tai daugiausia taikoma \u017emon\u0117ms, turintiems ry\u0161k\u0173 auk\u0161t\u0173 da\u017eni\u0173 klausos praradim\u0105, kai \u017eem\u0173 da\u017eni\u0173 klausa n\u0117ra pakankama elektrinei-akustinei stimuliacijai (EAS).[1]<\/a><\/sup><\/sup><\/p>\n

\u0160iuo metu \u201eMED-EL FLEX\u201c elektrod\u0173 sistemos yra vienintel\u0117s KI elektrod\u0173 sistemos su tokiu patvirtinimu. Austrijoje implantacija pagal \u0161i\u0105 indikacij\u0105 buvo galima ir anks\u010diau, ta\u010diau FDA patvirtinimas dar kart\u0105 stipriai patvirtina, kad \u201eFLEX\u201c elektrodai gali unikaliai i\u0161saugoti esam\u0105 klaus\u0105.<\/p>\n

Moksli\u0161kai \u012frodyta<\/h3>\n

Leidimas buvo pagr\u012fstas i\u0161samiais moksliniais tyrimais. Buvo analizuoti anonimizuoti \u201eMED-EL\u201c kochlearini\u0173 implant\u0173 su \u201eFLEX\u201c elektrodais naudotoj\u0173 duomenys, surinkti visos Europos KI registre, remiantis Vienos konsensusu. \u0160is konsensusas buvo parengtas 2023 m. 24 chirurg\u0173 i\u0161 skirting\u0173 \u0161ali\u0173. Analiz\u0117s rezultatai atspindi \u012fvairi\u0173 chirurg\u0173 ir ligonini\u0173 praktin\u0119 patirt\u012f skirtingomis s\u0105lygomis. KI naudotojai taip pat neatitiko joki\u0173 speciali\u0173 atrankos kriterij\u0173 ir nebuvo implantuoti taikant konkre\u010di\u0105 chirurgin\u0119 technik\u0105. Nepaisant to, daugeliu atvej\u0173 likutin\u0117 klausa be KI i\u0161liko net pra\u0117jus dvejiems metams po implantacijos.[2]<\/a><\/sup><\/sup><\/p>\n

Pana\u0161\u016bs rezultatai buvo gauti analiz\u0117se, atliktose pagal Amerikos otorinolaringologijos akademijos standartus, taip pat specialiame daugiacentriniame klausos i\u0161saugojimo tyrime. Pastarasis parod\u0117, kad net tie asmenys, kuri\u0173 nat\u016brali klausa nebuvo i\u0161saugota, jau po \u0161e\u0161i\u0173 m\u0117nesi\u0173 su KI geriau suprato kalb\u0105 nei anks\u010diau su klausos aparatais \u2013 tiek tyloje, tiek triuk\u0161mingoje aplinkoje.<\/p>\n

FDA patvirtinimas patvirtina klinikin\u0119 patirt\u012f<\/h3>\n

\u201eFDA i\u0161pl\u0117sti kriterijai geriau atspindi dabartin\u0119 klinikin\u0119 praktik\u0105 ir pagerina pacient\u0173 prieig\u0105 prie \u0161ios nepaprastos technologijos\u201c, \u2013 ai\u0161kina prof. Meredith Holcomb, AuD, Majamio medicinos universiteto klausos implant\u0173 programos vadov\u0117. Kevin D. Brown, MD, PhD, \u0160iaur\u0117s Karolinos universiteto Chapel Hill Otologijos ir neurootologijos skyriaus vadovas, priduria: \u201eJei \u0161iems pacientams naudojame unikaliai pritaikytas \u201eFLEX\u201c elektrod\u0173 sistemas, leid\u017eian\u010dias i\u0161saugoti \u017eem\u0173 da\u017eni\u0173 klaus\u0105, jie taip pat gali pasinaudoti visais kombinuoto elektrinio ir akustinio gird\u0117jimo vienoje ausyje privalumais.\u201c<\/p>\n

Atliekant bet koki\u0105 kochlearin\u0119 implantacij\u0105 i\u0161lieka tam tikra rizika prarasti esam\u0105 klaus\u0105, ta\u010diau tie, kurie nepasiekia pakankam\u0173 rezultat\u0173 su klausos aparatais, netur\u0117t\u0173 atid\u0117lioti implantacijos. \u201eSu \u201eFLEX\u201c elektrod\u0173 dizainu \u201eMED-EL\u201c suk\u016br\u0117 vienintelius kochlearinius implantus, kurie daugeliui naudotoj\u0173 \u012frodytai i\u0161saugo likutin\u0119 klaus\u0105\u201c, \u2013 teigia \u201eMED-EL\u201c \u012fk\u016br\u0117ja ir generalin\u0117 direktor\u0117 Ingeborg Hochmair. Kaip pabr\u0117\u017eia \u201eMED-EL\u201c: \u201ePacientai visada buvo m\u016bs\u0173 auk\u0161\u010diausias prioritetas.\u201c<\/p>\n

\u201eMED-EL\u201c kochleariniai implantai yra pirmieji ir kol kas vieninteliai, FDA patvirtinti suaugusiesiems, turintiems likutin\u0119 \u017eem\u0173 da\u017eni\u0173 klaus\u0105. \u0160ie \u012frodymai \u2013 kartu su unikaliu \u201eMED-EL Anatomy Based Fitting\u201c (ABF) pritaikymu \u2013 tur\u0117t\u0173 paskatinti KI kandidatus ry\u017etis implantacijai anks\u010diau, net jei jie dar turi naudingos likutin\u0117s klausos.<\/p>\n

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Nuorodos<\/h4>\n
    \n
  1. <\/a>https:\/\/blog-medel-pro\/EN-US\/Cochlear-Implants\/FDA-Expands-med-el-criteria-for-adults-with-residual-hearing\/<\/a> \u2191<\/a><\/li>\n
  2. <\/a>Visi\u0161kai gauta pagal Vienos susitarim\u0105: did\u017eiausias 15 decibel\u0173 pokytis esant 125, 250 ir 500 herc\u0173; i\u0161 dalies gauta: kei\u010diasi ne daugiau kaip 30 decibel\u0173. \u2191<\/a><\/li>\n
  3. Adunka OF, Gantz BJ, Dunn C, Gurgel RK, Buchman CA. Minimum Reporting Standards for Adult Cochlear Implantation. Otolaryngol Head Neck Surg.<\/em> 2018 Aug;159(2):215\u2013219.: at 125, 250 and 500 Hertz maximum 80 decibels hearing loss.<\/li>\n<\/ol>\n<\/div>\n<\/div><\/div><\/div><\/div><\/div>\n","protected":false},"excerpt":{"rendered":"

    D\u0117l susir\u016bpinimo i\u0161saugoti likusi\u0105 klaus\u0105 kandidatai kartais daugel\u012f met\u0173 atid\u0117lioja kochlearin\u0119 implantacij\u0105. Ta\u010diau \u201eFLEX\u201c elektrodai gali i\u0161saugoti likutin\u0119 klaus\u0105 \u2013 tai dabar patvirtinta net unikaliu FDA patvirtinimu!<\/p>\n","protected":false},"author":10,"featured_media":32564,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[411],"tags":[],"class_list":["post-32513","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-sveikata"],"yoast_head":"\nOficialiai pripa\u017eintas klausos i\u0161saugojimas - Lithuanian<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/lifelonghearing.com\/lt\/oficialiai-pripazintas-klausos-issaugojimas\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Oficialiai pripa\u017eintas klausos i\u0161saugojimas - Lithuanian\" \/>\n<meta property=\"og:description\" content=\"D\u0117l susir\u016bpinimo i\u0161saugoti likusi\u0105 klaus\u0105 kandidatai kartais daugel\u012f met\u0173 atid\u0117lioja kochlearin\u0119 implantacij\u0105. 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