{"id":32600,"date":"2026-05-04T08:06:12","date_gmt":"2026-05-04T08:06:12","guid":{"rendered":"https:\/\/lifelonghearing.com\/hr\/?p=32600"},"modified":"2026-05-04T08:06:12","modified_gmt":"2026-05-04T08:06:12","slug":"ocuvanje-sluha-sluzbeno-priznato","status":"publish","type":"post","link":"https:\/\/lifelonghearing.com\/hr\/ocuvanje-sluha-sluzbeno-priznato\/","title":{"rendered":"O\u010duvanje sluha slu\u017ebeno priznato"},"content":{"rendered":"

Regulatorno tijelo potvr\u0111uje: MED-EL FLEX elektrode \u010duvaju preostali sluh kod korisnika kohlearnih implantata.<\/h1><\/div>

Zbog zabrinutosti za o\u010duvanje preostalog sluha, kandidati ponekad odga\u0111aju kohlearnu implantaciju godinama. Me\u0111utim, FLEX elektrode mogu sa\u010duvati zaostali sluh – \u010dinjenica koja je sada \u010dak potvr\u0111ena jedinstvenim odobrenjem FDA!<\/strong><\/p>\n

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

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U pro\u0161losti se pretpostavljalo da s kohlearnom implantacijom pacijent gubi svaki preostali sluh. To je \u010desto odvra\u0107alo pojedince s progresivnim gubitkom sluha od podvrgavanja kohlearnoj implantaciji, \u010dak i kada konvencionalna slu\u0161na pomagala odavno nisu pru\u017eila odgovaraju\u0107e razumijevanje govora.<\/p>\n

No, u 50 godina razvoja CI, tehnologija i kirur\u0161ke tehnike uvelike su se pobolj\u0161ale. Ve\u0107 2006. godine MED-EL je uveo posebno tanku i atraumatsku FLEX tehnologiju: \u010dak i kod srednjih i dugih FLEX elektrodnih nizova, sluh se mo\u017ee sa\u010duvati. \u010cak se i najdulji CI elektrodni niz na svijetu nudi u dizajnu za o\u010duvanje sluha kao FLEX 34.<\/p>\n

FLEX dizajn tako\u0111er olak\u0161ava CI kandidatima s preostalim sluhom da se odlu\u010de na pravovremenu implantaciju \u010dim govor vi\u0161e nije razumljiv \u010dak i sa slu\u0161nim pomagalima.<\/p>\n

O\u010duvanje sluha potvr\u0111eno od strane najstro\u017eeg tijela za izdavanje dozvola<\/h3>\n

Ameri\u010dka uprava za hranu i lijekove, ili skra\u0107eno FDA, smatra se najstro\u017eim regulatornim tijelom me\u0111u insajderima kada je rije\u010d o me\u0111unarodnoj medicinskoj tehnologiji. U listopadu 2024. odobrila je upotrebu MED-EL kohlearnih implantata s FLEX elektrodnim nizovima za odrasle osobe s umjerenim do te\u0161kim senzorineuralnim gubitkom sluha, pod uvjetom da imaju samo ograni\u010denu korist od slu\u0161nih pomagala. To se prvenstveno odnosi na pojedince sa zna\u010dajnim gubitkom sluha visoke frekvencije, \u010dija sposobnost sluha niske frekvencije nije dovoljna za elektri\u010dno-akusti\u010dnu stimulaciju (EAS).[1]<\/a><\/sup><\/p>\n

Trenutno su MED-EL FLEX elektrodni nizovi jedini CI elektrodni nizovi s ovim odobrenjem. U Austriji je implantacija za ovu indikaciju bila mogu\u0107a prije. Me\u0111utim, odobrenje FDA sna\u017eno potvr\u0111uje da FLEX elektrodni nizovi mogu sa\u010duvati postoje\u0107i sluh na uistinu jedinstven na\u010din.<\/p>\n

Znanstveno dokazano<\/h3>\n

Odobrenje se temeljilo na opse\u017enim znanstvenim studijama. Anonimizirani podaci korisnika MED-EL kohlearnih implantata s FLEX elektrodama, zabilje\u017eeni u europskom CI registru, analizirani su prema Be\u010dkom konsenzusu. Razvila su ga 2023. godine 24 kirurga iz razli\u010ditih zemalja. Rezultati analize odra\u017eavaju prakti\u010dna iskustva razli\u010ditih kirurga i bolnica u razli\u010ditim uvjetima. Korisnici CI-ja tako\u0111er nisu ispunjavali nikakve posebne kriterije odabira i nisu bili implantirani nikakvom posebnom kirur\u0161kom tehnikom. Ipak, u ve\u0107ini slu\u010dajeva preostali sluh bez CI-ja o\u010duvan je dvije godine nakon implantacije.[2]<\/a><\/sup><\/p>\n

Sli\u010dni ishodi zabilje\u017eeni su u analizama provedenim prema standardima Ameri\u010dke akademije otorinolaringologije[3]<\/a><\/sup>, kao i u namjenskoj multicentri\u010dnoj studiji o o\u010duvanju sluha. Potonje je tako\u0111er pokazalo da \u010dak i pojedinci \u010diji se prirodni sluh ne mo\u017ee sa\u010duvati posti\u017eu bolje razumijevanje govora sa svojim implantom nakon samo \u0161est mjeseci nego \u0161to su prethodno imali sa slu\u0161nim pomagalima, kako u tihom tako i u bu\u010dnom okru\u017eenju.<\/p>\n

FDA odobrenje potvr\u0111uje klini\u010dko iskustvo<\/h3>\n

“Pro\u0161ireni kriteriji FDA bolje odra\u017eavaju trenutnu klini\u010dku praksu i pobolj\u0161avaju pristup pacijenata ovoj nevjerojatnoj tehnologiji”, obja\u0161njava profesorica Meredith Holcomb, AuD, direktorica programa slu\u0161nih implantata na Medicinskom sveu\u010dili\u0161tu u Miamiju. Kevin D. Brown, dr. med., voditelj Odjela za otologiju i neurotologiju na Sveu\u010dili\u0161tu North Carolina-Chapel Hill, dodaje: “Ako koristimo jedinstveno prikladne FLEX elektrodne nizove za o\u010duvanje niskofrekventnog sluha za ove pacijente, i oni mogu iskoristiti sve prednosti kombiniranog elektri\u010dnog i akusti\u010dnog sluha u istom uhu.”<\/p>\n

Kod svake kohlearne implantacije uvijek postoji preostali rizik od gubitka postoje\u0107eg sluha, no osobe koje vi\u0161e ne posti\u017eu zadovoljavaju\u0107e rezultate sa slu\u0161nim aparatima ne bi trebale odga\u0111ati implantaciju. “S na\u0161im FLEX elektrodnim dizajnom, MED-EL je razvio jedine kohlearne implantate za koje je dokazano da u mnogim slu\u010dajevima o\u010duvaju preostali sluh”, obja\u0161njava Ingeborg Hochmair, osniva\u010d i izvr\u0161ni direktor MED-EL-a. Jer, kako nagla\u0161ava MED-EL: “Pacijenti su nam uvijek bili prioritet.”<\/p>\n

Kohlearni implantati MED-EL prvi su i zasad jedini odobreni od strane FDA za odrasle osobe s preostalim sluhom u niskofrekventnom rasponu. Ovaj dokaz \u2013 u kombinaciji s MED-EL-ovim jedinstvenim priborom temeljenim na anatomiji (ABF) \u2013 namijenjen je poticanju CI kandidata da nastave s implantacijom prije, \u010dak i ako jo\u0161 uvijek imaju neki korisni preostali sluh.<\/p>\n

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Reference<\/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>Potpuno dobiveno prema be\u010dkom konsenzusu: najvi\u0161e 15 decibela mijenja se pri 125, 250 i 500 herca; djelomi\u010dno dobiveno: najvi\u0161e 30 decibela mijenja. \u2191<\/a><\/li>\n
  3. <\/a>Adunka OF, Gantz BJ, Dunn C, Gurgel RK, Buchman CA. Minimalni standardi izvje\u0161\u0107ivanja za kohlearnu implantaciju odraslih. Otolaringolni kirur\u0161ki zahvat na vratu. 2018 Aug;159(2):215\u2013219.: na 125, 250 i 500 Hertz maksimalno 80 decibela gubitak sluha. \u2191<\/a><\/li>\n<\/ol>\n<\/div>\n<\/div><\/div><\/div><\/div><\/div>\n","protected":false},"excerpt":{"rendered":"

    Zbog zabrinutosti za o\u010duvanje preostalog sluha, kandidati ponekad odga\u0111aju kohlearnu implantaciju godinama. Me\u0111utim, FLEX elektrode mogu sa\u010duvati zaostali sluh – \u010dinjenica koja je sada \u010dak potvr\u0111ena jedinstvenim odobrenjem FDA!<\/p>\n","protected":false},"author":10,"featured_media":32657,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[411],"tags":[],"class_list":["post-32600","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-zdravlje-hr"],"yoast_head":"\nO\u010duvanje sluha slu\u017ebeno priznato - Croatian<\/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\/hr\/ocuvanje-sluha-sluzbeno-priznato\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"O\u010duvanje sluha slu\u017ebeno priznato - Croatian\" \/>\n<meta property=\"og:description\" content=\"Zbog zabrinutosti za o\u010duvanje preostalog sluha, kandidati ponekad odga\u0111aju kohlearnu implantaciju godinama. 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