{"id":33284,"date":"2026-04-24T07:33:18","date_gmt":"2026-04-24T07:33:18","guid":{"rendered":"https:\/\/lifelonghearing.com\/sk\/?p=33284"},"modified":"2026-04-24T07:33:18","modified_gmt":"2026-04-24T07:33:18","slug":"zachovanie-sluchu-je-oficialne-uznane","status":"publish","type":"post","link":"https:\/\/lifelonghearing.com\/sk\/zachovanie-sluchu-je-oficialne-uznane\/","title":{"rendered":"Zachovanie sluchu je ofici\u00e1lne uznan\u00e9"},"content":{"rendered":"

Regula\u010dn\u00fd \u00farad potvrdil: Elektr\u00f3dy MED-EL FLEX zachov\u00e1vaj\u00fa zvy\u0161kov\u00fd sluch u pr\u00edjemcov kochle\u00e1rneho implant\u00e1tu.<\/strong><\/em><\/h1><\/div>

Mnoh\u00ed kandid\u00e1ti na kochle\u00e1rny implant\u00e1t odkladaj\u00fa oper\u00e1ciu cel\u00e9 roky zo strachu, \u017ee pr\u00eddu o zvy\u0161ok svojho sluchu. FLEX elektr\u00f3dy v\u0161ak dok\u00e1\u017eu zvy\u0161kov\u00fd sluch zachova\u0165 \u2013 a tento fakt teraz dokonca potvrdzuje i jedine\u010dn\u00e9 schv\u00e1lenie FDA!<\/strong><\/p>\n

Eva Kohlov\u00e1<\/em><\/p>\n<\/div>

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V minulosti sa predpokladalo, \u017ee pri kochle\u00e1rnej implant\u00e1cii pacient nevyhnutne strat\u00ed ak\u00fdko\u013evek zvy\u0161kov\u00fd sluch. To \u010dasto odr\u00e1dzalo jednotlivcov s progres\u00edvnou stratou sluchu od podst\u00fapenia kochle\u00e1rnej implant\u00e1cie, aj ke\u010f im u\u017e be\u017en\u00e9 na\u010d\u00favacie pr\u00edstroje nedok\u00e1zali zabezpe\u010di\u0165 primeran\u00e9 porozumenie re\u010di.<\/p>\n

Za 50 rokov v\u00fdvoja KI sa v\u0161ak technol\u00f3gia aj chirurgick\u00e9 postupy v\u00fdrazne posunuli. U\u017e v roku 2006 predstavila spolo\u010dnos\u0165 MED\u2011EL mimoriadne tenk\u00fa a atraumatick\u00fa technol\u00f3giu FLEX: v\u010faka nej je mo\u017en\u00e9 zachova\u0165 sluch aj pri stredne dlh\u00fdch a dlh\u00fdch elektr\u00f3dach. Dokonca i najdlh\u0161ia KI elektr\u00f3da na svete, FLEX 34, je navrhnut\u00e1 tak, aby bola \u0161etrn\u00e1 k vn\u00fatorn\u00e9mu uchu.<\/p>\n

FLEX dizajn z\u00e1rove\u0148 u\u013eah\u010duje rozhodovanie kandid\u00e1tom, ktor\u00ed e\u0161te maj\u00fa zvy\u0161kov\u00fd sluch \u2013 m\u00f4\u017eu sa pre implant\u00e1ciu rozhodn\u00fa\u0165 v\u010das, akon\u00e1hle re\u010d u\u017e nie je zrozumite\u013en\u00e1 ani pri pou\u017e\u00edvan\u00ed na\u010d\u00favac\u00edch pr\u00edstrojov.<\/p>\n

Zachovanie sluchu potvrden\u00e9 najpr\u00edsnej\u0161\u00edm regula\u010dn\u00fdm \u00faradom<\/h3>\n

Americk\u00fd \u00darad pre kontrolu potrav\u00edn a lie\u010div (FDA), ktor\u00fd odborn\u00edci pova\u017euj\u00fa za najpr\u00edsnej\u0161iu regula\u010dn\u00fa autoritu v oblasti medic\u00ednskej techniky, schv\u00e1lil v okt\u00f3bri 2024 pou\u017e\u00edvanie kochle\u00e1rnych implant\u00e1tov MED\u2011EL s elektr\u00f3dami FLEX u\u00a0dospel\u00fdch so stredne \u0165a\u017ekou a\u017e \u0165a\u017ekou senzorineur\u00e1lnou poruchou sluchu, pokia\u013e im na\u010d\u00favacie pr\u00edstroje poskytuj\u00fa u\u017e len obmedzen\u00fd \u00fa\u017eitok. Toto sa t\u00fdka najm\u00e4 \u013eud\u00ed s v\u00fdraznou stratou sluchu vo vysok\u00fdch frekvenci\u00e1ch, ktor\u00fdch zvy\u0161kov\u00fd sluch v n\u00edzkych frekvenci\u00e1ch nesta\u010d\u00ed na elektricko\u2011akustick\u00fa stimul\u00e1ciu (EAS).[1]<\/a><\/sup><\/p>\n

V s\u00fa\u010dasnosti s\u00fa elektr\u00f3dy MED\u2011EL FLEX jedin\u00fdmi KI elektr\u00f3dami, ktor\u00e9 z\u00edskali tak\u00e9to schv\u00e1lenie. V Rak\u00fasku bola implant\u00e1cia pre t\u00fato indik\u00e1ciu mo\u017en\u00e1 u\u017e predt\u00fdm, av\u0161ak rozhodnutie FDA v\u00fdrazne potvrdzuje fakt, \u017ee elektr\u00f3dy FLEX dok\u00e1\u017eu mimoriadne \u00fa\u010dinne a \u0161etrne zachova\u0165 existuj\u00faci sluch.<\/p>\n

Vedecky potvrden\u00e9<\/h3>\n

Schv\u00e1lenie sa opiera o rozsiahle vedeck\u00e9 podklady. Anonymizovan\u00e9 \u00fadaje pou\u017e\u00edvate\u013eov kochle\u00e1rnych implant\u00e1tov MED\u2011EL s elektr\u00f3dami FLEX, zaznamenan\u00e9 v celoeur\u00f3pskom KI registri, boli analyzovan\u00e9 pod\u013ea tzv. Viedensk\u00e9ho konsenzu. Ten v roku 2023 vytvorilo 24 chirurgov z r\u00f4znych kraj\u00edn. V\u00fdsledky anal\u00fdzy tak odr\u00e1\u017eaj\u00fa re\u00e1lne sk\u00fasenosti mnoh\u00fdch lek\u00e1rov a klin\u00edk v r\u00f4znych podmienkach. Pou\u017e\u00edvatelia KI z\u00e1rove\u0148 neboli nijako \u0161peci\u00e1lne vyberan\u00ed a implant\u00e1cie neprebiehali \u017eiadnou v\u00fdnimo\u010dnou chirurgickou technikou. Napriek tomu sa vo v\u00e4\u010d\u0161ine pr\u00edpadov podarilo zachova\u0165 zvy\u0161kov\u00fd sluch aj dva roky po implant\u00e1cii.[2]<\/a><\/sup><\/p>\n

Podobn\u00e9 v\u00fdsledky priniesli tie\u017e anal\u00fdzy vykonan\u00e9 pod\u013ea \u0161tandardov Americkej akad\u00e9mie otolaryngol\u00f3gie[3]<\/a><\/sup>, ako i samostatn\u00e1 multicentrick\u00e1 \u0161t\u00fadia zameran\u00e1 na zachovanie sluchu. T\u00e1 navy\u0161e uk\u00e1zala, \u017ee aj jednotlivci, u ktor\u00fdch sa prirodzen\u00fd sluch nepodarilo zachova\u0165, dosiahli u\u017e po \u0161iestich mesiacoch s kochle\u00e1rnym implant\u00e1tom lep\u0161ie porozumenie re\u010di ne\u017e predt\u00fdm s na\u010d\u00favac\u00edmi pr\u00edstrojmi, a to v tichom i hlu\u010dnom prostred\u00ed.<\/p>\n

Schv\u00e1lenie FDA potvrdzuje klinick\u00e9 sk\u00fasenosti<\/h3>\n

\u201eRoz\u0161\u00edren\u00e9 krit\u00e9ri\u00e1 FDA lep\u0161ie odr\u00e1\u017eaj\u00fa s\u00fa\u010dasn\u00fa klinick\u00fa prax a zlep\u0161uj\u00fa pr\u00edstup pacientov k tejto v\u00fdnimo\u010dnej technol\u00f3gii,\u201c vysvet\u013euje profesorka Meredith Holcombov\u00e1<\/strong>, AuD<\/strong>, riadite\u013eka programu sluchov\u00fdch implant\u00e1tov na Lek\u00e1rskej univerzite v Miami. Kevin D. Brown, MD, PhD<\/strong>, ved\u00faci oddelenia otol\u00f3gie a neurootol\u00f3gie na univerzite v Severnej Karol\u00edne (University of North Carolina-Chapel Hill), dop\u013a\u0148a: \u201eAk u t\u00fdchto pacientov pou\u017eijeme jedine\u010dne vhodn\u00e9 elektr\u00f3dy FLEX na zachovanie n\u00edzkofrekven\u010dn\u00e9ho sluchu, m\u00f4\u017eu aj oni vyu\u017e\u00edva\u0165 v\u0161etky v\u00fdhody kombinovan\u00e9ho elektrick\u00e9ho a akustick\u00e9ho po\u010dutia v tom istom uchu.\u201c<\/p>\n

Pri ka\u017edej kochle\u00e1rnej implant\u00e1cii existuje ur\u010dit\u00e9 riziko straty zvy\u0161kov\u00e9ho sluchu, av\u0161ak \u013eudia, ktor\u00ed u\u017e s na\u010d\u00favac\u00edmi pr\u00edstrojmi nedosahuj\u00fa uspokojiv\u00e9 v\u00fdsledky, by z\u00e1krok nemali odklada\u0165. \u201eV\u010faka n\u00e1\u0161mu dizajnu elektr\u00f3d FLEX vyvinula spolo\u010dnos\u0165 MED\u2011EL jedin\u00e9 kochle\u00e1rne implant\u00e1ty, pri ktor\u00fdch bolo preuk\u00e1zan\u00e9, \u017ee u mnoh\u00fdch pr\u00edjemcov dok\u00e1\u017eu zachova\u0165 zvy\u0161kov\u00fd sluch,\u201c vysvet\u013euje Ingeborg Hochmairov\u00e1<\/strong>, zakladate\u013eka a gener\u00e1lna riadite\u013eka spolo\u010dnosti MED\u2011EL. Ako MED\u2011EL zd\u00f4raz\u0148uje: \u201ePacienti boli v\u017edy na\u0161ou najvy\u0161\u0161ou prioritou.\u201c<\/p>\n

Kochle\u00e1rne implant\u00e1ty MED\u2011EL s\u00fa prv\u00e9 a zatia\u013e jedin\u00e9, ktor\u00e9 FDA schv\u00e1lila pre dospel\u00fdch so zvy\u0161kov\u00fdm sluchom v n\u00edzkofrekven\u010dnom rozsahu. Toto potvrdenie v kombin\u00e1cii s jedine\u010dn\u00fdm pr\u00edstupom MED\u2011EL zalo\u017eenom na anatomicky prisp\u00f4sobenom nastaven\u00ed \u2013 Anatomy Based Fitting (ABF) \u2013 m\u00e1 povzbudi\u0165 kandid\u00e1tov na KI, aby sa pre implant\u00e1ciu rozhodli sk\u00f4r, hoci e\u0161te maj\u00fa nejak\u00fd funk\u010dn\u00fd zvy\u0161kov\u00fd sluch.<\/p>\n

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Referencie<\/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>\u00daplne splnen\u00e9 pod\u013ea Viedensk\u00e9ho konsenzu: zmena najviac 15 decibelov na frekvenci\u00e1ch 125, 250 a 500 hertzov; \u010diasto\u010dne splnen\u00e9: zmena najviac 30 decibelov. \u2191<\/a><\/li>\n
  3. <\/a>Adunka OF, Gantz BJ, Dunn C, Gurgel RK, Buchman CA. Minimum Reporting Standards for Adult Cochlear Implantation. Otolaryngol Head Neck Surg. 2018 Aug;159(2):215\u2013219.: pri 125, 250 a 500 hertzoch maxim\u00e1lne 80 decibelov strata sluchu. \u2191<\/a><\/li>\n<\/ol>\n<\/div>\n<\/div><\/div><\/div><\/div><\/div>\n","protected":false},"excerpt":{"rendered":"

    Mnoh\u00ed kandid\u00e1ti na kochle\u00e1rny implant\u00e1t odkladaj\u00fa oper\u00e1ciu cel\u00e9 roky zo strachu, \u017ee pr\u00eddu o zvy\u0161ok svojho sluchu. FLEX elektr\u00f3dy v\u0161ak dok\u00e1\u017eu zvy\u0161kov\u00fd sluch zachova\u0165 \u2013 a tento fakt teraz dokonca potvrdzuje i jedine\u010dn\u00e9 schv\u00e1lenie FDA!<\/p>\n","protected":false},"author":10,"featured_media":33313,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[411],"tags":[],"class_list":["post-33284","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-zdravie"],"yoast_head":"\nZachovanie sluchu je ofici\u00e1lne uznan\u00e9 - Slovak<\/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\/sk\/zachovanie-sluchu-je-oficialne-uznane\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Zachovanie sluchu je ofici\u00e1lne uznan\u00e9 - Slovak\" \/>\n<meta property=\"og:description\" content=\"Mnoh\u00ed kandid\u00e1ti na kochle\u00e1rny implant\u00e1t odkladaj\u00fa oper\u00e1ciu cel\u00e9 roky zo strachu, \u017ee pr\u00eddu o zvy\u0161ok svojho sluchu. 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