{"id":32495,"date":"2026-03-27T09:36:02","date_gmt":"2026-03-27T09:36:02","guid":{"rendered":"https:\/\/lifelonghearing.com\/lv\/?p=32495"},"modified":"2026-03-27T09:36:34","modified_gmt":"2026-03-27T09:36:34","slug":"dzirdes-saglabasana-ir-oficiali-atzita","status":"publish","type":"post","link":"https:\/\/lifelonghearing.com\/lv\/dzirdes-saglabasana-ir-oficiali-atzita\/","title":{"rendered":"Dzirdes saglab\u0101\u0161ana ir ofici\u0101li atz\u012bta"},"content":{"rendered":"

Regulat\u012bv\u0101 iest\u0101de apstiprina: MED-EL FLEX elektrodi saglab\u0101 atliku\u0161o dzirdi kohle\u0101ro implantu sa\u0146\u0113m\u0113jiem.<\/h1><\/div>

Lai saglab\u0101tu atliku\u0161o dzirdi, kandid\u0101ti da\u017ereiz atliek kohle\u0101ro implant\u0101ciju uz gadiem. Tom\u0113r FLEX elektrodi var saglab\u0101t atliku\u0161o dzirdi – to tagad apstiprina unik\u0101ls FDA apstiprin\u0101jums!<\/strong>
\nEva Kola (Eva Kohl)<\/em><\/p>\n<\/div>

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Agr\u0101k tika pie\u0146emts, ka, izmantojot kohle\u0101ro implant\u0101ciju pacients zaud\u0113 jebk\u0101du atliku\u0161o dzirdi. Tas bie\u017ei vien attur\u0113ja personas ar progres\u0113jo\u0161u dzirdes zudumu no kohle\u0101r\u0101s implant\u0101cijas, pat ja tradicion\u0101lie dzirdes apar\u0101ti jau sen nenodro\u0161in\u0101ja adekv\u0101tu runas sapratni.<\/p>\n

Bet 50 gadu laik\u0101 KI att\u012bst\u012bba, tehnolo\u0123ijas un \u0137irur\u0123isk\u0101s metodes ir iev\u0113rojami uzlaboju\u0161\u0101s. Jau 2006. gad\u0101 MED-EL ieviesa \u012bpa\u0161i pl\u0101nu un netraumatisku FLEX tehnolo\u0123iju: pat ar vid\u0113ja garuma un gariem FLEX elektrodu blokiem var saglab\u0101t dzirdi. Pat pasaul\u0113 gar\u0101kais KI elektrodu bloks tiek pied\u0101v\u0101ts dzirdes saglab\u0101\u0161anas dizain\u0101 k\u0101 FLEX 34.<\/p>\n

FLEX dizains ar\u012b atvieglo KI kandid\u0101tiem ar atliku\u0161o dzirdi izlemt par savlaic\u012bgu implant\u0101ciju, tikl\u012bdz runa vairs nav saprotama pat ar dzirdes apar\u0101tiem.<\/p>\n

Dzirdes saglab\u0101\u0161ana, ko apstiprin\u0101jusi stingr\u0101k\u0101 licenc\u0113\u0161anas iest\u0101de<\/h3>\n

ASV P\u0101rtikas un Medikamentu p\u0101rvalde jeb sa\u012bsin\u0101ti, FDA, tiek uzskat\u012bta par stingr\u0101ko regulat\u012bvo iest\u0101di starp nozar\u0113 iesaist\u012btaj\u0101m attiec\u012bb\u0101 uz starptautiskaj\u0101m medic\u012bnas tehnolo\u0123ij\u0101m. 2024. gada oktobr\u012b t\u0101 apstiprin\u0101ja MED-EL kohle\u0101ro implantu ar FLEX elektrodu blokiem izmanto\u0161anu pieaugu\u0161ajiem ar vid\u0113ji smagu l\u012bdz smagu sensorineir\u0101lu dzirdes zudumu, pat ja vien tie tikai da\u013c\u0113ji g\u016bst ieguvumu no dzirdes apar\u0101tiem. Tas galvenok\u0101rt attiecas uz cilv\u0113kiem ar iev\u0113rojamu augstas frekvences dzirdes zudumu, kuru zemas frekvences dzirdes sp\u0113ja nav pietiekama elektriski-akustiskajai stimul\u0101cijai (EAS).[1]<\/a><\/sup><\/p>\n

Pa\u0161laik MED-EL FLEX elektrodu bloki ir vien\u012bgie KI elektrodu bloki ar \u0161\u0101du apstiprin\u0101jumu. Austrij\u0101 implant\u0101cija \u0161ai indik\u0101cijai bija iesp\u0113jama jau iepriek\u0161. Tom\u0113r FDA apstiprin\u0101jums v\u0113lreiz apstiprina, ka FLEX elektrodu bloki var saglab\u0101t eso\u0161o dzirdi patiesi unik\u0101l\u0101 veid\u0101.<\/p>\n

Zin\u0101tniski pier\u0101d\u012bts<\/h3>\n

At\u013caujas pamat\u0101 bija pla\u0161i zin\u0101tniski p\u0113t\u012bjumi. MED-EL kohle\u0101ro implantu ar FLEX elektrodiem lietot\u0101ju anonimiz\u0113tie dati, kas re\u0123istr\u0113ti Eiropas m\u0113roga KI re\u0123istr\u0101, tika analiz\u0113ti saska\u0146\u0101 ar V\u012bnes konsensu. To 2023. gad\u0101 izstr\u0101d\u0101ja 24 \u0137irurgi no da\u017e\u0101d\u0101m valst\u012bm. Anal\u012bzes rezult\u0101ti atspogu\u013co da\u017e\u0101du \u0137irurgu un slimn\u012bcu praktisko pieredzi da\u017e\u0101dos apst\u0101k\u013cos. KI lietot\u0101ji ar\u012b netika atlas\u012bti p\u0113c \u012bpa\u0161iem atlases krit\u0113rijiem un implant\u0113\u0161ana netika veiktai, izmantojot k\u0101du konkr\u0113tu \u0137irur\u0123isku metodi. Tom\u0113r vairum\u0101 gad\u012bjumu atlikus\u012b dzirde bez KI tika saglab\u0101ta divus gadus p\u0113c implant\u0101cijas.[2]<\/a><\/sup><\/p>\n

L\u012bdz\u012bgi rezult\u0101ti tika zi\u0146oti anal\u012btik\u0101, kas veikta saska\u0146\u0101 ar Amerikas Otolaringolo\u0123ijas[3]<\/a><\/sup> akad\u0113mijas standartiem, k\u0101 ar\u012b \u012bpa\u0161\u0101 vair\u0101ku centru p\u0113t\u012bjum\u0101 par dzirdes saglab\u0101\u0161anu. Tas ar\u012b par\u0101d\u012bja, ka pat indiv\u012bdi, kuru dabisko dzirdi nevar\u0113ja saglab\u0101t, jau p\u0113c se\u0161iem m\u0113ne\u0161iem sasniedza lab\u0101ku runas sapratni ar savu KI, nek\u0101 iepriek\u0161 ar dzirdes apar\u0101tiem gan klus\u0101, gan trok\u0161\u0146ain\u0101 vid\u0113.<\/p>\n

FDA apstiprin\u0101jums apstiprina kl\u012bnisko pieredzi<\/h3>\n

\"FDA papla\u0161in\u0101tie krit\u0113riji lab\u0101k atspogu\u013co pa\u0161reiz\u0113jo kl\u012bnisko praksi un uzlabo pacientu piek\u013cuvi \u0161ai neticamajai tehnolo\u0123ijai,\" skaidro Maiami Medic\u012bnas universit\u0101tes dzirdes implantu programmas direktore prof. Meredita Holkomba (Meredith Holcomb). Kevins D. Brauns (Kevin D. Brown), MD, doktors, Zieme\u013ckarol\u012bnas-Kapelas Kalna Otolo\u0123ijas un Neirootolo\u0123ijas katedras vad\u012bt\u0101js, piebilst: \"Ja m\u0113s izmantojam unik\u0101li piem\u0113rotus FLEX elektrodu mas\u012bvus, lai saglab\u0101tu zemas frekvences dzirdi \u0161iem pacientiem, vi\u0146i var izmantot visas priek\u0161roc\u012bbas, ko sniedz apvienota elektrisk\u0101 un akustisk\u0101 dzirde vien\u0101 aus\u012b.\"<\/p>\n

Jebkuras kohle\u0101r\u0101s implant\u0101cijas gad\u012bjum\u0101 saglab\u0101jas atliku\u0161ais dzirdes zuduma risks, bet tiem, kuri nesasniedz apmierino\u0161u dzirdi ar dzirdes apar\u0101tiem, nevajadz\u0113tu atlikt implant\u0101ciju. \"Ar m\u016bsu FLEX elektrodu dizainu MED-EL ir izstr\u0101d\u0101jis vien\u012bgos kohle\u0101ros implantus, kam ir pier\u0101d\u012bts, ka tie saglab\u0101 atliku\u0161o dzirdi daudziem sa\u0146\u0113m\u0113jiem,\" skaidro Ingeborga Hohmeijera (Ingeborg Hochmair), MED-EL dibin\u0101t\u0101ja un vad\u012bt\u0101ja. Jo, k\u0101 uzsver MED-EL: \"Pacienti vienm\u0113r ir biju\u0161i m\u016bsu galven\u0101 priorit\u0101te.\"<\/p>\n

MED-EL kohle\u0101rie implanti ir pirmie un l\u012bdz \u0161im vien\u012bgie, ko FDA apstiprin\u0101jusi pieaugu\u0161ajiem ar atliku\u0161o dzirdi zemo frekven\u010du diapazon\u0101. \u0160ie pier\u0101d\u012bjumi kop\u0101 ar MED-EL unik\u0101lo uz anatomiju balst\u012bto apr\u012bkojumu (ABF) ir paredz\u0113ti, lai iedro\u0161in\u0101tu KI kandid\u0101tus veikt implant\u0101ciju \u0101tr\u0101k, pat ja vi\u0146iem joproj\u0101m ir der\u012bga atlikus\u012b dzirde.<\/p>\n

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Atsauces<\/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>Piln\u012bb\u0101 ieg\u016bts saska\u0146\u0101 ar V\u012bnes konsensu: maksim\u0101li 15 decibelu izmai\u0146as pie 125, 250 un 500 herciem; da\u013c\u0113ji ieg\u016bts: maksim\u0101li 30 decibelu izmai\u0146as. \u2191<\/a><\/li>\n
  3. <\/a>Adunka OF, Gantz BJ, Dunn C, Gurgel RK, Buchman CA. Oblig\u0101tie zi\u0146o\u0161anas standarti pieaugu\u0161o kohle\u0101rajai implant\u0101cijai. Otolaringola Galvas Kakla \u0136ir. 2018 Aug;159(2):215-219.: 125, 250 un 500 hercu maksimums 80 decibelu dzirdes zudums. \u2191<\/a><\/li>\n<\/ol>\n<\/div>\n<\/div><\/div><\/div><\/div><\/div>\n","protected":false},"excerpt":{"rendered":"

    Lai saglab\u0101tu atliku\u0161o dzirdi, kandid\u0101ti da\u017ereiz atliek kohle\u0101ro implant\u0101ciju uz gadiem. Tom\u0113r FLEX elektrodi var saglab\u0101t atliku\u0161o dzirdi – to tagad apstiprina unik\u0101ls FDA apstiprin\u0101jums!<\/p>\n","protected":false},"author":10,"featured_media":32555,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[418],"tags":[],"class_list":["post-32495","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-zinatne"],"yoast_head":"\nDzirdes saglab\u0101\u0161ana ir ofici\u0101li atz\u012bta - Latvian<\/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\/lv\/dzirdes-saglabasana-ir-oficiali-atzita\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Dzirdes saglab\u0101\u0161ana ir ofici\u0101li atz\u012bta - Latvian\" \/>\n<meta property=\"og:description\" content=\"Lai saglab\u0101tu atliku\u0161o dzirdi, kandid\u0101ti da\u017ereiz atliek kohle\u0101ro implant\u0101ciju uz gadiem. 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