{"id":33079,"date":"2025-11-06T13:47:06","date_gmt":"2025-11-06T13:47:06","guid":{"rendered":"https:\/\/lifelonghearing.com\/hu\/?p=33079"},"modified":"2025-11-06T13:47:06","modified_gmt":"2025-11-06T13:47:06","slug":"hivatalosan-elismert-hallasvedelem","status":"publish","type":"post","link":"https:\/\/lifelonghearing.com\/hu\/hivatalosan-elismert-hallasvedelem\/","title":{"rendered":"Hivatalosan elismert hall\u00e1sv\u00e9delem"},"content":{"rendered":"<p><div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-1 fusion-flex-container nonhundred-percent-fullwidth non-hundred-percent-height-scrolling\" style=\"--awb-border-radius-top-left:0px;--awb-border-radius-top-right:0px;--awb-border-radius-bottom-right:0px;--awb-border-radius-bottom-left:0px;--awb-flex-wrap:wrap;\" ><div class=\"fusion-builder-row fusion-row fusion-flex-align-items-flex-start fusion-flex-content-wrap\" style=\"max-width:1248px;margin-left: calc(-4% \/ 2 );margin-right: calc(-4% \/ 2 );\"><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-0 fusion_builder_column_1_1 1_1 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:100%;--awb-margin-top-large:0px;--awb-spacing-right-large:1.92%;--awb-margin-bottom-large:10px;--awb-spacing-left-large:1.92%;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-title title fusion-title-1 fusion-sep-none fusion-title-text fusion-title-size-one\" style=\"--awb-margin-top:0px;--awb-font-size:38px;\"><h1 class=\"fusion-title-heading title-heading-left fusion-responsive-typography-calculated\" style=\"margin:0;font-size:1em;--fontSize:38;line-height:1.3;\"><strong><em>Hat\u00f3s\u00e1gi j\u00f3v\u00e1hagy\u00e1s szerint a MED-EL FLEX elektr\u00f3d\u00e1k a cochle\u00e1ris implant\u00e1ci\u00f3 ut\u00e1n is v\u00e9dik a marad\u00e9k hall\u00e1st.<\/em><\/strong><\/h1><\/div><div class=\"fusion-text fusion-text-1\"><p><strong>A marad\u00e9k hall\u00e1suk meg\u0151rz\u00e9se \u00e9rdek\u00e9ben a cochle\u00e1ris implant\u00e1tum jel\u00f6ltek n\u00e9ha \u00e9vekig halogatj\u00e1k az implant\u00e1ci\u00f3t. A FLEX elektr\u00f3d\u00e1k azonban k\u00e9pesek meg\u0151rizni a marad\u00e9k hall\u00e1st &#8211; ezt a t\u00e9nyt most m\u00e9g az Amerikai FDA egyedi j\u00f3v\u00e1hagy\u00e1sa is meger\u0151s\u00edti!<\/strong><\/p>\n<p><em>Eva Kohl<\/em><\/p>\n<\/div><div class=\"fusion-image-element \" style=\"--awb-caption-title-font-family:var(--h2_typography-font-family);--awb-caption-title-font-weight:var(--h2_typography-font-weight);--awb-caption-title-font-style:var(--h2_typography-font-style);--awb-caption-title-size:var(--h2_typography-font-size);--awb-caption-title-transform:var(--h2_typography-text-transform);--awb-caption-title-line-height:var(--h2_typography-line-height);--awb-caption-title-letter-spacing:var(--h2_typography-letter-spacing);\"><span class=\" fusion-imageframe imageframe-none imageframe-1 hover-type-none\"><img decoding=\"async\" width=\"1400\" height=\"652\" title=\"tanzen_featured\" src=\"https:\/\/lifelonghearing.com\/hu\/wp-content\/uploads\/sites\/4\/2025\/11\/tanzen_featured.jpg\" data-orig-src=\"https:\/\/lifelonghearing.com\/hu\/wp-content\/uploads\/sites\/4\/2025\/11\/tanzen_featured.jpg\" alt class=\"lazyload img-responsive wp-image-33080\" srcset=\"data:image\/svg+xml,%3Csvg%20xmlns%3D%27http%3A%2F%2Fwww.w3.org%2F2000%2Fsvg%27%20width%3D%271400%27%20height%3D%27652%27%20viewBox%3D%270%200%201400%20652%27%3E%3Crect%20width%3D%271400%27%20height%3D%27652%27%20fill-opacity%3D%220%22%2F%3E%3C%2Fsvg%3E\" data-srcset=\"https:\/\/lifelonghearing.com\/hu\/wp-content\/uploads\/sites\/4\/2025\/11\/tanzen_featured-200x93.jpg 200w, https:\/\/lifelonghearing.com\/hu\/wp-content\/uploads\/sites\/4\/2025\/11\/tanzen_featured-400x186.jpg 400w, https:\/\/lifelonghearing.com\/hu\/wp-content\/uploads\/sites\/4\/2025\/11\/tanzen_featured-600x279.jpg 600w, https:\/\/lifelonghearing.com\/hu\/wp-content\/uploads\/sites\/4\/2025\/11\/tanzen_featured-800x373.jpg 800w, https:\/\/lifelonghearing.com\/hu\/wp-content\/uploads\/sites\/4\/2025\/11\/tanzen_featured-1200x559.jpg 1200w, https:\/\/lifelonghearing.com\/hu\/wp-content\/uploads\/sites\/4\/2025\/11\/tanzen_featured.jpg 1400w\" data-sizes=\"auto\" data-orig-sizes=\"(max-width: 1024px) 100vw, (max-width: 640px) 100vw, 1200px\" \/><\/span><\/div><\/div><\/div><\/div><\/div><div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-2 fusion-flex-container nonhundred-percent-fullwidth non-hundred-percent-height-scrolling\" style=\"--awb-border-radius-top-left:0px;--awb-border-radius-top-right:0px;--awb-border-radius-bottom-right:0px;--awb-border-radius-bottom-left:0px;--awb-flex-wrap:wrap;\" ><div class=\"fusion-builder-row fusion-row fusion-flex-align-items-flex-start fusion-flex-content-wrap\" style=\"max-width:1248px;margin-left: calc(-4% \/ 2 );margin-right: calc(-4% \/ 2 );\"><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-1 fusion_builder_column_1_1 1_1 fusion-flex-column\" style=\"--awb-bg-blend:overlay;--awb-bg-size:cover;--awb-width-large:100%;--awb-margin-top-large:0px;--awb-spacing-right-large:1.92%;--awb-margin-bottom-large:0px;--awb-spacing-left-large:1.92%;--awb-width-medium:100%;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-text fusion-text-2\"><p>Kor\u00e1bban \u00e1ltal\u00e1nos felt\u00e9telez\u00e9s volt, hogy cochle\u00e1ris implant\u00e1ci\u00f3 eset\u00e9n a p\u00e1ciens elvesz\u00edti a megmaradt term\u00e9szetes hall\u00e1s\u00e1t. Ez gyakran visszatartotta a fokozatosan roml\u00f3 hall\u00e1s\u00fa embereket a m\u0171t\u00e9tt\u0151l \u2013 m\u00e9g akkor is, amikor a hagyom\u00e1nyos hall\u00f3k\u00e9sz\u00fcl\u00e9kek m\u00e1r r\u00e9g nem biztos\u00edtottak megfelel\u0151 besz\u00e9d\u00e9rt\u00e9st.<\/p>\n<p>Az elm\u00falt 50 \u00e9v CI-fejleszt\u00e9seinek k\u00f6sz\u00f6nhet\u0151en azonban a technol\u00f3gia \u00e9s a seb\u00e9szeti elj\u00e1r\u00e1sok jelent\u0151sen fejl\u0151dtek. A MED-EL m\u00e1r 2006-ban bevezette a k\u00fcl\u00f6n\u00f6sen v\u00e9kony, atraumatikus FLEX technol\u00f3gi\u00e1t; a marad\u00e9k hall\u00e1s m\u00e9g a k\u00f6zepes \u00e9s a hossz\u00fa FLEX elektr\u00f3d\u00e1kkal is meg\u0151rizhet\u0151. A vil\u00e1g leghosszabb CI-elektr\u00f3d\u00e1ja is hall\u00e1smeg\u0151rz\u0151 kialak\u00edt\u00e1sban \u00e9rhet\u0151 el FLEX 34 n\u00e9ven.<\/p>\n<p>A FLEX diz\u00e1jn megk\u00f6nny\u00edti a d\u00f6nt\u00e9st azok sz\u00e1m\u00e1ra, akiknek van m\u00e9g marad\u00e9k hall\u00e1suk: amint a besz\u00e9d m\u00e1r hall\u00f3k\u00e9sz\u00fcl\u00e9kkel sem \u00e9rthet\u0151, id\u0151ben el lehet hat\u00e1rozni az implant\u00e1ci\u00f3t.<\/p>\n<h3><strong>A legszigor\u00fabb enged\u00e9lyez\u0151 hat\u00f3s\u00e1g \u00e1ltal meger\u0151s\u00edtett hall\u00e1sv\u00e9delem<\/strong><\/h3>\n<p>Az Amerikai Egyes\u00fclt \u00c1llamok \u00c9lelmiszer- \u00e9s Gy\u00f3gyszer\u00fcgyi Hivatala, az FDA (U.S. Food and Drug Administration) \u00a0\u2013 amelyet a nemzetk\u00f6zi orvostechnol\u00f3giai ter\u00fcleten a legszigor\u00fabb szab\u00e1lyoz\u00f3 hat\u00f3s\u00e1gk\u00e9nt tartanak sz\u00e1mon \u2013 2024 okt\u00f3ber\u00e9ben enged\u00e9lyezte a MED-EL cochle\u00e1ris implant\u00e1tumok FLEX elektr\u00f3d\u00e1inak alkalmaz\u00e1s\u00e1t feln\u0151tt p\u00e1ciensekn\u00e9l, akik k\u00f6zepes\u2013s\u00falyos fok\u00fa idegi eredet\u0171 (szenzorineur\u00e1lis) hall\u00e1sveszt\u00e9sben szenvednek, \u00e9s csak korl\u00e1tozott m\u00e9rt\u00e9kben profit\u00e1lnak a hall\u00f3k\u00e9sz\u00fcl\u00e9kb\u0151l. Az enged\u00e9ly els\u0151sorban azokra vonatkozik, akikn\u00e9l jelent\u0151s magasfrekvenci\u00e1s hall\u00e1sveszt\u00e9s \u00e1ll fenn, \u00e9s az alacsony frekvenci\u00e1kon megmaradt hall\u00e1s nem elegend\u0151 az elektro-akusztikus stimul\u00e1ci\u00f3hoz (EAS).<a href=\"#_ftn1\" name=\"_ftnref1\">[1]<\/a><\/p>\n<p>Jelenleg a MED-EL FLEX elektr\u00f3d\u00e1k az egyetlen CI-elektr\u00f3d\u00e1k, amelyek ilyen j\u00f3v\u00e1hagy\u00e1ssal rendelkeznek. Ausztri\u00e1ban ezt az indik\u00e1ci\u00f3t kor\u00e1bban is alkalmazt\u00e1k, az FDA-enged\u00e9ly azonban er\u0151teljesen meger\u0151s\u00edti, hogy a FLEX elektr\u00f3d\u00e1k egyed\u00fcl\u00e1ll\u00f3 m\u00f3don k\u00e9pesek meg\u0151rizni a megl\u00e9v\u0151 hall\u00e1st.<\/p>\n<h3><strong>Tudom\u00e1nyosan bizony\u00edtott<\/strong><\/h3>\n<p>Az enged\u00e9lyez\u00e9s kiterjedt tudom\u00e1nyos vizsg\u00e1latokon alapult. A MED-EL cochle\u00e1ris implant\u00e1tumot \u00e9s FLEX elektr\u00f3d\u00e1t haszn\u00e1l\u00f3 p\u00e1ciensek anonimiz\u00e1lt adatait egy Eur\u00f3pa-szint\u0171 CI-regiszterb\u0151l gy\u0171jt\u00f6tt\u00e9k, majd a B\u00e9csi konszenzus szerint elemezt\u00e9k. Ezt a krit\u00e9riumrendszert 2023-ban, 24 orsz\u00e1gos h\u00e1tter\u0171 seb\u00e9sz k\u00f6zrem\u0171k\u00f6d\u00e9s\u00e9vel dolgozt\u00e1k ki. Az eredm\u00e9nyek val\u00f3s klinikai tapasztalatokat t\u00fckr\u00f6znek, elt\u00e9r\u0151 k\u00f6r\u00fclm\u00e9nyek k\u00f6z\u00f6tt m\u0171k\u00f6d\u0151 seb\u00e9szek \u00e9s k\u00f3rh\u00e1zak adatai alapj\u00e1n. A CI-haszn\u00e1l\u00f3k nem estek \u00e1t k\u00fcl\u00f6nleges betegv\u00e1logat\u00e1son, \u00e9s nem egyetlen, egys\u00e9ges m\u0171t\u00e9ti technik\u00e1t alkalmaztak. Ennek ellen\u00e9re az esetek t\u00f6bbs\u00e9g\u00e9ben a megmaradt (CI n\u00e9lk\u00fcli) hall\u00e1s m\u00e9g k\u00e9t \u00e9vvel a be\u00fcltet\u00e9s ut\u00e1n is meg\u0151rz\u0151d\u00f6tt.<a href=\"#_ftn2\" name=\"_ftnref2\">[2]<\/a><\/p>\n<p>Hasonl\u00f3 eredm\u00e9nyekr\u0151l sz\u00e1moltak be az Amerikai F\u00fcl-orr-g\u00e9g\u00e9szeti Akad\u00e9mia (American Academy of Otolaryngology) standardjai szerint v\u00e9gzett elemz\u00e9sek is, valamint egy kifejezetten hall\u00e1smeg\u0151rz\u00e9sre f\u00f3kusz\u00e1l\u00f3, multicentrikus vizsg\u00e1lat. Ut\u00f3bbi azt is kimutatta, hogy m\u00e9g azokn\u00e1l is, akikn\u00e9l a term\u00e9szetes hall\u00e1s nem volt meg\u0151rizhet\u0151, a cochle\u00e1ris implant\u00e1tummal m\u00e1r hat h\u00f3nap ut\u00e1n jobb besz\u00e9d\u00e9rt\u00e9s \u00e9rhet\u0151 el, mint kor\u00e1bban hall\u00f3k\u00e9sz\u00fcl\u00e9kkel \u2013 csendes \u00e9s zajos k\u00f6rnyezetben egyar\u00e1nt.<\/p>\n<h3><strong>Az FDA j\u00f3v\u00e1hagy\u00e1sa meger\u0151s\u00edti a klinikai tapasztalatokat<\/strong><\/h3>\n<p>\u201eAz FDA kib\u0151v\u00edtett indik\u00e1ci\u00f3s krit\u00e9riumai jobban t\u00fckr\u00f6zik a jelenlegi klinikai gyakorlatot, \u00e9s jav\u00edtj\u00e1k a betegek hozz\u00e1f\u00e9r\u00e9s\u00e9t ehhez a kiv\u00e9teles technol\u00f3gi\u00e1hoz\u201d \u2013 magyar\u00e1zza Prof. Meredith Holcomb, AuD, a Miami Egyetem (University of Miami) hall\u00e1simplant\u00e1tum-programj\u00e1nak igazgat\u00f3ja. Kevin D. Brown, MD, PhD, a University of North Carolina\u2013Chapel Hill Otol\u00f3giai \u00e9s Neurootol\u00f3giai Tansz\u00e9k\u00e9nek vezet\u0151je hozz\u00e1teszi: \u201eHa a kifejezetten erre alkalmas FLEX elektr\u00f3d\u00e1kat haszn\u00e1ljuk az alacsony frekvenci\u00e1s hall\u00e1s meg\u0151rz\u00e9s\u00e9re, ezek a p\u00e1ciensek is \u00e9lvezhetik az elektromos \u00e9s akusztikus hall\u00e1s kombin\u00e1ci\u00f3j\u00e1nak minden el\u0151ny\u00e9t ugyanabban a f\u00fclben.\u201d<\/p>\n<p>Minden cochle\u00e1ris implant\u00e1ci\u00f3 hordoz n\u00e9mi rezidu\u00e1lis kock\u00e1zatot a megl\u00e9v\u0151 hall\u00e1s elveszt\u00e9s\u00e9re, ugyanakkor akik hall\u00f3k\u00e9sz\u00fcl\u00e9kkel nem \u00e9rnek el kiel\u00e9g\u00edt\u0151 eredm\u00e9nyt, nem \u00e9rdemes halogatniuk a be\u00fcltet\u00e9st. \u201eA FLEX elektr\u00f3da-diz\u00e1jnnal a MED-EL olyan cochle\u00e1ris implant\u00e1tumokat fejlesztett, amelyekr\u0151l bizony\u00edtott, hogy sok esetben meg\u0151rzik a megmaradt hall\u00e1st\u201d \u2013 hangs\u00falyozza Ingeborg Hochmair, a MED-EL t\u00e1rsalap\u00edt\u00f3ja \u00e9s vez\u00e9rigazgat\u00f3ja. A MED-EL filoz\u00f3fi\u00e1ja szerint: \u201eA betegek mindig is az els\u0151 helyen \u00e1lltak.\u201d<\/p>\n<p>A MED-EL cochle\u00e1ris implant\u00e1tumai az els\u0151k \u2013 \u00e9s egyel\u0151re az egyetlenek \u2013, amelyeket az FDA j\u00f3v\u00e1hagyott alacsony frekvenci\u00e1s marad\u00e9k (rezidu\u00e1lis) hall\u00e1ssal rendelkez\u0151 feln\u0151ttek sz\u00e1m\u00e1ra. Ez a bizony\u00edt\u00e9k \u2013 kieg\u00e9sz\u00fclve a MED-EL egyed\u00fcl\u00e1ll\u00f3 Anatomy-Based Fitting (ABF) illeszt\u00e9si megk\u00f6zel\u00edt\u00e9s\u00e9vel \u2013 arra \u00f6szt\u00f6nzi a CI-jel\u00f6lteket, hogy hamarabb d\u00f6ntsenek a be\u00fcltet\u00e9s mellett, m\u00e9g akkor is, ha m\u00e9g rendelkeznek bizonyos m\u00e9rt\u00e9k\u0171 hasznos hall\u00e1smaradv\u00e1nnyal.<\/p>\n<p><a href=\"#_ftnref1\" name=\"_ftn1\">[1]<\/a> <a href=\"https:\/\/blog-medel-pro\/EN-US\/Cochlear-Implants\/FDA-Expands-med-el-criteria-for-adults-with-residual-hearing\/\">https:\/\/blog-medel-pro\/EN-US\/Cochlear-Implants\/FDA-Expands-med-el-criteria-for-adults-with-residual-hearing\/<\/a><\/p>\n<p><a href=\"#_ftnref2\" name=\"_ftn2\">[2]<\/a> Teljes m\u00e9rt\u00e9kben a b\u00e9csi konszenzus szerint: legfeljebb 15 decibel v\u00e1ltoz\u00e1s 125, 250 \u00e9s 500 hertz; r\u00e9szlegesen kapott: legfeljebb 30 decibel v\u00e1ltoz\u00e1s.<\/p>\n<\/div><\/div><\/div><\/div><\/div><\/p>\n","protected":false},"excerpt":{"rendered":"<p>A marad\u00e9k hall\u00e1suk meg\u0151rz\u00e9se \u00e9rdek\u00e9ben a cochle\u00e1ris implant\u00e1tum jel\u00f6ltek n\u00e9ha \u00e9vekig halogatj\u00e1k az implant\u00e1ci\u00f3t. A FLEX elektr\u00f3d\u00e1k azonban k\u00e9pesek meg\u0151rizni a marad\u00e9k hall\u00e1st &#8211; ezt a t\u00e9nyt most m\u00e9g az Amerikai FDA egyedi j\u00f3v\u00e1hagy\u00e1sa is meger\u0151s\u00edti!<\/p>\n","protected":false},"author":8,"featured_media":33080,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[418],"tags":[],"class_list":["post-33079","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-tudomany"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v24.3 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Hungary<\/title>\n<meta name=\"description\" content=\"Az els\u0151 cochle\u00e1ris implant\u00e1tum 1977-es be\u00fcltet\u00e9se \u00f3ta a CI-technol\u00f3gia jelent\u0151s fejl\u0151d\u00e9sen esett \u00e1t - ezzel egy\u00fctt a besz\u00e9d\u00e9rt\u00e9s \u00e9s a CI-eszk\u00f6z\u00f6k hangmin\u0151s\u00e9ge is sokat fejl\u0151d\u00f6tt. 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