{"id":8385,"date":"2026-04-24T14:10:25","date_gmt":"2026-04-24T14:10:25","guid":{"rendered":"https:\/\/www.healthoptibody.com\/?p=8385"},"modified":"2026-04-24T14:10:25","modified_gmt":"2026-04-24T14:10:25","slug":"cure-for-deafness-breakthrough-gene-drug-otarmeni-set-to-be-offered-free-to-american-children-with-total-hearing-loss-following-fda-approval","status":"publish","type":"post","link":"https:\/\/www.healthoptibody.com\/?p=8385","title":{"rendered":"Cure for deafness: Breakthrough gene drug Otarmeni set to be offered FREE to American children with total hearing loss following FDA approval"},"content":{"rendered":"<p><\/p>\n<div id=\"js-article-text\" wp_automatic_readability=\"105.64862861379\">\n<p class=\"author-section byline-plain\">By <a href=\"https:\/\/www.dailymail.com\/profile-125\/luke-andrews.html\" class=\"author\">LUKE ANDREWS, U.S. SENIOR HEALTH CORRESPONDENT<\/a> <\/p>\n<p class=\"byline-section\"><span class=\"article-timestamp article-timestamp-published\"> <span class=\"article-timestamp-label\">Published:<\/span> <time datetime=\"2026-04-24T14:55:29+0100\"> 09:55 EDT, 24 April 2026 <\/time> <\/span> | <span class=\"article-timestamp article-timestamp-updated\"> <span class=\"article-timestamp-label\">Updated:<\/span> <time datetime=\"2026-04-24T15:01:05+0100\"> 10:01 EDT, 24 April 2026 <\/time> <\/span> <\/p>\n<p> <!-- ad: https:\/\/mads.dailymail.co.uk\/v8\/us\/health\/none\/article\/other\/para_top.html --> <!-- CWV --><!--[if !IE]><!--> <link href=\"https:\/\/www.dailymail.com\/static\/mol-fe\/static\/mol-fe-async-bundle\/11.72.0\/articleDefer.css\" media=\"all\" rel=\"stylesheet\" type=\"text\/css\" \/> <!--<![endif]--> <!--[if IE]>\n<link href=\"https:\/\/www.dailymail.com\/static\/gunther\/1.17.0\/registration--.css\" media=\"screen\" rel=\"stylesheet\" type=\"text\/css\" \/>\n<![endif]--> <!--[if !IE]><!--> <link href=\"https:\/\/www.dailymail.com\/static\/gunther\/18.4.3\/registration--.css\" media=\"all\" rel=\"stylesheet\" type=\"text\/css\" \/> <!--<![endif]--><!--[if IE]>\n<link href=\"https:\/\/www.dailymail.com\/static\/gunther\/1.17.0\/all-ie8-9--.css\" media=\"all\" rel=\"stylesheet\" type=\"text\/css\" \/>\n<link href=\"https:\/\/www.dailymail.com\/static\/gunther\/1.17.0\/all1-ie8-9--.css\" media=\"all\" rel=\"stylesheet\" type=\"text\/css\" \/>\n<![endif]--> <!--[if !IE]><!--> <link href=\"https:\/\/www.dailymail.com\/static\/mol-fe\/static\/mol-fe-sync-bundle\/15.83.1\/desktop.css\" media=\"all\" rel=\"stylesheet\" type=\"text\/css\" \/> <link href=\"https:\/\/www.dailymail.com\/static\/gunther\/18.5.0\/all--.css\" media=\"all\" rel=\"stylesheet\" type=\"text\/css\" \/><link href=\"https:\/\/www.dailymail.com\/static\/gunther\/18.5.0\/all1--.css\" media=\"all\" rel=\"stylesheet\" type=\"text\/css\" \/> <!--<![endif]--> <!--[if IE 8]>\n\n<![endif]--> <!--[if IE 9]>\n\n<![endif]--> <!--[if IE]>\n\n<![endif]--> <!--[if !IE]> -->  <!--<![endif]--><!-- SiteCatalyst code version: H.20.3.\n    Copyright 1997-2009 Omniture, Inc. More info available at\n    http:\/\/www.omniture.com -->  <\/p>\n<p>         <!-- End SiteCatalyst code version: H.20.3. -->  <!--[if IE]>\n\n<![endif]--> <!--[if !IE]> -->   <!--<![endif]--><!--[if IE]>\n  \n  <noscript><link rel=\"stylesheet\" href=\"https:\/\/www.dailymail.com\/static\/gunther\/gunther-2159\/video_bundle--.css\"><\/noscript>\n  \n<![endif]--> <!--[if !IE]> --> <link rel=\"preload\" href=\"https:\/\/www.dailymail.com\/static\/videoplayer\/7.16.0\/styles\/mol-fe-videoplayer.min.css\" as=\"style\" onload=\"this.rel=\" stylesheet=\"\" \/> <noscript><link rel=\"stylesheet\" href=\"https:\/\/www.dailymail.com\/static\/videoplayer\/7.16.0\/styles\/mol-fe-videoplayer.min.css\" \/><\/noscript>  <!-- <![endif]-->\n          <link rel=\"stylesheet\" type=\"text\/css\" href=\"https:\/\/scripts.dailymail.co.uk\/static\/mol-fe\/static\/mol-fe-xpmodule-related-story-factbox\/2.6.0\/styles.css\" \/>\n<p>          <!-- CWV --><\/p>\n<div itemprop=\"articleBody\" wp_automatic_readability=\"104.31582278481\">\n<p class=\"mol-para-with-font\">A breakthrough treatment that could allow deaf children to hear a whisper has been approved in the US \u2014 and is set to be offered to American children for free.<\/p>\n<p class=\"mol-para-with-font\">The Food and Drug Administration gave the green light to Regeneron&#8217;s gene therapy Otarmeni on Thursday, a treatment for a rare form of hearing loss that leaves babies completely deaf or only able to hear very loud sounds from birth.<\/p>\n<p class=\"mol-para-with-font\">The condition, known as OTOF-related hearing loss, affects about 50 babies in the US every year and is caused by a mutation in the OTOF gene, which causes a malformed protein to be made that stops signals from sounds being transferred to the brain.<\/p>\n<p class=\"mol-para-with-font\">In clinical trials involving 20 children with the mutation, 16 showed significant improvements in hearing after receiving the therapy.\u00a0<\/p>\n<p class=\"mol-para-with-font\">Five of the children were also able to hear a whisper for the first time.<\/p>\n<p class=\"mol-para-with-font\">Experts have hailed the treatment as &#8216;life-changing&#8217; for families, while Regeneron&#8217;s vice president said it marked the beginning of a &#8216;new era&#8217; of hearing loss treatments.<\/p>\n<p class=\"mol-para-with-font\">Sierra Smith, whose two-and-a-half-year-old son Travis was treated with the gene therapy, said it had opened up a &#8216;different world&#8217; to her family.<\/p>\n<p class=\"mol-para-with-font\">She said: &#8216;Watching him be able to interact with other children and even him knowing his name now and turning when I say his name is the craziest thing.<\/p>\n<div class=\"artSplitter mol-img-group\" style=\"\" wp_automatic_readability=\"8\">\n<div class=\"mol-img\">\n<div class=\"image-wrap\"> <img loading=\"lazy\" decoding=\"async\" id=\"i-f9e1ae8f15a0c1f9\" src=\"https:\/\/i.dailymail.com\/1s\/2026\/04\/24\/14\/108131647-15762335-image-a-1_1777037436443.jpg\" height=\"423\" width=\"634\" alt=\"OTOF-related hearing loss is a genetic condition where sounds are not transmitted from the ear to the brain (stock image)\" class=\"blkBorder img-share\" style=\"max-width:100%\" loading=\"lazy\" \/> <\/div>\n<\/p><\/div>\n<p class=\"imageCaption\">OTOF-related hearing loss is a genetic condition where sounds are not transmitted from the ear to the brain (stock image)<\/p>\n<\/div>\n<p><iframe data-xpmodule-iframe-resizable=\"\" scrolling=\"no\" name=\"xp-iframe-moczdk2idwlgku2jyu\" class=\"iframe-creator \" src=\"https:\/\/i.dailymail.co.uk\/i\/html_modules\/Annie\/tests\/240905-healthsubheading\/240905-healthsubheading\/index.html\" allow=\"clipboard-write\" height=\"45\" style=\"border: 0; width: 0; min-width: 100%; \" wp_automatic_readability=\"2\" id=\"xp-iframe-moczdk2idwlgku2jyu\"><\/p>\n<p>Your browser does not support iframes.<\/p>\n<p>    <\/iframe><\/p>\n<p class=\"mol-para-with-font\">&#8216;I can tell him how much I love him \u2014 it&#8217;s such a different world.&#8217;<\/p>\n<p class=\"mol-para-with-font\">Before the new treatment was approved, the only option for children with the condition was cochlear implants, which restored the ability to hear speech and music but not softer sounds.<\/p>\n<p class=\"mol-para-with-font\">Unlike the gene therapy, the implants did not give children 24\/7 hearing and required batteries to function.<\/p>\n<p class=\"mol-para-with-font\">The OTOF gene codes for Otoferlin, a critical protein in the ear&#8217;s inner hair cells that is essential for transmitting sound signals to the brain.<\/p>\n<p class=\"mol-para-with-font\">In the condition, a mutated version of this protein is made that leaves patients unable to hear anything or only very loud sounds.<\/p>\n<p class=\"mol-para-with-font\">In the new treatment, physicians use a modified virus to deliver a working copy of the OTOF gene to cells, which helps to restore hearing.\u00a0<\/p>\n<p class=\"mol-para-with-font\">The virus is infused into the cochlea, the bony cavity within the inner ear, during a surgery similar to that needed for placing cochlear implants. These implants can be given to children from nine months old.<\/p>\n<p class=\"mol-para-with-font\">In the clinical trial, side effects of the medication included infection or inflammation of the ear, vomiting, nausea and dizziness.<\/p>\n<p class=\"mol-para-with-font\">The approval was yesterday touted by President Donald Trump, who said that the medication would be available via TrumpRx.<\/p>\n<p class=\"mol-para-with-font\">It was part of a wider deal Regeneron signed with the administration to offer its medicines at lower prices for the Medicaid program and for cash payers.<\/p>\n<p class=\"mol-para-with-font\">Trump said: &#8216;I&#8217;m thrilled \u200bto announce that one of the most respected pharmaceutical companies anywhere in the world, frankly, I know it very well is Regeneron, and it&#8217;s agreed to offer their prescription medications at heavily discounted most favored \u200bnation prices.&#8217;<\/p>\n<p class=\"mol-para-with-font\">FDA Commissioner Dr Marty Makary said: &#8216;Today&#8217;s approval is a significant milestone in the treatment of genetic hearing loss.<\/p>\n<p class=\"mol-para-with-font\">&#8216;Through the national priority voucher pilot program, the agency is accelerating therapies for rare diseases with unmet medical needs while proving we can successfully review even the most complex submissions&#8230; in significantly shortened timeframes.&#8217;<\/p>\n<p class=\"mol-para-with-font\">The treatment was approved via the national priority voucher program, a program to accelerate review times for breakthrough treatments from 10 to 12 to one to two months.<\/p>\n<p class=\"mol-para-with-font\">More than 50 million Americans suffer from hearing loss, estimates suggest, making it the third most common chronic condition in the country.<\/p>\n<\/div>\n<p>            <!-- ad: https:\/\/mads.dailymail.co.uk\/v8\/us\/health\/none\/article\/other\/inread_player.html --><\/p>\n<div class=\"column-content cleared\">\n<div class=\"shareArticles\">\n<h3 class=\"social-links-title\">Share or comment on this article:<br \/>\n                        Cure for deafness: Breakthrough gene drug Otarmeni set to be offered FREE to American children with total hearing loss following FDA approval<\/h3>\n<\/p><\/div>\n<\/p><\/div>\n<p>            <ad-slot position=\"smart_feed\"><\/ad-slot><\/p>\n<p>            <ad-slot position=\"after_article\"><\/ad-slot><\/p><\/div>\n","protected":false},"excerpt":{"rendered":"<p>By LUKE ANDREWS, U.S. SENIOR HEALTH CORRESPONDENT Published: 09:55 EDT, 24 April 2026 | Updated: 10:01 EDT, 24 April 2026 A breakthrough treatment that could allow deaf children to hear a whisper has been approved in the US \u2014 and is set to be offered to American children for free. The Food and Drug Administration<\/p>\n","protected":false},"author":1,"featured_media":8386,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[520],"tags":[],"class_list":{"0":"post-8385","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-hot"},"_links":{"self":[{"href":"https:\/\/www.healthoptibody.com\/index.php?rest_route=\/wp\/v2\/posts\/8385","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.healthoptibody.com\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.healthoptibody.com\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.healthoptibody.com\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.healthoptibody.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=8385"}],"version-history":[{"count":0,"href":"https:\/\/www.healthoptibody.com\/index.php?rest_route=\/wp\/v2\/posts\/8385\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.healthoptibody.com\/index.php?rest_route=\/wp\/v2\/media\/8386"}],"wp:attachment":[{"href":"https:\/\/www.healthoptibody.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=8385"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.healthoptibody.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=8385"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.healthoptibody.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=8385"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}