{"id":29723,"date":"2026-08-17T09:56:59","date_gmt":"2026-08-17T13:56:59","guid":{"rendered":"https:\/\/www.notaoficial.com\/s\/?p=29723"},"modified":"2026-08-22T10:00:19","modified_gmt":"2026-08-22T14:00:19","slug":"samsung-formaliza-la-autorizacion-de-la-fda-para-la-funcion-de-audifono-otc-en-los-galaxy-buds","status":"publish","type":"post","link":"https:\/\/www.notaoficial.com\/s\/2026\/08\/17\/samsung-formaliza-la-autorizacion-de-la-fda-para-la-funcion-de-audifono-otc-en-los-galaxy-buds\/","title":{"rendered":"Samsung formaliza la autorizaci\u00f3n de la FDA para la funci\u00f3n de aud\u00edfono OTC en los Galaxy Buds"},"content":{"rendered":"<p data-path-to-node=\"1\">Samsung Electronics anunci\u00f3 la aprobaci\u00f3n oficial por parte de la Administraci\u00f3n de Alimentos y Medicamentos de EE. UU. (FDA) para incorporar la funci\u00f3n de aud\u00edfono de venta libre (<i data-path-to-node=\"1\" data-index-in-node=\"225\">Over-The-Counter<\/i>, OTC) en sus auriculares. El desarrollo permite a adultos mayores de 18 a\u00f1os con p\u00e9rdida auditiva percibida de leve a moderada gestionar su audici\u00f3n sin prescripci\u00f3n ni ex\u00e1menes presenciales.<\/p>\n<h3 data-path-to-node=\"3\">Diagn\u00f3stico, calibraci\u00f3n y tecnolog\u00eda de procesamiento<\/h3>\n<p data-path-to-node=\"4\">La suite de salud auditiva se integra en el men\u00fa de Ajustes del sistema sin depender de software de terceros:<\/p>\n<table data-path-to-node=\"5\">\n<thead>\n<tr>\n<td><strong>Componente \/ Prueba<\/strong><\/td>\n<td><strong>Especificaci\u00f3n T\u00e9cnica<\/strong><\/td>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td><span data-path-to-node=\"5,1,0,0\"><b data-path-to-node=\"5,1,0,0\" data-index-in-node=\"0\">Hearing Test (SaMD)<\/b><\/span><\/td>\n<td><span data-path-to-node=\"5,1,1,0\">Software m\u00e9dico (<i data-path-to-node=\"5,1,1,0\" data-index-in-node=\"17\">Software as a Medical Device<\/i>) que realiza audiometr\u00eda tonal pura por o\u00eddo en <b data-path-to-node=\"5,1,1,0\" data-index-in-node=\"94\">5 minutos<\/b>.<\/span><\/td>\n<\/tr>\n<tr>\n<td><span data-path-to-node=\"5,2,0,0\"><b data-path-to-node=\"5,2,0,0\" data-index-in-node=\"0\">Generaci\u00f3n de Audiograma<\/b><\/span><\/td>\n<td><span data-path-to-node=\"5,2,1,0\">Clasifica la audici\u00f3n en niveles: <i data-path-to-node=\"5,2,1,0\" data-index-in-node=\"34\">normal<\/i>, <i data-path-to-node=\"5,2,1,0\" data-index-in-node=\"42\">leve<\/i>, <i data-path-to-node=\"5,2,1,0\" data-index-in-node=\"48\">moderada<\/i>, <i data-path-to-node=\"5,2,1,0\" data-index-in-node=\"58\">grave<\/i> o <i data-path-to-node=\"5,2,1,0\" data-index-in-node=\"66\">profunda<\/i>.<\/span><\/td>\n<\/tr>\n<tr>\n<td><span data-path-to-node=\"5,3,0,0\"><b data-path-to-node=\"5,3,0,0\" data-index-in-node=\"0\">F\u00f3rmula de Ajuste Cl\u00ednico<\/b><\/span><\/td>\n<td><span data-path-to-node=\"5,3,1,0\">Calibraci\u00f3n mediante el algoritmo est\u00e1ndar <b data-path-to-node=\"5,3,1,0\" data-index-in-node=\"43\">NAL-NL2<\/b> para personalizar frecuencias altas, susurros y voces distantes.<\/span><\/td>\n<\/tr>\n<tr>\n<td><span data-path-to-node=\"5,4,0,0\"><b data-path-to-node=\"5,4,0,0\" data-index-in-node=\"0\">Procesamiento de Audio<\/b><\/span><\/td>\n<td><span data-path-to-node=\"5,4,1,0\">Reducci\u00f3n activa de ruido de fondo y tecnolog\u00eda de formaci\u00f3n de haces (<i data-path-to-node=\"5,4,1,0\" data-index-in-node=\"71\">beamforming<\/i>) para aislamiento vocal frontal.<\/span><\/td>\n<\/tr>\n<tr>\n<td><span data-path-to-node=\"5,5,0,0\"><b data-path-to-node=\"5,5,0,0\" data-index-in-node=\"0\">Ecosistema de Salud<\/b><\/span><\/td>\n<td><span data-path-to-node=\"5,5,1,0\">Sincronizaci\u00f3n de resultados de la prueba y registros de exposici\u00f3n al ruido en <b data-path-to-node=\"5,5,1,0\" data-index-in-node=\"80\">Samsung Health<\/b>.<\/span><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<h3 data-path-to-node=\"7\">Proceso de validaci\u00f3n y despliegue comercial<\/h3>\n<ul>\n<li><b data-path-to-node=\"8,0,0\" data-index-in-node=\"0\">Evidencia Cl\u00ednica:<\/b> La tecnolog\u00eda evolucion\u00f3 a partir del sistema de amplificaci\u00f3n (PSAP) introducido en 2020 con los Galaxy Buds+. El algoritmo actual se dise\u00f1\u00f3 junto a los <i data-path-to-node=\"8,0,0\" data-index-in-node=\"173\">National Acoustic Laboratories<\/i> (NAL) y el <i data-path-to-node=\"8,0,0\" data-index-in-node=\"215\">Samsung Medical Center<\/i> (SMC), respaldado por pruebas de la Universidad Vanderbilt, la Universidad Estatal de San Jos\u00e9 y la Universidad de Memphis.<\/li>\n<li><b data-path-to-node=\"8,1,0\" data-index-in-node=\"0\">Disponibilidad:<\/b> Las funciones estar\u00e1n disponibles en Estados Unidos y mercados autorizados durante el <b data-path-to-node=\"8,1,0\" data-index-in-node=\"102\">cuarto trimestre de 2026<\/b> para los modelos <b data-path-to-node=\"8,1,0\" data-index-in-node=\"144\">Galaxy Buds3 Pro<\/b> y <b data-path-to-node=\"8,1,0\" data-index-in-node=\"163\">Galaxy Buds4 Pro<\/b>.<\/li>\n<li><b data-path-to-node=\"8,2,0\" data-index-in-node=\"0\">Requisitos del Entorno:<\/b> Se requiere vincular los auriculares a un dispositivo Galaxy con la interfaz <b data-path-to-node=\"8,2,0\" data-index-in-node=\"101\">One UI 8<\/b> o posterior.<\/li>\n<\/ul>\n","protected":false},"excerpt":{"rendered":"<p>Samsung Electronics anunci\u00f3 la aprobaci\u00f3n oficial por parte de la Administraci\u00f3n de Alimentos y Medicamentos de EE. UU. (FDA) para incorporar la funci\u00f3n de aud\u00edfono de venta libre (Over-The-Counter, OTC) en sus auriculares. El desarrollo permite a adultos mayores de 18 a\u00f1os con p\u00e9rdida auditiva percibida de leve a moderada gestionar su audici\u00f3n sin prescripci\u00f3n [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":29724,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[93,146,2],"tags":[9782,10632,10529,9707,15],"wppr_data":{"cwp_meta_box_check":"No"},"_links":{"self":[{"href":"https:\/\/www.notaoficial.com\/s\/wp-json\/wp\/v2\/posts\/29723"}],"collection":[{"href":"https:\/\/www.notaoficial.com\/s\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.notaoficial.com\/s\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.notaoficial.com\/s\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.notaoficial.com\/s\/wp-json\/wp\/v2\/comments?post=29723"}],"version-history":[{"count":1,"href":"https:\/\/www.notaoficial.com\/s\/wp-json\/wp\/v2\/posts\/29723\/revisions"}],"predecessor-version":[{"id":29725,"href":"https:\/\/www.notaoficial.com\/s\/wp-json\/wp\/v2\/posts\/29723\/revisions\/29725"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.notaoficial.com\/s\/wp-json\/wp\/v2\/media\/29724"}],"wp:attachment":[{"href":"https:\/\/www.notaoficial.com\/s\/wp-json\/wp\/v2\/media?parent=29723"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.notaoficial.com\/s\/wp-json\/wp\/v2\/categories?post=29723"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.notaoficial.com\/s\/wp-json\/wp\/v2\/tags?post=29723"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}