{"id":3286,"date":"2024-11-05T16:46:48","date_gmt":"2024-11-05T23:46:48","guid":{"rendered":"https:\/\/neurotucson.com\/?p=3286"},"modified":"2024-11-05T16:47:01","modified_gmt":"2024-11-05T23:47:01","slug":"envoy-medical-gains-fda-approval","status":"publish","type":"post","link":"https:\/\/neurotucson.com\/envoy-medical-gains-fda-approval\/","title":{"rendered":"Envoy Medical Gains FDA Approval"},"content":{"rendered":"<div class=\"wp-block-image\">\n<figure class=\"alignright size-full is-resized\"><img decoding=\"async\" width=\"480\" height=\"152\" src=\"https:\/\/neurotucson.com\/wp-content\/uploads\/2024\/11\/envoymedical002.jpg\" alt=\"\" class=\"wp-image-3289\" style=\"width:326px;height:auto\"\/><\/figure><\/div>\n\n\n<h2 class=\"wp-block-heading\">Envoy Medical Gains FDA Approval for Pivotal Study of Fully Implanted Acclaim\u00ae\u00a0\u00a0Cochlear Implant<\/h2>\n\n\n\n<p>Envoy Medical, Inc. (NASDAQ: COCH), a leader in hearing health innovation, announced that the FDA has approved its Investigational Device Exemption (IDE) application for a pivotal study of the Acclaim\u00ae Fully Implanted Cochlear Implant. This device, unlike traditional cochlear implants, uses an implanted sensor designed to work with the ear\u2019s natural structure to capture sound. CEO Brent Lucas highlighted this FDA approval as a major step toward offering more discrete and effective solutions for those with severe to profound hearing loss, noting that around 95% of eligible patients currently do not receive cochlear implants. Envoy Medical plans to collaborate with top U.S. cochlear implant centers for this study, pending Institutional Review Board (IRB) approvals.<br><br>The FDA approved the study in stages, allowing initial data collection on a subset of patients before expanding to the full cohort. The Acclaim\u00ae received FDA Breakthrough Device Designation in 2019, underscoring its potential to address significant hearing loss in adults.\u00a0\u00a0<br><br><strong>Dr. Jacob and the team of audiologists at Ear &amp; Hearing | Center for Neurosciences have been chosen as one of a handful of initial Otology\/Neurotology practices across the United States for this Pivotal Study of the Acclaim device, are currently working on the details for onboarding the clinical trial, and are hoping to start enrolling patients in the near future.\u00a0<\/strong><br><br>Envoy Medical\u2019s portfolio also includes the FDA-approved Esteem\u00ae Fully Implanted Active Middle Ear Implant, designed for 24\/7 use without external components. This IDE approval aligns with the company\u2019s vision to become a market leader in the hearing industry, setting the stage for further advancements and expanded patient options.<\/p>\n\n\n\n<p>For more information on Envoy Medical\u2019s devices and clinical updates, visit\u00a0<a href=\"https:\/\/www.envoymedical.com\/\">Envoy Medical\u2019s website<\/a>.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Envoy Medical Gains FDA Approval for Pivotal Study of Fully Implanted Acclaim\u00ae\u00a0\u00a0Cochlear Implant Envoy Medical, Inc. (NASDAQ: COCH), a leader in hearing health innovation, announced that the FDA has approved its Investigational Device Exemption (IDE) application for a pivotal study of the Acclaim\u00ae Fully Implanted Cochlear Implant. This device, unlike traditional cochlear implants, uses an&#8230;<\/p>\n","protected":false},"author":2,"featured_media":3276,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_seopress_robots_primary_cat":"none","_seopress_titles_title":"","_seopress_titles_desc":"","_seopress_robots_index":"","schema":"","fname":"","lname":"","position":"","credentials":"","placeID":"","no_match":false,"name":"","company":"","review":"","address":"","city":"","state":"","zip":"","lat":"","lng":"","phone1":"","phone2":"","fax":"","mon1":"","mon2":"","tue1":"","tue2":"","wed1":"","wed2":"","thu1":"","thu2":"","fri1":"","fri2":"","sat1":"","sat2":"","sun1":"","sun2":"","hours-note":"","footnotes":""},"categories":[22],"tags":[],"class_list":["post-3286","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news"],"_links":{"self":[{"href":"https:\/\/neurotucson.com\/wp-json\/wp\/v2\/posts\/3286"}],"collection":[{"href":"https:\/\/neurotucson.com\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/neurotucson.com\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/neurotucson.com\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/neurotucson.com\/wp-json\/wp\/v2\/comments?post=3286"}],"version-history":[{"count":4,"href":"https:\/\/neurotucson.com\/wp-json\/wp\/v2\/posts\/3286\/revisions"}],"predecessor-version":[{"id":3293,"href":"https:\/\/neurotucson.com\/wp-json\/wp\/v2\/posts\/3286\/revisions\/3293"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/neurotucson.com\/wp-json\/wp\/v2\/media\/3276"}],"wp:attachment":[{"href":"https:\/\/neurotucson.com\/wp-json\/wp\/v2\/media?parent=3286"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/neurotucson.com\/wp-json\/wp\/v2\/categories?post=3286"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/neurotucson.com\/wp-json\/wp\/v2\/tags?post=3286"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}