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      <title>Essilorluxottica receives US, EU, green light for OTC Audio Glasses</title>
      <description>
        <![CDATA[Essilorluxottica SA received U.S. FDA clearance for its over-the-counter Nuance Audio Glasses, which combines sight and sound technologies, to help people improve their vision and hearing. The device also received a CE mark certification under the Medical Devices Regulation from the EU authorities.]]>
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      <guid>http://www.bioworld.com/articles/716792</guid>
      <pubDate>Mon, 03 Feb 2025 11:00:00 -0500</pubDate>
      <link>https://www.bioworld.com/articles/716792-essilorluxottica-receives-us-eu-green-light-for-otc-audio-glasses</link>
      <media:content url="https://www.bioworld.com/ext/resources/Stock-images/Therapeutic-topics/ENT/Hearing-loss-illustration.webp?t=1738616487" type="image/jpeg" medium="image" fileSize="191144">
        <media:title type="plain">Hand cupping ear to illustration hearing loss</media:title>
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      <title>FDA approves Apple Airpods as OTC hearing aid</title>
      <description>
        <![CDATA[The U.S. FDA approved Apple Inc.’s Airpods Pro 2 as an over-the-counter assistive hearing device for adults with mild-to-moderate hearing loss, making the ubiquitous devices the first assistive hearing technology to receive this designation. ]]>
      </description>
      <guid>http://www.bioworld.com/articles/712063</guid>
      <pubDate>Fri, 13 Sep 2024 12:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/712063-fda-approves-apple-airpods-as-otc-hearing-aid</link>
      <media:content url="https://www.bioworld.com/ext/resources/BMT-source/2024/Apple-AirPod-Pro2-13sept24.webp?t=1726260200" type="image/jpeg" medium="image" fileSize="92205">
        <media:title type="plain">Apple AirPod Pro2 and Hearing Test</media:title>
        <media:description type="plain">Apple Airpods Pro 2. Credit: Apple, Inc.</media:description>
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    <item>
      <title>Patent update: Sonorous seeks protection for improved braided stents for treating pulsatile tinnitus</title>
      <description>
        <![CDATA[The latest patent application from Sonorous NV Inc. described novel self-expanding braided stents with variable radial force for treating pulsatile tinnitus in patients under conscious sedation by altering pressure gradients in their sinuses/vessels.]]>
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      <guid>http://www.bioworld.com/articles/701274</guid>
      <pubDate>Thu, 28 Sep 2023 12:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/701274-patent-update-sonorous-seeks-protection-for-improved-braided-stents-for-treating-pulsatile-tinnitus</link>
      <media:content url="https://www.bioworld.com/ext/resources/BMT-source/2023/Patent highlights/Sonorous-braided-stents-28sept23.webp?t=1695933941" type="image/jpeg" medium="image" fileSize="122146">
        <media:title type="plain">Sonorous braided stents</media:title>
        <media:description type="plain">US20230293283-A1, “Self-expanding devices and related processes.”Assignee: Sonorous NV Inc.Inventors: Ferrera, Dave; Le, Dawson; Takahashi, RandallIPC Codes: A61F 2/06Publication date: Sept. 21, 2023 (also published as WO2022165166Earliest priority details: US2022584887, Jan. 26, 2022</media:description>
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      <title>Two members of US Senate blast industry over OTC hearing aids </title>
      <description>
        <![CDATA[The U.S. FDA’s rule for over-the-counter (OTC) hearing aids was several years late coming out, but the rule has nonetheless proven controversial from the outset. Two members of the U.S. Senate have blasted device makers for what they allege is interference with the rulemaking process via “astroturf” campaigns to prod hearing aid users to influence the agency’s final rule.]]>
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      <guid>http://www.bioworld.com/articles/520604</guid>
      <pubDate>Fri, 08 Jul 2022 13:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/520604-two-members-of-us-senate-blast-industry-over-otc-hearing-aids</link>
      <media:content url="https://www.bioworld.com/ext/resources/Stock-images/Therapeutic-topics/ENT/hearing-aid-device-fitting.webp?t=1634679990" type="image/png" medium="image" fileSize="502147">
        <media:title type="plain">Photo of doctor inserting hearing aid in patient's ear</media:title>
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    <item>
      <title>Patient Square hears the call of Eargo, invests $125M</title>
      <description>
        <![CDATA[Sounds like Eargo Inc. received good news as Patient Square Capital signed a definitive agreement to purchase $100 million in senior secured convertible notes plus an additional $25 million in future investment subject to certain conditions. The new funds provide some breathing room for the hearing aid company, which has been rocked by a $34.37 million settlement with the Department of Justice (DOJ), questions about its ability to remain on the Nasdaq exchange following delayed filings of its 2021 annual report and first quarter 2022 report and a 97% drop in its stock price since its high in February 2021.]]>
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      <guid>http://www.bioworld.com/articles/520133</guid>
      <pubDate>Mon, 27 Jun 2022 13:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/520133-patient-square-hears-the-call-of-eargo-invests-125m</link>
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        <media:title type="plain">Product image</media:title>
        <media:description type="plain">Eargo hearing aid system. Credit: Eargo Inc.</media:description>
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      <title>First cochlear implant placed using robotic guidance in a hybrid operating room</title>
      <description>
        <![CDATA[PARIS – The team from the ENT surgery department at Clermont-Ferrand University Hospital recently placed a cochlear implant into a patient with profound deafness using the Collin Medical SAS otologic robot in a hybrid operating room known as Imabloc.]]>
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      <guid>http://www.bioworld.com/articles/515076</guid>
      <pubDate>Wed, 12 Jan 2022 13:00:00 -0500</pubDate>
      <link>https://www.bioworld.com/articles/515076-first-cochlear-implant-placed-using-robotic-guidance-in-a-hybrid-operating-room</link>
      <media:content url="https://www.bioworld.com/ext/resources/BMT-source/2022/01-12-Robotol-Collin-Medical.webp?t=1642030097" type="image/png" medium="image" fileSize="562193">
        <media:title type="plain">Robotol surgical robot </media:title>
        <media:description type="plain">Robotol, the remotely operated robot for assisting minimally invasive ENT surgery, from Collin Medical SAS.</media:description>
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    <item>
      <title>FDA’s hearing aid draft rule pushes agency back into debate over class II device preemption</title>
      <description>
        <![CDATA[The FDA published a draft rule on Oct. 19 for over-the-counter hearing aids, four years after the Food and Drug Administration Reauthorization Act (FDARA) had directed the agency to do so by 2020. One of the potentially more problematic aspects of the draft is that the rule would be preemptive of state law on several points, including consumer protections, a consideration that could serve as a flashpoint in future litigation.]]>
      </description>
      <guid>http://www.bioworld.com/articles/512543</guid>
      <pubDate>Tue, 19 Oct 2021 13:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/512543-fdas-hearing-aid-draft-rule-pushes-agency-back-into-debate-over-class-ii-device-preemption</link>
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        <media:title type="plain">Photo of doctor inserting hearing aid in patient's ear</media:title>
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      <title>Innerscope acquires Ihear, expands direct-to-consumer hearing aid platform</title>
      <description>
        <![CDATA[Innerscope Hearing Technologies Inc. acquired the assets and operations of Ihear Medical Inc. for an undisclosed amount. The deal significantly boosts Innerscope’s position in the emerging market of direct-to-consumer and over-the-counter hearing products, an important development in the run-up to the FDA’s expected release next month of new regulations for hearing aids that can be sold in stores without a prescription.]]>
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      <guid>http://www.bioworld.com/articles/512084</guid>
      <pubDate>Tue, 05 Oct 2021 13:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/512084-innerscope-acquires-ihear-expands-direct-to-consumer-hearing-aid-platform</link>
      <media:content url="https://www.bioworld.com/ext/resources/Stock-images/Deals-and-MAs/Acquisition-target.webp?t=1633027501" type="image/png" medium="image" fileSize="442060">
        <media:title type="plain">Acquisition target</media:title>
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    <item>
      <title>Eargo reports $18.2M in third quarter revenue</title>
      <description>
        <![CDATA[Eargo Inc., a medical device company specializing in hearing aids, reported $18.2 million in third quarter revenue, driven by sales of the company&rsquo;s Neo Hifi hearing aid system and a decrease in the sales return accrual rate. Revenue was up 135% over the third quarter of 2019.]]>
      </description>
      <guid>http://www.bioworld.com/articles/500475</guid>
      <pubDate>Fri, 20 Nov 2020 13:00:00 -0500</pubDate>
      <link>https://www.bioworld.com/articles/500475-eargo-reports-182m-in-third-quarter-revenue</link>
      <media:content url="https://www.bioworld.com/ext/resources/BMT-source/2020/11-20-Eargo-hearing-aid-system.webp?t=1605914087" type="image/png" medium="image" fileSize="1215991">
        <media:title type="plain">Product image</media:title>
        <media:description type="plain">Eargo hearing aid system. Credit: Eargo Inc.</media:description>
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    <item>
      <title>FDA grants breakthrough status to Envoy Medical’s Acclaim cochlear implant</title>
      <description>
        <![CDATA[Envoy Medical Corp. got some early support for its Acclaim fully implantable cochlear implant, with a breakthrough device designation from the U.S. FDA. If approved, it would be the first cochlear implant to address hearing loss without the use of any external components.]]>
      </description>
      <guid>http://www.bioworld.com/articles/436128</guid>
      <pubDate>Mon, 29 Jun 2020 13:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/436128-fda-grants-breakthrough-status-to-envoy-medicals-acclaim-cochlear-implant</link>
      <media:content url="https://www.bioworld.com/ext/resources/BMT-source/2020/6-29-Envoy-Medical-Acclaim.webp?t=1593466453" type="image/png" medium="image" fileSize="156260">
        <media:title type="plain">Product images of Acclaim models 9000 and 9200</media:title>
        <media:description type="plain">Acclaim cochlear implant. Credit: Envoy Medical Corp.</media:description>
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    <item>
      <title>Newman dissents from Federal Circuit’s treatment of preamble in Cochlear v. Oticon</title>
      <description>
        <![CDATA[Two judges with the U.S. Court of Appeals for the Federal Circuit sided with the Patent Trial and Appeal Board (PTAB) in a patent dispute between Oticon Medical and Cochlear, but the third judge, Pauline Newman took issue with the decision. Newman said the majority applied &ldquo;an improper analytical technique&rdquo; to determine that the preamble to a patent does not limit the related claims, despite that prior art cited to dispute the patent had been &ldquo;disavowed by the preamble.&rdquo;]]>
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      <guid>http://www.bioworld.com/articles/435222</guid>
      <pubDate>Tue, 19 May 2020 13:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/435222-newman-dissents-from-federal-circuits-treatment-of-preamble-in-cochlear-v-oticon</link>
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        <media:title type="plain">Gavel and scales</media:title>
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