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		<title>hearing aid &#8211; Samsung Global Newsroom</title>
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            <title>hearing aid &#8211; Samsung Global Newsroom</title>
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				<title><![CDATA[Samsung’s Hearing Aid Feature on Galaxy Buds Cleared by FDA]]></title>
				<link>https://news.samsung.com/global/samsungs-hearing-aid-feature-on-galaxy-buds-cleared-by-fda</link>
				<pubDate>Tue, 11 Aug 2026 22:00:00 +0000</pubDate>
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				<dc:creator><![CDATA[Samsung Newsroom]]></dc:creator>
						<category><![CDATA[Mobile]]></category>
		<category><![CDATA[Press Releases]]></category>
		<category><![CDATA[FDA]]></category>
		<category><![CDATA[Galaxy Buds3 Pro]]></category>
		<category><![CDATA[Galaxy Buds4 Pro]]></category>
		<category><![CDATA[hearing aid]]></category>
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									<description><![CDATA[Samsung Electronics today announced that its Galaxy Buds Hearing Aid feature has received U.S. Food and Drug Administration (FDA) clearance. The feature enables compatible Galaxy Buds to serve as an over-the-counter (OTC) hearing aid, offering users 18 years and older a convenient solution for addressing perceived mild to moderate hearing loss — which may be […]]]></description>
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<p>Samsung Electronics today announced that its Galaxy Buds <strong>Hearing Aid</strong> feature has received U.S. Food and Drug Administration (FDA) clearance. The feature enables compatible Galaxy Buds<sup data-fn="4a0959d9-20d3-47a9-a213-c7c7df560085" class="fn"><a href="#4a0959d9-20d3-47a9-a213-c7c7df560085" id="4a0959d9-20d3-47a9-a213-c7c7df560085-link">1</a></sup> to serve as an over-the-counter (OTC) hearing aid,<sup data-fn="ab550802-908c-4d66-98af-9cf8a96f4b60" class="fn"><a href="#ab550802-908c-4d66-98af-9cf8a96f4b60" id="ab550802-908c-4d66-98af-9cf8a96f4b60-link">2</a></sup> offering users 18 years and older a convenient solution for addressing perceived mild to moderate hearing loss — which may be indicated by difficulty following conversations in noisy environments — without a prescription or clinic visit. Users can also diagnose their hearing with the Galaxy Buds <strong>Hearing Test</strong> feature, which is registered as a Software as a Medical Device (SaMD) and provides medical-grade results.</p>



<p>“Hearing health is a vital component of our overall well-being, profoundly impacting how we communicate, connect with loved ones and engage with the world,” said Hon Pak, Senior Vice President and Head of the Digital Health Team for the Mobile eXperience (MX) Business at Samsung Electronics. “With the latest clearance from the FDA, we are expanding access to hearing support and making proactive care effortless by integrating the Hearing Test and Hearing Aid functionality directly into the Galaxy Buds.”</p>



<p>Hearing loss is incredibly common, yet it remains one of the most overlooked health conditions worldwide. The World Health Organization (WHO) estimates that globally, more than 1.5 billion people experience some degree of hearing loss — a figure projected to reach 2.5 billion people by 2050. Despite this, many people who could benefit from hearing aids do not use them due to high cost, social stigma or limited access to professional care.</p>



<p>Samsung has been committed to advancing hearing support technologies for consumers since 2020. That year, the company introduced a Personal Sound Amplification Product (PSAP) feature on Galaxy Buds+.</p>



<p>The PSAP feature was clinically validated in 2021 as effective support for daily communication for those with hearing loss, building the foundation for the Hearing Aid feature. To develop this new OTC solution, Samsung collaborated closely with the National Acoustic Laboratories (NAL) and Samsung Medical Center (SMC). The resulting technology is backed by robust clinical validation studies conducted at Vanderbilt University Medical Center, San Jose State University and the University of Memphis.</p>



<figure class="wp-block-image size-full"><img width="1000" height="667" src="https://img.global.news.samsung.com/global/wp-content/uploads/2026/08/10105731/Samsung-Mobile-Samsung-Hearing-Aid-Feature-Galaxy-Buds-FDA_main1.jpg" alt="By navigating to the Galaxy Buds menu in Settings, users can complete a self-administered Hearing Test in just five minutes." class="wp-image-176281" /><figcaption class="wp-element-caption">▲ Example of a Hearing Test result</figcaption></figure>



<figure class="wp-block-image size-full"><img width="1000" height="667" src="https://img.global.news.samsung.com/global/wp-content/uploads/2026/08/10105810/Samsung-Mobile-Samsung-Hearing-Aid-Feature-Galaxy-Buds-FDA_main2.jpg" alt="Based on those results, the Hearing Aid feature amplifies the sounds users have difficulty hearing." class="wp-image-176282" /><figcaption class="wp-element-caption">▲ Hearing Aid settings screen</figcaption></figure>



<p>Samsung’s holistic hearing health experience centers around two major features integrated directly into Galaxy Buds without requiring a separate app.<sup data-fn="2bc4773d-223c-4d41-8a28-28641e6d5d38" class="fn"><a href="#2bc4773d-223c-4d41-8a28-28641e6d5d38" id="2bc4773d-223c-4d41-8a28-28641e6d5d38-link">3</a></sup> By navigating to the Galaxy Buds menu in Settings, users can complete a self-administered <strong>Hearing Test</strong> in just five minutes. Using clinical-grade, pure-tone audiometry, the software tests each ear individually to pinpoint the user’s specific hearing deficits. It then generates an audiogram with accuracy comparable to a professional audiologist’s evaluation. The results categorize the user’s hearing as normal or one of four stages of hearing loss: mild, moderate, severe or profound.</p>



<p>Based on those results, the <strong>Hearing Aid </strong>feature amplifies the sounds users have difficulty hearing — such as high frequencies, surrounding whispers and distant voices — personalized to each user’s hearing profile. Hearing Aid also supports additional advanced features typically found in premium hearing aids, such as noise elimination and beamforming, which help focus sounds in front of the user and suppress background noise.</p>



<p>Galaxy Buds use NAL-NL2, recognized globally as the clinical standard formula for fitting prescription hearing aid. This advanced approach ensures highly personalized, accurate results tailored to each individual’s hearing profile.</p>



<p>To give users a comprehensive view of their overall wellness, hearing-related insights — including noise exposure levels and Hearing Test results — are accessible directly within the Samsung Health app.</p>



<hr class="wp-block-separator has-alpha-channel-opacity" />



<h4 class="wp-block-heading"><strong><u>Availability</u></strong><br>The Hearing Aid and Hearing Test features will be available on Galaxy Buds3 Pro and Galaxy Buds4 Pro in the U.S. and select approved markets in Q4 2026.</h4>



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<ol class="wp-block-footnotes"><li id="4a0959d9-20d3-47a9-a213-c7c7df560085">Available on Galaxy Buds3 Pro and Galaxy Buds4 Pro only. <a href="#4a0959d9-20d3-47a9-a213-c7c7df560085-link" aria-label="Jump to footnote reference 1"><img src="https://s.w.org/images/core/emoji/16.0.1/72x72/21a9.png" alt="↩" class="wp-smiley" style="height: 1em; max-height: 1em;" />︎</a></li><li id="ab550802-908c-4d66-98af-9cf8a96f4b60">Availability may vary by market, model or paired device. The Hearing Aid feature is intended for users 18 years and older with perceived mild to moderate hearing loss and is not a substitute for professional diagnosis or treatment by a qualified clinician. <a href="#ab550802-908c-4d66-98af-9cf8a96f4b60-link" aria-label="Jump to footnote reference 2"><img src="https://s.w.org/images/core/emoji/16.0.1/72x72/21a9.png" alt="↩" class="wp-smiley" style="height: 1em; max-height: 1em;" />︎</a></li><li id="2bc4773d-223c-4d41-8a28-28641e6d5d38">Full support requires a compatible Galaxy device with One UI 8 or later. <a href="#2bc4773d-223c-4d41-8a28-28641e6d5d38-link" aria-label="Jump to footnote reference 3"><img src="https://s.w.org/images/core/emoji/16.0.1/72x72/21a9.png" alt="↩" class="wp-smiley" style="height: 1em; max-height: 1em;" />︎</a></li></ol>]]></content:encoded>
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				<title><![CDATA[Hearing Loss Initiative uSound for Samsung Gets Official Launch in Jujuy]]></title>
				<link>https://news.samsung.com/global/hearing-loss-initiative-usound-for-samsung-gets-official-launch-in-jujuy</link>
				<pubDate>Wed, 22 Aug 2018 10:30:59 +0000</pubDate>
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				<dc:creator><![CDATA[Samsung Newsroom]]></dc:creator>
						<category><![CDATA[CSR]]></category>
		<category><![CDATA[hearing aid]]></category>
		<category><![CDATA[Samsung Argentina]]></category>
		<category><![CDATA[uSound]]></category>
		<category><![CDATA[WHO]]></category>
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									<description><![CDATA[uSound for Samsung, an app that helps users to test for potential hearing loss, will be distributed throughout the Argentinian province of Jujuy Last Friday, the uSound for Samsung project was officially launched in Purmamarca, Jujuy. The event was attended by Argentinian President Mauricio Macri along with hundreds of people from different communities throughout the […]]]></description>
																<content:encoded><![CDATA[<p style="text-align: center"><span style="font-size: 15px"><em>uSound for Samsung, an app that helps users to test for potential hearing loss, will be distributed throughout the Argentinian province of Jujuy</em></span></p>
<p>Last Friday, the <em><a href="https://news.samsung.com/global/helping-people-detect-and-prepare-for-hearing-loss">uSound for Samsung</a></em> project was officially launched in Purmamarca, Jujuy. The event was attended by Argentinian President Mauricio Macri along with hundreds of people from different communities throughout the Jujuy province. <em>uSound for Samsung</em> facilitates the early detection of hearing loss through a simple three-step process using a smartphone and a pair of headphones.</p>
<p><div id="attachment_103749" style="width: 715px" class="wp-caption alignnone"><img aria-describedby="caption-attachment-103749" class="size-full wp-image-103749" src="https://img.global.news.samsung.com/global/wp-content/uploads/2018/08/uSound-por-Samsung-part-2_main_1.jpg" alt="" width="705" height="470" /><p id="caption-attachment-103749" class="wp-caption-text">uSound for Samsung will help give Jujeños access to a simple three-step preliminary diagnosis* that can be done on a smartphone</p></div></p>
<p>According to the <a href="http://www.who.int/news-room/fact-sheets/detail/deafness-and-hearing-loss" target="_blank" rel="noopener">WHO</a>, over 5% of the world suffers from hearing loss, with <a href="http://servicios.infoleg.gob.ar/infolegInternet/anexos/165000-169999/169441/norma.htm" target="_blank" rel="noopener">estimates</a> showing that more than 3 million people in Argentina experiencing this problem. By encouraging early detection, authorities hope to avoid irreversible hearing loss, encourage learning and promote cognitive development in children, facilitate social inclusion, and raise awareness about hearing loss so appropriate public policies can be made.</p>
<p>The uSound initiative is spearheaded by young entrepreneurs from Jujuy and presents innovation with purpose, allowing for simple and effective technologies to help people detect potential hearing loss using just their smartphones. The app then provides users with a risk report allowing them to take the appropriate action and get further advice from a hearing loss specialist if necessary. The data collected will also contribute to the intelligent allocation of resources for the communities that require them. uSound and the government of Jujuy share an ambitious goal: that this local project will be promoted, developed and spread throughout the world, therefore helping more people and inspiring new solutions in the future.</p>
<p><div id="attachment_103750" style="width: 715px" class="wp-caption alignnone"><img loading="lazy" aria-describedby="caption-attachment-103750" class="size-full wp-image-103750" src="https://img.global.news.samsung.com/global/wp-content/uploads/2018/08/uSound-por-Samsung-part-2_main_2.jpg" alt="" width="705" height="470" /><p id="caption-attachment-103750" class="wp-caption-text">A resident of Jujuy tests uSound for Samsung</p></div></p>
<p>The launch event took place at <em>Los Colorados</em> in Jujuy. The first 300 audiometric tests were conducted, with the total number in the Jujuy province expected to reach 30,000 in the next three months. There was also VR content available which illustrated the difficulties people with different levels of hearing loss experience, enabling guests to empathize with those affected and get a taste of what they go through.</p>
<p><div id="attachment_103751" style="width: 715px" class="wp-caption alignnone"><img loading="lazy" aria-describedby="caption-attachment-103751" class="size-full wp-image-103751" src="https://img.global.news.samsung.com/global/wp-content/uploads/2018/08/uSound-por-Samsung-part-2_main_3.jpg" alt="" width="705" height="470" /><p id="caption-attachment-103751" class="wp-caption-text">Sang Jik Lee, President, Samsung Electronics Argentina (left), President Mauricio Macri (center) and Governor Gerardo Rubén Morales, Jujuy Province (right) were among the hundreds that attended the uSound for Samsung launch event</p></div></p>
<p>During the event, Jujuy’s Governor Gerardo Morales highlighted the work of the young uSound team and recalled their humble beginnings in Tilcara, saying, “From a 4 × 4 room, with great effort this team have created an application that has been recognized by various institutions around the world, including <a href="https://www.hbs.edu/news/articles/Pages/nvc-semifinalists.aspx" target="_blank" rel="noopener">Harvard</a>, demonstrating the best of Jujeño’s entrepreneurship.”**</p>
<p>Sang Jik Lee, President of Samsung Argentina, said, “This project proves that when we work together, we can do the impossible, using innovation with purpose as our guide.”</p>
<p><div id="attachment_103752" style="width: 715px" class="wp-caption alignnone"><img loading="lazy" aria-describedby="caption-attachment-103752" class="size-full wp-image-103752" src="https://img.global.news.samsung.com/global/wp-content/uploads/2018/08/uSound-por-Samsung-part-2_main_4.jpg" alt="" width="705" height="470" /><p id="caption-attachment-103752" class="wp-caption-text">Ezequiel Escobar, CEO, uSound (right) shows Argentinian President Mauricio Macri (left) how uSound for Samsung works</p></div></p>
<p>Ezequiel Escobar, CEO and co-founder of uSound, said, “We held this event at Los Colorados because it connects us with our Pachamama, with our roots and because we wanted to show that it is possible to innovate in Jujuy and make a difference globally. It is in this context that today, together with Samsung and the Jujuy Ministry of Health, we are implementing technology with a purpose. <em>uSound for Samsung</em> is a free mobile tool to detect potential hearing loss that will have an immense scope. Starting in Jujuy with 30,000 tests over the next 90 days, we hope to reach 500,000 users by the end of the year in Argentina and millions worldwide.” **</p>
<p>For more information about <em>uSound for Samsung</em>, visit: <span><a href="http://usoundporsamsung.com.ar" target="_blank" rel="noopener">http://usoundporsamsung.com.ar</a></span></p>
<p><span style="font-size: small"><em>* Not a medical diagnosis</em></span></p>
<p><span style="font-size: small"><em>** Translated from Spanish and edited for clarity</em></span></p>
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