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		<title>Analog vs digital hearing aids : equivalence confirmed !</title>
		<link>https://www.frenchear.com/analog-vs-digital-hearing-aids-equivalence-confirmed/</link>
					<comments>https://www.frenchear.com/analog-vs-digital-hearing-aids-equivalence-confirmed/#respond</comments>
		
		<dc:creator><![CDATA[Michel Mathieu]]></dc:creator>
		<pubDate>Wed, 22 Jul 2020 15:37:13 +0000</pubDate>
				<category><![CDATA[Products]]></category>
		<category><![CDATA[Uncategorized]]></category>
		<category><![CDATA[#analogvsdigital]]></category>
		<guid isPermaLink="false">https://www.frenchear.com/?p=1851</guid>

					<description><![CDATA[<p>An independent study was conducted in 2011 at the “Hörzentrum Oldenburg” (Hearing Center Oldenburg) in Germany to compare Lyric, a modern extended wear analog hearing aid, with digital hearing aids. Participants The 12 participants in the study were experienced users of digital hearing aids. These subjects underwent various tests at the beginning of the study [&#8230;]</p>
<p>The post <a rel="nofollow" href="https://www.frenchear.com/analog-vs-digital-hearing-aids-equivalence-confirmed/">Analog vs digital hearing aids : equivalence confirmed !</a> appeared first on <a rel="nofollow" href="https://www.frenchear.com">FrenchEar</a>.</p>
]]></description>
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<p>An independent <a rel="noreferrer noopener" href="https://www.semanticscholar.org/paper/A-comparison-of-Lyric-with-digital-hearing-aids/e83f9d8e8010cff5d1124f6d9abe7e43d0f58b9f" target="_blank">study</a> was conducted in 2011 at the “<a rel="noreferrer noopener" href="https://www.hoerzentrum-oldenburg.de/en/home.html" target="_blank">Hörzentrum Oldenburg</a>” (Hearing Center Oldenburg) in Germany to compare <a rel="noreferrer noopener" href="https://www.phonak.com/com/en/hearing-aids/lyric-invisible-hearing-aids.html" target="_blank">Lyric</a>, a modern extended wear analog hearing aid, with digital hearing aids. </p>
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<h2>Participants</h2>
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<p>The 12 participants in the study were experienced users of digital hearing aids. These subjects underwent various tests at the beginning of the study while wearing their own digital hearing aids. The same tests were readministered after the subjects had been fitted and experienced a brief adaptation period with a Lyric device.</p>
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<h2>Testing</h2>
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<p>The test parameters consisted of speech tests in both quiet and noisy situations, a localization test, and a measure of the listening effort required under varying noise conditions.</p>
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<h2>Results</h2>
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<p>The results showed that Lyric <strong>performed as effectively as</strong> the digital hearing aids. <strong>Despite its analog technology</strong> and comparatively limited adjustment options, Lyric <strong>did not present any disadvantage for the user</strong>.  <strong>No difference could be observed</strong> between the different measurement conditions of the hearing effort test. Lyric and the digital hearing aids <strong>received comparable ratings, on average</strong>.</p>
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<h2>However</h2>
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<p>For the case of Lyric, however, it was also revealed that it is not suitable for every user, beyond the high cost, due to its requirement to fit the anatomy of the ear canal. </p>
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<h2>Learn more</h2>
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<p>Based on <a rel="noreferrer noopener" href="https://www.frenchear.com/analog-vs-numerique/" target="_blank">subjective testimonials</a> and official audiological tests as demonstrated here, the analog amplification must again be available in the world of audiology in spide of the monopoly of digital technology. This is why FrenchEar is creating the rebirth of this "old" technology into a very modern, connected, and "one size fits all" device called FE1+. Click <a rel="noreferrer noopener" href="https://www.frenchear.com/fe1-hearing-devices-and-its-autonomous-station/" target="_blank">here</a> to learn more about it!</p>
<!-- /wp:paragraph --><p>The post <a rel="nofollow" href="https://www.frenchear.com/analog-vs-digital-hearing-aids-equivalence-confirmed/">Analog vs digital hearing aids : equivalence confirmed !</a> appeared first on <a rel="nofollow" href="https://www.frenchear.com">FrenchEar</a>.</p>
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		<item>
		<title>Audiology&#8217;s future: services-centered?</title>
		<link>https://www.frenchear.com/audiologys-future-services-centered/</link>
		
		<dc:creator><![CDATA[Michel Mathieu]]></dc:creator>
		<pubDate>Thu, 16 Jan 2020 16:11:35 +0000</pubDate>
				<category><![CDATA[Audiology]]></category>
		<category><![CDATA[Bundle or unbundle]]></category>
		<category><![CDATA[New patients profiles]]></category>
		<category><![CDATA[Stand alone audiological acts]]></category>
		<guid isPermaLink="false">https://www.frenchear.com/?p=1518</guid>

					<description><![CDATA[<p>New patients profiles For decades, all audiologists have been selling hearing aids in combination with their hearing services as a hearing care professional providing audiological procedures. This “all-inclusive” system is defended by the entire profession as being essential to the satisfaction of hearing impaired. Still, it is currently being baited with the arrival in 2020 [&#8230;]</p>
<p>The post <a rel="nofollow" href="https://www.frenchear.com/audiologys-future-services-centered/">Audiology&#8217;s future: services-centered?</a> appeared first on <a rel="nofollow" href="https://www.frenchear.com">FrenchEar</a>.</p>
]]></description>
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<h2>New patients profiles</h2>
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<p> For decades, all audiologists have been selling hearing aids in combination with their hearing services as a hearing care professional providing audiological procedures. This “all-inclusive” system is defended by the entire profession as being essential to the satisfaction of hearing impaired. Still, it is currently being baited with the arrival in 2020 of Over-The-Counter hearing aids (OTC Hearing Aid), which will involve the appearance of new patients profiles seeking audiological services only. </p>
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<h2>Stand-alone audiological acts </h2>
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<p> Audiologist's profession is, therefore, on the verge of a profound reform of its sector, obliging it to identify, detail and structure its audiological acts to be able to offer them "à la carte" when necessary. As a reminder, the profession of an audiologist is one that can: </p>
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<ul><li>accurately assess the hearing system</li><li>understand the communication needs of an individual</li><li>determine the effects of this hearing loss</li><li>interpret the results precisely</li><li>advise, choose and sell optimal acoustic solutions</li><li>realize objective and subjective measurements of prosthetic gain</li><li>ensuring the control overtime of the adapted equipment</li><li>monitor hearing progress and compliance </li></ul>
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<p> The audiologist does much more than selling hearing aids. He is trained and able to practice numerous other very specifics, recognized and sought-after acts. Moreover, some of its skills will increasingly be exercised remotely via e-audiology. </p>
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<h2> Bundle or unbundle? </h2>
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<p> Market figures unanimously show that a small percentage of the hearing impaired are fitted factually. Does this ultimately discredit the historical model which couples audiological services and the sale of hearing aids? What is certain is that new models will appear in audiology, probably in favor of decoupling device sales and services. </p>
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<p> Everything indicates that the market will not choose one or the other but the two because there is room for these two models, which in the end are not fundamentally opposed. Let’s be ready for changes in a future where audiology will focus on services dedicated to the hearing impaired via specific audiological acts and mastered by audiologists, the only professionals dedicated to hearing rehabilitation.  </p>
<!-- /wp:paragraph --><p>The post <a rel="nofollow" href="https://www.frenchear.com/audiologys-future-services-centered/">Audiology&#8217;s future: services-centered?</a> appeared first on <a rel="nofollow" href="https://www.frenchear.com">FrenchEar</a>.</p>
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			</item>
		<item>
		<title>How are our ears linked to the health of the entire body ?</title>
		<link>https://www.frenchear.com/otc-vs-psap-vs-ha/</link>
		
		<dc:creator><![CDATA[Michel Mathieu]]></dc:creator>
		<pubDate>Tue, 03 Dec 2019 05:03:40 +0000</pubDate>
				<category><![CDATA[Audiologie]]></category>
		<category><![CDATA[Audiology]]></category>
		<category><![CDATA[hearing health]]></category>
		<guid isPermaLink="false">https://www.frenchear.com/?p=405</guid>

					<description><![CDATA[<p>In this article, I want to describe more than 10 points that connect ears to our health. Naturally, all of them have been scientifically demonstrated. The good news comes with hearing aids because with it there are no more identified over-risks compared to people without a hearing loss, all things equal otherwise. "The seeds of [&#8230;]</p>
<p>The post <a rel="nofollow" href="https://www.frenchear.com/otc-vs-psap-vs-ha/">How are our ears linked to the health of the entire body ?</a> appeared first on <a rel="nofollow" href="https://www.frenchear.com">FrenchEar</a>.</p>
]]></description>
										<content:encoded><![CDATA[<!-- wp:paragraph -->
<p>In this article, I want to describe more than 10 points that connect ears to our health. Naturally, all of them have been scientifically demonstrated. The good news comes with hearing aids because with it there are no more identified over-risks compared to people without a hearing loss, all things equal otherwise.</p>
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<blockquote class="wp-block-quote"><p> "The seeds of healthy aging are sown early."&nbsp;&nbsp; </p><cite> Kofi Annan </cite></blockquote>
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<h2>Cognitive decline</h2>
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<p>Those with hearing loss experience a 30-40% greater decline in thinking abilities compared to those without hearing loss. Adults with uncorrected hearing loss are more likely to develop dementia or memory problems.</p>
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<h2>Fall</h2>
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<p>Safety/balance people with mild hearing loss (25dbHL) are 3 times more likely to have a history of falling. Every additional 10 decibels of hearing loss increases the chances of falling by 1.4 times.</p>
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<h2>Depression</h2>
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<p>Uncorrected hearing loss gives rise to poorer quality of life, isolation and reduced social activity, leading to depression.</p>
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<h2>Tinnitus</h2>
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<p>90% of people with tinnitus also have hearing loss. Tinnitus affects 1 in 5 people and can be caused by hearing loss, an ear injury or a circulatory system disorder.</p>
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<h2>Diabets</h2>
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<p>Hearing loss is twice as common in people with diabetes compared to those without. 70% of diabetics aged 50 to 69 have hearing loss in high frequencies. Adults whose blood glucose is higher than normal but not enough for a diabetes diagnosis, have a 30% higher rate of hearing loss compared to those with normal blood sugar.</p>
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<h2>Heart health</h2>
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<p>The inner ear is extremely sensitive to blood flow. Studies show that a healthy cardiovascular system - a person's heart, arteries, and veins - has a positive effect on hearing. Inadequate blood flow and trauma to the blood vessels of the inner ear can contribute to hearing loss.</p>
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<h2>Smoking</h2>
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<p>Current smokers have a 70% higher risk of having hearing loss than nonsmokers.</p>
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<h2>Hypertension</h2>
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<p>There is a significant association between high blood pressure and hearing loss. Hypertension can be an accelerating factor of hearing loss in older adults.</p>
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<h2>Obesity</h2>
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<p>Higher body mass index (BMI) and larger circumference are associated with increased risk of hearing loss in women.</p>
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<h2>Ototoxicity</h2>
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<p>They are more than 200 medications on the market today that are known to cause hearing loss (toxic to the ears). The list of known ototoxic drugs includes: Aspirin, Quinine, Water pills, some anticancer drugs, some anesthetics, environnement chemicals, etc.</p>
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<h2>Eye Health</h2>
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<p>Vision helps you identify where a sound is coming from. If you have vision and hearing loss, your ability to target sound location is compromised. The amplification from hearing aids helps compensate for the vision loss.</p>
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<h2>Osteoporosis</h2>
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<p>A study linked osteoporosis and hearing loss, theorizing that demineralization of the three middle ear bones may contribute to conductive hearing impairment.</p>
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<h2>Isolation</h2>
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<p>Adults 50 years and olders with untreated hearing loss are more likely to report depression, anxiety, anger and frustration, emotional instability and paranoia, than those who wear hearing aids.</p>
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<h6><strong><em>Sources for this article : </em></strong></h6>
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<p style="font-size:11px">Olyer, Anne L. (n.d). Untreated Hearing Loss in Adults - A Growing National Epidemic. Retrieved from http://www.asha.orfg/Aud/Articles/Untreated-Hearing-Loss-in-Adults/ | Better Hearing Institute. (n.d.). Hearing Loss Treatment. Retrieved from: http://www.betterhearing.org/hearingpedia/hearing-loss-treatment  | Norton, A. (2015). Older Adults’ Hearing Loss May Be Tied to Earlier Death. HealthDay News. Retrieved from http:// health.usnews.com/health-news/articles/2015/09/24/older-adults-hearing-loss-may-be-tied-to-earlier-death  | World Health Organization. (2015). Deafness and hearing loss. Retrieved from: http://www.who.int/mediacentre/ factsheets/fs300/en/  | «Cigarette Smoking and Hearing Loss - The Epidemiology of Hearing Loss Study», Journal of the American Medical Association, juin 1998, vol. 279, et “Serum Cotinine Level and Incident Hearing Loss: A Case-Control Study,” Archives of Otolaryngology, Head and Neck Surgery, novembre 2004, Vol. 130, p 1260-1264. | Bainbridge, K. (n.d.). Diabetes and Hearing Impairment: An Epidemiological Perspective. The American SpeechLanguage-Hearing Association. Retrieved from: http://www.asha.org/aud/articles/diabetes-hearing-impairment/ | Friedland, D. R., Cederberg, C., &amp; Tarima, S. (2009). Audiometic pattern as a predictor of cardiovascular status: Development of a model for assessment of risk. The Laryngoscope, 119:4733-486. Retrieved from: http:// onlinelibrary.wiley.com/doi/10.1002/lary.20130/abstract  | Agarwal, S., Mishra, A., Jagade, M., Kasbekar, V. &amp; Nagle, S. K. (2013). Effects of Hypertension on Hearing. Indian J Otolaryngol Head Neck Surg. 2013 December; 65(Suppl 3): 614–618. Published online 2013 February 17. Retrieved from: http://www.ncbi.nlm.nih.gov/pmc/ articles/PMC3889339/  | Lin, F. R., Yaffe, K., Xia, J., Xue, Q., Harris, T. B., Purchase-Helzner, E.,Simonsick, E. M. (2013). Hearing Loss and Cognitive Decline in Older Adults. JAMA Internal Medicine,173(4), 293-299. doi:10.1001/ jamainternmed.2013.1868  | Johns Hopkins Medicine. (2011). Hearing Loss And Dementia Linked in Study. Retrieved from: http://www.hopkinsmedicine.org/news/media/releases/hearing_loss_and_dementia_linked_in_study | Johns Hopkins Medicine. (2012). Hearing Loss Linked to Three-Fold Risk of Falling. Retrieved from: http://www. hopkinsmedicine.org/news/media/releases/hearing_loss_linked_to_three_fold_risk_of_falling |  Reinemer, M., &amp; Hood, J. (1999). Untreated Hearing Loss Linked to Depression, Social Isolation in Seniors. Audiology Today, 11(4). Retrieved from: http://www.audiology.org/publications-resources/document-library/untreated-hearing-loss-linkeddepression-social-isolation | Li, C. M. &amp; Hoffman, H. J. (2014). Untangling the Link Between Hearing Loss and Depression. Retrieved from: http://journals.lww. com/thehearingjournal/Fulltext/2014/07000/Untangling_the_Link_ Between_Hearing_Loss_and.2.aspx | Kochkin, S. (2007). The Impact of Untreated Hearing Loss on Household Income. Retrieved from: http://www.betterhearing.org/sites/default/files/hearingpedia-resources/The Impact of Untreated Hearing Loss on Household Income.pdf | Kochkin, S. (2007). The Impact of Untreated Hearing Loss on Household Income. Retrieved from: http://www.betterhearing.org/sites/default/files/hearingpedia-resources/The Impact of Untreated Hearing Loss on Household Income.pdf  • The National Institutes of Health (NIH) • National Institute on Deafness and Other Communication Disorders (NIDC) • National Council on Aging (NCOA) • Sergei Kochkin, Ph.D. The Impact of Treated Hearing Loss on Quality of Life - Better Hearing Institute, Washington, DC. www.betterhearing.org/Hearingpedia • Frank Lin, M.D. (2014) Hearing Loss Linked to Accelerated Brain Tissue Loss. • Johns Hopkins Medicine News Release. Date de parution : 22 janvier 2014 • Ha-Sheng Li-Korotky, Au.D., Ph.D., M.D. (2012) Age-Related Hearing Loss: Quality of Care for Quality of Life. The Gerontologist, Volume 52, Issue 2 Pp. 265-271 • Karen J. Cruickshanks, PhD; Ronald Klein, MD ; Barbara E. K. Klein, MD ; Terry L. Wiley, PhD ; David M. Nondahl, MS ; Ted S. Tweed, MS. (1998) Cigarette Smoking and Hearing Loss: The Epidemiology of Hearing Loss Study. JAMA. 1998;279(21):1715-1719. doi:10.1001/jama.279.21.1715 • Hull RH, Kerschen SR. (2010) The influence of cardiovascular health on peripheral and central auditory function in adults: a research review. Am J Audiol. 2010 Jun;19(1):9-16. doi: 10.1044/1059-0889(2010/08-0040). • De Moraes Marchiori LL, de Almeida Rego Filho E, Matsuo T (2006) Hypertension As a Factor Associated with Hearing Loss. Braz J Otorhinolaryngol. Jul-Aug;72(4):533-40. • Babich, M., Hoffmeister, D. &amp; Doughty, A. (2009). Osteoporosis and Conductive Hearing Loss: A Novel Model of Clinical Correlation. Article no 148 de PHILICA.COM. • American Tinnitus Association, ATA.org • www.mayoclinic.com/health/tinnitus/DS00365 • INSERM U 897 épidémiologique et neurophysiologique du vieillissement  cérébral Cohorte PAQUID (personnes agées QUID) 3777 personnes de plus de 65 ans, suivis depuis 1988. • “Perte d’audition et déclin cognitif chez le sujet âgé : approche épidémiologique” (2015)  Hélène Amiéva - Professeur de Pshychogérontologie et Chercheur à l’INSERM U897 - Bordeaux</p>
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<!-- /wp:paragraph --><p>The post <a rel="nofollow" href="https://www.frenchear.com/otc-vs-psap-vs-ha/">How are our ears linked to the health of the entire body ?</a> appeared first on <a rel="nofollow" href="https://www.frenchear.com">FrenchEar</a>.</p>
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			</item>
		<item>
		<title>Hearing Aid, OTC Hearing Aid, Self‐Fit OTC Hearing Devices or PSAP ?</title>
		<link>https://www.frenchear.com/hearing-aid-or-otc-hearing-aid-self%e2%80%90fit-otc-hearing-devices-or-psap/</link>
					<comments>https://www.frenchear.com/hearing-aid-or-otc-hearing-aid-self%e2%80%90fit-otc-hearing-devices-or-psap/#respond</comments>
		
		<dc:creator><![CDATA[Michel Mathieu]]></dc:creator>
		<pubDate>Sun, 10 Nov 2019 09:52:13 +0000</pubDate>
				<category><![CDATA[Market]]></category>
		<category><![CDATA[OTC Hearing Aid]]></category>
		<category><![CDATA[Over The Counter Hearing Aid]]></category>
		<category><![CDATA[Personal Sound Amplification Product]]></category>
		<category><![CDATA[PSAP]]></category>
		<guid isPermaLink="false">https://www.frenchear.com/?p=1088</guid>

					<description><![CDATA[<p>Guideline based on FDA's informations for the Over-The-Counter Market. What are hearing aids ? Hearing aids are sound-amplifying devices designed to aid people who have a hearing impairment. They are medical devices regulated by the FDA and delivered by a hearing aid provider or an audiologist. Most hearing aids share several similar electronic components, including [&#8230;]</p>
<p>The post <a rel="nofollow" href="https://www.frenchear.com/hearing-aid-or-otc-hearing-aid-self%e2%80%90fit-otc-hearing-devices-or-psap/">Hearing Aid, OTC Hearing Aid, Self‐Fit OTC Hearing Devices or PSAP ?</a> appeared first on <a rel="nofollow" href="https://www.frenchear.com">FrenchEar</a>.</p>
]]></description>
										<content:encoded><![CDATA[<!-- wp:quote -->
<blockquote class="wp-block-quote"><p><em>Guideline based on FDA's informations for the Over-The-Counter Market</em>.</p></blockquote>
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<h2><strong><em>What are hearing aids ?</em></strong></h2>
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<p>   </p>
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<p>Hearing aids are sound-amplifying devices designed to aid people who have a hearing impairment. They are medical devices regulated by the FDA and delivered by a hearing aid provider or an audiologist. Most hearing aids share several similar electronic components,  including a microphone that picks up sound; amplifier circuitry that makes the sound louder; a miniature loudspeaker (receiver) that delivers the amplified sound into the ear canal; and batteries that power the electronic parts. Hearing aids differ by design, the technology used to achieve amplification (i.e., analog vs. digital) and special features. Some hearing aids also have earmolds or earpieces to direct the flow of sound into the ear and enhance sound quality. The selection of hearing aids is based on the type and severity of hearing loss,  listening needs, and lifestyle.</p>
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<p>    </p>
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<h2><strong><em>What are Over-The-Counter hearing aids?</em></strong></h2>
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<p>    </p>
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<p>A new class of over-the-counter (OTC) hearing devices is coming. <a href="https://www.congress.gov/bill/115th-congress/senate-bill/670">The OTC Hearing Aid Act of 2017</a> that was passed by Congress and signed by President Trump on August 18, 2017 requires the FDA to create and regulate a category of OTC hearing aids for adults with “perceived” mild-to-moderate hearing loss and to ensure the devices meet the same high standards for safety,  consumer labeling, and manufacturing protection that all other medical devices must meet. How should the US Food and Drug Administration (FDA) define and regulate these devices? A consensus published August 14, 2018 by four national hearing care professional organizations recommends the devices be called “Self-fit OTC Hearing Devices” and be intended for mild-to-moderate hearing losses of 26-55 dB HL (26 max HFA-FOG/110 dB max output), offer input compression and volume controls, contain clear and easy-to-understand labeling both on the inside and outside of the packaging, and require at last one FDA 510(k) filing to ensure the basic safety and efficacy of the device. The 35-page consensus statement, “Regulatory Recommendations for OTC  Hearing Aids: Safety &amp; Effectiveness,” was developed by a Working  Group of the American Academy of Audiology (AAA), Academy of Doctors of Audiology (ADA), American Speech-Language-Hearing Association<a rel="noreferrer noopener" href="http://www.hearingreview.com/2018/08/otc-hearing-aid-consensus-statement-published-aaa-ada-ihs-asha/american%20speech-language-hearing association" target="_blank"> </a>(ASHA), and International Hearing Society (IHS).  The consensus paper is divided into five key recommendations:</p>
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<ul><li>Establish product requirements appropriate for OTC hearing devices targeting mild‐to‐moderate adult hearing impairment.</li><li>Out-of-the-box labeling with “Red Flag” warnings and a strong recommendation to consult with a licensed hearing care professional.</li><li>Inside-of-the-box labeling.</li><li>Define new OTC category as “Self-fit OTC Hearing Devices” and use risk class requirements for safety and effectiveness.</li><li>Adequate provisions for consumer protection and oversight by Federal Trade Commission (FTC).</li></ul>
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<p>    </p>
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<h2><strong><em>What are Self-fitting air-conduction hearing aid?</em></strong></h2>
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<p>    </p>
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<p>According to the FDA’s definition, the self-fitting air-conduction hearing aid is a wearable sound-amplifying device that is intended to compensate for impaired hearing and incorporates technology, including software, that allows users to program their hearing aids. This technology integrates user input with a  self-fitting strategy and enables users to independently derive and customize their hearing aid fitting and settings. The new Class II self-fitting classification within hearing aids should not be confused with the still-to-come Over-the-Counter (OTC)  Hearing  Aid classification that FDA is developing witch is designed to provide better affordability and accessibility for adults with perceived mild-to-moderate hearing loss, and give them access to OTC hearing aids without being seen by a hearing care professional. In contrast, the new Class II self-fitting device—the Bose Hearing Aid is the first example—is a hearing aid within the  “traditional” Class I (for non-wireless air conduction hearing aids) and  Class II (for wireless air-conduction and bone conduction hearing aids) medical device categories as established by FDA. However, the new classification includes a fairly extensive list of  “special controls” intended to address risks to “health and mitigation measures.” </p>
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<ul><li>Clinical data must evaluate the effectiveness of the self-fitting strategy.</li><li>Electroacoustic parameters, including maximum output limits,  distortion levels, self-generated noise levels, latency, and frequency response, must be specified and tested.</li><li>Performance data must demonstrate the electromagnetic compatibility (EMC), electrical safety, and thermal safety of the device.</li><li>Software verification, validation, and hazard analysis must be performed.</li><li>If the device incorporates wireless technology: (A) Performance testing should validate safety of exposure to non-ionizing radiation;  (B) Performance data should validate wireless technology functions; and  (C) Labeling should specify instructions, warnings, and information  relating to wireless technology and human exposure to non-ionizing  radiation.</li><li>Usability testing must demonstrate that users can correctly use the device as intended under anticipated conditions of use.</li><li>Patient labeling must include the following: (A) Information on how a  patient can self-identify as a candidate for the device; (B)  Information about when to seek professional help; (C) A warning about  using hearing protection in loud environments; (D) A warning about  staying alert to sounds around you; (E) Technical information about the  device, including information about electromagnetic compatibility; and  (F) Information on how to correctly use and maintain the device.</li></ul>
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<p>    </p>
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<h2><strong><em>What are Personal Sound Amplification Products?</em></strong></h2>
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<p>   </p>
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<p>Personal Sound Amplification Products (PSAPs) are intended to amplify environmental sound for non-hearing impaired consumers.  They are not intended to compensate for hearing impairment.  Examples of situations in which PSAPs typically are used include hunting (listening for prey), bird watching, listening to lectures with a distant speaker, and listening to soft sounds that would be difficult for normal hearing individuals to hear (e.g., distant conversations, performances).  Because PSAPs are not intended to diagnose, treat, cure or mitigate disease and do not alter the structure or function of the body, they are not devices as defined in the Food, Drug, and Cosmetic Act.  As such, there is no regulatory classification, product code, or definition for these products.  Furthermore, there are no requirements for registration of manufacturers and listing of these products with the FDA.   However, PSAPs are subject to applicable provisions of the Radiation Control for Health and Safety Act of 1968, under which the FDA regulates electronic products that emit sonic vibrations, such as sound amplification equipment. (See also 21 CFR 1000.15.)  Manufacturers of PSAPs must report defects and adverse events and take other measures described in 21 CFR Part 1003.  Manufacturers of PSAPs must also comply with the requirements to repurchase, repair, or replace electronic products required under 21 CFR Part 1004.  </p>
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<p>    </p>
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<h2><strong><em>What are FrenchEar FE1+ Universal Acoustic Solution?</em></strong></h2>
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<p>  </p>
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<p>The first version of the FE1+ universal acoustic solution is not a medical device. It is therefore not a Hearing Aid (HA) for which an FDA 501 (k) marketing authorization is required. As the regulation on Over-The-Counter Hearing Aid was not stopped prior to August 2020, the first version of the FE1+ is therefore classified as a Personal Sound Amplification Product (PSAP).  However, FrenchEar is developing a future version of its PSAP that will become an OTC Hearing Aid particularly suitable for mild to moderate deafness. </p>
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<p>     </p>
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<p>     </p>
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<h6>Citations for this article :</h6>
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<p class="has-small-font-size"><a href="https://www.fda.gov/news-events/press-announcements/fda-allows-marketing-first-self-fitting-hearing-aid-controlled-user">https://www.fda.gov/news-events/press-announcements/fda-allows-marketing-first-self-fitting-hearing-aid-controlled-user</a></p>
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<p class="has-small-font-size"><a href="https://www.audiology.org/sites/default/files/publications/resources/20180130_AuD_Guide_OTC.pdf">https://www.audiology.org/sites/default/files/publications/resources/20180130_AuD_Guide_OTC.pdf</a></p>
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<p class="has-small-font-size"><a href="https://www.hearing.org/hearingorg/document-server/?cfp=hearingorg/assets/File/public/Consensus-Paper_OTC-HA.pdf">https://www.hearing.org/hearingorg/document-server/?cfp=hearingorg/assets/File/public/Consensus-Paper_OTC-HA.pdf</a></p>
<!-- /wp:paragraph --><p>The post <a rel="nofollow" href="https://www.frenchear.com/hearing-aid-or-otc-hearing-aid-self%e2%80%90fit-otc-hearing-devices-or-psap/">Hearing Aid, OTC Hearing Aid, Self‐Fit OTC Hearing Devices or PSAP ?</a> appeared first on <a rel="nofollow" href="https://www.frenchear.com">FrenchEar</a>.</p>
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					<wfw:commentRss>https://www.frenchear.com/hearing-aid-or-otc-hearing-aid-self%e2%80%90fit-otc-hearing-devices-or-psap/feed/</wfw:commentRss>
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		<title>Hearing impaired from countries with tonal languages</title>
		<link>https://www.frenchear.com/langue-tonale/</link>
		
		<dc:creator><![CDATA[Michel Mathieu]]></dc:creator>
		<pubDate>Thu, 10 Oct 2019 05:04:11 +0000</pubDate>
				<category><![CDATA[Market]]></category>
		<category><![CDATA[tonal languages]]></category>
		<guid isPermaLink="false">https://www.frenchear.com/?p=407</guid>

					<description><![CDATA[<p>" Your most dissatisfied customers are your greatest source of learning. " Bill Gates There is no inherent reason why the vocal output of an English speaker should be any different from a person speaking Chinese. However, the frequency band importance of a Chinese speaker has greater value in the lower frequencies than for English [&#8230;]</p>
<p>The post <a rel="nofollow" href="https://www.frenchear.com/langue-tonale/">Hearing impaired from countries with tonal languages</a> appeared first on <a rel="nofollow" href="https://www.frenchear.com">FrenchEar</a>.</p>
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										<content:encoded><![CDATA[<!-- wp:quote {"className":"is-style-default"} -->
<blockquote class="wp-block-quote is-style-default"><p><em>" Your most dissatisfied customers are your greatest source of learning. "</em></p><cite>Bill Gates</cite></blockquote>
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<p>There is no inherent reason why the vocal output of an English speaker should be any different from a person speaking Chinese. However,  the frequency band importance of a Chinese speaker has greater value in the lower frequencies than for English because Chinese relies more on pitch changes in the lower-frequency vowels.</p>
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<p>Indeed, the Chinese as 60% of the languages ​​in the world are said tonal language, in which the pronunciation of the syllables of a word is subjected to a precise tone, that is to say to a determined relative height or a characteristic melody. A modification of this tone then leads to another word and another meaning.</p>
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<p>The hearing aids distributed in these countries, which count in the hundreds of millions of people, are identical to those adapted for populations with atonal languages. This results in a great dissatisfaction of the hearing impaired, confirmed by the audiologists themselves. According to EHIMA Japan Track 2015, overall satisfaction in Japan with hearing aid is 39% only.</p>
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<p>Indeed, if hearing loss affects all humans worlwide physiologically and statistically at first on high frequencies, it is not by amplifying these frequencies, however deficient that the intelligibility of individuals speaking a tonal language will be optimized.</p>
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<p>While there is an official "tonal languages" option in the National Australian Laboratories' NAL-NAL calculation formulas for digital hearing aids, this only works significantly on low frequencies, which are slightly enhanced for the occasion.</p>
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<p>To optimize the acoustic indices that make the intelligibility of tonal languages, it is indeed necessary to be able to highlight formants and formal transitions F0, F1 and F2 which are observed between 100Hz and 900Hz.</p>
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<p>FrenchEar's acoustic-linguistic conclusions on the specific key indexes of these languages have had a direct impact in the strategy of evolution in the technologies implemented for future FrenchEar devices.  Based on linear adjustments to low frequencies thanks to its analog amplification allowing an excellent bass dynamics,  FrenchEar will cleverly work to highlight the variations of the formal transitions of these fundamental tonal language frequencies whose relative height of sound affects the meaning of the words themselves.</p>
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<p></p>
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<p></p>
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<h6><strong><em>Citations for this article:</em></strong></h6>
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<p class="has-small-font-size">Chasin M. How hearing aids may be set for different languages. <em>Hearing Review</em>. 2008;15(11):16-20</p>
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<p class="has-small-font-size">EHIMA,  Results JapanTrak 2018</p>
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<p class="has-small-font-size"> National Acoustic Laboratories (NAL) // www.nal.gov.au</p>
<!-- /wp:paragraph --><p>The post <a rel="nofollow" href="https://www.frenchear.com/langue-tonale/">Hearing impaired from countries with tonal languages</a> appeared first on <a rel="nofollow" href="https://www.frenchear.com">FrenchEar</a>.</p>
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		<title>Hearing aid : Digital or Analog ? And why not both ?</title>
		<link>https://www.frenchear.com/hearing-aid-digital-or-analog-and-why-not-both/</link>
		
		<dc:creator><![CDATA[Michel Mathieu]]></dc:creator>
		<pubDate>Mon, 30 Sep 2019 17:07:03 +0000</pubDate>
				<category><![CDATA[Testimonials]]></category>
		<category><![CDATA[Analog hearing aid]]></category>
		<guid isPermaLink="false">https://www.frenchear.com/?p=645</guid>

					<description><![CDATA[<p>"I do not oppose analog and digital amplification. I just think that both have their place in audiology." Michel MATHIEUFrenchEar CEO &#38; Founder Hearing aid manufacturers have always claimed that digital features have been the subject of advanced research. They presented us as indispensable the WDRC, the large number of channels, the very complex signal [&#8230;]</p>
<p>The post <a rel="nofollow" href="https://www.frenchear.com/hearing-aid-digital-or-analog-and-why-not-both/">Hearing aid : Digital or Analog ? And why not both ?</a> appeared first on <a rel="nofollow" href="https://www.frenchear.com">FrenchEar</a>.</p>
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<p></p>
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<blockquote class="wp-block-quote"><p><em><strong>"I do not oppose analog and digital amplification. I just think that both have their place in audiology."</strong></em></p><cite>Michel MATHIEU<br>FrenchEar CEO &amp; Founder</cite></blockquote>
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<p>Hearing aid manufacturers have always claimed that digital features have been the subject of advanced research. They presented us as indispensable the WDRC, the large number of channels, the very complex signal processing etc. The transition from analog to digital was motivated on the one hand by the fad of the arrival of a new technology and on the other hand by the search for increased benefit for the hearing impaired suffering from recruitment and intolerance to very complex sound environments.</p>
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<p>But this transition, experienced very difficult by some hearing impaired, made the mistake of forgetting that some of them could continue to prefer the simplicity of the analog amplification without any delay processing, even if sometimes the consequences of a sensorineural hearing loss do not allow the auditory cortex to optimise the auditory treatment in a noisy environment.</p>
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<p>The audiology market is starting to talk about analog again. I let you appreciate the relevance of this article published on September 11, 2019:</p>
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<p><a href="https://slate-com.cdn.ampproject.org/c/s/slate.com/technology/2019/09/hearing-aids-digital-analog-sound-music.amp">https://slate-com.cdn.ampproject.org/c/s/slate.com/technology/2019/09/hearing-aids-digital-analog-sound-music.amp</a></p>
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<p>As a hearing care professional, I was speechless when the hearing impaired explained to me in their own words why they prefer analog sound, whether about Lyric or about their old device necessarily renewed by a digital device. It went against everything I had been taught. This is where the analog amplification, disappeared from audiology field, has imposed itself to me. Not as a miraculous solution but great enough in its simplicity to be revisited.</p>
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<p class="has-small-font-size">Citations for this article:</p>
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<p class="has-small-font-size"><em>Official study comparing Lyric analog amplification with digital hearing aids :   <br></em><a href="https://pdfs.semanticscholar.org/e83f/9d8e8010cff5d1124f6d9abe7e43d0f58b9f.pdf">https://pdfs.semanticscholar.org/e83f/9d8e8010cff5d1124f6d9abe7e43d0f58b9f.pdf</a></p>
<!-- /wp:paragraph --><p>The post <a rel="nofollow" href="https://www.frenchear.com/hearing-aid-digital-or-analog-and-why-not-both/">Hearing aid : Digital or Analog ? And why not both ?</a> appeared first on <a rel="nofollow" href="https://www.frenchear.com">FrenchEar</a>.</p>
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		<title>The Truth : Digital vs Analog Hearing Aid.</title>
		<link>https://www.frenchear.com/analog-vs-numerique/</link>
		
		<dc:creator><![CDATA[Michel Mathieu]]></dc:creator>
		<pubDate>Mon, 16 Sep 2019 05:02:03 +0000</pubDate>
				<category><![CDATA[Audiology]]></category>
		<category><![CDATA[Analog hearing aid]]></category>
		<guid isPermaLink="false">https://www.frenchear.com/?p=401</guid>

					<description><![CDATA[<p>« Whenever you find yourself on the side of the majority, it is time to pause and reflect » Mark Twain It is so easy to write pages and pages on this divided theme by crossing the pros and the cons, the fundamental acoustic truths and highly scientific and audiological explanations. We don't want to [&#8230;]</p>
<p>The post <a rel="nofollow" href="https://www.frenchear.com/analog-vs-numerique/">The Truth : Digital vs Analog Hearing Aid.</a> appeared first on <a rel="nofollow" href="https://www.frenchear.com">FrenchEar</a>.</p>
]]></description>
										<content:encoded><![CDATA[<!-- wp:quote -->
<blockquote class="wp-block-quote"><p><em>«  Whenever you find yourself on the side of the majority, it is time to pause and reflect  » </em></p><cite> Mark Twain </cite></blockquote>
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<p>It is so easy to write pages and pages on this divided theme by crossing the pros and the cons, the fundamental acoustic truths and highly scientific and audiological explanations. We don't want to start here an analog vs digital debate and we don't say digital devices shouldn’t exist, just that analog devices should as well.</p>
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<p>Even if some cochlear distortions do not allow the brain to do perfecty  alone the hearing treatment in a noisy environment, we don’t believe there are any goods medical or audiological explications for completely phasing out analog hearing devices on the healthcare market. </p>
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<p>We chose to put the debate on another level by giving the floor to the hearing impaired with 3 very interesting testimonials : </p>
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<blockquote class="wp-block-quote"><p> I<em>’m 71 &amp; began wearing 1 aid in mid 30s, wearing 2 aids in 40s. I  have hi frequency loss [all in my family have same loss]. For me, analog  aids have a much more natural sound with no delays or processing as  digitals. I’m in process of getting new aids &amp; the hi tech aids are  “pushed” on customers. Digitals give me headache, ear aches, make my  head spinn &amp; even affect my vision. Audiologists do not seem to  understand why, making me feel very “whimpy”  &amp; they continue to tell me to just keep trying to adjust to the  problems of digitals. Not everyone wants their lives dictated by hi  technology &amp; learn to work all the gadgets that accompany digital  aids. I crave the natural sounds of my voice &amp; the families voices. I  don’t like the delays in changing/processing of the digitals. Analog  are just more comfortable, kinda like my old 'jammies:). It’s difficult  to explain to anyone not hard of hearing, but I compare digital to  getting the latest hi tech computer system with glare &amp; learning new  systems when Windows 98 looks beautiful &amp; does the simple tasks  necessary [I have both due to working &amp; W’98 is still my favorite  &amp; most beautiful screen]. In short, analog much more resembles  natural hearing with much less hassle [especially for we seniors] than  the digital. Digital is too challenging for me &amp; does not offer  better hearing in return. I want to relax &amp; enjoy life, not  constantly learning new technology which give me headache, earache,  balance problems/etc. Most important to me also, is control with an  on/off switch &amp; volume control. Digitals want to think for me. I  want to think for myself &amp; be in control of my hearing/life. I think  the reason there are not more responses to this thread is that most of  us who are hearing impaired don’t realize all the information online  and/or be in denial. Hearing impaired persons are twice as tired at the  end of the day as so much energy is used just to hear/understand speech  &amp; we probably do not sit in front of a computer as much. I do a lot  of online research, but only research hearing when I have a problem. I  need to stay updated so I won’t get so stressed out when time to get new  aids/problems. I do hope the values of analog aids will be noticed  &amp; more analog aids made available to consumers. Probably not enough  profit for this to happen though. Hi tech=hi $$$. </em></p><cite> <a href="https://forum.hearingtracker.com/u/grannyhears">grannyhears</a> </cite></blockquote>
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<p></p>
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<blockquote class="wp-block-quote"><p> <em>Analogs have real surround amplified sound.  Plain and simple amplified  sound.  I have 2 (...) CIC that are 15yrs old (repaired and recased  over the years).  I just purchased a pair of (...) CIC  digitals.  Hate them.  Still trying to get use to them but will probably  take them back.  I had the ability to tune out sounds naturally with my  analogs.  Perhaps people that are not able to do that tend to like the  digitals better.  The analogs were my first and only hearing aids until I  recently purchased these digitals.  I don’t like the fact that the  digitals tune out sounds not under your control.  They sound so  artificial…cheap.  The tv doesn’t sound very good at all.  I can’t use  my cordless phone due to excessive feedback (probably not recessed  enough).  With my analogs, if there was a sudden loud sound, they would  cut out for a couple seconds then come back on.  I didn’t have that “in a  bottle” sound or sound direction problem.  The tv and stereo sounded  great.  I could hear EVERYTHING.  I want to hear EVERYTHING.  Isn’t that  the purpose of wearing hearing aids? lol  It’s great with analogs!  I  only hope that they can continue to repair my analogs.  It’s becoming  harder to find places that will.  They need to bring back analogs as a  choice when purchasing hearing aids.  I know I would buy another pair!!   I don’t know what I’m going to do if mine decide to fizzle out  completely or they just can’t be repaired any more.  Now there are “some” advantages of the digitals that are cool: the  remote control, the wireless (great for tv-like wearing headsets),  bluetooth and feedback cancellation (when putting them on, taking them  off or when someone hugs you).  However, I feel analogs are far better.   Hope this helps. </em></p><cite> <a href="https://forum.hearingtracker.com/u/Bazinga">Bazinga</a></cite></blockquote>
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<p></p>
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<blockquote class="wp-block-quote"><p><em>As a 55 year old retired Physician with profound  hearing loss I have run the gamut of hearing aids from analog to  advanced digital. I began wearing hearing aids at age 27. After  approximately 28 years of using hearing aids of every possible kind and  tweaked in every way imaginable, I have come to find  no benefit in  having digital aids over analogs. In fact I find analogs much softer and  more tolerable to my ears and so I wear them longer. Perhaps this is  due to the profundity of my loss so that I find no benefit in digital  aids.<br> However like many others, I find it very stressful whenever I go to  an audiologist as they insist on pressuring me into purchasing digital  aids ignoring the fact of my reporting no added benefits over the analog  aids.<br> Like any medical professional, audiologists as well a companies  producing hearing devices need to once again learn to LISTEN to their  patients. Not all deafness is physical and on the part of many medical  professionals is only selective deafness to patient’s  real needs as  opposed to their perceived needs.<br> I for one have reverted back to analog aids and would encourage  others to voice their opinions to their providers. Newer is NOT always  better. It depends on the person and their needs both physically as well  as financially.<br>Just another opinion FWIW </em></p><cite><a href="https://forum.hearingtracker.com/u/Silent_Doctor">Silent_Doctor</a>   </cite></blockquote>
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<p></p>
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<h6>Citations for this article:</h6>
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<p class="has-small-font-size"><a rel="noreferrer noopener" aria-label=" (s’ouvre dans un nouvel onglet)" href="https://forum.hearingtracker.com/t/what-is-it-about-analog-sound-you-like-best/16511/51" target="_blank">https://forum.hearingtracker.com/t/what-is-it-about-analog-sound-you-like-best/16511/51</a></p>
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<p class="has-small-font-size"><a href="https://forum.hearingtracker.com/t/bringing-back-analog-hearing-aids/46770">https://forum.hearingtracker.com/t/bringing-back-analog-hearing-aids/46770</a></p>
<!-- /wp:paragraph --><p>The post <a rel="nofollow" href="https://www.frenchear.com/analog-vs-numerique/">The Truth : Digital vs Analog Hearing Aid.</a> appeared first on <a rel="nofollow" href="https://www.frenchear.com">FrenchEar</a>.</p>
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