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助听器验配算法 |
发布: sharylh - 03-02-2019, 08:25 AM - 版块: 软件技术
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目前业界有4中验配方法
Fig6 由安森美可以从安森美公司提供,下面的需要别的渠道得到
NAL-NL1公式、
NAL-NL2公式、
DSL-V5公式
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What’s New About NAL-NL2? |
发布: sharylh - 03-02-2019, 07:45 AM - 版块: 软件技术
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一直一来助听器验配算法是NAL-NL1 之类的,现在有最新的NAL-NL2从语音清晰度和响度上得到了很大的提升,从 国外the hearing reveiw网站上有些介绍,摘录下。
http://www.hearingreview.com/2012/09/wha...t-nal-nl2/
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http://www.hearingreview.com/2012/09/wha...t-nal-nl2/
What’s New About NAL-NL2?
Published on September 2, 2012
Here is a short summary of some of the key changes to the ubiquitous NAL fitting algorithm, including the formula’s latest approach to compression attack-times, gender differences, binaural/monaural fittings, cases of mild-to-moderate loss, the wearer’s primary spoken language, and other factors.
Editor’s Note: Dr Galster regularly publishes commentary on interesting articles in the hearing care literature. This article was adapted from his March 1, 2012 blog post found at galster.net in which he and Dr Stevens focus on research from the 2011 paper published in Hearing Research by Keidser et al.[sup]1[/sup]
For years, the National Acoustics Laboratories’ NAL-NL1 has been the benchmark for compressive, independently derived, prescriptive formulas.[sup]2[/sup]The recently introduced NAL-NL2 advances their original formula with knowledge gained from a wealth of empirical data collected with NAL-NL1.[sup]2[/sup]Similarities between NAL-NL1 and NAL-NL2 include:
1.[size=2] [/size]The primary goals of maximizing speech intelligibility while not exceeding overall normal loudness at a range of input levels, and
2.[size=2] [/size]The use of predictive models for speech intelligibility and loudness.[sup]3,4[/sup]
The speech intelligibility model used in both NAL-NL1 and NAL-NL2 differs from the Speech Intelligibility Index (SII).5 The ANSI SII assumes that, regardless of hearing loss, speech should be fully understood when all speech components are audible. Included in NAL-NL1 is a modification to the SII proposed by Ching and colleagues.6 This modification or effective audibility factor assumes that, as hearing loss becomes more severe, less information can be extracted from the speech signal. More recent data have been collected to derive an updated effective audibility factor for use with NAL-NL2.1
The NAL-NL2 formula includes constraints to prevent compression ratios from exceeding a maximum value for a given frequency or degree of hearing loss. Modifications were based on data suggesting that users with severe or profound hearing loss prefer lower compression ratios than those prescribed by NAL-NL1, when fitted with fast-acting compression.7 However, there is evidence to suggest that higher compression ratios could be used in this population with slow-acting compression. Therefore, in the case of severe or profound hearing losses, the new formula prescribes lower compression ratios for fittings with fast-acting compression than those with slow-acting compression. For mild and moderate losses, compression speed does not affect prescribed compression ratios.
Based on experimental outcomes with NAL-NL1 fittings, the development of NAL-NL2 took various attributes of the hearing aid user into consideration, such as gender, binaural listening, experience level, age, and language. In the case of gender, Keidser and Dillon8 studied the real-ear insertion gain measurements for the preferred frequency responses of 187 adults, finding that, regardless of experience or degree of hearing loss, female participants preferred an average of 2 dB less gain than male participants. As a result, gender differences are factored into each fitting.
The NAL-NL2 method still prescribes greater gain for monaural fittings than it does for binaural fittings. This difference is similar to the NAL-NL1 formula.9 Recent studies suggest that the binaural to monaural loudness difference may be less than previously indicated.10 For symmetrical hearing losses, the binaural difference ranges from 2 dB for inputs below 50 dB SPL to 6 dB for inputs above 90 dB SPL, so binaurally fitted users will have higher prescribed compression ratios than monaural users. For asymmetrical losses, the binaural correction decreases as the asymmetry increases
Experience with hearing aids as it relates to degree of hearing loss is a consideration in the NAL-NL2 formula. Keidser and her colleagues11 found that, with increasing severity of hearing loss, new users prefer progressively less prescribed gain than experienced hearing aid users. Although this observation does not agree with several other studies,12,13 the NAL-NL2 recommends gain adaptation for new hearing aid users with moderate or severe hearing loss. Further details of this discrepancy will be addressed in a future publication (personal communication, Gitte Keidser, 2012).
The developers of the NAL-NL2 formula determined that adults with mild-to-moderate hearing loss preferred less overall gain for 65 dB inputs than would be prescribed by NAL-NL1.11 This is corroborated by other studies13,14 in which hearing aid users with mild-to-moderate hearing loss preferred less gain for high and low level inputs. These reports indicate that participants generally preferred slightly less gain and higher compression ratios than those prescribed by NAL-NL1—a preference that was incorporated into the revised prescriptive procedure.
The NAL-NL2 also takes the hearing aid user’s language into consideration. For speakers of tonal languages (eg, many East Asian languages, including Chinese), slightly more low-frequency gain is prescribed. Increased gain in the low-frequency region more effectively conveys fundamental frequency information, an especially important cue for recognition of tonal languages.
Like its predecessor, the NAL-NL2 fitting formula leverages theoretical models of intelligibility and loudness perception to maximize speech recognition without exceeding normal loudness. The revised formula takes into consideration a number of factors other than audiometric information and benefits from extensive empirical data collected using NAL-NL1. Ultimately, the NAL-NL2 procedure results in a slightly flatter frequency response, with relatively more gain across low and high frequencies and less gain in the mid-frequency range than in the NAL-NL1 formula.
The study of objective performance and subjective preference with hearing aids is constantly evolving, and the NAL-NL2 prescriptive method may be a step toward achieving increased acceptance by existing hearing aid users and improved spontaneous acceptance by new hearing aid users.
Acknowledgements
The authors thank Gitte Keidser, PhD, for her comments on a draft of this summary. Many of the works cited were completed by Drs Keidser, Harvey Dillon, PhD, and the talented research staff of the NAL and other laboratories. This article was based on an original blog post (March 1, 2012) found at: http://galster.net
References
1.[size=2] [/size]Keidser G, Dillon H, Flax M, Ching T, Brewer S. The NAL-NL2 prescription procedure. Audiol Res. 2011;1(e24):88-90.
2.[size=2] [/size]Dillon H. Page Ten: NAL-NL1: A new procedure for fitting non-linear hearing aids. Hear Jour. 1999;52:10-16.
3.[size=2] [/size]Moore BCJ, Glasberg B. A model of loudness perception applied to cochlear hearing loss. Aud Neurosci. 1997;3:289-311.
4.[size=2] [/size]Moore BCJ, Glasberg B. A revised model of loudness perception applied to cochlear hearing loss. Hear Res. 2004;188:70-88.
5.[size=2] [/size]American National Standards Institute (ANSI). Methods for calculation of the speech intelligibility index. ANSI S3.5-1997. New York City: Acoustical Society of America; 1997.
6.[size=2] [/size]Ching T, Dillon H, Byrne D. Speech recognition of hearing-impaired listeners: Predictions for audibility and the limited role of high frequency amplification. J Acoust Soc Am. 1998;103(2):1128-1140.
7.[size=2] [/size]Keidser G, Dillon H, Dyrlund O, Carter L, Hartley D. Preferred low and high frequency compression ratios among hearing aid users with moderately severe to profound hearing loss. J Am Acad Audiol.2007;18(1):17-33.
8.[size=2] [/size]Keidser G, Dillon H. What’s new in prescriptive fittings down under? In: Palmer CV, Seewald R, eds. Hearing Care for Adults 2006. Stafa, Switzerland: Phonak AG; 2006:133-142.
9.[size=2] [/size]Dillon H, Keidser G, Ching T, Flax M. The NAL-NL2 Prescription Formula. Paper presented at: Audiology Australia 19th National Conference; May 2010; Sydney, Australia.
10.[size=2] [/size]Epstein M, Florentine M. Binaural loudness summation for speech and tones presented via earphones and loudspeakers. Ear Hear.2009;30(2):234-237.
11.[size=2] [/size]Keidser G, O’Brien A, Carter L, McLelland M, Yeend I. Variation in preferred gain with experience for hearing aid users. Int J Audiol.2008;47(10):621-635.
12.[size=2] [/size]Convery E, Deidser G, Dillon H. A review and analysis: Does amplification experience have an effect on preferred gain over time? Aust N Z J Audiol. 2005;27(1):18-32.
13.[size=2] [/size]Smeds K, Keidser G, Zakis J, et al. Preferred overall loudness. II: Listening through hearing aids in field and laboratory tests. Int J Audiol. 2006;45(1):12-25.
14.[size=2] [/size]Zakis J, Dillon H, McDermott HJ. The design and evaluation of a hearing aid with trainable amplification parameters. Ear Hear.2007;28(6):812-830.
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未来的助听器,会往哪方面发展? |
发布: sharylh - 01-31-2019, 11:37 AM - 版块: 市场动态
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文章来源于: http://wemedia.ifeng.com
未来的助听器会发展成什么样?在可以预见的未来,助听器的发展有三个主题。
1、小型化
从19世纪末的桌面大小到20世纪末的重量不足一克,助听器外型尺寸越来越小。尽管目前还未找到进一步大幅度减小助听器外型尺寸的有效方法,但作为趋势,助听器肯定会越做越小,越做越美观。微型助听器不仅是制造商的希望,更是广大助听器使用者的要求。
2、个性化
随着相关听力知识的普及,人们会越来越重视自己的听力,同时也会发现听力损失完全相同的听力障碍者极少,每个听障者的听力状况都有其特殊的一面。因此,为每个听障者个别定制助听器以保证使用效果必然会成为发展趋势。
3、智能化
要想进一步提高助听质量(比如清晰度)就必须使助听器具备记忆能力、重新编码能力等“智能”,比如抗噪声、声源定向定位、音质定位等各类类耳蜗性能。这一切,需要计算机技术与数字化技术的支持。智能化助听器已经开始受到广泛重视,但作为商品还远远没有成熟,远远不能满足广大特殊用户的需求。
1、智能手机远程调试
随着现代人对手机越来越依赖,助听器的发展也会跟智能手机挂钩。例如通过手机app直接链接控制助听器一些功能的调试,减少传统助听器需要到店里调试的麻烦。也可以在用户佩戴助听器之后,通过互联网将助听器状态链接到开发者的电脑上,由专家远程为使用者更精准地调控助听器。
2、无线充电
电池续航能力一直以来都是智能充电产品的一项难题,由于智能化以后,处理的信息也会增多,进而用电量也会增加。除了对充电电池本身的研究,也有很多人在使用功耗和处理信息方面做研究,希望去掉一些无效运算也能节约电脑,增加续航。
不过直到现在还没有一款颠覆性的产品和处理方案。这对未来助听器来说有很大发展空间,同时也是难题。也许就会因为其他功能差别不大的情况下,电池的续航会成为他们最终的考虑。
3、双耳波束形成技术
研究人员发现,当正常听力的人在不同强度的背景噪声中听同一个简短的故事时,大脑感知听力的神经活动是一致的,双耳波束形成技术就是利用这一原理。研究者Mejia表示,通过对测量分析算法的改进从佩戴者那里获得大脑神经信号,并利用这些信息来控制助听器的降噪系统是可行的。双耳波束形成技术——超级定向麦克风技术将会成为未来助听器的共同特征。助听器也将会更聪明,能够学习个人的听觉偏好,并在环境变化中随着这些听觉偏好迅速做出调整。
4、视觉引导技术
有一项新的技术正在研究——视觉引导技术,简单的说就是,你看哪里就能听到哪里的声音。现在的数字助听器都有降噪功能,但并不能有效的排除所有噪声,仍然不能满足佩戴者的所有要求。新的视觉引导技术如果实现,就能精准的听见目标人物说话,排除其他杂音。
5、认知控制技术
通过大脑神经的控制,想听哪里就听哪里。哥伦比亚大学正在进行一项研究,将语音处理技术和听觉注意力解码技术结合,形成了一项认知控制技术。可根据佩戴者神经信号的解码信号来选定特定的音频接收通道,再由系统自动将目标声与噪声分开,并分析听者想听的声音,最后做到放大目标声。研究人员表示,这项技术在助听器上的实际应用已经不存在何理论上的问题。
未来的助听器将会如何发展?我们拭目以待。
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2018年前25个助听器必备功能文章 |
发布: sharylh - 01-31-2019, 11:05 AM - 版块: 市场动态
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本文来源海外网站摘录:http://www.hearingreview.com --2019.1.2
Editor’s Picks: Top-25 ‘Hearing Review’ Feature Articles in 2018
Published on January 2, 2019
[img=466x0]http://a360-wp-uploads.s3.amazonaws.com/wp-content/uploads/hearingr/2018/12/dreamstime_m_98991142-466x310.jpg[/img]
Last week, we showcased the most important news items in The Hearing Review during 2018. This week, we’ll present the Editor’s Picks for the 25 most important feature articles featured in Hearing Review during the past year, listed in chronological order.
[img=75x0]http://a360-wp-uploads.s3.amazonaws.com/wp-content/uploads/hearingr/2013/03/jergerMug2008-02_opt-214x300.jpeg[/img]
James Jerger, PhD
The Remarkable History of Right-Ear Advantage, by James Jerger, PhD (January 2018 HR)
For good reasons, the auditory system of humans evolved with a right-ear advantage (or left-ear disadvantage) as speech processing required more of the brain. Dr Jerger takes readers on a remarkable journey of the auditory system and looks at some of the interesting implications of right-ear advantage in terms of binaural processing, speech understanding, and amplification.
[img=83x0]http://a360-wp-uploads.s3.amazonaws.com/wp-content/uploads/hearingr/2017/12/Screen-Shot-2017-12-26-at-1.54.20-PM-259x300.png[/img]
Melanie A. Ferguson, PhD
Hearing Aids for Adult Mild-to-Moderate Hearing Loss: An Interview with Melanie Ferguson, PhD, by Douglas Beck, AuD (January 2018 HR)
Dr Ferguson and Dr Beck discuss the evidence for how hearing aids benefit adults with mild-to-moderate hearing loss, as well as Dr Ferguson et al’s systematic review on the subject which was recently published in the Cochrane Database.
How Should Modern Hearing Aids Be Programmed for Verification with REM? By Erica D. Koehler, AuD, and Neil A. Wright, AuD (February 2018 HR)
You’re not alone if you ask, “Should I turn off the advanced features when doing REM?”
SPECIAL REPORT: Hearing Care and “Value-based Reimbursement” in Medicine, by Lena Kauffman (March 2018 HR)
John Bakke, MD, Barbara Weinstein, PhD, Gabrielle Saunders, PhD, and David Blanchard explain how the new world of “value-based” or “outcomes-based” reimbursement is changing medicine, and how it may end up revolutionizing audiology and hearing healthcare.
Real-life Applications of Machine Learning in Hearing Aids, by Oliver Townend; Jens Brehm Nielsen, PhD; and Jesper Ramsgaard, MA (April 2018 HR)
A look into the present and future of hearing aid processing and post-fitting adjustments for patients.
These Hearing Aids Make Everything Sound Digital!By Marshall Chasin, AuD (April 2018 HR)
In a “blind taste test,” patients should not be able to tell the difference between analog and digital hearing aids. Here are some possibilities (and potential remedies) if the disparities do indeed actually exist.
[img=83x0]http://a360-wp-uploads.s3.amazonaws.com/wp-content/uploads/hearingr/2018/03/Todd-Ricketts-240x300.jpg[/img]
Todd Ricketts, PhD
Real-ear, Cognition, Speech-in-Noise, and More: An Interview with Todd Ricketts, PhD, by Douglas Beck, AuD(April 2018 HR)
Dr Beck interviews Todd Ricketts, PhD, of Vanderbilt University about how many people actually purchase hearing aids each year, what we can and cannot say about hearing loss and dementia, the RECD and speech in noise measures, and more.
Mythbusters’ Myth #4: I Have to Discuss the Audiogram, by Mary Beth Jennings, PhD; Christopher Lind, PhD; and Nerina Scarinci, PhD
How often have we looked into the faces of our clients and their families as we describe the audiogram only to find anxious, blank, or confused faces staring back at us?
[img=136x0]http://a360-wp-uploads.s3.amazonaws.com/wp-content/uploads/hearingr/2018/07/TraynorPt2_Fig3-300x214.jpg[/img]
Figure 3. Porter’s Five Forces. From Glaser and Traynor 2018.2 Reprinted with permission from Plural Publishing.
Survival Strategies in a Competitive Hearing Healthcare Market, by Robert M. Traynor, EdD, MBA(June 2018 HR)
Dr Traynor offers his perspectives on industry consolidation and the current major trends that could influence strategies of an independent practice owner.
[img=91x0]http://a360-wp-uploads.s3.amazonaws.com/wp-content/uploads/hearingr/2018/07/VictorBray0718-248x300.png[/img]
Victor Bray, PhD
WEBINAR: Depression, Hearing Loss, and Treatment with Hearing Aids, by Victor Bray, PhD, sponsored by Hamilton CapTel
An overview of important research into hearing loss, depression, loneliness, dual-sensory losses, and other chronic conditions, as well as an update about current research into treatment with hearing aids, assistive devices, and other options.
Clinical Speech Audiometry in the Age of the AERP, by James Jerger, PhD(July 2018 HR)
Dr Jerger explores two different ways to think about clinical speech audiometry relative to assessing total listening effort: 1) Altering the task from repetition to decision, and 2) Evaluating the response evoked by the decision via an AERP paradigm.
[img=89x0]http://a360-wp-uploads.s3.amazonaws.com/wp-content/uploads/hearingr/2017/01/AnuSharmaRetouch-232x300.jpg[/img]
Anu Sharma, PhD
Cortical Neuroplasticity in Hearing Loss: Why It Matters in Clinical Decision-Making for Children and Adults, by Anu Sharma, PhD, and Hannah Glick, AuD (July 2018 HR)
With a better understanding of cortical brain changes associated with hearing loss, the potential to develop objective brain-based tools (ie, biomarkers) increases. Drs Sharma & Glick explain how the brain actually changes in response to sound.
Effects of Amplification on Cortical Electrophysiological Function, By Sridhar Krishnamurti, PhD, and Larry Wise, AuD (July 2018 HR)
A review of the possible use of speech-evoked CAEP as an objective hearing aid validation measure, data suggesting the clinical value of CAEPs for assessing cortical changes from amplification, as well how we might use this data in audiology services to demonstrate patient benefit.
[img=88x0]http://a360-wp-uploads.s3.amazonaws.com/wp-content/uploads/hearingr/2018/07/Hampton_dementia_infographic_Lancet-149x300.jpg[/img]
Figure 1. Risk factors for dementia. Image used with permission from [i]The Lancet.[/i]
Nine Risk Factors Associated with Dementia, by Dennis Hampton, PhD (August 2018 HR)
Revisiting the 2017 Lancet publication that includes hearing loss as a major risk factor for dementia.
eAudiology: Shifting from Theory to Practice, by Joseph Montano, EdD; Gina Angley, AuD; Colleen Ryan-Bane, MS; William Campbell, MClSc, et al (September 2018 HR)
A concensus statement that provides recommendations to hearing care providers for integrating eAudiology into their existing practice as a means to reach new patients, enhance patient care, and increase the value of their services.
Pediatric Amplification, Noise Management, and Incidental Learning, by Douglas Beck, AuD; Elaine Ng, PhD, and Maureen Doty Tomasula, AuD(September 2018 HR)
Should noise reduction algorithms be used in pediatric hearing aid fittings? Here is an examination of the rationale and arguments from the literature which generally support the use of advanced noise-reduction techniques and technologies for children.
Using Audiology to Extend a Musician’s Career, by Marshall Chasin, AuD (October 2018 HR)
An introduction to a special issue designed to helping musicians, and those who like to listen to music, extend their playing careers and listening enjoyment.
OTC: Let’s Get on the Same Page! By Karl Strom (October 2018 HR)
Now that we’ve defined (at minimum) what an OTC hearing device should look like, maybe it’s time to start defining a minimal standard for what a professional hearing aid fitting should look like.
We’re Going to Have to Move! By Dennis Van Vliet, AuD
Dr Van Vliet describes a recent clinical encounter in which the engineer-patient ultimately embraced and accepted his amplification.
Audiologic Considerations for People with Normal Hearing Sensitivity Yet Hearing Difficulty and/or Speech-in-Noise Problems, by Douglas L. Beck, AuD; Jeffrey L. Danhauer, PhD; Harvey B. Abrams, PhD, et al (October 2018 HR)
Hearing care professionals often encounter people who complain of hearing difficulties and trouble hearing in noise, but when tested, present with hearing sensitivity and thresholds that are within “normal limits.” This article reviews the audiological evidence regarding this unique population.
[img=142x0]http://a360-wp-uploads.s3.amazonaws.com/wp-content/uploads/hearingr/2018/10/Voss_Fig1_ValenteChickenSlide-300x168.jpg[/img]
Figure 1. The chicken/hearing aid pricing analogy used by Dr Valente in his patient counseling readily shows how different services—in this case, the various states of preparation in a chicken dinner—result in widely different prices for what are essentially the same meal.
Coupler and Real-Ear Performance between PSAPs and Hearing Aids, by Adam Voss, AuD, Kristi Oeding, AuD, A.U. Bankaitis, PhD, John Pumford, AuD, and Michael Valente, PhD(November 2018 HR)
Before jumping to the conclusion that any PSAP and/or OTC hearing device would be suitable for the many different types of hearing losses, we need to look at their coupler and real-ear performance data. This study suggests current PSAPs are suitable for mild losses only.
A Comparison of Automated Real-Ear and Traditional Hearing Aid Fitting Methods, by Paula Folkeard, AuD; John Pumford, AuD; Parvaneh Abbasalipour, MSc; Nicole Willis, and Susan Scollie, PhD
Several “autoREMfit” systems have been developed to assist in hearing aid fittings. This article evaluates the Audioscan VerifitLINK, that could be integrated into any manufacturer’s software, and documents its performance in target matching during hearing aid fitting.
[img=82x0]http://a360-wp-uploads.s3.amazonaws.com/wp-content/uploads/hearingr/2018/11/Don_Nielsen-188x300.jpg[/img]
Donald Nielsen, PhD
CEDRA: A Consumer Questionnaire to Detect Disease Risk Before Hearing Aid Purchase, by Donald W. Nielsen, PhD (December 2018 HR)
The free CEDRA questionnaire, which is designed to identify the risk of diseases with ear and hearing symptoms to help maintain consumer safety while dispensing hearing aids and other hearing amplification devices when licensed providers are not involved.
Evaluating Select Personal Sound Amplifiers and a Consumer-Decision Model for OTC Amplification, by Ron Leavitt, AuD, Ruth Bentler, PhD, and Carol Flexer, PhD (December 2018 HR)
OTC hearing devices are coming, but how should they function and for whom should they be recommended? Six case studies are presented, with the results showing that people with true moderate hearing loss may not be well served by what has been characterized as a “consumer-decides” model of care.
Development and Clinical Applications of the ORCA Repeat and Recall Test (RRT), by Christopher Slugocki, PhD, Francis Kuk, PhD, and Petri Korhonen, MSc (December 2018 HR)
Appreciating the unique difficulties related to speech understanding in noise and working memory is critical to tailoring individualized interventions in hearing healthcare. The Repeat and Recall Test shows promise as a tool for better hearing aid fittings.
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Over-the-Counter (OTC) Hearing Aid Act: What You Need To Know |
发布: sharylh - 01-31-2019, 10:49 AM - 版块: 市场动态
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For decades, the hearing assistance of any kind has been seen as something meant for our grandparents, but the fact is hearing loss affects people of all ages starting as early as early 20’s. Because of this, many believe eventually everyone will be wearing some sort of hearing device in the near future. Hearing devices can both improve our ability to hear sounds and with new technology continuously being developed, they can be discreet and comfortable.
Recently, Hearing Aids have made their way to the forefront of the news. Like with all news, when loads of information become available it can sometimes become hard to sift through the information to understand. Because of this, we’ve sifted through and have trimmed down the important information to provide you with the basics when it comes to deciding whether going down the Hearing Aid trail or if you could get away with an OTC Hearing Aid.
Noted in a recent blog titled, “The Hearing Gap: Accessibility and the Consequences of Hearing Loss,” one of the many reasons people who needed hearing assistance did not get help was because often hearing loss was not a priority for policymakers. For years, hearing loss straddled the lines between being a healthcare issue, a public health concern, and a lifestyle issues.
Luckily, our Senators were listening and became aware of the difficulties associated with hearing loss and the undeniable benefits surrounding making OTC Hearing Aids accessible. Last summer the Senate’s near-constant gridlock came to a rare agreement giving Senator, Elizabeth Warren, a bipartisan legislative win. The Senate voted 94 to 1 to pass a broad Food and Drug Administration bill, the “Over the Counter Hearing Aid Act. The act contained a measure written by the Massachusetts Democrat specifically designed to provide greater public accessibility and affordability with over-the-counter (OTC) hearing aids. The OTC Hearing Aid Act enables adults with the detected mild-to-moderate hearing loss to access OTC hearing aids without visiting or being seen by a hearing care professional.
While the FDA continues to regulate hearing aids it does not consider OTC Hearing Aids to be medical devices when labeled for recreational or any other use by individuals with normal hearing. Yet, specific safety regulations related to sound output levels apply to these products. It is important to note, per the FDA’s website there are currently no products that can claim to address hearing loss that are or claim to be OTC hearing aids within the meaning of section 520(q) of the FD&C Act as amended by FDARA.
Currently, hearing aids continue to be restricted [medical] devices, for which sales must follow applicable federal and state requirements overseen by the FDA (Food & Drug Administration) including monitoring by a medical professional.
It is important to note, while the OTC Hearing Aid Act is wonderful news and will provide those with mild hearing issues some assistance, it is not meant for someone with any significant hearing loss. If you suspect you suffer from any form of hearing loss, please visit our website to take advantage of your FREE hearing exam near you today. It is always best to lean on the safe side and have your hearing tested.
Should you need a hearing aid, our Lucid Certified Hearing Specialists will be able to help you identify and give practical advice on what hearing aids are available to you. Our specialists will provide you with recommendations on particular models, so you can be confident you’re making the right choice. To keep them working effectively and safely, you need a proper diagnosis from a licensed professional, and regular visits for follow-up and maintenance. Hearing care professionals ensure you are fit properly. This can save you thousands of dollars in future medical costs you’re risking by self-diagnosing and choosing over-the-counter hearing aids that provide more amplification than you need and can result in further hearing damage.
In closing, it is important to note TWO FACTS should you suspect hearing loss.
#1 According to the National Institute on Deafness and Other Communication Disorders only 1 of 5 people who could benefit from a hearing aid actually wear one.
#2. The Johns Hopkins School of Medicine found in a 12-year study conducted by their neurology department that untreated hearing loss increased the risk for dementia.
THE FINE DETAILS:
Below are the details of The OTC Hearing Aid Act provided by Congress.gov.
The bill amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration (FDA) to categorize certain hearing aids as over-the-counter hearing aids and issue regulations regarding those hearing aids.
The regulations for over-the-counter hearing aids must: (1) provide reasonable assurances of safety and efficacy; (2) establish output limits and labeling requirements; and (3) describe requirements for the sale of hearing aids in-person, by mail, or online, without a prescription.
State and local governments may not establish or continue in effect requirements specifically applicable to hearing products that are not identical to FDA requirements and that restrict or interfere with the servicing or sale of over-the-counter hearing aids.
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Advanced Hearing Aids: Wearables You’ll Want to Wear |
发布: sharylh - 01-28-2019, 03:54 AM - 版块: 硬件区
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In many wearable devices, wireless connectivity is quickly becoming more commonplace, instead of a feature found only on high-end devices. Wireless technology makes it much easier for users to control their device, ultimately helping to make the user experience more enjoyable and increase adoption. Still today, making control adjustments (e.g., volume control, program selection, etc.) on a hearing aid can be challenging. Users can make adjustments manually by selecting the one or two small buttons on the device. Some may be able to do this while it is still on the ear, but others may have to remove it beforehand. Another option requires using a dedicated manufacturer specific remote control, or a relay device (a larger unit typically worn around the neck), if operations using a smartphone are desired. Most hearing aids available today don’t possess the ability to communicate directly with smartphones, so this additional unit is needed in order to convert the proprietary radio link hearing aids use into a standard Bluetooth[sup]®[/sup] link smartphones can understand.
Since many people today already carry and use smartphones, using it to communicate with and control the user’s hearing aids has by far the most appeal. Adding to its ease-of-use, custom smartphone applications feature intuitive icons and touch controls which are friendly for all levels of technical understanding. For hearing aids, these apps allow users to easily check their devices’ battery levels, and optimize program or volume control settings of left and right hearing aids individually. Other features can include alerts to incoming texts or phone calls, or the use of RSSI (Received Signal Strength Indicator) to help locate a misplaced hearing aid.
Using wireless technology, audio can be streamed digitally to the hearing aid from an external source such as a sound system or a television equipped with an ancillary device. This can provide a more immersive entertainment experience for the wearer, with better audio quality. Wireless technologies such as Bluetooth Low Energy (BLE) now provide the opportunity to deliver better and more discrete user experiences for hearing-aid wearers. Several hearing aid manufacturers have enabled BLE in their hearing aids by creating a direct radio link between the device and smartphone, eliminating the need for a relay or third-party unit.
Within any hearing aid form factor(from Behind-the-Ear (BTE) to Receiver-in-Canal (RIC)), the designer must arrange the receiver, the battery and associated circuitry, user controls for volume adjustment and program switching, and the audio digital signal processor (DSP) and associated peripherals including memory and now a Bluetooth radio transceiver. One or more microphones are usually needed, to enable background-noise cancellation and directional sound pick-up. The power consumption of the additional radio subsystem must also be considered to minimize any impact on the overall system to avoid demanding a larger, heavier battery to supply more energy.
System-in-Package (SiP) solutions can help overcome the space limitations of miniature devices by integrating several components into a single package.
Designed specifically for hearing aids, Ezairo[sup]®[/sup] 7150 SL is a wireless-enabled audio processing hybrid module which can easily be integrated into a standard BTE shell. Based on the programmable Ezairo 7100 digital signal processing (DSP) platform, the miniature hybrid module features precision quad-core architecture. Ezairo 7150 SL provides multi-protocol wireless support, is optimized for 2.4 GHz license- free radio bands, and is compatible with BLE as well as custom protocol variants to deliver ultra-low-power stereo audio streams. To store important hearing aid parameters, Ezairo 7150 SL provides 2 Mb of non-volatile memory (EEPROM).
To further assist with development, ON Semiconductor has produced a complete reference design of an Ezairo 7150-SL based BTE hearing aid, including the hybrid module, required passive components, and 2.4 GHz radio antenna to help designers develop and refine their own device. The reference design is comprised of fully- assembled hardware, a sample Android™ application, and firmware for stereo audio streaming via a remote dongle and Control over BLE.
Multi-protocol wireless support enables advanced hearing aid features such as Control over Bluetooth Low Energy (CoBLE) using a smartphone or tablet, and audio streaming via a remote dongle that plugs into the standard audio output jack of the source equipment. The audio streaming protocol uses a proprietary low-latency radio link that consumes very little power (only about 4-5 mA off a standard Zinc-Air hearing aid battery).
The stereo audio streaming feature allows users to hear audio from any external source like televisions or car radios through the use of a small transmitter dongle. The dongle can also operate in remote microphone mode, further enhancing the user’s listening experience in challenging situations, like noisy environments or class rooms where the speaker might be far away.</p><p>
Advanced features, especially wireless connectivity, hold the potential to revolutionise quality of life for hearing aid wearers. Physical space constrains have been a key factor in limiting progress, but sophisticated integration techniques and new radio technologies have now helped to enable wireless connectivity, such as Control over BLE and low-latency audio streaming, without the need for bulky relay devices. These features now set the scene for dramatic improvements to the end-user experience, helping to transform hearing aids from a device someone needs to use into one they’ll want to use.
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