五、在欧盟委员会备案的思比易功效研究报告（中文摘要翻译件附后）
标题：
[B]A Summary Report of The Efficacy Studies of SpeechEasy: Self-contained ear-level devices delivering altered auditory feedback (AAF) for the application with those who stutter[/B]
作者：
Dr. Tao Jiang
（注：作者系加拿大达尔豪斯大学大众传播与沟通失调系教授，美国听力学会高级会员，1997年获得加拿大国家言语疾病及听力学学会颁发的“大众传播杰出奖”）
Introduction
Based on the Evaluation Of Clinical Data : A Guide For Manufacturers And Notified Bodies, this report intends to summarize a number of efficacy studies on the Self-contained ear-level devices delivering altered auditory feedback (AAF) for the application with those who stutter. After reviewing all the clinical data and published literature, we have selected those that meet the requirements by 90/385/EEC (AIMD) [1] and 93/42/EEC (MDD) [2] for the purpose of this report. Importantly, we are confident that the studies indicate SpeechEasy is in conformity with the intended purpose in relation to the safety and performance. The studies cited here are all peer reviewed and published in recognized academic journals, such as the International Journal of Language & Communication Disorders and American Annals of Biomedical Engineering. The devices used in those studies are exactly the same as those that Micro-DSP Technology Co., Ltd. manufactures and is presently applying for CE marking.
The reviewer of the article holds a post secondary degree in communication disorders and is presently an associate professor at School of Human Communication Disorders of Dalhousie University, Halifax, Canada. With all credentials, Dr. Jiang is capable of writing this report on SpeechEasy.
Background
The fact that stuttering is reduced when individuals who stutter speak under conditions of altered auditory feedback (AAF) has been evident for more than 45 years. Conditions of AAF known to reduce stuttering relative to non-AAF (NAF) include delayed auditory feedback (DAF) (Naylor 1953, Chase et al. 1961, Kalinowski et al. 1993, 1996, 1999, MacLeod et al. 1995), frequency-altered feedback (FAF) (Howell et al. 1987, Kalinowski, et al. 1993, Hargrave et al. 1994, MacLeod, et al. 1995, Stuart et al. 1996, 1997a, Armson and Stuart 1998), masked auditory feedback (MAF) (Shane 1955, Maraist and Hutton 1957, Kalinowski et al. 1993), and reverberation (Adamczyk et al. 1975, 1979, Smolka and Adamczyk 1992). MAF has been shown to be less efficient in reducing stuttering than DAF and FAF (Howell et al. 1987, Kalinowski et al. 1993). Kalinowski et al. (1993) and MacLeod et al. (1995) reported DAF and FAF to be equally effective in reducing stuttering, while Howell et al. (1987) in a seminal paper reported FAF to be more effective than DAF. Traditionally, forms of AAF have been generated by electronic signal processing devices, however, passive mechanical devices may produce AAF effects as well (Stuart et al. 1997b). The method in which AAF reduces stuttering remains undetermined. It was originally speculated that those who stutter had an abnormal speech–auditory feedback loop. It was thought that this abnormality was corrected or bypassed while speaking under DAF. Numerous models were proposed to describe the
nature of the potential cause/effect relationship (Cherry and Sayers 1956, Mysak 1966, Webster and Lubker 1968). Following the initial excitement, the importance of audition in stuttering, however, was diminished. The auditory system was discounted as an etiologic factor in stuttering based, in part, on the argument that it was too slow for on-line correction of speech (Borden 1979). This notion has since been challenged, as well (Stuart et al. 2002). Imaging studies have implicated the role of the auditory system on a central level and on a time scale compatible with Andrew Stuart et al. 2 LCD(gamma) LCD30727.3d 10/10/03 16:19:43 Rev 7.51n/W (Jan 20 2003) the behavioural effects of DAF on the overt manifestations of the disorder. It was also argued that the fluency enhancing properties of DAF and MAF were most likely due to an ‘altered’ manner of speaking (i.e. an emphasis on phonation achieved via slowing down through extended syllable duration; Wingate 1976, Perkins 1979). Similarly others have espoused the notion that ‘the functional variable in regard to the reduction of stuttering is not DAF, but prolonged speech, and the latter can be produced without reliance on a DAF machine’ (Costello- Ingham 1993: 30). In fact, almost all behavioural stuttering therapies from the
1800s to the present day have used slow speech rate in some form as a therapeutic
strategy (Van Riper 1973). Kalinowski and colleagues have since refuted the notion that a slow rate of speech is a necessary antecedent for stuttering reduction while one who stutters speaks under AAF. In a series of papers, they demonstrated that stuttering is
reduced under conditions of AAF while speaking at a fast intelligible rate of speech
(Kalinowski et al. 1993, 1996, Hargrave et al. 1994, MacLeod et al. 1995). Their results demonstrated reductions in stuttering rate between 70 and 90% regardless of speaking rate. This discovery contradicted the notion of the importance of slowed speech to fluency induced by AAF. That is, when syllable prolongation is eliminated, such as when speaking at a fast rate, the fluency enhancing properties of AAF are just as robust (i.e. a slowed speech rate is not a necessary antecedent for fluency improvement). It is reasonable, therefore, to speculate that the relevant variable(s) for fluency enhancement under conditions of AAF are related to auditory function. This shift necessitated a re-examination of the role of AAF in the reduction stuttering (Stuart and Kalinowski 1996).
At the same time, the stout findings of stuttering reduction with AAF were coupled with frustrating clinical observations. That is, those who stutter that were trained to reduce speech rate via specific articulatory/vocal targets did not always meet with clinical success. While speech may be more fluent following this traditional stuttering ‘motoric’ therapy approach, it was typically unnatural sounding (Runyan and Adams 1979, Martin et al. 1984, Metz et al. 1990, Runyan et al. 1990, Franken et al. 1992, Kalinowski et al. 1994) and not likely to be generalized from the therapy room to situations of daily living (e.g. Boberg 1981, Craig et al. 1996, Onslow et al. 1996). Put simply, relapse was frequent. The application of wearable prosthetic devices using AAF as an adjunct or alternative to current stuttering therapy became apparent and was voiced repeatedly (Armson et al. 1995, Kalinowski et al. 1995, 1995, 1996, Hargrave et al. 1994, MacLeod et al. 1995, Stuart et al. 1996, 1997a, Armson and Stuart 1998). The impetus behind the application of AAF in a prosthetic device for stuttering reduction was fivefold (Stuart et al. 2003): First, the reduction of stuttering under AAF is achieved virtually spontaneously with no conscious effort similar to that observed with choral or shadowed speech (Andrews et al. 1983, Armson et al. 1995). Second, AAF reduces stuttering in individuals with mild and severe stuttering without a sacrifice in perceived speech naturalness (White et al. 1995, Stuart et al. 2003). Third, stuttering reduction occurs during both the production of conversational speech and oral reading (Armson and Stuart 1998). Fourth, a significant reduction in stuttering rate can be achieved with monaural feedback
regardless of ear relative to NAF (Stuart et al. 1997a). Finally, the robust effects of
AAF occur outside the laboratory environment such as public speaking in front
of various audience sizes (Armson et al. 1997) and speaking on the telephone to
Altered auditory feedback in-the-ear devices 3 LCD(gamma) LCD30727.3d 10/10/03 16:19:43 Rev 7.51n/W (Jan 20 2003) strangers (Zimmerman et al. 1997). It has also been recently reported that repeated exposure after 3 months’ exposure to DAF outside the clinical environment with minimal clinical guidance produces a carry-over effect and significant reductions in stuttering are observed in the absence of AAF (Van Borsel et al. 2003). Prosthetic devices incorporating AAF have been available as a therapy alternative
in the past. Unfortunately, however, devices have not been cosmetically appealing (i.e. inconspicuous self-contained at the ear-level). That is, technology has been limited to conspicuous devices that are body worn incorporating additional head worn pieces for signal delivery (Donovan 1971, Gruber 1971, Grant 1973, Pollock et al. 1976, Low and Lindsay 1979). Only recently was a self-contained earlevel device for application with those who stutter achieved (Stuart et al. 2003). The recently developed device incorporates a microdigital signal processor core that reproduces the high fidelity of unaided listening and auditory self-monitoring while at the same time delivering AAF. DAF and FAF signals in combination or isolation can be generated to the user in a cosmetically appealing custom in-the-canal (ITC) and completely in-the-canal (CIC) design. Programming of the device was achieved through a personal computer, interface and fitting software.
In the past, there were many reports of success of using DAF and FAF to treat people with stuttering disorders with bulky devices in labs; however, recently, there have been some reports investigating the efficacy of SpeechEasy since 2000. I have selected some of research literature and present here for review.
Efficacy Studies
Self-contained ear-level devices delivering altered auditory feedback (AAF) for the application with those who stutter have only been recently developed. A series of studies were carried out by researchers in USA, Canada and other parts of the world. However, a bulk of literature comes from Department of Communication Sciences and Disorders, East Carolina University, Greenville, NC, USA. This group consists of Andrew Stuart, Joseph Kalinowski, Michael P. Rastatter, Tim Saltuklaroglu and Vikram Dayalu, Tao Jiang, Peter Xia, John Jiang, et al. They have produced more than 50 papers on this topic. For the simplicity of this summary, I have selected two most recent efficacy studies since SpeechEasy was first developed in 2000.
The first one was conducted in 2001 after one year of its use. The title of this study was Four Months Efficacy Study of SpeechEasy and the results were presented in a poster session in the annual conference of American Speech and Hearing Association. In this study, 4 adults (ages 21-54) and 4 children (ages 9 – 16) with moderate to severe stuttering participated in this study. No participant had been diagnosed with any other speech, language, or hearing disorders. The primary selection criteria for participating in this study were a moderate to severe stuttering severity and a residing in the vicinity of Greenville, NC. Each of the participants was provided with a custom fit SpeechEasy device. The children were provided with ITC (in-the-canal) models of the SpeechEasy. The adults were provided with CIC (completely-in-the-canal) models of the SpeechEasy. Baseline measures of stuttering were recorded while reading and during conversation before implementing the SpeechEasy Protocol. Upon inserting the SpeechEasy in the ear, each participant underwent approximately 30 minutes of training in order to obtain maximum fluency enhancement from the SpeechEasy. This training included: sensory training to facilitate listening to the altered signal, and motor training - only when necessary to obtain higher fluency levels. These consisted of making small intermittent changes in speech production in order to ‘highlight’ the altered speech signal without compromising speech naturalness.
All participants returned once in the next 4 months for minor adjustments to the parameters of their SpeechEasy device. After approximately 4 months of continual use of the SpeechEasy (participants reported using the SpeechEasy device at least 7 hours per day), stuttering frequencies were again obtained for all participants. Frequency counts of stuttering were again conducted during reading and conversation, while using the SpeechEasy and without using the SpeechEasy. For all frequency counts of stuttering, approximately 300 syllables of speech were collected. Stuttering was defined as part-word repetitions, tension-filled prolongations and postural fixations. Statistical significance between frequency counts were computed by means of a series of paired sample T-tests (alpha = 0.05).
The results of the study indicate that the immediate fluency enhancement provided by implementing the SpeechEasy protocol appears to be stable after 4 months of continued use. No significant increases in stuttering frequencies were found in reading or conversation over time when the SpeechEasy was used. The SpeechEasy provides efficient and effective symptom management of stuttering. It does not appear to be a curative agent.
The second study was conducted at the same lab by the title of Investigations of the impact of altered auditory feedback in-the-ear devices on the speech of people who stutter: initial fitting and 4-month follow-up. It was published in International Journal of Language & Communication Disorders (2003, VOL. 38, NO. 00, 1–21). Aims of the studies examine the first therapeutic application of self-contained ear-level devices in three experiments. The effect of the device on the proportion of stuttered syllables and speech naturalness was investigated following initial fitting and at 4 months post-fitting. Methods & Procedures: Three experiments were undertaken: In Experiment 1, the effect of a self-contained in-the-ear device delivering AAF was investigated with those who stutter during reading and monologue. Two adolescents and five adults who stuttered read and produced monologue with and without a device fit monaurally. The device provided a frequency shift of z500 Hz in combination with a delayed auditory feedback of 60 ms. Custom-made ITC and CIC devices were fabricated for four adults and four youths in Experiment 2. The effect of group (i.e. youth versus adult), time (i.e. initial fitting versus 4-month follow-up), speech task (i.e. reading versus monologue), and device (i.e. present versus absent) on stuttering rate was examined. In Experiment 3, 15 naive listeners rated the speech naturalness of speech produced by the participants in Experiment 2. Speech samples from six conditions were rated: reading and monologue without the device at the initial visit, reading and monologue with the device at the initial visit, and reading and monologue with the device at 4 months.
Experiment 1
Two adolescent males, four adult males, and one adult female who stutter (M~21.9 years, SD~7.3), participated in Experiment 1. A self-contained in-the-ear prosthetic fluency device was used. The device components were manufactured by Micro-DSP (Chengdu, People’s Republic of China). Monaural device fittings were employed with all participants as no significant differences in stuttering rate for right versus left monaural conditions has been demonstrated (Stuart et al. 1997a). The test ear was randomly selected. The device settings were the same for all participants: FAF was set at 500 Hz up and combined with a DAF setting of 60 ms. Each participant in Experiment 1 read different 300-syllable passages extracted from junior high texts in social studies and science. Passages had similar theme and syntactic complexity. Participants produced 300 syllables of monologue speech. Both speech tasks were produced with and without a device. For all conditions, participants were instructed not to use any previously used or taught therapeutic strategies or techniques to control or reduce stuttering. A trained research assistant analyzed the speech samples from the video recordings. The first 300 syllables produced by the participants were analyzed for each condition. Means and standard errors for proportion of stuttered syllables per 300 syllables (i.e. number of stuttered syllables/300 syllables) as a function of device (i.e. present versus absent) and speech task (i.e. reading versus monologue) are analyzed. A two-factor analysis of variance with repeated measures was performed to investigate the effect of speech task and device on the proportion of stuttered syllables. the proportion of stuttered syllables was significantly reduced with the device in place regardless of reading or monologue. Stuttering events were significantly reduced with persons who stutter while experiencing AAF via an in-the-ear device. The proportion of stuttered syllables was reduced by approximately 90% during reading and 67% during monologue.
Experiment 2
In Experiment 2, Eight individuals with developmental stuttering participated in Experiment 2. Four participants were adults (M~38.0 years, SD~15.9) and four were youth (i.e. one child and three adolescents; M~12.5 years, SD~2.6). None of those enrolled in Experiment 1 described above participated in Experiment 2. The apparatus employed in Experiment 2 were the same as that in Experiment 1 with one exception: personal ear-level devices were constructed in either ITC or CIC custom-made shell designs. Monaural device fittings were employed with all participants. The same testing with instruction as described in Experiment 1 followed fitting and orientation: participants read 300 syllable passages and produced 300 syllables of monologue speech with and without a device. The device settings were the same for all participants: FAF was set at 500 Hz up and combined with a DAF setting of 60 ms. At 4 months post-fitting (¡1 week), participants returned to the clinic for follow-up testing. Participants again read different 300 syllable passages and produced 300 syllables of monologue speech with and without a device. In all, each participant produced eight samples of speech (i.e. four from the initial assessment and four from the assessment at 4 months). A count of stuttered syllables was determined from the video recordings for all participants for each condition. The first 300 syllables produced by the participants were analyzed for each condition. The research assistant and a second research assistant recalculated the number of stuttered syllables for 50% of the speech samples chosen at random. Means and standard errors for proportion of stuttered syllables per 300 syllables (i.e. number of stuttered syllables/300 syllables) as a function of group (i.e. youth versus adult), time (i.e. initial versus 4 months), speech task (i.e. reading versus monologue), and device (i.e. present versus absent) are analyzed. A four-factor mixed analysis of variance was performed to investigate differences in mean proportions of stuttering events as a function of group, time, speech task, and device. These findings indicate the proportion of stuttering events was significantly reduced with the device in place regardless of speech task or group and remained so after 4 months of time.
Experiment 3
Fifteen naive young adult undergraduate students attending East Carolina University, Greenville, NC, participated in Experiment 3 (M~23.1 years, SD~4.0; 4 males and 11 females). Twelve speech samples were extracted from the video recordings of each participant in Experiment 2. Two separate 15-s audio segments of uninterrupted speech were randomly selected from each participant’s speech production under the following six conditions in Experiment 2: reading and monologue without the device at initial visit, reading and monologue with the device at initial visit, and reading and monologue with the device at 4 months. Speech naturalness ratings took place in a classroom setting. Participants were asked to rate each speech sample without being provided an operational definition of speech naturalness. The listeners rated each track for naturalness in which ‘1’ was ‘highly natural’ and ‘9’ was ‘highly unnatural’. Verbal instructions were identical to that used by Martin et al. A 5-min rest was provided at the end of 48 tracks. In all four sets of contrasts, it was found that mean naturalness ratings of speech samples generated with the device were judged more natural sounding than those without the device. Naive listeners rated the speech samples produced by those who stutter while wearing the device significantly more natural sounding than those produced without Altered auditory feedback in-the-ear devices. This was true for both adult and youth, reading and monologue, and during initial fitting and at post-fitting follow-up. Put simply, the perceived naturalness of speech samples from people who stutter was significantly improved.
The findings of these experiments are threefold. First, it was demonstrated in Experiment 1 that an in-the-ear device electronically delivering AAF effectively reduced stuttering. Second, this is the first report of a reduction in the proportion of stuttered syllables evidenced with the device in place during reading and monologue for adults and youth at fitting and 4 months post-follow-up. Finally, naive listeners rated the speech produced by those who stutter while wearing the device significantly more natural sounding than without the device. Again, this was constant for adults and youth while reading and with monologue. This finding is consistent with previous reports of speech produced under FAF: White et al. (1995) reported clinicians evaluated speech produced by those who stutter under FAF as significantly more natural-sounding than their speech under NAF.
The third study was a technical investigation of SpeechEasy published in 2003 by the American Annals of Biomedical Engineering by Andrew Stuart1, Shixiong Xia2, Yining Jiang2, Tao Jiang2,3, Joseph Kalinowski1, & Michael P. Rastatter. The study was entitled as The First Self-Contained In-The-Ear Device To Deliver Altered Auditory Feedback: Applications For Stuttering. The purpose of the study was to describe and analyze the design and operating characteristics of the first self-contained in-the-ear device to deliver altered auditory feedback is described for applications with those who stutter. The ear-level device to inhibit stuttering was constructed in both an in-the-canal (ITC) and completely-in-the canal (CIC) hearing aid shell design. The shells were generated from an ear impression and fabricated by a standard light-curable acrylic shell mold material (Audalite™). In addition to the DSP core described above, both models incorporate an electret condenser microphone (Knowles TM4546 Self-Contained In-The-Ear Device To Deliver AAF 6 and Knowles EM4346 for the CIC and ITC model, respectively) and a Class D amplified magnetic receiver (Knowles ES3207). Both models utilize multiple channels, automatic gain control–input, adaptive feedback suppression, dual time constants, microphone noise suppression, and a noise attenuation algorithm. First, on a practical level, these devices free researchers from the reliance on generating
altered auditory feedback via devices that are not in situ (e.g., racks of electronic signal
processing equipment). Second, on an empirical level, the robust effects of DAF and FAF observed in laboratory and controlled situations of daily living suggest that the device should have some therapeutic success.
The fourth report was entitled Auditory Sidetone and the Management of Stuttering:
From Wollensak to SpeechEasy by Richard M. Merson, Coordinator of Clinical Research and Special Clinical Projects in the Speech-Language Pathology Department of
William Beaumont Hospital in Royal Oak, Michigan. In his study, he compiled the data from his patients fitted with SpeechEasy. In his study, he describes the seventy three SE Users that chose to purchase the SE after an evaluation at the Beaumont Stuttering Center. Fifty-four were males between the ages of 14 years and 67 years ( mean of 29.1) and 19 were females between the ages of 11 years and 66 years of age ( mean of 36.8). The results indicate that the average reduction in stuttering ( stuttering=% syllables stuttered) after wearing the SE for at least one hour (immediate effect) was 79% for the males and 82% for the females. The immediate fluency effect ( % stuttering reduced) was noted in 91 of the 176 (52%) PWS who were evaluated for the SE had a 75% to 100% immediate fluency effect (reduction in stuttering). 49 of the 73 (67%) PWS who decided to purchase the SE had a 75% to 100% immediate fluency effect.
In conclusion, from the above four studies, it is clear that SpeechEasy is an effective therapeutic device to treat people with stuttering problems. In addition to achieving the effectiveness as evidenced in labs, it has more advantages in real world situations where naturalness and relaxed communication is required. The technical data as well as clinical data point out that the device meets all safety requirements and is in compliance with the risk analysis report provided by the manufacturer.
[SIZE="3"]中文摘要翻译：
[B]思比易功效研究报告概要：
―项运用AAF（改变听觉反馈）技术治疗口吃问题的耳内式产品[/B]
蒋涛 博士
简介
基于一些口吃临床数据上的研究， 我们采用改变听觉反馈原理而研发出了置于人体耳内的口吃矫正器。这里特别选择出一些符合90/385/EEC (AIMD) [1]和93/42/EEC (MDD) [2]标准并在行业知名刊物上同期发表的一些文章， 例如语言&传播失调国际月刊以及美国生物医学工程年报等。 我们相信思比易在安全和性能的指标是可以达到大家预期要求的水准的。 全文中提及这项产品正是由四川微迪数字技术有限公司生产的且正在申请CE认证的思比易。
背景资料
传统运用AAF原理研究治疗口吃已有45年历史，但这种单一被动接收声音信号的机械产品本身会产生AAF效应， 而导致了低下的治疗效果， 因此，运用AAF技术抑制口吃的方法至今没有得到业内认可。 同时， 随着DAF和FAF的原理在治疗口吃方面的成功案例和研究报告逐渐增多， 它们的科学性也逐渐被关注和认可。 但因初期开发的相关产品都外型笨重，不易患者携带因此最终没有成功投放市场。 思比易却是一项带有这项技术，且外形轻巧，秘密置于人体耳内的口吃矫正产品。 自2000年起， 关于它功效的调查试验报告就陆续在相关刊物上发表， 证明了它在口吃治疗方面的强大功效。
功效研究
将AAF技术应用在口吃矫正器上的研究在近几年又有了新的发展。 一系列的相关研究实验不断的在美国、加拿大和世界其它国家开展。 但绝大多数有实质意义的实验报告都是出自位于美国东卡罗莱那州大学的传播失调系的一群致力于口吃科学研究的学者们之手。 关于这个课题， 他们发表的论文就达50余篇之多。 在这里， 我们摘取了自思比易产品诞生以来的一些报告供大家参考借鉴。
第一项实验是在思比易投入市场一年以后进行的。 研究报告的题目是《使用思比易四月后效果调查》，这篇报告最终也以专栏的形式刊登在美国听力学年会的刊物上。 这项实验的主要方法，是邀请8名带有中重度口吃障碍的患者（4名成人，4名儿童）通过一些方法测定出他们的口吃严重度。 然后根据每人不同的特点，为他们定做了不同的思比易。 （儿童佩戴耳道式，成人佩戴完全耳内式）。 在他们练习思比易治疗口吃方案以前，通过观察他们阅读和对话测出他们的各项口吃参数， 作为接下来实验结果的参照标准。 在这些参与者带上思比易后，我们还对他们就如何正确使用思比易和达到最佳言语流畅度的相关技巧进行了30分钟的教授培训。
在他们八人佩戴思比易四个月后，我们重新邀请他们重新参与思比易的功效实验。 通过同样的方式比较他们佩戴思比易前后的口吃严重度。 搜集了他们阅读或谈话中的300个音节，并且确定了口吃的定义是出现单词重复、说同一单词时间超长等的现象。
最后通过各项测试方法， 得出患者使用思比易四月后的效果与刚佩戴时完全一样！在使用思比易的过程中， 患者的口吃出现频率不会出现大的增长。 可以肯定思比易为广大口吃人群提供了快捷高效的解决办法。
第二项研究是通过三项不同的小实验来观察口吃患者在刚刚验配思比易时和佩戴四月后的效果调查。 结果显示思比易有三重作用： 第一， 可以证明AAF原理在思比易――置于耳内式口吃矫正器上的应用非常成功和有效。 第二， 通过观察患者在佩戴思比易前后谈话和自言自语时出现口吃的音节的比例，发现思比易对减少出现口吃的音节和改善言语自然度上有很大的帮助。 第三， 以上结论与前面通过FAF（频率改变反馈原理）测试的结果完全一致。 利用FAF治疗口吃的效果远远比NAF（未使用听觉反馈原理）更明显。
第三项研究是由Andrew Start, Shixiong Xia, Yining Jiang, Tao Jiang, Joseph Kalinowskil, Michael P. Rastatter 共同设计实施的。 研究报告题为《改变听觉反馈技术在世界首创耳内式口吃矫正器上的成功应用》。 这项研究的目的在于分析耳内式口吃矫正器在设计和开发上如何最大程度地利用改变听觉反馈技术来治疗口吃问题的。
第四项研究的报告题为《听力的障碍以及如何正确的管理口吃》， 报告中， 研究人――Richards M. Merson, 根据他治疗过的口吃患者带上思比易的情况， 得出了一整套科学分析数据。 并且在73名佩戴思比易的患者中进行调查， 证明患者在带上思比易一小时后能够起到缓解口吃的效果的，男性中占79％， 女性占82％， 言语流畅度得到立即改善的， 占总人数的75％。
综上所述， 通过以上四项研究， 可以表明思比易确是一项治疗口吃的有效手段。 除了在试验室进行的这些试验所起到的效果以外， 它也能提高和改善人们说话的流畅度和松弛度。相关临床试验数据也证明了这项产品是完全达到相关安全标准以及制造商的风险分析报告的要求。[/SIZE]
（待续）
