Background
Drs. Joseph Kalinowski, Andrew Stuart and Michael Rastatter have spent the past 14 years researching the effect of delayed auditory feedback (DAF) and frequency auditory feedback (FAF) on stuttering. Since 1992, their research has involved hundreds of individuals in the United States and Europe. Their findings led to the development of the SpeechEasy, anti-stuttering fluency device, which emulates the effect of choral speech, thereby inhibiting stuttering and producing fluency. By altering the pitch or frequency that the individual hears through altered auditory feedback, or the sound of their own voice, the SpeechEasy inhibits stuttering and produces fluency. Since receiving the patents on the device in 1999, East Carolina University in concert with the research team has worked with teams of engineers and investors to develop a wearable device that would transfer the results they discovered in the clinic to everyday life.
Research Findings
Drs. Kalinowski, Stuart and Rastatter have published more than 47 research articles and abstracts in numerous scientific and professional journals regarding their findings in the use of DAF and FAF to produce fluency in individuals who stutter. Stuart and Rastatter have also extensively studied how the brain interprets speech patterns and sounds along with brain activity of individuals who stutter.
Licensing
East Carolina University in Greenville, N.C., owns the patents for the SpeechEasy device. In spring 2001, the university granted licensing and marketing rights to Janus Development Group, a technology transfer spin-off company. The digital processing chip for the SpeechEasy is manufactured by Micro-DSP Technology Co. Ltd., in China and placed in its custom-fit molds at a factory in Maine. As part of the fitting process, molds are made of each patient's ear canal to custom-fit the device. The International Audiology Center of Canada, Inc., is the parent company of Micro-DSP. Darwin Richards is president of Janus Development Group, located in Greenville, N.C.
Total Sold
Since June 2001, more than 1,000 individuals nationwide have been fitted with the SpeechEasy device. Janus clinics are averaging 100 fittings per month at this time. As part of the fitting process, patients are given a thorough assessment of the extent of their stuttering. Each device is specifically calibrated to produce the most-effective results for the individual.
Anyone interested in being tested and fitted for the device may contact East Carolina University via e-mail at stuttering@ecu.edu or via telephone (252) 744-6104 or contact any of the Janus clinics for an appointment. Janus is expanding its clinics all across the U.S. with a large expansion planned for the Chicago area this spring. The company hopes to have 30 new dispensers established by February 2003 and 70 by the end of this year. By June, Janus plans to open international clinics in Europe.
Once they are fitted, individuals are taken through a series of exercises and therapies to maximize fluency and to train themselves to listen for the DAF or FAF signal in order to move pass stuttering blocks. The fitting session can range from two to three hours, depending on the needs of the individual patient. Patients are also encouraged to leave the clinic with the device to test it in everyday situations, such as shopping, eating at a restaurant or interacting with other people in public. When they return to the clinic, adjustments for volume or frequency are made, depending on the individual's need. Follow-up assessments are also provided, when needed. Approximately 15 percent of the patients fitted in the ECU clinic have returned for follow-up assessments and minor adjustments.
Kalinowski, who has stuttered severely since childhood, was the first individual to be fitted with the wearable device. He received the SpeechEasy in June 2001 and continues to experience a high rate of fluency using the device.
Model Specifications
The SpeechEasy comes in three separate models - Behind The Ear (BTE), In The Canal (ITC) and Completely In Canal (CIC). The cost ranges from $4,400 to $4,900 and depends upon the model chosen..
The BTE model is the largest and most durable of the models and attaches to a mold that fits in the ear. The ITC model fits inside the ear with only a small portion of the device being visible. It has an external volume control. The CIC model is the smallest of the three available and the entire device fits in the ear canal with nothing showing externally. The volume of the CIC is set and controlled using a personal computer. The devices use a 100 percent digital sound and can provide a combination of delayed auditory feedback and frequency altered feedback, based on the needs of the individual. In addition, the device does not interfere with a person's listening capabilities.
Food & Drug Administration
The United States Food and Drug Administration has exempted most Class 1 devices. The SpeechEasy fluency device falls under the exempt group within Class 1 of the 510(k) classification of anti-stammering devices.
However, manufacturers are required to register with the FDA. On Aug. 12, 2001, the FDA issued the following device establishment registration number for the SpeechEasy.
FDA Registration Number: 1066749
Product Code: KTH
Document Listing Number: 8120987
Clinic Results
Through its clinic, ECU has seen an 80 to 90 percent effectiveness in reducing stuttering for individuals fitted with the device. The rate of fluency varies by individual. East Carolina University is now enrolling patients who have been fitted with the device in an efficacy study to determine the long-range effectiveness of the SpeechEasy and fluency rates of its users. The first efficacy study will be completed in November 2002.
Faculty Information
Rastatter is a professor of the Department of Communication Sciences and Disorders within the College of Allied Health Sciences. He came to ECU in 1994 as chairman of the department and to establish the Ph.D. program in Communication Sciences and Disorders. Based on an earlier research affiliation with Kalinowski and Stuart, Rastatter recruited Kalinowski and Stuart to ECU to form the Stuttering Research Group. Kalinowski came to ECU in 1995 and Stuart in 1996, both from Dalhousie University from Halifax, Nova Scotia. Kalinowski and Stuart, an audiologist, are each associate professors in CSDI at ECU. The College of Allied Health Sciences is part of the ECU Division of Health Sciences, which also includes the Brody School of Medicine, the College of Nursing and the Laupus Health Sciences Library.
For more information via the Internet on the SpeechEasy, go to www.ecu.edu/csd/speecheasy or www.speecheasy.com or call (252) 744-6104 e-mail at stuttering@ecu.edu. To reach Darwin Richards and Janus Development Group, call (252) 551-9042.
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07/25/06
