Volume 3 Number 3, 1996

FDA Denies BGC’s Second Petition
BGC Enterprises, Inc. learned on February 26, 1996 that their petition to lower the classification of the Audio Effects Generator (formerly known as the Audio Tone Enhancer/Trainer) was denied by the Food and Drug Administration (FDA). The ruling was supposed to be made by the end of October, 1995, but the decision was delayed for undisclosed reasons. The FDA ruling means that both the Audio Effects Generator and the AudioKinetron are considered by the FDA to be Class III medical devices, and neither device has received FDA approval.

This decision by the FDA has many implications. Research on the efficacy of the AIT devices must first receive FDA approval prior to being conducted; the devices cannot be sold in the U.S.; and the devices cannot be transported to another state, for any reason, within the country. In contrast to a Class II medical device, a Class III medical device requires much more research documentation to obtain FDA approval. Practitioners who continue to offer AIT should contact their insurance company to learn about their liability coverage for using Class III non-approved medical devices. It is also suggested that they discuss this issue with an attorney.

BGC Enterprises plans to submit a Pre-Market Approval application to the FDA to try to reclassify the device again. The SAPP Corporation has not yet decided whether to submit a petition to change the classification of the AudioKinetron to a Class II.

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Update on Florida AIT Situation
Articles in the last issue two issues of The Sound Connection described actions taken by the Florida Department of Health and Rehabilitative Services (HRS). AIT was stopped in three Florida clinics, and some of the equipment was confiscated. In the last issue of The Sound Connection, we prematurely reported that the AIT devices had been returned to the practitioners. This information was obtained from one of the practitioners who was under investigation. We recently spoke to Sandra Stoval at the HRS, and she stated that a settlement was made. The AIT devices were returned to the practitioners under the condition that they do not advertise, promote, nor use the AIT devices in the state of Florida until the FDA has approved the devices.

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Computer Program Researched to Treat Disabilities
Researchers from Rutgers University in New Brunswick, New Jersey, and the University of California in San Francisco have developed a new approach to train the brain to recognize hard-to-hear sounds. Dr. Paula Tallal of Rutgers reported that the major problem in many children with language learning disabilities is that their brains do not process certain sounds fast enough. Many speech sounds, such as the stop-consonant syllables (i.e., ba, pa, ta), have a very short period before the initial consonant sound changes to the vowel. These stop-consonants occur in normal conversation at speeds of 40 milliseconds or less, while vowel-rich sounds and consonants, like “m,” may resonate for 100 milliseconds or more. When the brain requires a longer time than normal to respond to these sounds, children will have difficulty distinguishing these sounds; and the auditory message will be confused or distorted.

The researchers have developed a computer program to lengthen these speech sounds so they will stand out from the rest of the speech, so that children with language disabilities can learn to recognize them. Video games have been designed to reward children when they recognize these sounds and respond correctly. As they become more proficient, the syllables are gradually shortened until they are processed in real time.

The computerized training program requires three hours of training a day, five days a week for a one-month period. A group of 22 children, who were performing well below age level, participated in the program last summer. Post-test scores showed as much as two years improvement. Dr. Tallal, who refers to the exercises as “aerobics for the brain,” thinks the exercises may strengthen the connections between the neurons responsible for distinguishing fast-moving sounds. Neuroscientist Michael Merzenich, at UC San Francisco, believes the program may be retraining the auditory cortex to hear fast transition phonemes. Dr. Merzenich believes that an inherited susceptibility to middle ear infections in the first six months of life could explain at least some of the language problems experienced by young children.

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Two New Books Focus on Sensory Issues
Gail Gillingham has written an excellent book for all involved with autistic individuals. Autism: Handle With Care is the ideal gift for teachers, therapists, physicians, grandparents and baby sitters. This book discusses the differences in sensory processing that result in many “autistic mannerisms” or “stimulatory” behaviors that characterize the disorder. As the reader progresses through each chapter that details the various sensory abnormalities, he/she will learn about differences in sensory processing, experienced by individuals with autism. A new understanding and appreciation for the person with autism will emerge. “Unusual” behaviors will no longer seem unusual when viewed from a new perspective. Once the reader fully understands how super sensitivity to stimulation impacts the person with autism, he/she will finally begin to understand how to relate to and help that person cope within our society.

Temple Grandin’s recently released book, Thinking In Pictures, is another example of the valuable contributions that Temple has given to all those interested in understanding autism and the sensory differences involved. Temple shares her thoughts, experiences and personal perspectives on autism in a detailed and heart-warming manner.

The reader may see connections between Temple’s experiences and those of their family member or friend who has autism. Perhaps the most captivating theme that runs throughout the book is Temple’s ability to perceive things from “a cow’s eye view.” This unusual gift moves full circle and brings understanding to the world as experienced by those with autism.

To order either of these books, call Future Education at: 1-800-489-0727.

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SAIT’s Internet Web Site Receives Worldwide Attention
The Society for Auditory Integration Training’s (SAIT) Web site was unveiled on January 1, 1996. Since this date, we have received letters and email (electronic mail) from parents and professionals around the world. Many of them asked specific questions about auditory integration training (AIT). Others requested a complimentary copy of SAIT’s newsletter.

The Web site contains information about SAIT as well as AIT. Information on SAIT includes the purpose of SAIT, a history of the organization, and a listing of Board of Directors, Officers, and Professional Advisory Board members. Information on AIT includes a summary of research studies, a discussion of theories, the FDA status, and answers to frequently asked questions. The URL address to locate SAIT’s Web site is: http://www.teleport.com/~sait/ This address can be accessed by anyone using the World Wide Web, either through nation-wide servers (e.g., America Online, Prodigy, CompuServe, Microsoft Network, and Delphi) or through local computer servers. Please let us know if you have any suggestions for the Web site.

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Why are there several narrow band filters on the AIT devices that are not used for training?
Both the Audio Effects Generator (formerly known as the Audio Tone Enhancer/Trainer) and the AudioKinetron have filter settings which are not currently recommended for use. The filters on the Audio Effects Generator are: 187.5 Hz, 375 Hz, and 12 KHz. BGC Enterprises plans to develop an audiometer which will be able measure hearing acuity at these frequencies. Then, if the person has peaks at one or more of these frequencies, the filters can be applied.

Two filters on the AudioKinetron are not supposed to be used during the listening sessions. They are 4.0 KHz and 6.0 KHz. According to Dr. Guy Berard, hearing at 6.0 KHz is not reliable because it varies from moment to moment. Dr. Berard has referred to this frequency as the ‘wandering frequency.’ At one time, a filter was supposed to be applied at 4.0 KHz only if a peak was also present at 8.0 KHz (referred to as a `4-8′ primary pair). Last year, Dr. Guy Berard recommended that the ‘4-8’ primary pair should not be filtered because a peak at 4.0 KHz is not reliable since it depends partly on acuity at 6.0 KHz (the wandering frequency). In addition, an independent peak at 4.0 KHz should never be filtered. If, through careful studies, researchers find that filtering 4.0 KHz and/or 6.0 KHz is beneficial, then these filters are available.

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Wisconsin AIT Study Shows No Difference Between Experimental (AIT) and Placebo Group and Placebo Group
Description. “A Double-Blind, Placebo Controlled Study of the Efficacy of Auditory Integration Training,” Zollweg, W, Vance, V., and Palm, D. The study was conducted at the Chileda Habilitation Institute, La Crosse, Wisconsin. A summary of the study was reported in ADVANCE for Speech-Language Pathologists and Audiologists, January 6, 1996.

Methods. The study involved a double-blind research design using the Audio Tone Enhancer/Trainer. Thirty participants were assigned at random to either an experimental (AIT) group or a control-placebo group. The participants were 7 to 24 years old, and the majority carried diagnoses of mild to profound mental retardation. Some of the participants were diagnosed as having autism. A breakdown of the number of subjects with each diagnosis was not available. Evaluations were conducted using audiometric tests, a Loudness Discomfort Level test, and the Aberrant Behavior Checklist at 3, 6, and 9 months following AIT.

Results. Although no differences were found between the AIT and control groups with respect to hearing and behavioral changes, both groups showed improvements. The results from the Loudness Discomfort Level test indicated that the control group had a higher tolerance for the frequency 250 Hertz than the AIT group at the 9-month post assessment measure.

Conclusions. The investigators concluded that AIT was of no value in the population studied.

Comment. This study appears to conflict with prior randomized studies of the effect of AIT on autism. There are several points, however, that suggest that this study had methodological flaws which may have led to misleading conclusions:

1) Study population. It appears that this study was conducted predominantly among subjects with mental retardation, which is a population distinct from those with autism. AIT may not be effective with people with mental retardation. In fact, we are not aware of any claims made by Dr. Guy Berard or other AIT practitioners with respect to this disorder.

2) Technical design. It is not clear from the written report whether the modulation and narrow band filters were set correctly. Attempts to obtain these details and copies of the audiograms from the investigators have not been successful.

In light of these comments, it is difficult to support the authors’ conclusions with regard to the effects of AIT on autism.

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Theory of Auditory Integration Training
‘Calming effect of music.’ Stephen Edelson. One of the most frequently reported changes as a result of AIT is an overall calmness in the listener. This description is reported by parents as well as by the people who participated in AIT listening sessions. Some changes which may result from AIT and be indicative of a calming effect include better sleeping, an increase in attention span, a decrease in anxiety, and a decrease in hyperactivity.

We have all heard: “Music soothes the savage beast.” Since the modulation inherent in the AIT music is stimulating, it seems possible that the intensity associated with AIT somehow calms down the person’s arousal system. One can also argue that a person is better able to learn once he/she is able to calm down and attend to his/her environment.

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Tests for the Evaluation of Learning Disabilities: Dr. Guy Berard
When I started treating children for their learning disabilities, I was collaborating with a psychologist. She referred her patients to me so I could rule out possible hearing anomalies before doing her own work. She gave me the results of the tests that she had obtained from these children. As I was personally interested, I also made another series of tests, before and after auditory integration training (AIT).

I was pleasantly surprised to notice, with a certain percentage of these children, that there was a very good improvement in the results of these tests: an average increase of about 10 points in I.Q. and one year in mental age. These results were confirmed by the psychologist.

Of course, it was out of the question for me, unless being totally dishonest or short-minded, to conclude that two sessions a day of AIT through my device, for 10 days, could lead to such a miracle. Ten hours of treatment cannot lead to 10% improvement in intelligence and mental age of an individual!

A possible explanation is that part of the usual tests are vocal: the child is asked some questions by the examiner. It appears obvious that if the child does not hear normally or a difficulty in hearing exists, this will cause a difficulty in understanding and consequently in responding correctly to the questions on the test. This was exactly the case with my daughter, who was suffering from very serious auditory distortions. Her answers were absolutely incredible because of her abnormal hearing.

Of course, the normal objection concerns the questions which are written, and not spoken, because these were giving the same positive results. It would take many pages to explain in detail how this occurs. I will just indicate this way. When you are reading a newspaper or a book, “with your eyes,” without speaking the words that you are seeing, your brain does not register each letter of each word that you are reading. It registers the word itself that you feel like pronouncing. Then it goes through the hearing area of the brain. If the hearing system is disturbed, there will be a problem in understanding what you are reading, or what one is asked to do.

I have many experiences confirming this opinion, but as I indicated, the subject is too deep to be detailed in one page. The conclusion is that one should be very prudent, quite sure that you perfectly understand the significance of a test before asserting its result.

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Alternative Approaches to Tinnitus, Meniere’s Disease and Hearing Loss
The Sound Connection recently published articles about managing tinnitus and hypersensitive hearing (1995, Volume 2, #4). Here are some `natural’ interventions for tinnitus, Meniere’s disease and hearing loss that may be of interest to those who suffer from these problems.

A Finnish study, conducted over a 9-month period, found that a diet high in saturated fat greatly increased the incidence of sensorineural hearing loss, whereas hearing was significantly better for those with a lower fat diet. At the end of the first five years of the study, the diets were switched. Four years later, the group whose hearing had been good on the low fat diet showed significant deterioration in their hearing; and the previously high-fat diet, poor hearing group showed improved hearing.

Research studies on low blood sugar (hypoglycemia) have indicated a possible link with tinnitus, hearing loss and/or Meniere’s disease. Basically, hypoglycemia increases the release of adrenaline which constricts the blood vessels in the inner ear. This idea is based on studies indicating a higher incidence of hypoglycemia in patients with sensorineural loss as well as patients with Meniere’s disease. In one study, 58% of sensorineural hearing loss patients had a hypoglycemic glucose tolerance curve, a common measure used to diagnose low blood sugar. (Yannick & Goselin,Journal of the American Audiological Society, 1975, 2, 15-18).

Research on the use of Ginkgo biloba, a standardized extract of the leaves of the ginkgo tree, suggests improvement in hearing. Elderly individuals suffering from “chronic cerebral insufficiency” (poor blood flow to the brain) display dramatic improvements in short- and long-term memory as well as reductions in tinnitus, hearing loss and vertigo through daily use of ginkgo biloba. (Vorberg, Clinical Trials Journal, 1985, 22, 149-57). According to studies with younger individuals, gingko biloba may reverse the progression of tinnitus when started within one year of onset (Meyer,Presse Medicine, 1986, 15, 1562-1564).

Studies have also indicated a high correlation between stress, depression and tinnitus. Counseling and stress reduction techniques such as biofeedback and meditation may help some patients. (Marion & Cevette, Mayo Clinical Proceed., 1991, 66, 614-20).

Just as the causes of these conditions vary, effective treatments will differ across individuals. The approaches previously mentioned may not be effective for everyone, but they offer options that may be worth trying.

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Information About KOSS Headphones
Practitioners who use the Audio Effects Generator (formerly known as the Audio Tone Enhancer/Trainer) have often complained about the high cost of the KOSS HV/PRO headphones. These headphones are used because they have the correct impedance level of 100 Ohms. Headphones with different impedance levels should not be used for the Audio Effects Generator because the quality of the output will be changed, which may reduce the effectiveness of the listening sessions. Furthermore, an impedance mismatch will cause strain on the AIT device and reduce the life-expectancy of the device (see The SAIT Newsletter, 1994, Vol. 1, #4).

The expense associated with the HV/PRO headphones is due, in part, to its limited lifetime warranty. KOSS will not replace headphones which are damaged due to improper use or abuse. If the headphones should become defective, they can be sent to KOSS for repair. There is a minimum charge of $5.00 to cover the cost of handling. In the United States, the headphones can be sent to: KOSS, Ltd., 4129 North Port Washington Avenue, Milwaukee, WI 53212. In Canada, the cost of handling is $6.00; and the headphones can be sent to: KOSS, Ltd., 1220 Corporate Drive, Burlington, Ontario L7L 5R6, Canada. Practitioners who live in other countries are instructed to contact their local distributor to learn how to get KOSS headphones serviced under the conditions of the warranty.

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Two Dr. Stephen Edelsons?
There has been much confusion lately, especially on the Internet, regarding where Dr. Stephen Edelson works and what is his area of specialty. The truth of the matter is that there are two Stephen Edelsons who are active in the field of autism. One is Stephen M. Edelson, Ph.D. who lives in Portland, Oregon, works with Dr. Bernard Rimland and is the President of the Society for Auditory Integration Training. The other is Stephen B. Edelson, M.D. who lives in Atlanta, Georgia, and works in the field of medicine and nutrition. Besides working in the field of autism, both have popular Web pages on the Internet. Dr. Stephen M. Edelson has organized a general autism Web site at www.autism.org/, whereas Dr. Stephen B. Edelson has organized a medical and nutritional Web site at www.envprevhealthctratl.com/