Volume 1 Number 4, 1994

Research Update on Obtaining FDA Approval
Researchers around the world are empirically studying the efficacy of auditory integration training (AIT). The studies are in different phases of completion– some researchers are still collecting data, some are analyzing the data, and a couple of researchers have submitted their reports for publication.

Audio Tone Enhancer/Trainer. BGC Enterprises, Inc. has sponsored research on the Audio Tone Enhancer/Trainer for the past 3 years. A number of studies have been completed or are nearly completed.

Audiokinetron. The SAPP Corporation, the manufacturers of the Audiokinetron, has recently decided to donate their equipment to researchers in the U.S. who would like to empirically investigate the effectiveness of their device and AIT. However, they do not have the funds to sponsor such research. The Georgiana Organization does not plan to sponsor nor organize research involving the Audio- kinetron; however, they would like to collaborate with researchers who are interested in studying the effects of their new AIT device–the AudioScion.

The May, 1994 American Journal of Speech – Language Pathology will be publishing a paper titled ‘Auditory Integration Training in Autism.’ The study involved a total of 445 subjects with autism and examined several issues including: changes in sound sensitivity, filtering peaks, comparison of three AIT devices, and changes in subjects’ hearing. The first study on the efficacy of auditory integration training, also conducted by Drs. Rimland and Edelson, will be appearing in the Journal of Autism and Developmental Disorders soon.

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Clarification of Some FDA Issues
In the winter issue of The SAIT Newsletter (Vol. 1, No. 3), the recent opinion of the FDA was presented and explained according to the information available. This was based on our disucssions with Paul Hyman, the lawyer who represented the SAPP Corporation at the FDA hearing. We would like to expand on a couple of issues to help clarify them. The FDA has the authority to regulate the importation and interstate transportation of medical devices. This regulatory power applies to the Audiokinetron since the FDA has now classified it as a medical device. It is anticipated that this opinion and these regulations will soon be applied to other AIT devices, though at the present time only the Audiokinetron is specified.

This has several implications for practitioners. Research should not be conducted without pre-approval from the FDA. The reason for this is to prevent practitioners from side-stepping the FDA approval process by simply stating they are conducting research. If a practitioner wishes to import an Audiokinetron for research purposes, it is necessary to obtain approval for the study from the FDA before the device can be imported. At the present time, these devices cannot be purchased nor imported for private practice.

Another implication affects practitioners who presently own Audiokinetrons and use them in their private practice. FDA regulations now prohibit the shipping or transportation of the device across state lines for any purpose. This includes taking the device to another state for demonstration at a conference or workshop, for purposes of providing AIT, or for service or repair. The FDA has the authority to enforce its regulations by intercepting, detaining or confiscating devices which are involved in interstate transportation.

As a medical device, the Audiokinetron also falls under the FDA’s regulatory powers governing claims that can be made regarding improvements in a human condition. The FDA requires scientific clinical research to be completed before specific claims of improvement can be made. The studies must document the results obtained before claims can be used in advertising or promotion of the procedure. In other words, practitioners must be careful in presenting information to prospective clients, or when speaking publicly, not to make statements that are not yet supported by FDA approved clinical studies.

These regulations present some restrictions and inconveniences in the practice of AIT for both practitioners and families. However, it is important for all concerned with the development of this procedure that we accept and respect the regulations. If practitioners should ignore the FDA’s ruling and conduct research without FDA approval, or transport the devices across state lines, the FDA could stop the use of the devices entirely and/or confiscate the machines throughout the country. Therefore, we ask all of those involved with AIT to work within these restrictions so as not to jeopardize the validation and future growth of AIT.

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A Message from Bernard Rimland, Ph.D.
As most SAIT members know, Dr. Rimland, the founder of the Autism Society of America, and the Director of the Autism Research Institute in San Diego, was instrumental in bringing AIT to the United States. His association with Dr. Guy Berard dates back to the late 1970’s, and he encouraged Annabel Stehli to write The Sound of a Miracle, about the remarkable recovery of her daughter Georgie, attributable to AIT. Drs. Rimland and Edelson have collaborated closely on many autism projects for a number of years, including several experimental studies of AIT.

Greetings SAIT Members!
I am please to be invited to contribute to this issue of The Sound Connection. There are so many topics to discuss that I’m afraid this message may seem disjointed: Bear with me!

Unexpected benefits! A very welcome but unexpected benefit of AIT is that the offices of many AIT practitioners have become important centers for information on alternative (non-drug) means of helping autistic and autistic- like children. Our institute has received hundreds of letters and phone calls from parents who were told about our free(!) information package on diagnosis, vitamin B6, DMG, allergies, etc., for autism. There are now 18 consecutive studies showing vitamin B6 and magnesium to be helpful in autism, and no studies showing negative or harmful effects. To receive your free information packet, write to us at ARI, 4182 Adams Ave., San Diego, CA 92116. If you would also like to receive a copy of our 60-minute VHS videotape “Vitamin B6 and Magnesium in the Treatment of Autism,” send $6.00, and mention you are a SAIT member. This tape ordinarily sells for $16.00.

Theories of AIT. The May issue of the American Journal of Speech-Language Pathology will carry not only the first article by Dr. Edelson and me on our 445-subject study of AIT in autism, but also, as is the very commendable practice of the AJSLP, comments by two highly qualified reviewers and a response to the comments by Rimland and Edelson. What really bothered both reviewers was- -you guessed it!–the lack of a good theory on how AIT might work. That bothers lots of people, including us. But as we pointed out in our rejoinder (which we titled “Is Theory Better than Chicken Soup?”), human history provides multitudes of examples of therapies which were found to help people long before–sometimes centuries before–theories were generated which could account for why the therapies were helpful. I think you’ll enjoy our response.

Most of the theories advanced are essentially mechanical in nature. I remember discussing with Guy Berard during my visit to Annecy in 1987, that if his findings with regard to audition in depressed and suicidal patients are borne out by research, AIT must then necessarily function importantly at the biochemical level, since depression and suicidal ideation are certainly bio- chemical rather than anatomical. (A recent study of the brains of suicides showed that 22 of 22 had low levels of brain serotonin!)

Now a very bright mother of an autistic child has come up with an extremely intriguing theory–well documented with recent papers in the biological and neurological literature–implicating a defect in melanin metabolism as a possible cause of the hearing–and other sensory–defects in autism. Yes, I know, melanin is the pigment that causes differences between people in skin color. But, did you know–I didn’t–that melanin serves important functions in the inner ear, one of which is, like melanin in the skin, to protect tissue from excess energy? The mother who is working on this–a professor of English(!) is preparing a paper on it. When copies are available, we will let you know in The Sound Connection.

Melanin, and its underlying hormone melatonin, are deeply involved in the metabolism of vitamin B6 and serotonin, as well as the amino acid tyrosine.

The FDA again! Melatonin, though a hormone rather than a nutrient, is a very safe substance, widely available in health food stores as a 3 mg. tablet or capsule. One to three tablets, taken 40 minutes before bedtime, often improves sleeping very nicely.

Yesterday’s mail brought a very welcome thank-you letter from a mother in Texas whose autistic son almost destroyed his family with his sleepless night rampages. The melatonin I told her about worked like a miracle, she said, very quickly.

Also in yesterday’s mail was a letter saying the FDA was about to remove melatonin from the market. Studies of normal people taking 1,200 mg/day show it to be safe, but the FDA doesn’t care.

What can you do. The FDA is a tyrannical, despotic, bullying bureaucracy, paid for by our tax dollars, but indifferent to our interests. They don’t care if AIT, vitamins, tryptophan, melatonin, etc., help people without endangering them. FDA wants to dominate the citizens, not help them.

PLEASE, call, write, and visit your Representatives and Senators. Tell them that as a citizen (and a voter!), you object to the FDA interfering with your personal right to purchase and use any products (e.g., vitamins, devices) you want–unless the FDA can prove these products are clearly dangerous. The burden of proving harm should be on the FDA itself. They can attach a label to the device, or a package insert in the bottle, advising people of their opinion, but they should not be entitled to prohibit you, as a citizen, from exercising your freedom of choice. (I would suggest you not bring up the AIT device per se. There aren’t enough of us to raise the AIT issue effectively, and it might just antagonize the FDA further against the AIT device.) But do bring up the really important generic issue, that as a citizen you are interested in learning what advice the FDA has, but are not willing to let them prohibit you from buying and using whatever non-dangerous product you choose. Tell your Representative and Senator that you strongly favor the concept of the Hatch-Richardson Bill. The FDA must stop its “Big Brother” domination of the citizens. We don’t want the FDA to “protect” us. Phone 202-224-3121 and ask to speak to the health affairs assistant for your Representative or Senator. Please don’t delay. Time is short!

It is good to be working with SAIT and its members.

Cordially,

Bernard Rimland, Ph.D.

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PRACTITIONER’S FORUM
In each issue, we will address questions that are commonly asked by practitioners about AIT. If you have a question, please send it to us.

According to Dr. Guy Berard and many practitioners, the auditory peaks in one’s hearing, as evident in the audiogram, decrease or are eliminated after receiving 10 hours of AIT. Does this indicate that the AIT devices induce hearing loss in order to reduce the auditory peaks?

A reduction in peaks after 10 hours of AIT does not indicate hearing loss. The notion of setting filters to induce hearing loss is a common misunderstanding of the AIT process. If an audiogram can be obtained from a listener prior to the AIT listening sessions, filters may be used to dampen those frequencies which the person hears too well–the peaks. Thus, the listener does not hear these frequencies during the 10 hours of AIT.

A great deal of research has shown that noise-induced hearing loss occurs at 4000 Hertz and its adjoining frequencies. Noise-induced hearing loss is a physiological process related to the shape of the cochlea. The cochlea is shaped like a snail shell, where high frequencies are perceived along the wide, outermost part of the cochlea; and low frequencies are perceived at the small, innermost part. Basically, the fluid in the cochlea vibrates in a wave-like motion when sound enters from the middle ear. When a sound occurs, the motion of the fluid first strikes the area along the first curve in the cochlea (around 4000 Hertz) before traveling further into the cochlea. A very loud sound can cause a strong impact against the first curve, and this impact can lead to hair cell damage at 4000 Hertz and its adjacent areas. Thus, an extremely loud tone at 250 Hertz can cause hearing loss at 4000 Hertz. Noise-induced hearing loss is reflected on an audiogram by a trough or valley at 4000 Hertz and the adjacent frequencies. If AIT induced hearing loss, it would be indicated by this pattern in audiograms obtained after AIT, which has not been the case.

In a recent study, Drs. Rimland and Edelson (1994) observed a general flattening of the audiogram as well as a slight increase in the person’s overall acuity. Interestingly, the general flattening of the audiogram was found in an experimental condition in which filters were used and in a condition where filters were not used.

There are several theories that attempt to explain the reduction in peaks as a result of AIT. Two of these theories are presented in a new featured section of the newsletter on theories of AIT.

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Earphone Care
Earphone care is an important part of the AIT process, which includes proper functioning and cleanliness of the headsets. In general, it is a good idea to have at least one extra headset in order to avoid delays and a general disruption of the listening sessions. When replacing headsets and/or purchasing an extra set, it is important to use the exact impedance level recommended by the manufacturer. The impedance level for the Audiokinetron is 50 ohms, and the impedance level for the Audio Tone Enhancer/Trainer is 100 ohms. Although changing the impedance level, even slightly, may not be audible to most people, there may be critical differences that may influence the effectiveness of the AIT listening sessions. If the impedance levels do not match, it may place electronic strain on the AIT device, shortening its life span.

If a backup or replacement headset has the same impedance level but is a different model number or is made by a different manufacturer, you should request a copy of the audio specifications and compare it with the specifications of the earphones that came with your AIT device. If the output of the earphone sounds different than the one that came with your machine, we strongly recommend that you exchange the earphones for another set. Unfortunately, at this stage of AIT development, little is known about what auditory information makes AIT effective, let alone how much variation from a ‘standard’ is permissible. To be conservative, it is best not to deviate from the original parameters of whichever AIT device you are using.

Although Radio Shack sells many headsets, neither the specification sheet nor the packaging contains information regarding the impedance level. Unfortunately, the dealers do not have this information available in their catalogs; and they must contact their main office. Sears’ packaging clearly states the impedance levels.

There has also been some concern about the life span of the average headset. According to the technical manager at KOSS headquarters (Tele. 800-USA-KOSS), earphones either work or they don’t work, with two exceptions. If the earphone diaphragm (a thin plastic membrane) has a hole, it will still work but the listener may notice a rattling sound when the headset is moved. In addition, the quality of the sound will be altered. For AIT purposes, headsets with this problem must be replaced.

Loudness and quality may also be affected when the headset is connected to the AIT device using a very long extension cord or using several extension cords. One should compare the sound output by first plugging the earphones directly into the AIT device and then plugging the earphones into the AIT device using an extension cord(s). If there is a noticeable difference in the loudness or quality of the sound, the number of extension cords and/or total length of the cord should be reduced.

Another problem that can reduce or eliminate the output is corrosion on the headphone plug. This type of corrosion is clear in color and feels slimy. A corroded plug should be wiped with an eraser or an alcohol swab.

The cushion of the earphone should also be cleaned on a regular basis to avoid contamination among listeners from dermatitis or fungal infections. Manufacturers of recreational headsets know little about this problem since the type of headsets used for AIT are made for personal use rather than for clinical use.

Isopropal alcohol will destroy many types of germs on contact, but it may not destroy all of them. Alcohol may also cause the leatherette of some earphone cushions to crack. Once the leatherette earphone cushion is damaged, the acoustics of the earphone are altered; and the earphone cushion should be replaced. Open-air sponge-type earphone cushions cannot be cleaned with liquid preparations; however, a spray disinfectant may be helpful.

A good germ killer would be a non-alcohol based disinfectant which is often used in hospitals and clinics. These types of disinfectants kill a broad range of germs. Interestingly, some ‘baby wipe’ products contain a mild disinfectant and are also alcohol-free.

As a basic rule, all cleaners should be used with caution because the earphone diaphragm will be damaged if it gets wet. In addition, many of the people receiving AIT have numerous skin and respiratory allergies or sensitivities to strong chemical cleaners. We suggest contacting the headset manufacturer to obtain the minimum cleaner dilution for effective use.

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Theories of Auditory Integration Training
In this new section of The Sound Connection, we will present various theories on why auditory integration training works for some individuals. The theories can be classified in different ways, such as those explaining a reduction in auditory peaks, a reduction in sound sensitivity, and an increase in attention as well as postulating change in the middle ear, inner ear, brainstem, and mid- brain. Each issue will contain summaries of some of these theories.

Reduction in Peaks through Filtering

Guy Berard. ‘Reduction in peaks due to a decrease in stimulation.’ During the AIT listening sessions, filters are used to dampen those frequencies which the person hears too well. Dr. Berard theorizes that filtering will reduce sensitivity due to the lack of stimulation to certain areas of the cochlea and/or the brain during the listening sessions. Furthermore, those area(s) of the cochlea and/or brain which are not filtered receive intense stimulation; and this stimulation causes a slight improvement in hearing.

Thus, the peak frequencies are slightly reduced because of a lack of stimulation, and the non-peak frequencies are slightly improved because of stimulation. The end result is a relatively straight line.

Stephen Edelson. ‘Reduction in peaks due to lateral inhibition.’ This theory is actually an extension of Berard’s theory of reducing auditory peaks using filters. One phenomenon that occurs throughout our sensory system is neural inhibition, in which some neurons, when stimulated, inhibit the activation of other neurons. In addition, a phenomenon called ‘lateral inhibition’ occurs when a stimulated area inhibits an adjacent area which is not receiving stimulation.

Since the filtered frequencies are not stimulating certain portions of the cochlea and/or part(s) of the brain, stimulation of the adjacent, non-sensitive, (non-filtered) areas may be laterally inhibiting, and possibly conditioning, the sensitive filtered area(s). Thus, sensitive areas are inhibited by the adjacent, non-sensitive areas.

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Interview with Georgiana Thomas
Georgiana Thomas’s early life was described in her mother’s book, The Sound of a Miracle, by Annabel Stehli. One of the major problems related to her autism was her extreme sensitivity to many sounds. At the age of 11, her mother brought her to France to be treated by Dr. Guy Berard for her sound sensitivity. Georgie is now 28 years old, is married, and lives in Corvallis, Oregon.

Q: Do sounds bother you now?

Georgie: No, sounds don’t bother me; but I still hear very well. Sounds have not bothered me since I received auditory training when I was 11 years old.

Q: Do you have any sensory problems now?

Georgie: I still have a very keen sense of smell. I have had a bionic sense of smell all of my life; however, I can now suppress my sensitivity to smell. It could become Georgie interview a problem if I let it be, but I am very good at ignoring it.

Q: How is married life?

Georgie: Great, it couldn’t be better. I am very happy living in Corvallis and working in Corvallis and Portland.

Q: What are you working on these days?

Georgie: Art is a big part of my life, and I am working very hard on it. I just started my 10th painting in a series. All of my paintings are rather large, ranging from 2 by 3 feet to 4 by 5 feet. Some of the paintings involve acryllic on canvas, and my recent works all involve acryllic on plywood.

I am also working for Portland State University with Professor Ann Fullerton. We are developing a self-determination curriculum for children and adults with autism. The curriculum is designed to deal with many problems in autism–and most are related to the senses. The foundation of the curriculum is to teach self-awareness, self-advocacy, and self-confidence. This curriculum could also be used for people without autism.

Q: What plans to you have for the future?

Georgie: After the curriculum is completed, I plan to travel around the country to disseminate information about the program. I think I will always be involved in the field of autism. I also hope to exhibit my artwork in the near future, and then I will start working on another series.