Volume 6 Number 3, 1999

The FDA and AIT Devices
Our office has received numerous letters, faxes, and emails asking about the Food and Drug Administration’s (FDA) position regarding auditory integration training (AIT) devices. We have invited the FDA to write a statement for our newsletter to clarify their position. Here is the FDA’s reply:

This is in response to your request for clarification regarding the promotion of auditory integration training (AIT) devices. First consider the promotion of AIT devices as a medical device and the scientific data that has been submitted to FDA. The Agency has not reviewed any data that show AIT is effective in treating any medical condition or disability, nor has the Agency received any data that show AIT devices are substantially equivalent to a legally marketed device. To date, no AIT device for medical claims has been cleared by the FDA for marketing in the United States.

For the promotion of an AIT device for non-medical purposes, a manufacturer could not promote any device that is intended for the cure, mitigation or treatment of a disease or a condition. Therefore, a device not intended for medical purposes may not be promoted for the purpose of treating autism, attention deficit disorder, or any other physical or mental condition. Currently, the AIT device, if used solely as an educational aid, would not be considered a medical device.

Robert F. Munzner, Ph.D.
Center for Devices and Radiological Health
Food and Drug Administration
Rockville, Maryland

Editor’s Note: Contrary to numerous rumors, the FDA has not approved any AIT devices. The Center for Devices and Radiological Health is primarily concerned with the use of medical devices. As stated in the final sentence of the FDA’s statement, if an AIT device is used only as an educational teaching aid, then it would not be considered a medical device. Consequently, the AIT device would not fall under the jurisdiction of the FDA. This is welcome news to those who have been active in the area of AIT for the past several years.

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Educational Data Needed to Document AIT Efficacy
In the recent past, most of the research studies on auditory integration training (AIT) have focused on measuring behavioral changes and reduction of auditory hypersensitivity. Now, with the FDA opinion regarding AIT devices for educational purposes, we need to emphasize the measurement of other aspects which will directly document more specific, educational outcomes. This is not to say that behavioral improvements and reduction of auditory hypersensitivity are not educationally-related, or worthy achievements. They are, and will continue to be. However, we also need to look at other areas of possible change, such as reading comprehension, spelling, problem solving, language concepts, handwriting and drawing, math skills, etc. To be most meaningful, the post- testing should be done about two to three months post-AIT rather than at the conclusion of the ten hours of listening. This type of objective documentation of efficacy will be useful in demonstrating the purpose and value of AIT to school personnel and parents.

The Society for Auditory Intervention Techniques (SAIT) is interested in hearing from practitioners who may have already done pre- and post-measurements with tests such as the Test of Language Development (TOLD), Test of Problem-Solving Abilities, any of the language concept tests (i.e., Boehm, Bracken, Bankson), tests of auditory skills/processing such as the Screening Test for Auditory Processing Disorders (SCAN), reading comprehension and math skills tests. Documented changes in handwriting and drawing are also important. Parents may also help by letting us know of any significant changes in test scores obtained through school evaluations. If any practitioners have suggestions for tests that may be helpful in this process, please contact SAIT.

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More on the `Mozart Effect’
The last issue of The Sound Connection (1999, Vol. 6, No. 2) listed several Mozart audiocassettes and compact discs which are being sponsored by Don Campbell, author of The Mozart Effect.

We have received a report from a parent who played two of Don Campbell’s Mozart audiocassettes to her autistic child. The parent reported a dramatic increase in activity level when her child began listening to the cassette entitled ‘Mozart in Motion.’ Additionally, she observed a calming effect when her child began listening to the audiocassette entitled ‘Relax, Daydream, and Draw.’

We would like to hear from other parents and professionals who have tried these recordings and have observed behavioral changes.

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Hemi-Sync: It’s More Than Music, It’s Metamusic
Forty years ago, Robert A. Monroe, then a successful radio producer, began to work with the use of sound to induce sleep-learning. The primary tool for his work was a little known technique using a binaural beat to induce altered states of consciousness. Monroe constructed many different binaural beat patterns that aided in this purpose and was awarded a patent for a technology now trademarked as Hemi-Sync. Monroe and a team of researchers have continued to improve upon Hemi-Sync technology through the years.

Hemi-Sync facilitates the synchronization of electrical wave patterns in the left and right hemispheres of the brain – said to be an optimal condition for improving human performance. To accomplish this, Hemi-Sync uses blended and sequenced sound patterns which can gently lead one into focused, whole-brain states of consciousness. While this condition occurs naturally in day-to-day life, it usually exists only for random, brief periods of time. Hemi-Sync is intended to enable you to achieve and sustain this highly productive, whole- brain state effortlessly. Thus, a Hemi-Sync relaxation tape encourages the brain to produce brain waves that are naturally characteristic of a relaxed state; when you want an especially sharp focus of attention for peak performance, a concentration tape helps your brain achieve this state.

There are a variety of Hemi-Sync exercises made available to the general public through Interstate Industries, Inc. Metamusic is one of the most widely accepted and used varieties of Hemi-Sync. The purposes of each piece differ in intention, with the Hemi-Sync helping to induce a relaxed and receptive state within the listener. Metamusic may be used to create a more sustained focus of attention, facilitate a more balanced activation of the information processing capabilities of both the right and left hemispheres of the brain, reduce fearfulness and negativity which interfere with the learning of new skills, and reduce tactile defensiveness and sensory overload. Metamusic with Hemi-Sync has been used successfully with children with disabilities.

Hemi-Sync Metamusic is not subliminal or hypnotic. It does not “make” an individual do anything. It creates an effect that helps the person achieve the state they wish to be in, for example, relaxed, or a state of high concentration with focused attention. Hemi-Sync is not recommended for individuals who have a tendency towards seizures.

There are currently 27 Metamusic titles from which to choose. The styles range from contemporary re-workings of well-known classics, to moving melodies that sound as if they would appear on the best of movie sound tracks. Hemi-Sync cassette tapes and CD’s can be enjoyed over a stereo speaker system or through stereo headphones. A simple “boom box” can be used effectively for one or two children. Detachable speakers are best for classroom use. The listener should be positioned equally between the two stereo speakers. The impact of this music is usually seen fairly quickly, but it also does have an accumulative effect. If there is an adverse response to a tape, just stop that tape and try different ones. No long term adverse responses have been reported.

For more information, call 800-541-2488, or visit the website at www.hemi- sync.com

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Study Suggests Music is Linked to Basic Mental Activity
New research presents direct evidence that music stimulates specific areas of the brain responsible for activities such as memory, motor control, timing and language. Researchers have also located specific areas of mental activity linked to emotional responses to music. The study was conducted at McGill University in Montreal by neuroscientist Anne Blood. She states “You can activate different parts of the brain, depending on what music you listen to.” Therefore, music can stimulate parts of the brain that are underactive in particular disorders. The findings were presented at a recent meeting of the Society for Neuroscience in Los Angeles.

As a result of these new studies, researchers have found that the brain:

— responds directly to harmony. Changes in neural activity were monitored by a PET scanner. Results indicate that different parts of the brain involved in emotion are activated depending upon whether the music is pleasant or dissonant.

— interprets written musical notes and scores in an area on the brain’s right side. That region corresponds to an area on the opposite side of the brain known to process written words and letters.

— grows in response to musical training the way a muscle responds to exercise. Classically trained, male musicians have significantly larger brains than men who have not had extensive musical training. The cerebellum was 5% larger in expert male musicians. There was not a size difference in the brains of female musicians; however, the sample size of women may have been too small to be certain. (see related article on pages 6 and 7.)

— has distinct patterns of activity for harmony, melody and rhythm. They involved both sides of the brain, not just the right side. Melody affects both sides equally, harmony and rhythm seem to activate the left side more strongly than the right.

Preliminary research in laboratory animals and humans suggests that music may play some role in enhancing intelligence. This concept has enticed some politicians in Florida, Georgia and other states to lobby for school children to have regular exposure to Mozart sonatas, though the research has not yet been replicated or confirmed.

Music is already being used as a therapeutic tool for cognitive rehabilitation of stroke victims. According to Lawrence Parsons at the University of Texas in San Antonio, some stroke patients who have lost their ability to speak retain their ability to sing. This opens an avenue for therapists to retrain the brain’s speech centers. Patients sing what they wish to say and some improve their fluency.

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What is Auditory Conceptualization?: Marna Scarry-Larkin
“Auditory Conceptualization” is a term coined by Pat and Charles Lindamood in 1968. It is a central nervous system function that allows an individual to notice the sameness/difference, order and number of speech sounds in words and syllables. Today we think of these processes as “Phonemic Awareness.”

An individual with reading, spelling or speech problems often has difficulty judging the contrast between sounds. Sometimes sounds and whole syllables are added or deleted from words.

Typical reading errors for children and adults with auditory conceptualization weakness are: “was” for SAW, and “form” for FROM. Typical spelling errors are: “frist” for FIRST and “spot” for SPOUT. Typical speech errors are: “pisgetti” for SPAGHETTI, “ax” for ASK, and “chim-i-ny” for CHIMNEY.

This problem can persist into adulthood and usually these individuals consider themselves to be “bad spellers.” The treatment is to develop auditory processing skills from a simple isolated sound level (/p/) to simple syllables (e.g., pop), complex syllables (e.g., spot, sports), and multi-syllable levels (e.g., sportsmanship). It is critical to develop auditory, visual, and motor- kinesthetic feedback for the person to become self-monitoring and self- correcting.

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International Association of Berard Practitioners
The International Association of Berard Practitioners (I.A.B.P.), located in Antwerp, Belgium, is planning to distribute its first newsletter on auditory integration training in early summer, 1999. This newsletter will contain relevant information on AIT. The newsletter will also allow readers to ask questions and raise issues regarding the practice of AIT.

An I.A.B.P. conference is also proposed for January or February, 2000. This international conference will include lectures and poster sessions; and it will bring together practitioners, researchers, and interested parents to discuss issues related to AIT.

I.A.B.P. is associated with VOLUNTAS, a non-profit organization, directed by Roland De Beuckelaer. VOLUNTAS is dedicated to helping parents with handicapped children. This program provides home therapy programs for families with children suffering from neurological problems, such as cerebral palsy, autism, dyslexia, Down Syndrome, and language disturbances.

If you would like more information about I.A.B.P., their fax number is: 011-32- 3-647-0169; and their email address is: voluntas@glo.be.

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The Effects of Early Music Experience
In the last issue of The Sound Connection, we summarized the research findings on the ‘Mozart Effect.’ Several studies have documented short-term improvements in spatial reasoning skills in students after listening to certain Mozart musical compositions. Other studies have shown that music training during the childhood years may have an impact on both spatial and verbal skills.

Rauscher and her colleagues at the University of Wisconsin published a 1997 study in which preschool children participated in one of three experimental groups: (a) 34 children received piano keyboard lessons; (b) 20 children received private computer lessons; and (c) 24 children did not receive any specific lessons (control group). Participants were given pre- and post- assessment tests, and these tests included a spatial-temporal reasoning test and several spatial recognition tests. The results showed that those who received the piano keyboard lessons performed significantly better on the spatial temporal test than both those who received computer lessons and those in the control group. This improvement lasted at least one day. There were no post- assessment differences with respect to the spatial recognition tests.

In 1998, Chan, Ho, and Cheung at the University of Hong Kong studied the effects of music training on verbal and visual learning. Their study included 30 college female students who had six or more years of formal training with a musical instrument before the age of 12, and 30 college female students who had no formal music training (control group). Chan and her colleagues found that those students who had formal music training learned significantly more lists of words than those without such training. Similar to the findings of Rauscher described above, there were no differences in the subjects’ ability to remember visual images.

In a related study published earlier this year, Graziano, Peterson, and Shaw, researchers at the University of California at Irvine, examined students’ performance on a Spatial-Temporal Math Video Game. The game was designed to teach fractions and proportions to school-age children. In one of their studies, 237 second-grade children, (ages ranged from 6 years, 8 months to 8 years, 5 months), played the math video game. Interestingly, those children who also received piano keyboard lessons performed significantly better on a math evaluation program as compared to children who did not receive piano keyboard lessons.

In another related study, Schlaug and his colleagues at the Heinrich-Heine University in Dusseldorf, Germany, used magnetic resonance imaging (MRI) to study the corpus callosum in 30 professional musicians and 30 control subjects who were matched on age, sex, and handedness. The corpus callosum is a band of fibers which connects the left and right hemispheres of the brain. Schlaug found that the anterior half of the corpus callosum was significantly larger in the professional musicians than in the matched control subjects. Additionally, the largest areas were found in those musicians who had received music training before the age of 7 years. Schlaug also stated these results may indicate an increased number of neural fibers crossing through the corpus callosum which, in turn, would influence communication between the two hemispheres.

In a recent article published in Trends in the Neurosciences (1999), Dr. Rauschecker of the Georgetown Institute for Cognitive and Computational Sciences commented on the auditory cortex and early music training. Dr. Rauschecker stated that the auditory cortex is important in the perception of speech, music, and auditory space; and the plasticity of the brain allows for early musical experience to help ‘fine tune’ the child’s auditory system. Additionally, Dr. Rauschecker proposed that music training expands the representation of harmonic sounds in the auditory cortex.

One problem with the studies mentioned above is that those individuals who received music training during the childhood years may also have received a more enriched educational environment. Future researchers should try to control for this possible confounding variable.

Overall, these findings on early musical experience are promising; and they support the idea that music may play an important role in brain development and learning.