Volume 6 Number 2, 1999

FDA Clarifies Its Position Regarding AIT Devices: Stephen M. Edelson, Ph.D.
The Food and Drug Administration (FDA) recently clarified its position on auditory integration training (AIT) devices, allowing these devices to be distributed in the United States–but only as non-medical devices. That is, AIT devices can be marketed in the U.S. as training, learning, teaching and educational devices. Any claims which may be perceived as `medical’ would fall under the jurisdiction of the FDA. These include making claims regarding treatment effectiveness or claims involving benefits from using the devices other than training benefits.

This decision by the FDA occurred as a consequence of the Georgiana Institute’s recent attempt to obtain approval for their new AIT device, `EARliest Adventures in Sound Digital Auditory Aerobics.’ After their application was turned down as a `medical device,’ a representative of the Georgiana Institute objected strongly to this categorization and argued that the device was never intended for medical purposes; it is intended only as a training device. The FDA simply responded by stating that they do not regulate educational devices; they only regulate `medical’ devices. If their AIT device is not used for medical purposes, then it does not fall under FDA jurisdiction. This would also apply to other AIT devices as well.

According to an FDA official, the manufacturers of the AIT devices who sell their equipment in the U.S. must truly sell them as “teaching,” “learning,” “educational,” or “training” devices, and NOT `medical’ devices. A clear example would be using AIT devices in an “institution of learning” or “to help people learn better.” Additionally, if an AIT practitioner promotes his/her services by using terms that could be considered `medical,’ such as cure, treat or prevent a condition or disease (e.g., autism, ADHD, dyslexia, sound sensitivity), the FDA might also hold the manufacturer/importer responsible.

Reminder: A medical device is broadly defined as a device intended to cure, treat or prevent a disease or condition, or is intended to affect the structure or any function of the body.

An FDA official has agreed to write an article regarding the FDA’s position on AIT devices. This article will be published in the next issue of The Sound Connection.

History. Let’s not repeat the errors from the past. Those who have been involved in the field of AIT for several years are aware of the early strong warnings made by Drs. Bernard Rimland and Stephen M. Edelson. When the AIT devices began to be imported into the U.S., Drs. Rimland and Edelson warned the manufacturers, promoters and AIT practitioners to be careful in the way they marketed their use of these devices. AIT was clearly to be presented solely as a training procedure; ‘medical’ claims, which were common at that time, would likely attract interest by the FDA. Unfortunately, these words of caution fell upon deaf ears. Drs. Rimland and Edelson again urge manufacturers, promoters, and practitioners to avoid using words such as `treatment’ and `therapy’ as well as avoid stating its use for a specific disease, disorder, or condition (e.g., autism, ADHD, sound sensitivity, language delayed, etc.). As we insisted in the early 1990’s, the “T” in AIT stands for “Training.”

Given this welcome development, SAIT is hopeful that AIT will become more widely available. We will keep our readers informed of any new information about AIT devices as it becomes available.

Status of AIT Devices
EARliest Adventures in Sound Digital Auditory Aerobics. The Georgiana Institute have already begun conducting 1 1/2-day training seminars throughout the United States. For more information, write to The Georgiana Institute (P.O. Box 10, Roxbury, CT 06783; 1-888-257-9516). The musical source for “EARliest Adventures” includes 20 pre-recorded compact discs; an EQattenuator to attenuate auditory peaks; a compact disc player, and a pair of headphones.

This music played by “EARliest Adventures” is not copyrighted by the artists, and this bypasses the problem currently faced by many AIT practitioners who use commercial, copyrighted music during the listening sessions. However, both Guy Berard, designer of the AudioKineton, and Bill Clark, designer of the BGC Audio Tone Enhancer/Trainer, are empathic in requiring that the music meet certain requirements. That is, the music must cover a wide frequency range and have a good beat/tempo. These two requirements apply to approximately 5% of commercially available music. Clark screened over a thousand compact discs before arriving at his list of 70 recommended CDs. For a copy of this list, send a self-addressed stamped envelope to SAIT. It is not yet known how well the Georgiana Institute’s CD’s will meet these requirements.

The “EARliest Adventures” device should not be confused with the Electronic Auditory Stimulation effect (EASe) discs produced by Vision Audio (Vision Audio, 611 Anchor Drive, Joppa, MD 21085; 410-679-1605). The “EARliest Adventures” uses an audio equalizer (the EQattenuator, which is similar to an audio spectrum analyzer which can be purchased at electronic stereo stores) to attenuate specific auditory peaks, whereas the EASe discs do not use such filters. Note: to date, research involving autistic individuals has not shown any benefits from using narrow-band filters.

AudioKinetron. The SAPP Corporation, the manufacturers of the AudioKinetron, are aware of the FDA’s recent decision; and they will likely begin distributing a new AIT device in the U.S. this year. Based on Dr. Berard’s experience working with hundreds of AIT practitioners over the past 10 years, the new device will include several improvements over the AudioKinetron. At the present time, the SAPP Corporation has not determined a price for this device. Dr. Guy Berard will be organizing teaching seminars in the U.S. in the near future. Due to his health, he may not be able to travel to the U.S. to teach his method. In this case, he will select several individuals who he feels are qualified to teach his method.

Audio Tone Enhancer/Trainer. BGC Enterprises was informed of the FDA’s decision, but we have not heard any decision regarding the distribution of their AIT device, the Audio Tone Enhancer/Trainer.

The `Mozart Effect’: Is There Truly an Effect?
There has been much talk recently concerning the effects of classical music on cognition. One popular view is that exposure to Mozart’s music may improve spatial reasoning. In the past two years, Don Campbell has brought this idea to the forefront with his 1997 book, The Mozart Effect (see review in The Sound Connection, 1997, Vol. 5, No., 2), and in a series of compact discs and audiocassettes in 1998 (see this issue, News and Notes, page 3). Dr. Alfred Tomatis has, for many years, stressed the importance of listening to Mozart’s music on one’s general well-being; and this style of music is an integral part of Tomatis’ method.

The `Mozart Effect’ received a great deal of media attention in 1993 after the publication of a study conducted by Frances Rauscher, Gordon Shaw, and Katherine Ky in 1993 at the University of California at Irvine (Dr. Rauscher is a former cellist and is now at the University of Wisconsin). This study was published in the well-respected scientific journal, Nature (1993, vol. 365, p. 611). In their study, 84 college students participated in one of three conditions for 10 minutes: (1) they listened to Mozart’s `Sonata for Two Pianos in D Major,’ (2) they listened to a relaxation tape, or (3) they did not listen to sound (silence). The participants then completed a spatial-reasoning test which was taken from the Stanford-Binet intelligence test. The results indicated that those students who listened to the Mozart piece scored 8 to 9 points higher than those in the other two conditions. However, this `Mozart effect’ lasted for only 10 to 15 minutes.

Some people have taken this finding several steps further by assuming that listening to this particular piano sonata, listening to Mozart’s music in general, and/or simply listening to classical music for a longer period of time may have an impact on one’s thinking processes and possibly on intelligence. In fact, after hearing about the `Mozart effect,’ Governor Zell Miller of Georgia announced a health-related program last year in which classical music would be played to every newborn baby in the state in order to improve his/her abilities in spatial, temporal reasoning. (The audiocassettes and compact discs were not purchased using taxpayer money; but rather, they were donated by major music companies.)

Since the publication of Rauscher et al. study, research has been somewhat mixed. Several follow-up studies by Rauscher and her colleagues provide additional support for the `Mozart effect.’ In 1995, Rauscher and her colleagues investigated spatial reasoning abilities in 79 college students who listened to Mozart’s piano sonata, listened to various other musical pieces, or did not listen to music. Subjects who listened to the Mozart music performed significantly better than the other two control conditions. In 1998, Rauscher and her colleagues studied the `Mozart effect’ in laboratory rats. These rats were exposed to Mozart’s piano sonata in utero and for two months postpartum. There were several other comparison groups in the study including rats who listened to minimalist music, rats who listened to white noise, and rats who heard no sound (silence). The rats who were exposed to Mozart’s music learned to maneuver in a T-maze much faster and with fewer errors than rats in the other three groups.

Three studies by Dr. Rideout at Ursinus College in Collegeville, Pennsylvania provide further evidence in support of the `Mozart effect.’ In 1997, Rideout and Taylor replicated the `Mozart effect’ in 32 college studies using two different spatial-reasoning tasks. In 1996, Rideout and Laubach studied 8 college students who listened to Mozart’s piano sonata in one condition and no music in another condition. Changes in EEG (i.e., brain wave activity) were examined prior to and while engaged in two spatial-reasoning tasks. Rideout and Taylor found that subjects performed better on these tasks after listening to the Mozart music. In addition, the EEG recordings were slightly correlated with the students’ performance (i.e., increased activity was associated with increase in performance).

In 1998, Hughes, Daaboul, Fino, and Shaw, researchers at the University of Illinois Medical Center, had patients with seizures listen to Mozart’s piano sonata. In 23 of 29 instances, there was a dramatic decrease in epileptic activity while listening to this music. Interestingly, these researchers also documented a substantial decrease in epileptic activity in a comatose patient while being presented with Mozart music.

In 1998, Johnson, Cotman, Tasaki, and Shaw studied the effects of Mozart’s music on a set of twins who were both suffering from Alzheimer’s disease. One twin listened to Mozart’s piano sonata, and the other twin listened to songs from the 1930’s in one condition and no music in another condition. The twin who listened to Mozart’s piano sonata performed much better on a spatial- temporal task than the twin who participated in the two placebo conditions.

Similar to most areas of research, there are studies which do not support the `Mozart effect.’ Rideout, Dougherty, and Wernert (1998) instructed college students to perform a spatial performance task involving folding and cutting paper after participating in one of three conditions. The three conditions were: (1) listening to Mozart’s piano sonata, (2) listening to a contemporary music piece with similar characteristics as Mozart, or (3) listening to a relaxation tape. Subjects in both music conditions performed much better on the spatial performance task than those who listened to the relaxation tape. This finding indicates that the `Mozart effect’ may not be dependent on Mozart’s music specifically, but this effect may be dependent on one or more characteristics of the music (e.g., a good tempo).

In 1995, two years following the publication of Rauscher’s first study on the `Mozart effect,’ two studies failed to replicate the effect. In one study conducted by Newman and his colleagues, 114 college students listened to Mozart’s music, a relaxation tape, or no music. These researchers did not find any differences among these three groups on a spatial reasoning task. In a second study, this one conducted by Carstens, Huskins, and Hounshell, 51 students first listened to either Mozart’s piano sonata or no music, and then worked on a spatial task called the `Revised Minnesota Paper Form Board.’ There were no reported differences between these two groups.

Two additional studies, both published in 1997, did not support the `Mozart effect.’ Steele, Ball, and Runk presented 36 college students a backwards digit span task, i.e., recalling 9-digit strings in reverse order. Using a within- subject design, the students participated in three conditions–Mozart music, a recording of rain, or no sound. The results indicated no difference between these three conditions. Carlson and his colleagues attempted to document the `Mozart effect’ in monkeys using a memory task. These subjects participated in various experimental conditions including Mozart’s music, simple rhythms, white noise, and no sound. Interestingly, the monkeys performed best in the white noise condition and worst in the Mozart music condition.

In a paper published in Perception and Motor Skills in 1998 (Vol. 86, p. 835-841), Rauscher and Shaw noted that studies designed to find the `Mozart effect’ have employed a variety of populations (e.g., humans, rats, monkeys) and methodological designs (e.g., music compositions, dependent measures). This may be the reason why some research studies support the `Mozart effect’ whereas others do not.

Listening to music is non-invasive, is usually a pleasant experience, and may have the potential to affect cognition positively. More research is needed to assess the validity of the `Mozart effect’ as well as to determine whether this effect can last for relatively long periods of time. The `Mozart effect’ is clearly a fascinating subject which has the potential to have far-reaching implications.

Editor’s Note: There is also a growing body of evidence indicating that active involvement in music, such as singing and/or playing a musical instrument, may improve spatial as well as verbal abilities. An article summarizing several of the major studies on this topic will be published in the next issue of The Sound Connection.

Secretin: Help for Sound Sensitivity?
The Autism Research Institute (ARI) in San Diego continues to receive positive reports on the effectiveness of secretin on autistic and PDD individuals. These reports have come primarily from parents and physicians. Of the many benefits reported, one is the reduction in sound sensitivity.

ARI has been distributing the Secretin Outcome Survey (SOS) to parents since last October. There are now over 200 completed surveys, and ARI has released results from their first set of statistical analyses in January, 1999. These results have been summarized in the most recent issue of the Autism Research Review International as well as on the Internet (www.secretin.com). Dr. Rimland, Director of the ARI, has agreed to publish the sound sensitivity results in this issue of The Sound Connection.

On the SOS form, parents were asked to rate their child’s improvement on a number of factors using the following scale: ‘0’: none, ‘1’: possible, ‘2’: moderate, ‘3’: significant, and ‘4’: great. Of the 207 surveys collected so far, 167 parents responded to the question on sound sensitivity.

Fifty-five, (33%), of the parents indicated at least some reduction in sound sensitivity in their children. Of these, eight, (15%), indicated that the improvement was significant or great (i.e., ‘3’ or ‘4’ on the rating scale). Over half of the parents, (60%), indicated that, when improvement in sound sensitivity occurred, it was apparent during the first week; and by the end of the third week, almost all, (95%), had indicated that they noticed the change in their children. Three parents, (2%), indicated that their child’s sound sensitivity got worse.

There is still a need to obtain more information regarding secretin. If you have given secretin to your child, ARI would appreciate your completing the survey and returning it to ARI. If you know of families who are trying secretin, ARI would also appreciate your distributing the SOS form to them. A copy of this form has been enclosed with this newsletter. Although ARI wants completed SOS forms for all who have been given secretin, two categories are of special interest: (1) adolescents and adults; and (2) those who did not respond the first time secretin was given, but did respond after the second or third infusion.

Introducing Fast ForWord 2
The Scientific Learning Corporation has released a sequel to their Fast ForWord training program, Fast ForWord 2. This new program is designed for children who need further help in language and reading skills. Fast ForWord 2 is available only to those students who have completed Fast ForWord. Students can begin this new program at any time after completing the first program.

The Fast ForWord 2 program builds upon and reinforces skills taught in Fast ForWord including listening/comprehension, sound/letter correspondence, processing speed as well as decoding, spelling, and vocabulary skills. The games are interesting and challenging.

There are no formal data to support the effectiveness of Fast ForWord 2 at this time, but there are many testimonials supporting its efficacy. Readers can learn more about Fast ForWord 2 by visiting the Scientific Learning Corporation’s web site at: www.fastforword.com or by writing to: Scientific Learning Corporation, 1995 University Avenue, Suite 400, Berkeley, CA 94794, U.S.A.

Oliver Sacks Discusses Auditory Sensitivity
In an interview on Public Broadcasting System last year, Oliver Sacks was asked several questions about Temple Grandin since he had written an extensive article about Temple in the New Yorker which was entitled `An Anthropologist from Mars.’ Here is a brief excerpt from this interview:

Interviewer: She’s a fascinating person and her sense is that her nervous system is more highly sensitive than someone who is not autistic; and that’s part of the problem why maybe autistic people react the way they do to being touched, to bright lights, whatever–it’s a hypersensitivity or ….

Oliver Sacks: Oh, absolutely. And she describes how, as a child, she said her ears were like microphones and turned up to full intensity; and I think the business of editing and focusing and establishing a background may be very difficult. I mean, we think wouldn’t it be nice to be more intense, more sensitive to everything; but we need the controls and inhibitions; and there may just be too much for an autistic person.