Volume 4 Number 3, 1997

FDA Labels Tomatis’ Electronic Ear as a `Medical Device’
In a recent decision, the Food and Drug Administration (FDA) declared the Tomatis Electronic Ear a Class III medical device. An official at the FDA was unable to give us the exact date of their ruling. The law defines a `medical device’ broadly as a device which is intended to cure, treat, or prevent a disease or condition, or is intended to affect the structure or any function of the body.

Additionally, the FDA’s Division of Import Operations and Policy issued an `import alert’ statement on February 5, 1997. The memo, which was distributed to FDA agencies throughout the country, stated that the Electronic Ear “met the criteria for detention without physical examination.”

This decision by the FDA follows the categorization of the AudioKinetron and the Audio Tone Enhancer/Trainer as Class III `medical devices.’ In order to receive approval, the FDA reviews and evaluates the research with respect to the effectiveness of a device and its safety. All three devices have not received approval from the FDA.

A Description of the Tomatis Listening Program
Dr. Alfred Tomatis, a French physician, developed a method which is reported to improve the functioning of individuals, using sound stimulation. This method was originally termed the `Audio-Psycho-Phonology’ approach, but some practitioners of this method have recently referred to it as auditory integration training (AIT). This should not be confused with the Berard method of AIT which is different both in its methodology and assumptions.

The Tomatis’ method is based on the idea that the ear integrates auditory information at every level of the nervous system. The Tomatis program stresses listening which is considered an active process accomplished with intention and desire. In contrast, hearing is considered a passive reception of sound. Tomatis believes that the voice can produce only sounds audible to the ear. Therefore, if the ear hears distorted words or sounds, the voice will reproduce these distortions. Tomatis also believes that the desire to listen may be reduced by a variety of emotionally-related problems, including illness, trauma, and experiences in one’s environment.

Eventually, only limited input may be received by an individual who has unconsciously tuned out his/her environment. The Tomatis program is said to recreate meaningful stages of listening development, and may include listening to the sounds of the womb or the mother’s voice, in an effort to reestablish a person’s desire to listen.

The Listening Program goals are:

      1. to establish good functional use of both vestibular and cochlear listening,


      2. to establish the emotional desire to use the auditory system,


      3. to have both systems improve the relational aspect of the individual to self, others and the environment.


    (Billie M. Thompson, 1994)

The Tomatis method emphasizes listening to high frequency sounds. Initially, a person listens to both low and high frequencies, (similar to the modulation used in the Berard method); but the low frequencies are gradually removed from the sound source. According to Dr. Tomatis, high frequency sounds energize or `charge’ the brain. In contrast to Berard’s method, the Tomatis method also consists of listening to the mother’s voice, to his/her own voice, songs, and stories. Berard had initially been a student of Tomatis. However, Berard developed his own approach because he felt that the Tomatis approach was too “psychological,” too time-consuming, and too expensive.

Issues Concerning the Tomatis Method
There are several issues or concerns about the efficacy of the Tomatis method. These include: research, underlying theory, number of hours and cost.

Research. There are only two studies, published in peer-reviewed journals, on the effectiveness of the Tomatis method. The results from one study, (Kershner et al. 1990 in Learning Disability Quarterly), showed that those who received this method did significantly worse on tests involving auditory discrimination and attention, and short-term auditory sequential memory compared to a control group.

The results from another study, (du Plessis and van Jaarsveld, 1988 in Suid- Afrikaanse Sielkundige), reported improvement in anxious children who received the Tomatis method; however, the evaluators were not blind to who did and who did not receive the treatment. These are the only known published studies examining the effectiveness of the Tomatis method.

Underlying Theory. According to Dr. Tomatis, a mother’s voice will affect the emotional development of her fetus. If the tone of the mother’s voice is harsh or cold, the fetus will feel unwanted and rejected. As a result, this emotional trauma will interfere with the later bonding between mother and child; and this may result in autism. Drs. Rimland and Edelson wrote in October, 1991: “Blaming the mothers for causing harm to the child, albeit unintentional harm, is a concept which is dead and should be buried. We believe that Tomatis should state his current position on this point precisely, if he no longer blames the mother.” As of March, 1997, Dr. Tomatis has not responded to this challenge.

Number of hours and cost. Compared to the Berard method, the Tomatis method requires many more hours of listening (often more than 100 hours); and the cost of the program is more expensive (often between $2,000 and $3,000).

To obtain a 3-page paper comparing the Tomatis method with the Berard method, written by Drs. Rimland and Edelson, write to the Autism Research Institute (4182 Adams Avenue, San Diego, CA 92116, U.S.A.), and include a stamped self- addressed envelope (32 cents postage).

Occasionally a listener’s eyes will move back-and-forth during the AIT listening sessions. Is the music different in each ear?

During the listening sessions, the same music is presented to both ears simultaneously. This is true for both the AudioKinetron and the BGC Audio Tone Enhancer/Trainer. The music is not presented in stereo.

We do not know why some individuals move their eyes back-and-forth during the listening sessions. One possibility is that these individuals can attend to sounds in only one ear at a time; and as a result, they switch back-and-forth between the two incoming sources (see article on stimulus overselectivity, The Sound Connection, Vol. 4, No. 2). Another possibility is that binaural (utilizing both ears) auditory perception is not in synch; and as a result, there is a delay in processing sounds between the two ears. The listener then focuses his/her attention to each sound separately as he/she perceives these at different points in time.

Although there are many theories on why some people may benefit from AIT, it would be expected that the `correct’ theory will ultimately account for this observed phenomenon.

`Fast ForWord’ After AIT
Two previous issues of The Sound Connection described a new computerized language program developed by the Scientific Learning Corporation (SLC) of San Francisco. The 6- to 8-week program, termed `Fast ForWord,’ has received a great deal of media attention over the past year; and SLC is currently teaching clinicians how to administer it. SAIT has heard reports that after receiving `Fast ForWord,’ some individuals lost the benefits they received from receiving AIT earlier. A possible explanation: The `Fast ForWord’ program involves wearing headphones over 1 hour a day, 5 days a week, for 6 to 8 weeks. Dr. Guy Berard has stated for many years that one should not wear headphones after receiving AIT, otherwise they may lose the benefits from the AIT training. If you know of any clients who have participated in the `Fast ForWord’ program following AIT, please let us know. We need to learn about clients who benefit, are unaffected, or are made worse by `Fast ForWord.’ We will share what we learn.

New Members Selected to the Professional Advisory Board
During a recent SAIT Board of Directors meeting, President Steve Edelson nominated three new members to the SAIT Professional Advisory Board. The BOD members unanimously approved the nominations of Dr. Temple Grandin, Lorna Jean King, and Deborah Woodward. The BOD also accepted the re-nominations of six previously selected Professional Advisory Board members: Drs. Margaret Bauman, Guy Berard, and Bernard Rimland, and Bill Clark, Carol Cloud, and Lynda Huggins.

SAIT’s BOD is grateful to have the expertise of these individuals available.

Published Study Examines the Volume Level of an AudioKinetron
Reference. Christine M. Rankovic, William M. Rabinowitz, and Gregory L. Lof, “Maximum Output Intensity of the Audiokinetron,” American Journal of Speech- Language Pathology, 1996, Vol. 5, 68-72.

Method and Results. The sound output levels of a single AudioKinetron, as used by a local AIT practitioner, were measured using a KEMAR manikin testing procedure. The highest output level used by the practitioner was measured at 110 dB SPL, and the maximum output level of the AIT device was measured at 118 dB SPL. The authors state that these output levels can be harmful to hearing, and warn that AIT is potentially dangerous.

Comment: The AIT device, like any compact disc or audiocassette player, can be set to play too loudly. Should all these devices be banned as potentially dangerous? Every practitioner is aware of his/her responsibility to make sure that the device is played at an appropriate level. Basing conclusions on a single, very probably atypical case, is a poor practice-the authors’ conclusions are not justified by their very limited data. It is surprising that a reputable journal would publish a paper based on so little substance.

SAPP Analyzes EASe Disc
The SAPP Corporation, the manufacturer of the AudioKinetron, has recently analyzed the EASe compact disc. The EASe acronym stands for `Electronic Auditory Stimulation effect,’ and it is reported to contain output from an AudioKinetron. The EASe disc was developed by Bill Mueller and is distributed by Vision Audio Inc.

In his memo, Pierre Suire of SAPP stated: “Concerning the analysis of the CD EASe, I inform you that this CD doesn’t include, in any way, the effects of the AudioKinetron, the `balance’ looks uncertain and is not one of our devices.”

However, in the last issue of The Sound Connection (1996, Vol. 4, No. 2, page 1), we reported that a frequency spectrum analysis conducted by Bill Clark, developer of the BGC Audio Tone Enhancer/Trainer, indicated that the EASe disc appeared to replicate accurately the output from the AudioKinetron.

We hope that an independent laboratory will analyze the EASe disc to determine its authenticity and that there will be sufficient research to examine the disc’s effectiveness. Dr. Jaak Panksepp of Bowling Green State University is completing a parent survey on the efficacy of the EASe disc. Additionally, Dr. Panksepp has recently examined biochemical changes in the brains of chicks as a result of exposure to the EASe disc. We plan to summarize his results in the next issue of The Sound Connection.

Antibiotics and Tubes in the Tympanic Membrane: Dr. Guy Berard
Antibiotics. Many individuals ask for my advice concerning the use of drugs during AIT. The answer is very simple:

      – If a safe medical treatment, including non-ototoxic medications, has been prescribed by their doctor, there is absolutely no problem with AIT and the drug,


      – Or, it is an ototoxic drug, and this problem is the same for everyone, undergoing AIT or not, everything shall be done to avoid these medications which shall be reserved only for cases imperatively requiring their use, for example, quinine for treating a crisis of malaria.


Ototoxic medications include:



      Sodium salicylate










Maybe there are others that I don’t know because they could have been discovered since the time I stopped practicing, but I have not seen anything on this subject in the medical publications that I receive.

The best solution for individuals is to ask their physician to avoid such medications.

Tubes in the Tympanic Membrane. The general rule is that AIT should not be applied on individuals wearing tubes or having a hole in the tympanic membrane. The reason is that tubes, as well as holes, disturb the functioning of the eardrum; and this may interfere with a perfect result of AIT.

The higher part of the eardrum transmits high frequency sounds to the cochlea through the circuit of the 3 ossicles (bones) to the oval window. The lower part of the eardrum transmits the low frequency sounds through the air of the tympanic box, to the round window, and then to the cochlea.

Consequently, the principle of AIT, which is to send alternating sounds of high and low frequencies to the ears, at the same intensity, will be distorted if an anomaly exists, a tube or hole, in the eardrum. The low frequencies will be heard weaker than the high ones.

Training individuals wearing tubes is not at all dangerous but may reduce the efficiency of the training.

[Note: Professor Erdem Cantekin of the Department of Otolaryngology, University of Pittsburgh of Medicine, believes that tubes are grossly overused, and may be appropriate only in a small percentage of those cases.]

Donna Williams, author of several outstanding books about her struggle with autism, has provided readers with valuable information about how she experiences the world and the impact that autism has had on her life. In her newest book, Autism, An Inside-Out Approach (Publisher: Jessica Kingsley: Bristol, PA), she once again shares her insights on a variety of issues.

Unfortunately, Donna misses the mark in her section on AIT, perhaps because this is a procedure in which she has not personally participated and must, therefore, rely on second-hand information. In the section about Auditory Integration Training (AIT), Donna explains her perceptions and ideas about the procedure. She says that AIT seeks to change the individual’s perception of pitch or volume and therefore, she does not believe that AIT really addresses some of the causes of the problems experienced by individuals with autism. She specifies that it is information overload caused by a number of simultaneous sound sources, the duration of bombardment and the rate of the bombardment relative to processing capacity that results in auditory hypersensitivity. Donna has correctly identified some of the causes of auditory hypersensitivity and processing difficulties, but she does not recognize that AIT may address these causes.

Dr. Berard has identified some of the auditory problems that many individuals have, including delays in timing and an inability to filter out extraneous sounds. When timing delays and figure/ground problems exist, the person has too much going on for processing to keep up. Individuals who have completed AIT have stated: “Now I understand what you say when you say it, without having to think about it,” “I can hear my own voice and other people’s voices better now,” and “The background noise does not bother me anymore.” These types of responses would indicate that individuals perceive a difference in the way they are processing auditory information, not a change in their perception of pitch and volume.

Practitioners in the field of AIT do not make the assumption that difficulties with auditory clarity are the sole cause of the comprehension problems experienced by autistic individuals. It is recognized that there may be diverse causes that may be addressed by a variety of approaches, including interventions such as AIT, nutritional therapy and sensory integration, as well as removal of toxins such as Nutrasweet, heavy metals and ototoxic medications from the body.

In the section on Special Tinted Lenses, Donna states that the lenses may also improve the functioning of other systems, including auditory processing, taste, smell and tactile processing due to the reduction in information overload. This effect has also been reported by those who have had AIT. With the reduction of stress and overload, and improved processing, the individual may find improvement in other areas of sensory processing, and in areas such as motor sequencing, balance and coordination, which are controlled by the cerebellar- vestibular system.

Donna’s explanations about the implications of drastically changing one’s perceptual reality are excellent. She recognizes that seriously altering any form of sensory perception can profoundly impact one’s emotional and mental functioning and may be overwhelming until the system adjusts. This type of response may occur as a result of AIT, and practitioners should assist families by providing aftercare consultation.

In her book, Donna provides much valuable information about many interventions and treatments that she has pursued. She seems to have an excellent grasp of many of the issues involved with the visual and biochemical problems associated with autism. Perhaps if Donna had personally experienced AIT, her perceptions and opinions would more accurately reflect the nature of the process. Nevertheless, Autism, An Inside-Out Approach offers a significant amount of information that should be helpful to parents, professionals and friends of people with autism.

English Researchers Obtain Large Grant to Study AIT
Oliver Mudford and Chris Cullen of Keele University along with Lorna Wing and Richard Mills (National Autistic Society) recently received a grant for $370,000 (U.S. equivalent) to study the efficacy of AIT in 16 autistic individuals. Their study will involve a multiple baseline procedure and will examine changes in behavior over a one-year period. These researchers plan to measure behavior on a monthly basis using several questionnaires which will be completed by parents and day-service staff. These questionnaires include: the Aberrant Behavior Checklist, the Conner’s Parent Rating Scales, and the Nisonger Child Behavior Rating Form. The research protocol also includes direct observation of the participants in their natural environment (e.g., school, special education facility). The researchers do not plan to examine changes in sound sensitivity, auditory processing, nor changes in physiology.