Volume 3 Number 1, 1995
Background information. In September, 1994, the FDA had classified the Audio Effects Generator as a class III ‘medical device.’ When a device is initially labeled a ‘medical device,’ it is automatically given a class III status. The manufacturer can then petition the FDA to change the classification to a II or a I.
The Geogiana Organization has recently asked parents and professionals to write to Congressman Michael Bilirakis, Chairman of the Congressional Oversight Committee of the FDA, to help persuade the FDA to lift the strict regulations placed on AIT devices, as well as other non-traditional interventions. There has been widespread dissatisfaction in the public and in Congress with the rigidity of FDA policies, which we believe will, before long, result in the development of new laws regarding regulation of health care services.
Susan Calliham, who operated two of the three clinics, was questioned by government authorities two weeks prior to the seizure. Ms. Calliham appeared on a local talk show, Kathy Fountain, and made enthusiastic claims about the uses of AIT, which may have raised concerns among authorities about the practice of AIT. At the present time, the HRS has not stopped other practitioners from conducting AIT, but it seems probable that other Florida practitioners will be contacted by the HRS in the near future.
This is not the first time that AIT devices have been confiscated from practitioners. When the FDA first heard about the Audiokinetron in 1993, they seized several devices at the U.S. Customs Department and prevented their release to practitioners. They also stopped the importation of these devices.
Currently, SAIT is aware of two other on-going investigations for the clinical practice of AIT by state authorities. One person is being investigated by the Board of Speech-Language Pathology and Audiology in Georgia, and another person is being investigated by the Agency for Health Care Administration in Florida. Both individuals have decided to stop their practice of AIT until these issues are resolved.
Class II devices are those for which general controls are insufficient to provide a reasonable assurance of safety and effectiveness but which can be appropriately used through compliance with “special controls,” such as performance standards, postmarket surveillance, patient registries, and other guidelines. Catheters and other needles, blood pressure monitors, and MRI machines are examples of Class II devices.
Class III devices entail the most potential risk to patients and are, therefore, the most heavily regulated class of devices. These include: devices for which general and special controls are not sufficient, products intended for use to support or to sustain human life or to prevent impairment of human health, and devices that present a potential unreasonable risk of illness or injury. Examples of Class III devices are implants and the new excimer ophthalmic lasers. Class III devices require premarket approval by the FDA, based on appropriate clinical trials.
Clinical trials on Class III devices are also subject to FDA approval insofar as they present a “significant risk” to the subjects. Such approval requires the filing of an investigational device exemption (IDE) with the FDA which includes: a protocol that has been approved and will be supervised by an Institutional Review Board (IRB), adequate informed consent, and appropriate record keeping and reports. For a nonsignificant risk device, which usually includes the Class I and II devices, an IDE does not need to be submitted to the FDA, but IRB approval is required.
The FDA has classified auditory integration training (AIT) devices as Class III devices which require the filing of an IDE to conduct clinical study. However, it may be anticipated that the FDA will eventually reclassify AIT devices to Class II, after one or more of them have been proven safe and effective for their intended use and will regulate them through special controls of some kind. (Most devices fall in Class II, but few special controls actually exist at present. Class II devices thus are currently treated the same as Class I devices, once they are cleared for marketing.)
While technically Class III devices should not be used in clinical practice without formal approval by the FDA, that agency is primarily concerned with interstate shipment of AIT devices under the FDC Act, rather than their use by qualified trainers. However, a state or local government agency, such as the Florida Health and Rehabilitative Services, may rely on the FDA’s ruling on the status of AIT devices to stop the clinical use of the device within their particular jurisdictions. Those who choose to provide AIT should be aware of the possibility that their devices could be confiscated by such state authorities (as well as by the FDA, if a state or local state or local agency asks the federal agency to act), that they may possibly lose their professional licenses, and that they may not be covered by their liability carriers. In some situations, criminal charges could be filed (e.g., practicing medicine without a license). SAIT believes that the AIT devices are both safe and effective and that the current problems with the FDA and with state authorities will soon be settled satisfactorily.
At present, there is a good deal of uncertainty about what further actions, if any, the FDA will take. If practitioners choose to provide AIT to those requesting it, it is crucial that no claims whatsoever, oral or written, be made about the value of AIT in treating or mitigating any condition: not autism not dyslexia, not hyperacusis, not attention deficit. NOT ANYTHING.
FDA regulations prohibit making “health claims” for any substance or device unless the FDA has given prior approval of the claims. All those who were trained to practice AIT should have had this explained very clearly to them–The “T” in AIT stands for “Training,” not “Therapy.” Practitioners should avoid the terms “therapy” and “treatment” because these words seem to imply a medical intervention.
If a person should choose to practice AIT and is asked if AIT will help condition “X,” the practitioner must answer only “FDA Regulations prevent me from making any claims that AIT will help any condition.” PERIOD.
People have heard about and read about AIT. When they come to a practitioner for AIT, the practitioner may tell them only that FDA regulations do not permit claims to be made. That’s the way it is for the time being.
Efforts are currently underway to induce the FDA to lift its ban on the sale of the BGC device. So far these negotiations seem promising. Even if the ban is lifted, it will still be illegal to make “health claims” unless these claims are explicitly approved by the FDA.
Watch SAIT’s newsletter, The Sound Connection, for further developments.
The Audio Effects Generator, developed by Bill Clark, modulates the frequencies as well as the volume level. This AIT device can be set to emulate the modulation of the AudioKinetron and can be set to modulate bandwidths of varying sizes throughout the frequency spectrum. The Audio Effects Generator also changes the volume level on a random basis by increasing the volume by 20 decibels (dB’s), decreasing the volume by 20 dB’s, or not modifying the volume level. The modulation of the volume cannot be controlled by the practitioner.
At the present time, research examining the efficacy of both AIT devices has not revealed any differences in effectiveness between these two AIT devices.
ADVANCE for Speech-Language Pathologists and Audiologists published a description of a single-subject study which investigated changes in brain functioning using Positron Emissions Test (PET) Scan technology (6/26/95, pp. 5). The research was conducted by Dr. Jackie Cimorelli and Melanie Highfill and involved an 8-year old male with mental retardation and autism. PET scans were conducted prior to a set of AIT listening sessions, one day after the listening sessions, and then six months later. The results at both the one-day and six- month follow-up evaluations indicated a normalization of brain activity, including a decrease in hyper-metabolism in the frontal lobe and an increase in activity in the occipital lobe.
These results were also discussed at a presentation by Dr. Cimorelli and Ms. Highfill at the 1994 Autism Society of America national conference which was held in Las Vegas. The ADVANCE article did not mention that the child had received a set of AIT listening sessions prior to this research study; thus, the baseline information used in the research study may not be considered an appropriate measure for comparison. In addition, these results need to be replicated on other subjects given the inherent variability in PET scans.
There will continue to be two membership categories, one for parents, with a new annual fee of $35, and one for professionals in the field of developmental disabilities, with an annual fee of $75. The change in membership fees will allow SAIT to establish better communication with professionals and parents about AIT (e.g., establish a WEB page on the Internet) as well as continue its efforts regarding the FDA situation. SAIT’s Board members felt that these new rates better reflect the modified purpose of SAIT at the present time.
For those individuals who joined SAIT as a professional or practitioner member and paid $150, your membership will expire on the first of the year; and you will be required to renew your membership at the new rate ($75) if you wish to maintain a membership in SAIT.
SAIT members will receive a letter in the near future which will describe the new membership policy in more detail.
Guy Berard’s recent decision to lower the minimum age for AIT to 3 years brought forth some questions for consideration. Practitioners wanted to know if SAIT’s paper providing “Basic Information on AIT” will be amended to reflect this lower age minimum. The paper currently states that 4 years is the minimum age.
Discussion also focused on whether there is a recommended maximum volume for 3 year olds. Some professionals feel that special caution should be used when 3 year olds receive AIT since the OSHA standards for noise exposure are based on adult research.
Maintenance of the AIT devices was discussed. Deborah Woodward explained how to clean the headphone plug to prevent corrosion and dust accumulation. She suggested wiping the plug with an alcohol swab, but recommended against placing anything into the hole in which the plug is inserted.
Calibration issues and monitoring volume output with a sound level meter were also discussed. It was explained that the BGC is not recalibrated when practitioners send it to be serviced. If there is a problem, a new board is installed since it is a completely sealed component and cannot be recalibrated. As explained in previous issues of The Sound Connection, sound level meters should be used to monitor volume output.
Sometimes practitioners make changes in the standard procedures for AIT, such as providing “booster” sessions or extra hours of listening. This issue raises some concerns, and it was emphasized that parents must be informed when changes are made. Since there is no research data available yet to validate the effectiveness of “booster” sessions, the reasons for this change in protocol should be discussed with parents. According to Dr. Berard, AIT should always be given for just the total of ten hours, never more. AIT can be repeated after a period of time has elapsed (9-12 months in the case of autism). This time interval depends upon the individual case and disability being addressed.
Lois Blackwell presented information on standards of practice, training, and extended ongoing peer review; and Carol Cloud, a parent whose son completed AIT, assisted parents with questions to ask a practitioner when seeking AIT services.
Jenness Roth, another parent whose son completed AIT, discussed family arrangements and practical planning issues, as well as some of the possible temporary negative behavioral effects. Candace Timpson, mother of two children who have received AIT, reported on the positive behavioral changes she noted in both children, without any concurrent negative behaviors.
VEALE – Research Summaries: Tina Veale discussed several previous research studies that have been conducted during the past few years. Her presentation included a chart listing studies, numbers of subjects, data collection measures used, and results. Another chart listed behavioral changes commonly reported after AIT. Copies of the summary charts are available from Tina Veale at Comprehensive Concepts in Speech and Hearing, 9680 Cincinnati-Columbus Rd., Cincinnati, OH 45241, U.S.A. Please enclose a stamped self-addressed envelope with your request.
CIMORELLI – Long-term treatment effects of AIT: This study involved a double- blind experimental design consisting of measurements conducted pre-, post, and one year later to evaluate the long term effects of AIT. The study was completed by Dr. Jacqueline Cimorelli and Melanie Highfill. Eleven children with autism participated in the study, in which ten were assigned to the experimental group and one was assigned to the control group. Several measures were used in their study including a language sample, pragmatic analysis, the Woodcock-Johnson (a measure of cognitive abilities), and a preschool language scale. The results indicated an improvement in all ten subjects who participated in the experimental group.
The areas and degrees of improvement varied among participants, with six showing increased language abilities, five showed increased cognitive scores, five improved in motor skills and two showed improvement in hearing sensitivity. The control subject, who just listened to music, showed some improvement in language, cognition, and hearing sensitivity.
FRICK, SCHINAMAN, WOODWARD – AIT from a sensory integrative perspective: Deborah Woodward discussed the audiological issues relating to AIT. Sheila Frick and Dawn Schinaman presented their theory that AIT works on the vestibular system and should be considered a form of sensory integration therapy. These occupational therapists have given AIT simultaneously with sensory integration activities (e.g., swinging). Based on their clinical experience, they believe this approach may serve to reduce the negative effects which are sometimes associated with AIT. They have not yet conducted clinical research to document these observations.
When I started practicing AIT in France in 1963, I worked in the same manner that I had seen Tomatis work. The children were allowed to do everything they were interested in: reading comics, playing with toys, making designs, eating candies, etc.
Before I made my own device, I used the Tomatis Electronic Ear and was not satisfied with having to accumulate so many listening sessions, as this was very expensive for the parents. So I decided to design my own machine, completely different from the Electronic Ear.
The results obtained in my clients were soon much better, but sometimes there were unsatisfactory results- unsatisfactory and incomprehensible!
As I was one of my own patients, treating my hearing loss, I carried on hearing the music sent by records through my device while reading newspapers, letters, etc. One day, after being very interested in a book, I reached the end of the 30-minute session and was unable to remember what record I had heard! Then, I thought about the problem and found the solution.
To explain it, I will use the example I give to my trainees: If, during my participation in a dinner with 20 guests, I am sitting in front of a woman talking loudly (around 80 decibels) about the way to knit a pullover with 5 different colors, I will unconsciously block the ossicles in my middle ear since I don’t feel especially interested in knitting. Then, only a part of the woman’s speech, maybe 40 dBs will reach my brain, just as a rumbling.
If, simultaneously, a man 10 feet away from me, talks about salmon fishing, in a low voice, with only 30 dBs reaching my ear, I will be able to select and perceive the voice of the man, eliminating the 80 dBs about knitting.
My opinion is that all this selection is made at the level of the ossicles, but never mind if some specialists could argue that this selection takes place in another part of the ear-brain circuit, this doesn’t matter. The main problem is that if you are interested in doing something, you can avoid the disturbance of sounds coming to your ears, music, boring speech, etc. Whatever the mechanism, when I discovered what seemed to me an obvious fact, I decided to prohibit systematically, during the sessions, all other activities while listening to the music. Reading, playing, talking, designing, eating, etc. were forbidden, and my statistics confirmed the improvement of the results on my patients, children or adults.
Some of my trainees argue that expecting autistic children to sit for 30 minutes and to wear earphones, without playing with toys or having other activities, is impossible. I don’t agree with this objection, since I could always obtain this quietness with my clients. My opinion is that treating autistic children in France is different than in the U.S. In France, AIT was applied by my nurse or by myself with the child alone, without his/her parent, and there were no problems.
In the U.S., all my trainees give me the same argument; since parents are always present with their child when receiving treatments from professionals, it is very hard to modify or change this usual behavior. I think that if it is clearly, carefully explained that a better result might be obtained by using my suggestion, parents will agree and cooperate.
Practitioners are encouraged to photocopy the questionnaire and distribute them to all of their clients. The questionnaires can be returned to either the Autism Research Institute or to SAIT.
We hope the results from this survey will help change the FDA’s classification of the AIT devices from Class III to Class II.