Volume 1 Number 3, 1994

FDA Classifies Audiokinetron as a ‘Medical Device’
In a recent opinion addressing the import of ten Audiokinetron units, the Food and Drug Admin-istration’s (FDA’s) Center for Device and Radiological Health (CDRH) has classified the Audiokinetron as a “medical device.” The law defines a medical device broadly as an article 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. The FDA is expected to follow up the opinion with a written order preventing the import of the ten units or any future units of the Audiokinetron device.

The FDA’s classification of the Audiokinetron as a medical device does not imply that the product can cause harm. Rather, the agency is asserting its authority to regulate the product under the law, which requires that a medical device be submitted to the FDA for approval before it may be imported or shipped in interstate commerce in the United States.

The FDA’s decision relates directly to the agency’s authority to control importation of medical devices but also has direct and indirect implications for practitioners who are currently offering AIT to their clients. Under the import ruling, the Audiokinetron cannot be imported into the United States. Based on the reasoning in the letter, the Audiokinetron cannot be shipped through interstate commerce. That is, the FDA would interpret the law as preventing the transport of the Audiokinetron to another state for any purpose.

Despite the broad reach of the law, we understand that FDA does not normally interfere with the use or the interstate transport of a medical device in the possession of a licensed practitioner which is intended for his or her own professional use. The agency generally exercises its enforce-ment authority against the manufacturers and distributors of medical devices, rather than their users. Thus, the FDA has not directly addressed the use of the Audiokinetron to conduct AIT listening sessions as therapy or treatment for autism or any other disorders by licensed practitioners.

In addition, it is our understanding that the Audiokinetron can be used for purposes other than therapy or treatment, such as teaching a second language. This is outside of the FDA’s statutory jurisdiction.

Practitioners who desire to continue to offer AIT with the Audiokinetron are strongly advised to contact their professional liability insurance company to determine if their coverage will apply to a ‘non-approved’ medical device. It is suggested that practitioners review their policies first in order to ask specific questions regarding the policy.

If a practitioner should continue to offer AIT, SAIT strongly advises that they include a statement about the ‘non-approved’ medical status of the Audiokinetron in the informed consent form.

It is our understanding that, at the present time, the FDA’s ruling does not apply to the Audio Tone Enhancer/Trainer (BGC device) or any other similar AIT device currently available. However, the FDA’s reasoning could apply to all such products.

Under the FDA ruling, any plans to evaluate the efficacy of the Audiokinetron to treat autism or other disorders must receive prior approval from the FDA. No research should be done without such approval. This involves submitting an Investigational Device Exemption (IDE) application form to CDRH, which must include a research protocol that has been approved by an Institutional Review Board and an appropriate monitoring system to ensure appropriate ethical safeguards.

If you are not familiar with this process, you would be prudent to consult with appropriate experts or FDA officials. According to our legal counsel, private practitioners may conduct research, but they may have difficulty obtaining approval from the FDA because, aside from the procedural formalities, the research must be free of commercial interest and profit. The investigator may charge only an amount necessary to recover costs of the research.

The above description of the FDA’s ruling is an interpretation. We advise practitioners to check with their own legal counsel about the ruling and its implications.

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What Can Be Done to Obtain FDA Approval of a Medical Device?
Our advisors tell us that it would not be a good idea to write or call the FDA or our Congressional representatives about the AIT situation. This is different than the situation regarding vitamins, where the FDA is trying to get more authority. With regard to AIT, the FDA already has the authority, so it is much better to “keep cool” and let the lawyers work it all out.

It is in the best interest of the field for professionals and families to work together and cooperate fully with the Food and Drug Administration (FDA). Basically, extensive research on the Audiokinetron (and other AIT devices) is necessary to obtain FDA approval. The research must address the issue of accuracy of the claims made by the manufacturer as well as the safety of the treatment itself.

The most efficient way to obtain FDA approval is to conduct a large multi-site research project. Such a project will involve using similar procedural protocols and relying on various objective measurement techniques (e.g., audiological, behavioral, language, neurological). The final reports from these studies could then be organized and submitted to the FDA for review and approval. If these studies can be implemented in the near future, it may take as little as 1 1/2 to 2 years to receive FDA approval.

Obviously, funds will be needed to defray the costs of conducting research. Families and practitioners are encouraged to inform their local academic research centers about the status of AIT and to motivate them to investigate the effectiveness of AIT. Quite possibly, some colleges and universities will be willing to undertake or participate in research on AIT. Several have already expressed interest.

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Future Direction of SAIT
Given the FDA ruling on the Audiokinetron, the Board of Directors has decided to change SAIT’s direction for the present time. One goal of SAIT was to certify practitioners who perform AIT; but given the FDA’s ruling, it would be inappropriate for SAIT or any other organization to certify or license people to give AIT using a ‘non-approved’ medical device.

The Board of Directors has decided that SAIT’s first priority is to provide practitioners and families with information about the current status and pressing issues of AIT. SAIT will continue distributing its quarterly newsletter with an emphasis on research, legal advice, and other noteworthy news. A supplemental paper on a related topic will also be distributed on a quarterly basis to its members; such topics will include: sensory integration, visual training, and hearing anomalies.

SAIT membership will continue with current and new members needed more than ever to provide information and support as the clinical trials for the FDA approval begin. Once the Audiokinetron and other AIT devices receive FDA approval, SAIT will recommence its original mission to certify practitioners and to insure the ethical and professional practice of AIT. Below you will find current practices of SAIT, some of which will be kept in place and some of which will be revised given SAIT’s new direction at this time.

The associate level membership will remain unchanged with annual dues of $30 per year. However, since it is not appropriate for any organization to certify or license people using a ‘non-approved’ medical device, the professional membership category (which was for practitioners who had passed the examination for SAIT certification and who had the appropriate educational back- grounds), will be temporarily suspended pending FDA approval of the Audiokinetron (and other related devices). The Board of Directors has added a practitioner membership category. This membership category is open to practitioners who have been trained by an ‘approved’ instructor. No certification of these members will take place, and members in this category cannot use their SAIT membership status in their advertisements (this is reserved for when professional membership status is reinitiated).

Those practitioners who have already applied for professional membership and sent in $150 (to cover membership dues and the exam and processing fee) now have a choice regarding how and whether to continue their membership in SAIT.

CHOICE #1

SAIT will operate on the assumption (for now) that FDA approval will be granted within two years. Given this assumption, practitioners can choose to have SAIT continue to hold the $150 professional membership fee for those two years (or earlier if FDA approval is granted before two years). The $150 will be applied to past and current dues, and new practitioner membership dues will be waived for 1994. In 1995 the $40 membership fee would be due. If FDA approval is not given within two years (by 1996), $100 will be refunded. The remaining $50 will cover costs incurred during the past year (see below for more details). When FDA approval is granted (and professional membership status returns), your first year’s professional membership dues of $150 would be waived.

CHOICE #2

Practitioners may discontinue their membership in SAIT. Their application will be returned, and $100 of the membership fee will be refunded. The remaining $50 will cover costs incurred during the past year. These costs included monthly Board conference calls to establish and review policies, legal advice, the three quarterly newsletters, and distribution of other information regarding AIT. If the practitioner later decides to reapply for professional membership in SAIT, he/she will need to resubmit his/her application.

Practitioners who have already applied for professional member-ship are asked to complete the blue form included with this newsletter, and return the form to SAIT (2207 B Portland Road, Newberg, OR 97132). SAIT will continue to process already submitted and new applications for professional membership up until February 15, 1994. After this time, practitioners will need to wait until FDA approval to apply under this membership category. Individuals who wish to apply by the February 15, 1994 deadline must complete the professional application form and send this to SAIT along with the $150.

For practitioners who have not previously applied for profes-sional membership and who will now be new practitioner members, annual dues will be $40 (plus an additional $10 application processing fee for the first year). This membership category will be discontinued and professional membership will be reinstated when the device is approved.

Once the FDA approves the Audiokinetron and similar AIT devices, those practitioners who have already passed the review process will be required to take the certifying examination to become professional members. We hope the examinations will be available soon after the FDA’s decision.

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A Letter from Georgie
I have recently heard about the decision of the Food and Drug Administration, and I would like to say to families and practitioners: “Hang in there.” I am certain, in time, the Audiokinetron will be approved, as new treatments almost always need approval from the U.S. government. My main concern is that AIT get off to a good start and that it remain available to anyone who needs it.

The pioneer of AIT, Dr. Guy Berard in Annecy, France, is the one who gave me AIT when I was eleven, and it immediately changed my life. The music therapy of AIT equalized my auditory system which made my hearing within the normal range. To sum it up, I went from having bionic hypersensitive hearing to normal hearing within the ten day time frame of AIT.

I am a very strong advocate of AIT based on my personal experience and largely based on my experience in working with children, teenagers, and adults who have received the training; and then seeing how much they have progressed. My working as a consultant, public speaker, teacher’s assistant, and research assistant in the field of autism has been an extremely positive experience for me, and I plan to continue my work as God wills. I am also an artist, and that too, is a big part of my life.

I hope for the continued dissemination of AIT in the future so that some people with autism, who have a similar problem as I had, have a much better chance of a quality life.

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Sound – Field Testing and Behavioral Observation Audiology: What Is It?, and Can It Be Used for Determining Filter Settings?
Sound-field testing is used when the person cannot or will not wear headphones. The sounds are presented through speakers in the sound-treated booth, and the person is observed to see if he/she responds by turning or localizing to the source of the sound. Since both ears are exposed to the sounds presented, this type of test measures the response of the better hearing ear. Each ear is not individually tested.

Behavioral observation audiology (BOA) is used when the person cannot respond reliably with the requirements of traditional air and bone conduction audiometric testing. Classical conditioning is used to teach the person to associate a pleasant stimulus with the presentation of a tone. The person will learn to look for the stimulus when he hears the tone. Behavioral observation assessments may also include observations of changes in facial expression, eye movements, and body posture. BOA may be conducted with earphones or in sound field testing.

While these two methods of audiometric testing are valuable for determining possible hearing loss and can indicate whether the person hears with sufficient acuity for speech/language development, according to Dr. Guy Berard, they are not appropriate nor recommended for AIT audiograms upon which filter settings are based for the following reasons:

1. Audiograms for AIT must be obtained in a sound-quiet, not a sound-treated room. Dr. Berard emphasizes that what we want to know is how the person perceives sounds under ordinary conditions, not in a sound-proofed environment.

2. The configuration of an audiogram obtained in a sound-quiet room is different from one obtained in a sound-treated room.

3. BOA may not be sufficiently reliable to determine the precise point at which the person begins to hear sounds in a sound-quiet room, and this minimal threshold level is the point that needs to be measured. Dr. Berard requires a volitional response, such as answering with “yes/no,” from the person each time that he/she perceives the tone.

4. When headphones are not used in the testing, we cannot obtain the hearing pattern for each ear. We only know the results for the better ear.

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Autism Society of the Quad Cities and AIT
Members of the Autism Society of the Quad Cities (ASQC; a bi-state chapter located in Rock Island and Moline, Illinois, and Davenport and Bettendorf, Iowa) were interested in AIT. Unfortunately, there were no practitioners nearby; and given the lack of licensure for AIT, many parent members felt uncomfortable about selecting a practitioner at random.

The ASQC decided to: (1) buy its own Audio Tone Enhancer/Trainer (the BGC device) and compact discs; (2) subsidize a qualified local person’s training cost to Cincinnati, Ohio; (3) seek repayment by the newly trained practitioner at the rate of $250.00 per trainee until all training costs were recovered; and (4) seek grants to cover the cost of purchasing the BGC device. It was also decided that the practitioner be permitted to use the BGC and CDs without charge, provided that (a) the fee for AIT be jointly agreed between the practitioner and local chapter; and (b) persons in the metropolitan Quad Cities be given first priority for the training.

ASQC officers contacted and interviewed Quad Cities area professionals. Lisa Toalson, a teacher of students with autism in the Moline Public Schools, was selected. After training with Monica Doben-Stevens in Cincinnati, Lisa trained her first group in August, 1993. Since Lisa continues to teach full-time, training opportunities are restricted to winter break, spring break, and summer. With the completion of the December, 1993, training, ASQC will have recovered 100% of its costs.

The jointly determined fee was and remains $500 per trainee. Audiograms are provided without charge under Illinois special education laws. Iowa parents are presently contesting the refusal of area special education agencies to provide a comparable service without charge. For more information, contact ASQC Co- Presidents Linda Young (309-762-2995) or Linda Crouch (309-797-3448), Past President Gail Karp (319-359-5414), Treasurer Patrick Bihn (309-523-3976), or Lisa Toalson (309-755-1435).

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Routine Check of Equipment
Standard care of electrical and acoustical equipment includes regular checks to ensure its proper function. Since AIT sound amplifiers generally use a 5 carosel CD player for the music source, both components should be screened. Ideally, these routine checks should be conducted daily and documented; however, it is a good practice to also briefly listen to the headphones prior to each AIT session to ensure continued proper function throughout the day.

Check the CD carousel to ensure that:

 

  • a) the shuffle/random feature is functioning properly.
    b) all connection cords are attached to the AIT amplifier left to left, and right to right.
    c) CDs are clean. Check of the AIT amplifier itself should include the practitioner placing the headphones on and listening for:

        1) sound, free of static or unwanted distortion, coming from both earphones.
        2) while listening, move the wires to the headphone (paying particular attention to connections). Be alert for intermittent sound or a reduction in volume from loose or faulty connections.
        3) volume increase/decrease in the appropriate earphone. With the headphones on, ensure the attenuator for the left/right ear is controlling the volume for the expected earphone. Also listen for smooth volume changes, free of distortion or static.

    If any static, intermittent sound or distortion is found, the cord, earphone, or other problem should be repaired/replaced or the equipment not be used.

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    Using Filters for the AIT Listening Sessions
    The Autism Research Review International recently published a summary article on the results from the large-scale study conducted by Drs. Rimland and Edelson. There does not seem to be an advantage in using filters during the AIT listening sessions, indicating that the modulation of the music may be the only important component of the AIT process. As a result, some AIT practitioners are asking whether they should continue obtaining an audiogram and setting filters.At the present time, Drs. Rimland and Edelson believe that practitioners should continue to obtain audiograms and set filters. Since there was no statistical difference between those individuals who had filters and those who did not have filters, the listening sessions will not be less effective with filters. In addition, it is important to mention that one’s research findings are dependent on one’s measurements. It is possible that other measures, (e.g,. behavioral, social, language, emotional), may indicate a difference between those who received filters and those who did not.

    It is also important to obtain an audiogram to examine whether a person may have auditory problems which should be treated prior to receiving AIT. This may include: excessive cerumen (wax) in the outer ear, fluid in the middle ear, and/or inner ear problems.

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    Confusion with the Volume Level
    We received several letters and telephone calls about Dr. Edelson’s comments on the volume level in the last SAIT Newsletter (Volume 1, No. 2). We would like to clarify this issue for each AIT machine.Some practitioners are confused about the actual volume output level on the Audio Tone Enhancer/Trainer (BGC). That is, it was thought that the decibel level was simply the numerical value on the volume dial, multiplied by 8. In this way, the number 10 on the volume dial would indicate 80 decibels. However, there is no direct correspondence between the numbers of the volume dial and decibel level. The decibel level is affected by the recording level of the compact discs and the CD player’s output level. The maximum output level of the Audio Tone Enhancer/Trainer is reported to be 100 decibels.

    Several practitioners also thought the digital display on the Audiokinetron represents decibel level–thus 60 on the display would indicate 60 decibels. Dr. Guy Berard describes the digital display as representing “degrees” and not decibels. A degree is a relative number in which 60 degrees is twice as loud as 30 degrees. However, holding degrees constant, the actual decibel level will vary depending on the recording level of the sound source. Some compact discs are recorded at a very high level, and the actual output of the Audiokinetron may exceed 100 decibels. Volume will also vary according to the number of bars lit on the “gain” level and the number of filters used.

    As described in the last SAIT newsletter, a practitioner can obtain a general estimate of the output level of his/her AIT machine by using a sound level meter (set on the A scale at a slow response).

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    Photocopying Questionnaires/Checklists
    Many practitioners around the country have kept track of their clients by using various questionnaires and checklists. Although most practitioners purchased their questionnaires and checklists from the publisher or received permission from the author(s), some practitioners have borrowed a copy from a source and then made photocopies for their own use.It is important that people be aware of copyright laws. Individuals distributing copyrighted forms need to purchase the forms or obtain permission from the author and/or publisher.

    In addition, some practitioners are using very similar cover letters and consent forms developed by other practitioners and researchers. As a professional courtesy, one should ask permission to use these materials from the author(s) who developed them.