Petition
(Date) March 14,
2008
Dockets Management Branch, Food and Drug Administration, Department of
Health
and Human Services, Room 1-23, 12420 Parklawn Dr., Rockville, MD 20857.
CITIZEN PETITION
The undersigned submits this petition under the "Medical Device"
section of the Federal Food, Drug, and Cosmetic Act, the Public Health
Service
Act, or any other statutory provision for which authority has been
delegated to
the Commissioner of Food and Drugs (under 21 CFR, Part 5.10) to request
the
Commissioner of Food and Drugs to evaluate a certain form of device,
namely the
Tomatis Electronic Ear as well as other similar auditory training
devices to
determine whether this is a "medical device" as contemplated under
various sections of the Code, and then refrain from taking any form of administrative action, or
to approve the device.
A.
ACTION REQUESTED
B.
Petitioner
requests the Commissioner refrain from taking any form of administrative action, on
the grounds that the Electronic Ear is not a medical device, or, in the
alternative, commend it as a medical device useful in the treatment of
the
Tomatis Method. As an approved medical device, the Tomatis Method would
be
billable to insurance companies, in turn helping a million autistic
children
who at this time have no good treatment for their condition.
C.
STATEMENT OF GROUNDS
The Maryland Board of Occupational Therapy has threatened to revoke
Petitioner's license to practice Occupational therapy on the grounds
that
Petitioner operates a medical device, namely the Tomatis Electronic
Ear, which
is not approved by the FDA.
D.
Furthermore, the Maryland Board of Occupational
Therapy has
threatened to contact you (the FDA) with its own petition unless
Petitioner's
wife cease and desist from operating any Tomatis equipment.
E.
Petitioner alleges that in the last 17 years,
his
wife
(Valerie Dejean) has treated upwards of 2000 autistic children with the
Tomatis
Electronic ear and improved the condition of 90 percent of these
children and
conversely, worsened the condition of NONE of these children through a
system
known as the Tomatis Method of auditory training.
F.
The Manufacturer of the Tomatis Electronic
Ear
asserts that
his machine is an educational device and not a medical device.
G.
Petitioner asserts that the Electronic Ear
is a
very fancy
audio device resembling a "mixer" where the end result to the
client (or Patient) is a form of scratchy filtered music which is
listened to
by the client through a pair of fancy earphones, (fancy in the sense
that a
bone conduction device (such as those used in certain hearing-aids), is
used to
vibrate against the patient's skull providing Channel A of the audio),
and with
the regular earphones providing channel B with both right and left ear
receiving the same signal. The output of the electronic ear could
easily be
transferred to a stereo CD as a form of "educational" music, but
this would be a time consuming exercise in that there are several
hundred
possible settings where configuring the various dials and switches on
the
Electronic Ear and these settings are individualized when operated by a
skilled
practitioner. Nevertheless, after all is said and done, the only thing
that the
client receives is sound in the ears and vibration from the bone
conduction attachment.
H.
Nevertheless, this altered sound should not be
disregarded as
a harmless New Age device. It
has an
impact on balance and on many of the things that result from better
balance. How
it works: The ear has two main functions. One is hearing. The
second is
balance. It was Tomatis's discovery that by treating the ear with sound
that
one could alter the balance or vestibular function of the ear. When the
autistic child develops a better sense of balance, he distinguishes up
and down
and then stops spinning or stops watching the fan go around all day. He
begins
to get a sense of self
and other
because he
suddenly realized that he is a distinct
entity who is different from everything and everybody else. The he
realizes
that he has power over the universe. It is thus that a patient treated
for
balance begins a phase of life commonly known as the "terrible
twos". This is all possible because the altered sounds have affected
the
balance function of the ear. Is this then a medical device?
Petitioner's wife
has made what could be considered medical claims and has in the past
billed
insurance under OT insurance codes. The Commissioner may decide that
since
there exists an epidemic of autism in America, probably the result of
some
factor or factors scrambling the child's nervous systems, that the use
of such
a device as the Electronic Ear should be encouraged and treated as a
medical
device, billable to insurance companies. Petitioner's public policy
argument is
that with the current epidemic of autism, the use of this device should
be
treated very seriously, and its use encouraged. No other treatment for
autism
works nearly as well.
I.
The Maryland Occupational therapy Board is
prepared to bring
forth testimony that these is a lack of evidence in the form of double
blind studies
etc that this Tomatis Method works. This is true. Nevertheless there is
plenty
of anecdotal evidence of dramatic changes in the patients (clients) as
early as
the first day of treatment. Petitioner's wife has 2000 case studies to
present
as anecdotal evidence. The other 998,000 autistic children in this
country
should get some relief too.
J.
Freedom
of Speech claim. Since this method could,
with a
little ingenuity be delivered in the form of a thousand CDs or streamed
on the
internet in a pick and choose fashion it could be regarded by the
Commissioner
as some esoteric form of electronically modified music which would fall
under
the free speech clause of the 1st amendment of the U.S.Constitution. However it would require
one Electronic Ear to generate
the
musical data at the manufacturer's facility.
This
electronically
modified musical data could be created by a software program such as Cool
Edit in lieu of the Electronic
Ear
following the theories and tenets of Alfred A. Tomatis. Certain
software could
presumably be banned as dangerous except that this violates the free
speech
clause.
K.
ENVIRONMENTAL IMPACT STATEMENT
Petitioner prays for categorical exclusion
under 21 CFR 25.30, 25.31, 25.32, 25.33, or 25.34 or an environmental
assessment under Sec. 25.40 of this chapter.)
L.
CERTIFICATION
The undersigned certifies that, to the best knowledge and belief of the
undersigned, this petition includes all information and views on which
the
petition relies, and that it includes representative data and
information known
to the petitioner which are unfavorable to the petition.
__
_________________________
(Signature)
__William J. Kennick Esq.
Name of Petitioner
__1708 White Oak Dr., Silver Spring, MD
20910
(Mailing Address)
__212-706-1170