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DigiCare® Hearing Research & Rehabilitation
VIDEO OTOSCOPY OBSERVATIONS IN HEARING HEALTH PRACTICE
UTILIZING MIRACELL BOTANICALS SOLUTION
by Max Stanley Chartrand
(Note: The published versions of this article contain a
number of illustrations that we could not put on this
site.)
Introduction
Over a 20-month period we observed marked physical
changes in the external and middle ears in many of the
960 hearing impaired patients who followed a specified
regimen with Miracell Botanicals solution. From video
otoscopic and comparative history data gathered during
these observations, we noted repeatable trends relative
to the physical status of the ear and its plasticity
over time.
Our initial objectives were to test this botanical
product for safety, and to ascertain its suitability for
preparing otherwise “non-medically treatable” ears1
(under FDA Red Flags) for the successful adaptation to
acoustic couplers. However, during the course of
“before” and “after” video otoscopic observations we
also found that most ears with:
o Shallow-A tympanograms returned to “normal A”
o Adhesive otitis residue on tympanic membranes returned
to normal, opaque tissue
o Stress cracks and fissures healed over
o Small air-bone gaps at the TM returned to normal
compliance
o Chronic fungus, yeast, bacteria lining the ear canal
returned to normal pH
o Missing keratin and other epithelial disturbances
returned to normal
o Partially healed perforations grew back the middle
fibrous layer of tissue
o Overly flaccid pars flaccidae returned to normal state
The above are just a few of the dramatic non-medically
treatable improvements we saw in the course of simply
attempting to prepare patients for new hearing
instruments or earmolds. Through these observations we
have adjusted our regimen time for each patient, from
10-14 days for relatively “normal” ears, which may
simply be missing the keratin layer, and up to 30 days’
use for cases of long-term scar tissue, adhesive otitis
residue, calcium plaque, acoustic trauma, and those with
very shallow A tympanograms.
It must be pointed out, though, that we were unable to
make any specific prognostic claims regarding the use of
this product, for it has not yet undergone efficacy
studies. However, repeated experience and empirical
observation with so many patients has led us to promote
the universal use for every case of new users as they
prepare to take delivery of new hearing instruments, and
in ongoing patients who are experiencing discomfort,
itching or maladaptation problems with their current
hearing instruments. We’ve also instituted a
well-defined procedure for modification of ear
impressions BEFORE sending to the factory. Universal
Miracell utilization combined with ear impression
modification has helped reduce remakes in participating
practices to less than 5% and RFC to less than 2%.
I. MISSING PROTECTIVE KERATIN LAYER
One of the universal paradoxes of modern hygiene is the
use (or abuse) of cotton swabs in the external meatus.2
Indeed, it is not uncommon for a patient to inform
us---during otoscopy ---that they tried to get their
ears “clean” before coming to our office. Translated,
this means they virtually reamed out their ears with a
Q-tip or some other cotton swab, scraping off nearly all
of the protective keratin layer (or keratinocytes)3 and
even some of the epithelial cells from their ear
canals---the worst possible state for adapting to new
hearing aids.
In so doing, they’ve set up their external canals for
possible infection, and most certainly for
over-sensitivity in up to three of the four
neuroreflexes that affect, or even inhibit, adaptation
to the physical fit of today’s earmolds.4, 5 Indeed,
we’ve found these to comprise the largest segment of
failed trials and “mystery cases” too often encountered
in the hearing instrument industry.
What’s tragic about this finding is that it appears that
few in our profession are even aware of the existence
and importance of these physical landmarks, keratin
least of all. Though keratin itself, in biological
makeup, is essentially inorganic (like hair---non-vascularized,
non-innervated), this important protein shields the ear
canal from the growth of bacteria, fungus, yeast,
pseudomonas and other parasites, and helps maintains the
ear’s natural 5.2-7.0 pH environment by mixing apocrine
(cerumen) and sebaceous secretions into earwax.
Keratin also allows the “desquamated” growth of
epithelial cells beneath to migrate outward from the
tympanic membrane to the outer edge of the aperture or
opening of the ear canal. This conveyor belt-like
mechanism then “lifts” (by way of hair follicles) the
keratin, along with its collection of earwax, debris and
desquamated cells, just prior to reaching the aperture
of the concha area6 for easy removal. By this process,
the ears are “self-cleaning” and not in need of
mechanical “cleaning” per se, unless, of course, one
mechanically “impacts” earwax deeply into the canal.
We’ve also identified at least three
neuroreflexes---vagus (cough/occlusion), tympanic plexus
(red reflex), and lymphatic (swelling reaction to
pressure) in the cartilaginous area of the canal that
tend to act as “tripwires” for adaptation to hearing
aids and acoustic couplers. When protective keratin has
been removed by “cleaning” the ears these neuroreflexes
are laid bare for oversensitivity, and the invading
hearing aid or coupler becomes a “foreign object” as far
as the neurological system is concerned. In fact, just
the act of making an ear impression often removes so
much keratin that few ears---left untreated---will have
enough keratin grown back by delivery time to be able to
cushion the ear prosthesis from “own voice”, “too long”,
and “fuzzy sound” complaints--- complaints derived by
exposure of the above-described reflexes7.
Moreover, by following a uniform regimen of at least two
weeks’ use of Miracell by EVERY new patient, we have
been able to reduce remake rates to less than 5% and RFC
to about 2%. Of those in our DigiCare Network, who’ve
also adopted using Miracell as standard procedure,
similar experiences are reported. Later in this paper I
will discuss the procedures involved.
II. ADHESIVE OTITIS RESIDUE
Some of the most dramatic cases of improvement while
utilizing Miracell botanical were observed in the
changes that occurred with TMs thickened as a result of
long-standing residue of adhesive otitis media (glue
ear).8 In most cases, the incidence of chronic otitis
media had occurred during the patient’s first three
years of life, age 0-3 years. Imagine, if you will,
seeing an 82 year-old patient with residue resulting
from chronic OME (untreated) that occurred during early
childhood! Yet this phenomena can be commonly observed
in the hearing impaired population.
In a typical case of adhesive otitis residue,
tympanograms were A-shallow, accompanied with complaints
of painful barotrauma during sudden altitude changes.
Compliance at the TM is simply not flexible enough to
take up the slack between Eustachian tube pressure
equalizations (about every third or fourth swallow).
Appearance at the TM is generally opaque with
yellow-orange patches appearing from the mucosal side of
the TM. Most educational illustrations of these ears are
simply referred to as “normal”, but after having seen so
many of these lose the yellow-orange residue after 2-4
weeks’ use of Miracell we are convinced that these are
anything but “normal”. The resulting compliance changes
during Tympanometry have convinced us that these are not
“static states” of the TM, and that they can be
non-medically remedied.
It appears that the ingredients in Miracell penetrate
through at least 7 layers of tissue. In the case of the
TM there are only three (epithelial, fibrous & mucosal),
a relatively gossamer structure9 through which Miracell
ingredients can do their work. In the process of
inspiring accelerated epithelial cell growth it appears
that the residue and scar tissue of past (untreated)
infections “sloughs off” and is replaced with new,
pristine tissue, even down to the mucosal layer.
Compliance returns as air pressure distribution between
the pars flaccida and pars tensa equalizes, at least
without the degree of contrast found in the pre-treated
state.
Other benefits of this process, as will also be noted in
cases of tympanosclerosis et al, are:
o Reduced impedance at the TM; amplification is more
efficient with less transform distortion
o More normal loudness growth at the TM and throughout
the ossicular chain
o Reports of own-voice quality improvements
o Reduction of minor air-bone gaps (<10dB)
o Better wide range fidelity at the TM (if the aid’s
receiver is within 3/8” of the TM)
That last benefit apparently is the result of involving
the TM as the “speaker” that resonates at the lowest
possible fundamental (at about 20Hz in younger adults,
40-50Hz in the older adults). When the lower end of
fundamental resonance is expanded via amplification
there is also a converse extension in the high frequency
harmonics, as well. In fact, the lower the fundamental
resonance at the TM the higher potential resonance at
the other end of the frequency spectrum. Otherwise,
adhesive otitis residues tend to dampen the potential
range for both low fundamentals and high harmonic
response at the TM. Thus, the artificial narrowing of
the range of resonance at the TM can contribute to a
further reduction of spatial bandwidth in cases of
hearing impairment.
III. CALCIUM PLAQUE (TYMPANOSCLEROSIS)
Because of the rapid increase in osteoarthritis and
osteoporosis in the general population today, many
physicians are recommending mega doses of calcium
supplements to patients. While superficially we find
this a good recommendation, the problem now exists that
the type of calcium recommended or the pH states of the
physical body of those taking the extra calcium is
dramatically increasing the amount of “free calcium” in
their systems.
Free calcium is calcium that is absent an ionic charge,
or cannot be easily absorbed into the bones. Studies
show that many commercially prepared calcium supplements
have very poor absorption rates.11, 12 The question is
where does the rest of that calcium go? It can be argued
that unabsorbed free calcium contributes to eardrum
plaque, hardened cholesterol plaque and kidney stones.13
Where this brings us in oto-health is that the extra
unabsorbed calcium appears to be causing an inordinate
rise in cases of tympanosclerosis and skelatonization of
the TM10, and increased progressiveness in some cases of
otosclerosis.8 This can be visually through video
otoscopy as white or gray plaque on the TM, or by
patient reports of discomfort during sudden air pressure
changes, and by shallow A tympanogram. It also
evidenced, but not as easily measured, in some cases of
extremely rapid loudness growth from SRT to MCL (i.e.,
SRT=55dB, MCL=65dB). This milder form of
tympanosclerosis, generally considered medically
untreatable, causes other complications in hearing aid
fitting, is suspected in reducing fidelity and
amplification clarity.
Miracell Botanicals enters the picture in these cases by
being utilized daily for a period of 2-4 weeks,
depending upon TM compliance readings (via tympanometry).
It has been noted that most, if not all, of the plaques
come off the TMs, starting with patches of clear tissue
and progressively involving the remainder of TM surface.
Participants of our Tinnitus & Amplification 2002
Study15, who were also found to have objective tinnitus
and significant TM calcium plaques, and where medical
treatment had already been ruled out, were often
recommended an ionically-charged calcium supplement
taken in conjunction with external Miracell application.
These cases appeared to exhibit tinnitus aggravated or
magnified by otosclerosis and tympanosclerosis, and
consequently generally reported a lessening of some
component of their tinnitus.
IV. STRESS CRACKS/FISSURES & SMALL PERFORATIONS AT THE
TM
Obscure in the literature but prevalent in the hearing
impaired population are stress fissures on the tympanic
membrane as a result of a variety of events, such as
acoustic or mechanical trauma, barotrauma, aerotitis
media, or other non-medically treatable events16, 17,
18. Left in the wake of such stress upon the delicate
hearing structure are cracks in the TM that prevent
tympanometry compliance tests until healed over. But the
problem is that in cases where calcium plaque fills the
scar tissue over time, often result in uneven resonance
across the surface of the TM.
During the course of using Miracell botanical solution
we observed that these scars disappeared in most cases
as new epithelium rapidly grew in its place. In many
cases, the cracks and fissures completely disappeared.
This was an entirely unexpected bonus for our patients,
who also noted that sound resonated more naturally.
Complaints of chronic fullness or dullness also resolved
where TM scar tissue appeared to be the cause. In a few
cases, air conduction scores rose by 5-10dB in the low
frequencies, often reducing the small but important
air-bone gaps after a period of use.
V. EXCELLENT EAR CARE TRAINING FOR PATIENTS
By utilizing Miracell in the recommended manner,
patients enjoy a valuable educational experience in the
care of their ears.4 They learn about the ear and what
is proper for its ongoing care. They learn about the
several reflexes that heretofore have gone unmentioned,
but which can trip up their success with prosthetic
amplification. They learn good oto-health habits that
will stay with them for years to come. When using cotton
swabs, they understand how to avoid trauma to the ear
canal by not inserting to depths past the aperture of
the ear canal opening. They also learn of and avoid:
o The tissue devastation that occurs when using hydrogen
peroxide solutions
o Boric acid and other harsh solutions when ears itch
from regular contact with water
o All probing objects that can introduce bacteria, yeast
and fungus, including unclean ear plugs
o Exposure to loud noise and acoustic trauma
o Sudden altitude and pressure changes that can decimate
ear structures
o Ear candles and other home remedies that harm the ear
o Calcium supplements that promote an abundance of “free
calcium” plaque
PROCEDURE FOR USE SIMPLE, BUT CRITICAL
Hearing aid patients are instructed to literally
“inundate” the eardrum with the solution, as any amount
less will not reach the necessary structures of the ear.
The standard time of use is 10-14 days prior to
receiving new hearing aids or earmolds. But in cases
where such so-called “normalities” as absent keratin,
mild tympanosclerosis, adhesive otitis residue, etc. are
observed during video otoscopy, a 2-4 week course is
recommended.
Instructions for use of Miracell Botanicals solution are
as follows:
1. Remove cap from container
2. Tilt head to the side, and pour a generous amount
into each ear until one feels the solution on the
eardrum
3. Place a wad of tissue paper at the opening of the ear
to keep fluid from running back out
4. Leave tissue in ears for a period of about 15-20
minutes before removing
5. Repeat procedure once each day during the recommended
period of time
In conclusion, we’ve tried this same procedure with
various other products, and have found none to inspire
the kind of benefits experienced with Miracell
Botanicals. Indeed, other common preparations were
either caustic to ear tissues, lowered pH flora or
closed off air circulation to tissues (i.e., mineral
oil). Like about a dozen other products used regularly
in dispensing practice, Miracell does not require a
prescription nor is its use the practice of medicine. It
is simply a common sense approach to making hearing aid
fittings more comfortable and auditory rehabilitation
programs more effective.
Dr. Chartrand is director of research for DigiCare
Hearing Research & Rehabilitation, Rye, Colorado, and a
recognized professional education instructor in the
hearing industry. Contact: www.digicare.org.
References
1. Chartrand, M.S., “Video Otoscopy Observation &
Referral: The FDA Red Flags”, Hearing Professional,
Jan-Feb, 2003, pp. 9-14 (2003)
2. Chartrand, M.S., “But What’s Wrong with Q-tips®?”,
Archives, Audiology Online Newsletter:
www.audiologyonline.com, January (2003).
3. Johnson A., and Hawke, M., “The nonauditory
physiology of the external ear”, from Physiology of the
Ear, eds. A.F., and Santos-Sacchi, J., Raven Press: New
York, pp 41-58 (1988).
4. Chartrand, M.S., “Basic Course in External Ear Care”,
Hearing Library, DigiCare Hearing Research &
Rehabilitation: www.digicare.org (2002).
5. McSpaden, J. B., and McSpaden-Hickock, D.K., and
Hickock, R.L., “More than everything you wanted to know
about non-acoustic occlusion and venting,” Audecibel,
Jan-Mar (1993).
6. Hawke, M., “Atlas of Clinical Otoscopy”, Modern
Medicine of Canada, Vol. 36, No. 3, pp. 303-310, March
(1981).
7. Chartrand, M.S., and Chartrand, G.A., The Nuts &
Bolts of Auditory Rehabilitation, Continuing education
course for the International Institute for Hearing
Instruments Studies: Livonia, MI (2002).
8. Katzenmeyer, K., Vrabec, J., and Quinn, F.B.,
“Otosclerosis”, Grand Rounds Presentation, UTMB,
Department of Otolaryngology, October 27 (1999).
9. Sundstrom, J., and Mulligan, K., Neuroanatomy
Interactive Syllabus; Ch. 7: Auditory System, University
of Washington (2002).
10. Encyclopaedia of Medical Imaging, Volume VI:2,
Amersham Health, (2002).
11. Kohls K., Kies C., “Calcium bioavailability: A
comparison of several different commercially available
calcium supplements”, J Appl Nutr 44: 50-62 (1992)
12. Heaney R.P., Recker R.R., and Weaver C.M.,
“Absorbability of calcium sources: the limited role of
solubility”, Calcific Tissue Int, 46: 300-304 (1990).
13. Quinones, A., “EDTA Chelation and Calcium”,
www.anitafinley.com, (2000)
14. Calcium with ionic charge (benefits)
15. Tinnitus & Amplification Study 2002, Prospectus,
Hearing Library, www.digicare.org, (2003)
16. Middle Ear Barotrauma,
www.scuba-doc.com/midearbt.html, (2003) Ditto
17. Slattery, WH III, and Saadat, P., “Postinflammatory
medial canal fibrosis”, Am J Otol, 18:294-297, (1997)
18. Roland, P.S., “Chronic External Otitis”, Ear, Nose &
Throat Journal, June Supplement, (2001). |
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