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DigiCare® Hearing Research & Rehabilitation
Video Otoscopy Observations in Hearing Health Practice
Utilizing Miracell Botanical Solution
by Max Stanley Chartrand, Director of Research
Health & Human Services/Research in Communicative
Disorders
Introduction
Over the past 20 months we observed marked physical
changes in the external and middle ears in many of the
960 hearing impaired patients who followed a specific
regimen with the Miracell Botanicals solution. From the
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” ears
(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. Even at this point in time, not
a week passes that we do not find even more benefits of
this nature. Through these observations we have adjusted
our regimen time for each patient, from 10-14 days for
relatively “normal” ears and up to 30 days for long-term
cases of 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 claims of prognosis 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 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 reduced remakes 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.
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 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 three of the four neuroreflexes that
affect, or even inhibit, adaptation to the physical fit
of today’s earmolds. 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,
psuedomonas and other parasites, and helps maintains the
ear’s pH environment by mixing ceruminous and sebaceous
secretions into what we call “earwax”. It also allows
the “desquamated” growth of living epithelial cells
beneath to grow outward from the top of the upper rim of
the annular ring of the TM to the outer edge of the
aperture or the opening of the ear canal. By this
process, the ears are “self-cleaning” and not in need of
mechanical “cleaning” per se, unless, of course, one
mechanically “impacts” the wax into their canal.
We’ve also identified at least three
neuroreflexes---vagus (cough/occlusion), tympanic plexus
(re reflex), and lymphatic (swelling reaction to
pressure) in the cartilaginous area of the canal that
tend to act as “tripwires” for adaptation to acoustic
couplers. When protective keratin has been removed by
“cleaning” the ears these neuroreflexes are exposed and
made many times more sensitive. 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 reflexes.
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 by
long-standing residue of adhesive otitis media (glue
ear). In most cases, the incidence of chronic otitis
media had happened 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 from their
(untreated) ear infections from early childhood! Yet
this is common in the hearing impaired population.
In a typical case, 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 3rd
or 4th swallow). Appearance at the TM is generally
opaque with yellow-orange patches appearing on the
mucosal side (back) 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. The resulting compliance changes during
Tympanometry have convinced us that these are not
“static states” of the TM, and 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 structure through which it can do
its work. In the process of inspiring accelerated
epithelial cell growth it appears that the residue of
past (untreated) infections “sloughs off” and is
replaced with new, pristine tissue, even down to the
mucosal layer. Compliance comes up as does more even
pressure distribution between the pars flaccida and pars
tensa, at least without such great 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 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 absorbed into the bones easily. Studies
show that calcium supplements such as Tums and Rolaids,
for instance, have less than a 5% absorption rate; most
forms of calcium carbonate and citrate vary between
15-25% absorption. The problem is that the remaining
80-85% become “free calcium” that becomes deposited on
ear drums, joints, cholesterol plaque and as kidney
stones.
Where this brings us to oto-health is the extra
unabsorbed calcium appears to be causing an inordinate
rise in cases of tympanosclerosis and skelatonization of
the TM. This is often evidenced by white or gray plaque
on the TM, patient complaints of discomfort in air
pressure changes and by shallow A tympanogram. It also
evidenced, but not as easily measured, in cases of fast
loudness growth from SRT to MCL (i.e., SRT=55dB, MCL
65dB). This form of tympanosclerosis, generally
considered medically untreatable, causes other
complications in hearing aid fitting, primarily reduced
fidelity and amplification clarity.
Miracell 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 plaque comes off the
TMs, starting with patches of clear tissue and
eventually most of the TM. Patients on our Tinnitus &
Amplification 2002 Study also are changed to an
electrically-charged form of calcium (Chelated Calcium
Citrate with Vitamin D---usually 600mg per day) and
tinnitus aggravated or magnified by otosclerosis and
tympanosclerosis appears to lessen in almost every case.
In current standards of practice in hearing health ears
with this form of tympanosclerosis are considered
“normal”. In fact, textbook descriptions of “normal” TM
list “white” and “pearly” within the colorization
domain. We differ on that point, and now that we see
something can be done about these ears and the
improvements noted, feel it our professional obligation
to recommend this course of treatment as part of the
fitting regimen.
IV. STRESS CRACKS/FISSURES & SMALL PERFORATIONS AT THE
TM
Obscure in the literature but prevalent in the
population are stress fissures on the tympanic membrane
as a result of a variety of events, such as acoustic
trauma, trauma, barotraumas, aerotitis media, or other
traumatic events. Left in the wake of such stress upon
the delicate hearing mechanism are cracks in the TM that
prevent tympanometry compliance tests until healed over.
But the problem is that in most cases calcium plaque
fills the scar tissue leaving uneven resonance all
across the TM.
During the course of using Miracell botanical solution
we observed that these scars subsided 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.
V. EXCELLENT EAR CARE TRAINING FOR PATIENTS
By utilizing Miracell in the recommended manner,
patients enjoy a valuable educational experience. 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 or lack of success with prosthetic
amplification. They learn good health habits that will
stay with them for years to come. In using cotton swabs,
they understand how to avoid trauma to the ear canal by
refraining from 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
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 ear drum 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 “normalities” such as tympanosclerosis, missing
keratin, adhesive otitis residue, etc. are observed
during otoscopy patients are recommended a 2-4 week
course. The standard procedure is as follows:
1. Remove cap from container
2. Tilt head, pour a generous amount into each ear until
one feels the solution on the eardrum
3. Place a piece of tissue at the opening of the ear to
keep from running back out
4. Leave tissue in ears for a period of about 15-20
minutes before removing
5. Repeat procedure once per day during the recommended
period of time
In conclusion, we’ve tried this procedure with various
other products and have observed none to inspire the
kind of physical changes experienced with Miracell.
Indeed, all were either caustic to ear tissues, lowered
pH flora or closed off air circulation to tissues. Like
about a dozen other products used regularly in
dispensing practice, it 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 effective for hearing impaired
users.[page content goes here]
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