Max Stanley Chartrand, Ph.D.

(Behavioral Medicine)

CerumenManagement inthe Dispensing Practice

©2015 DigiCare® Behavioral Research

Attorney: Doctor, before you performed the autopsy, did you check for a

pulse?

Witness: No.

Attorney: Did you check for blood pressure? Breathing?

Witness: No, no.

Attorney: So, then it is possible the patient was alive when you began the

autopsy?

Witness: No.

Attorney: How can you be so sure, Doctor?

Witness: Because his brain was sitting on my desk in a jar.

Attorney: I see, but could the patient have still been alive, nevertheless?

Witness: Yes, I suppose he could have been alive…and practicing law.

Taken from an actual court transcription…

Cerumen Management in Dispensing: Expanded, Better Defined Scope of Practice in 2015

Section 101, 8c: Dispensing of hearing aids

includes…

Administering cerumen management in the course of

examining ears, taking ear impressions and/or fitting of

hearing aids,

Except…while engaged in routine cerumen removal [it is

discovered] trauma, continuous uncontrolled bleeding,

lacerations, or other traumatic injuries, [the dispenser] shall…

refer the patient to an otolaryngologist or a licensed

physician…”

Provisions re Cerumen Management in

New IHS Model Licensure Act: Section 113

(1) The licensee shall follow [state and] federal regulations, regarding Cerumen Management and referral of patients to a Medical Liaison.

(2) Training, Knowledge, and Skills.

(a) …[Obtain] training, knowledge, and skills necessary to perform [CM]

(b) Licensee shall obtain training that includes:

(i) Principles of [CM] including the anatomy of the ear canal and the ear

drum and classification of cerumen

(ii) Use of instruments [to remove/manage cerumen]

(iii) Techniques for cerumen removal

(iv) Recognition of complications

(v) Recognition of contraindications

(vi) Sanitation and safety procedures

Provisions re Cerumen Management in

New IHS Model Licensure Act: Section 113

(c) The licensee shall maintain documentation evidencing

…satisfactory completion of the training.

(3) Precautions:

(a) Licensee shall have established a Medical Liaison [within the

community] before performing cerumen removal

(b) Licensee may refer patients who exhibit contraindications [during]

cerumen removal requiring medical consultation or medical

intervention to a Medical Liaison

(c) Licensee shall carry appropriate Professional Liability insurance

before performing cerumen removal

(d) Licensee shall perform cerumen management using the customary

removal techniques commensurate with…training & experience

Practice Profile Scope of Practicere America’s Hearing Healthcare Team

0102030405060708090

100

Clin Assess Aud Assess

Dispenser

Audiologist

Physician

HA Related

Cerumen Management

Amp History

PT Audiometry

RE/SF/EA/CM

Amp Rec &/or

Referral

HA Related

Health History

Otoscopy

ME Assess

Flags/Referral

HA Related

Amplification

Servicing

Counseling

HA/Tinnitus/ALD/ADA

Clinical Assess

All Populations

Cochlear Impl

Pre/Post Op

Diagnose

Clin Tests

Clinical Assess

Cochlear Impl

Aud Function

Educational

Pre/post Op

Monitor Treat

Auditory Rehab

CI Prog/Rehab

Aud/Cognitive Treat

Balance Disorders

Post-Op Rehab

Peri-Post Treat Rehab

Tinnitus Management

Diagnose

Prescription/Treatment

Surgery

What are biomarkers? The National Institutes of Health (NIH) defines

biomarkers as:

“Characteristics that are objectively measured and evaluated as an indicator of normal biologic processes, pathogenic processes, or pharmacologic responses to a therapeutic intervention”

The FDA Red Flags are the Biomarkers that brought the dispensing profession into the larger community of health professionals

Abbreviated list of Red Flags:

Pain in the ear

Significant cerumen

Rapidly progressive loss

Sudden unilateral loss

Deformity of the ear

Active drainage

Acute dizziness

Average air-bone gap at .5K, 1K, and 2KHz >15dB

This is important: The entire body

can be affected in some way by

what occurs in the EAC region.

For example:

Hyper-reactivity in

Arnold’s (Vagus)

Reflex Can Evoke:

-Watering eyes

-Cough

-Gag effect

-Effortful phonation

-Chest tightness

-Heart tension(Pseudopericarditis)

-Nausea

Normal EAC Behavior with amplification relies upon two main components of physiology

The corneum stratum of EAC (unlike other areas of the human body,

the ear canal’s “epidermis” is 100%

keratin, rather than 85% with live

epithelial cells)

EAC Nuerophysiology &

vasculature (the guardians of EAC

immunology)

A Physiological Review of Mechanoreceptors in Human Skin

Corneum stratum of the epidermis comprises 100% of the External

Auditory Canal “epidermis”; no skin cells on the surface.

When EAC keratin is absent (via cotton swab trauma, low cellular pH, use of hydrogen peroxide, medication, diabetes mellitus II, etc., the mechanoreceptors of the EAC are exposed and become overly sensitive for hearing aid wear.

EAC Mechanoreceptors (You need to know them)

Hair follicles Senses slight air movement, incites vascular activity at TM

Meissner’s Corpuscles Senses light pressure near surface of epithelium, sends signal to tympanic plexus (Note: In complete reflex arc ceases

firing upon cessation of movement)

Pacinian Corpuscles Senses deep pressure in mid-level of tissue, sends signal to tympanic plexus region (Note: Excites cytokine and lymphocyte

production)

Vagal stimulation (via Arnold’s Branch)

Evokes various reflexes, including gag, cough, cardiac constriction, nausea in stomach

Trigeminal (Efferent neurons)

/Facial (Afferent neurons)

Controls vascularization & lymphatic activity (Note: Some aspects

have no parasympathetic response)

Evidence & Remediation of EAC

Neuroreflex Hyper-Reactivity

Trigeminal

(Red Reflex)

Hyper-vascularization re

Otoscope Speculum Placement

Requires increased gain/output after 15-30 minutes

Reduce/eliminate pressure in cartilaginous area of EAC or fit RIC

Vagus/Arnold’s Branch

(Cough Reflex)

Cough, gag reflex upon otoblock insertion

Complains of Non-acoustic occlusion, plugged sensation

Find most sensitive area & remove earmold material, or fit RIC

Lymphatic

(Tissue Swelling)

Painful sensitivity upon insertion of earmold in EAC—note missing keratin

HA becomes uncomfortable in short durations of wear, cannot acclimate

Improve keratin status before delivery, reduce pressure in EAC, or fit RIC

Reflex Label Observation Fitting Artifact Remedy

Use these one-of-a-kind tools to train staff, counsel patients, and sharpen your skills!

Since the introduction of video otoscopy in 1992, public health trends have changed dramatically

Chronic disease in every category has skyrocketed in the general population (Polypharmacy, DMII, Cancer, CVD & Neuropathies)

As cellular pH has dropped in the population in recent years, fungi, yeasts & pseudomonas, once rare , are now common

Incidence of absent EAC keratin has skyrocketed, making EAC mechanoreceptors overly sensitive to earmolds & hearings aids

Impacted cerumen has given way to keratosis obturans; untended cases progress to external ear cholesteatoma

Tympanosclerosis and other sclerotic plaques (due to acidosis) have proliferated approximately 5-fold in the general population

• Latent diabetes II case

Keratosis Obturans: Progression over 1-5

years into “the ingrown toenail of the ear”

• When cellular pH of the body falls below pH 7.1 (acidosis), external ear keratin can peel off at the rate of approx. 1mm per day. The example to the left is from a patient developing diabetes mellitus type 2 @ 6 months

• At year 4-5, several keratoses have formed, trapping dead skin cells, bacteria, amoeba, fungus, yeasts, etc., debris, and cerumen. Often mistaken for impacted cerumen

• Upon removal of just one of the keratoses, more are keratoses are revealed, each with their separate layers of keratin wrapped around the organisms listed above

• Upon removal of the final keratosis, a normal tympanic membrane is revealed

Potentially dangerous microorganisms

common to the external meatus

Acinetobacter Iwofii Long developing Impacted earwax

Sepsis; pneumonia; respiratory infections

Enterobacter Cloacae Untreated injury, infection (pseudomonas)

Sepsis, pneumonia, infection

Pseudomonas aeruginosa/anaerobic

Chronic EO, EM Irritation, pH<6.5

OE, Septicemia, pneumonia

S. areus Non-sterile earmolds, objects

Internal abscesses, carbuncles, boils

Aspergillus Favus -pH EM, hyper-natremia, DM II (dermatitis response)

Hypersensitive pneumonitis, other systemic disease

Candida Parapsilosis -pH EM, renal disease, thrush, DMII, gout

Candidiasis, skin Mucosal disease

Bacteria/Fungi Oto Culture Complications

DigiCare®

Introducing MiraCell’s ProEAR® Solution

16 years’ field observations:

Encourage keratin growth

Soothe ears re adaptation of earmolds

Help remove scar tissue, calcium plaque on eardrums, making amplification clearer

Soften hardened earwax for easier removal

Re-establish pH flora of ear canal (6.50-7.35)

Strengthen the ear’s immune system and dramatically reducing remakes & returns for credit

Standard Procedure for Using MiraCell’sProEAR® Botanical Solution in the Ear...

Tilt the head sideways & pour a generous amount of ProEAR solution into the ear (enough to cover the ear drum, evoking a shiver).

Place wad of tissue at the entrance of the canal and leave for at least 10-15 minutes

Do the same to opposite ear

Repeat procedure daily for 2 weeks & once weekly thereafter.

(Demonstration)DigiCare®

Patient: Doc, it’s been a month since my last visit with you and I still feel terrible.

Doctor: Did you follow the instructions on the medicine I gave you?

Patient: I sure did—the bottle said, “Keep Tightly Closed”

Video OtoscopyBiomarkers to Watch For

Peeled Keratin in EAC

Typical of many Pre-Diabetes and Diabetes Mellitus Type II cases, setting stage for a septic keratosis obturans, and ear canal overly sensitive. Other causes of this phenomena:

Hidden sepsis in jaw/teeth under crowns, root canals, periodontal disease

Prosthetic sepsis build-up (hips, knee, ankle, wrist, mesh screen, etc.)*

Other infections, eg recent upper respiratory infections (bronchitis, pneumonia, sinusitis

Intestinal infections, ulcerative colitis

In-grown toe nail, neuropathy of the legs/feet

*Note: Often accompanied by

persistent high blood sugar, A1C

scores.

Otitis Media/Acoustic & Barotrauma/

Tympanosclerosis/Scar Tissue

Mixed hearing loss

Flaccid Tympanometry

Bone loss

(otosclerosis/osteoporosis)

Programming challenges (resonance transfer abnormalities)

Medically intensive, refer for

cerumen management or risk

perforation

Epithelial/Congenital Abnormalities

Stenosis at Bony Isthmus

(Treacher-Collins)

Epidermis almost to the

bony isthmus

Yeasts growing from the TM

Absent keratin in EAC

“Blue Drum” Case

Aftermath of acute OME w/ barotrauma(airplane descent)

Pure-tone thresholds exhibit PTA of 65dB at 250Hz rising to 35dB at 2KHz

Complaints of own-voice (re occlusion), generalized vertigo, and disorientation

Normally, requires >3 months for recovery; in this case, recovery as shown in bottom photo required only 2 weeks’ use of MiraCell

Bottom photo, cleared to about 10dB of normal, little occlusion effect; return of light reflex

Earlier tinnitus complaint (buzzing, heartbeat) gave way to silence

Informed Consent

Documentation

Disclaimers

Verbal notification

FDA/HIPAA/State

DigiCare®

Other Medico-Legal issues

Set up your Community Hearing Healthcare Team

Develop lines of communication

Standardize medical information re case history

Professional Liability Insurance (example: >$3 million

up to $1 million per incident)

Observe practice boundaries

DigiCare®

CM Rules of Hygiene

Separate servicing areas from test sites

where possible

Keep equipment, tools clean, sterile---

think bacteriologically!

Always wash hands thoroughly between

patients/tasks

Use disinfectant on speculae between

patients/ears (alcohol does not disinfect)

Never insert a hearing aid after handling

without cleaning it first

Teach patients proper earmold hygiene

DigiCare®

Good ear care rules to follow:

Never insert Q-tips more than 1/3 into the ear canal

Avoid boric acid, hydrogen peroxide, acetic acid solutions

Ask for a video otoscopy exam from your doctor or

healthcare professional periodically

To help removing water from the ear canal, simply pull back

and downward on the pinna

Use Miracell® solution to prepare for new hearing aids,

before/after cerumen removal; any time the ear itches

Maintain ears by using Miracell® once per week if you swim,

wear hearing aids, or undergo frequent altitude changes

(Consumer Counseling)

Types of Cerumen Management*

Secondary Management: Otoscopic inspection, Otoblock

insertion/removal, Impression-taking, Hearing insertion/removal

Minimally Invasive: V/O wax loop, tweezers@3/4” depth

Gentle, Moderately Invasive: Softening agent, syringing

method (warm water/antiseptic solution)

Maximally Invasive: Jet Irrigation, Manual Curette Removal,

High Pressure Suction (Vacuum Pump—Caution!)

DigiCare®*Caution: Always ascertain use

of anti-coagulants, aspirin

Observation & Preparation…

Warm, Antiseptic Water (98-102o F)

After softened, gently remove keratosis

Debris gone, keratin migrating outward

Use these one-of-a-kind tools to train staff, counsel patients, and sharpen your skills!