FDA Red Flags: Video Otoscopy Observation & Referral


FDA Red Flags:

By Dr. Max S. Chartrand Ph.D.


Within the eight brief "red flag" otological-screening provisions of the U.S. Food & Drug Administration Hearing Aid Rule we find inclusive, comprehensive and uniform standards of observation for professionals involved in evaluating hearing status, dispensing hearing instruments and assistive devices, and making medical referral1.

Codified into federal regulation in 1977, the wisdom and foresight contained in these provisions have withstood the test of both time and experience. To this day, the regulation in its current form continues to assure consumers that medically treatable cases of auditory deficit, except those exempted by informed consent2, can and will receive medical treatment before non-medical solutions are pursued.

Though statistics show that approximately 90% of the hearing impaired population over the age of 18 suffer from non-medically treatable forms of hearing lesions, a very important 10% of the population do need and often respond successfully to medical treatment, when referred by dispensing professionals3. In a 1993 FDA field survey, it was found that 69% of patients utilized the waiver, the remainder opting to see their physicians before purchasing hearing aids, or about three times as many patients that statistically would be expected to require medical intervention4.

More importantly, advancements in research, technology, and professional education continue to open greater understanding of the many conditions that can potentially come under the current red flags. This ongoing development of knowledge requires that all dispensing professionals take more careful note of prospective hearing aid patients' medical and health status, including medications, and to work more closely with their family and ear physicians.

The advent of video otoscopy

Going from ordinary incandescent otoscopy to fiber optic to daylight-quality halogen-lamp technology has provided hearing health professionals with a great deal more information under routine inspection of the ears. But the single largest leap in technology came in the early 1990s with the advent of the video otoscope. This technology is still evolving as it enters the digital age. Freeze frame photography, wide-angle lens, blown-up onto high definition SVGA screens reveals even more microscopic information.

Video otoscopy is fast becoming a standard part of daily dispensing practice, as evidenced in recent surveys (see figure 2)5. Video otoscopy is also being built into real ear, programming and audiometric equipment, database patient management systems, and other diagnostic applications. If current trends continue it will only be a short time before video otoscopy is completely mainstreamed into every aspect of dispensing practice.

Improved observational capabilities suggest the need for increasingly more sophisticated continuing education and increased standards of practice, as well more interaction between allied professionals. It is the purpose of this paper to stimulate that movement, by listing a large array of oto-related conditions that may be better observed utilizing video otoscopy and through a more thorough case history interview than though conventional otoscopy.

Red Flag Review

These eight red flags provide for a host of conditions that may be observed during the patient case history and otoscopic examination. In most cases, the pathologies needing medical attention present within the external or middle ear. These include infection, allergy, trauma, deformity, and impaction. Other cases may involve possible cochlear, retrocochlear, or central pathologies. Therefore, it is important that dispensing practitioners be highly skilled in otoscopy, case history taking, and in recognizing potentially treatable conditions requiring medical referral.

A (hearing health professional) should advise a client to consult promptly with a licensed physician, preferably a physician that specializes in diseases of the ear, if the (hearing health professional) determines through inquiry, actual observation, or review of any other available information concerning the prospective user, that the client has any of the following conditions (updated language in parentheses):

  1. Visible congenital or traumatic deformity of the ear
  2. History of active drainage from the ear in the previous 90 days
  3. History of sudden or rapidly progressive hearing loss within the previous 90 days
  4. Acute or chronic dizziness
  5. Unilateral hearing loss of sudden or recent onset within the previous 90 days
  6. Audiometric air-bone gap equal to or greater than 15 decibels at 500 Hz, 1,000 Hz, and 2,000 Hz
  7. Visible evidence of significant cerumen accumulation or a foreign body in the ear canal
  8. Pain or discomfort in the ear

Flag #1: Visible congenital or traumatic deformity of the ear

Throughout the literature are identified myriad variations in size, shape, texture and coloration of the anatomy of the human ear, both normal and abnormal. Dispensing professionals should be able to recognize those differences, and to refer for congenital, acquired and traumatic deformities.

The term congenital connotes conditions that have existed since birth, i.e. whether developmental, deprivation or disease processes. Congenital ear deformities requiring reconstructive surgery are estimated at approximately 1 in 15,000 births in the U.S. population, such as the Treacher-Collins-Franschetti syndrome, a polygenic multifactorial developmental abnormality. Microtia and atresia may be accompanied by un- or under-developed middle ear ossicles, and orthodontic/mandible structures6.

Examples of acquired deformities are osteoma, hyperostosis, and exostosis7. Each represent a bony malformation of the external meatus canal often causing a narrowing or blockage of the canal opening toward the tympanic membrane. Traumatic deformity may involve a slap on the ear, blow to the head, violent explosion, extreme noise (>120dBSPL), hazardous chemical exposure, or embedment of a foreign object8. Deformities arising from trauma take forms too numerous to describe here. Evidence of bleeding, burns, swelling, discoloration, bone fracture, perforation, hemotympanum, and/or non-specific inflammation present reason for referral. Other trauma-induced conditions include cauliflower ear, perichondritis, and acquired atresia of the meatus.

Other deformities caused by disease may include:

  • Precancerous, benign, and malignant tumors, growths
  • Hematoma of the auricle
  • Mastoiditis with subperiosteal abscess
  • Herpes zoster oticus
  • External or middle ear cholesteatoma
  • Nodular melanoma
  • Ulcerated squamous cell carcinoma
  • Senile keratoma

Flag #2: History of active drainage from the ear in the previous 90 days

Suppurative exudates refer to the flow of pus from any part of the ear9. Etiology is determined via laboratory tests. However, the dispensing professional should have at least a rudimentary understanding of these conditions, and their associated pathologies:

Nonspecific Inflammation of the Ear. Allergy, dermatitis and diabetes mellitus can lead to chronic inflammation, epithelial atrophy and dry scales. In such cases the keratin layer of tissue is missing or separating from the epithelium. Chronic cases bring cycles of swelling and purulence, which can significantly interfere with the patient's ability to wear an earmold. Repeated episodes can cause maceration (soaking) of the meatal skin by purulent fluid until there is a reduction in elasticity of the skin and atrophy of the ceruminous and sebaceous glands. Keratin protein is also missing in most cases10. Disturbance of the pH balance of the tissue results, promoting growth of anaerobic amoeba (pseudomonas), fungus, yeast, and/or bacteria.

Bacterial and Viral Otitis Externa. Swimmer's ear is the common reference to a variety of bacterial and viral external ear infections11. Because of long periods of maceration (soaking) of the ear canal tissue and deep penetration of viral organisms, there is often a deep-seated phlegmonous suppurative inflammation.

Pseudomonas. Refers to a specific genre of anaerobic gram-negative organisms that often produce a most stubborn form of external otitis, especially for diabetics (including pre-, latent or manifest diabetes), or others with significant pH imbalance or autoimmune deficiency12. Left untreated this serious form of infection may cause insidious osteomyelitis of the temporal bone. Further, because pseudomonas is highly resistant to antibiotic therapy, under conservative treatment it may insidiously progress to the skull base because of deep tissue involvement, making it a potentially fatal disease13. It is the experience of the author that many of these cases can be latent and longstanding, and easily missed during a cursory medical examination. However, upon the fitting of a hearing instrument, providing an anaerobic environment, can expose the presence of latent pseudomonas. In such cases, it is critical that the dispenser and otolaryngologist discuss their observations.

Staphylococcus Aureus. This bacterium is considered the most common form of acute or chronic external otitis affecting approximately 10% of the U.S. population each year, primarily children14. Often there is a history of trauma by scratching, gouging, or using cotton swabs just prior to symptoms. In acute cases, the external meatus may close entirely due to edema, exudates (pus) and desquamation (shed tissue) as the bacterial medium. Pain is often evident while manipulating the pinna or surrounding tissues. Staphylococcus usually responds well to antibiotic therapy.

Furuncles. Sometimes described as a boil or skin abscess, can cause pain and swelling as well as purulent exudates. In such cases, latent or manifest diabetes may be at the root.

Herpes Zoster Oticus. Herpetic vesicles around the pinna, in the ear canal, and, sometimes, on the tympanic membrane characterize this disease. Becoming increasingly more common, medical referral and treatment is advised.

Otomycosis. A fungus, usually fungal mycelium, causes this common condition. Complaints are of itching, rarely of pain. Hence, a high incidence of such cases may be seen in the dispensing practice. Such cases should be cautioned about the use of Q-tips, which can cause the growth of other (secondary) bacteria. If whitish-yellow exudates are visible, hearing aid use is discouraged until antifungal treatment is completed.

Eczema of the Ear. Similar to otomycosis, eczema may take either the bacterial or fungal forms15. Continual exposure to moisture and absence of keratin tissue causes growth of pathogenic bacteria or fungi, especially with an earmold inserted. Fluctuation between inflammation, swelling, and drainage, and drying, scaling, and general irritation, this disease must receive medical attention to be brought under control. Note: some forms of eczema are caused by contact dermatitis or allergy to hair sprays, cosmetics, eyeglass frames, earmold plastics, cortisone use or antibiotics.

Flag #3: History of sudden or rapidly progressive hearing loss within the previous 90 days

Any sudden or rapidly progressive hearing loss would preclude dispensing activity until medical assessment. Many such cases need emergency attention, so it behooves the dispenser to refer to a physician immediately. Etiology could be trauma, infection, disease, cochlear stroke, allergy or ototoxicity. Below are listed some of the more frequently reported causes of sudden deafness:


  • temporal bone fracture
  • labyrinthine (cochleovestibular) concussion
  • direct injuries to middle or inner ear
  • barotrauma (drastic air pressure changes)
  • Caisson disease -acute acoustic trauma or catstrophe
  • mechanical incursion
  • foreign body incursion

Viral Disease

  • mumps, measles, chicken pox
  • influenza (neuritis statoacoustica)
  • adenovirus, whooping cough
  • scarlet fever, diphtheria, Coxsackie
  • viral cochleitis, herpes zoster otitis
  • epidemic parotitis, meningoencephalitis

Bacterial Disease

  • Meningitis, bacterial labyrinthitis
  • Richettsiae, Toxoplasma gondii

Ototoxic Aminoglycoside Antibiotics

  • streptomycin
  • dihydrostreptomycin
  • neomycin
  • kanamycin
  • gentamycin
  • vanomycin
  • viomycin
  • paranomycin
  • tobramycin
  • amikacin sulfate

Other Ototoxic Drugs

  • salicylates (aspirin), iodine
  • sulfa drugs, quinine
  • novocain, barbiturates, morphine, chloroform
  • furosemide, mannitol, hydrochlorothiazide (diuretics)

Other Known Ototoxic Substances

  • caffeine, alcohol, nicotine
  • lead, mercury, arsenic compounds
  • organic phosphate compounds, sulfur compounds
  • tetrachloroflourocarbon compounds, carbon monoxide
  • benzol, nitrobenzol, aniline dyes

Tumors of the Middle and Inner Ear

  • glomus tumor, osteoma,
  • middle ear carcinoma, cholesteatoma (benign)
  • acoustic neuroma, vestibular schwannoma16

Meniere's Disease, while a suspected cause of sudden deafness, will be discussed at greater length in the next section under "acute or chronic dizziness". For our purposes here it is important to point out that the three symptoms comprising this malady (tinnitus, deafness, and vertigo) may converge simultaneously or occur separately. The normal course of the disease (or syndrome) is often sudden and episodic. Its most pronounced symptoms usually vanish by the time of examination, leaving in their wake a progressively damaged hearing and balance peripheral organ. Often considered idiopathic, the most common causes are recognized as allergy, especially food allergy, lipoproteinemia (high blood lipids), ototoxicity (medication), and vascular disease.

Psychogenic forms. The discussion pertaining to sudden deafness would not be complete without some mention of a non-organic form of "sudden deafness" or psuedohypoacusis. "Hysterical deafness" is the vernacular for the form arising from tragic personal loss or acute emotional trauma17.

Flag #4: Acute or Chronic Dizziness

There are numerous medical conditions that can cause complaints of "dizziness". Many of the foregoing conditions mentioned above, whether disease, trauma, or ototoxicity may elicit such complaints. However, we must distinguish here between dizziness and vertigo. Dizziness may or may not involve ear pathology, but can be associated with nausea (vagus reflex in the stomach), giddiness (hyperventilation), faintness (asphyxia), or light-headedness (circulatory constriction). Vertigo, on the other hand, is a vestibular disorder affecting spatial nystagmus subjectively signaling an apparent (or visual) movement of the environment. Other forms may include ataxia and rototary vertigo18, both of which should be referred to a physician for immediate investigation. Perhaps medication is a cause, or serious otopathological illness, such as viral cochleitis, cochlear stroke, vestibular dysfunction, acoustic neuroma or Meniere's.

Meniere's Disease/Syndrome (or endolymphatic hydrops), as mentioned earlier, exhibits the triumvirate of tinnitus, deafness, and vertigo. Many sufferers complain of "roaring ears" and episodes of "dizziness" (vertigo), without an awareness of the hearing loss component. Post-attack symptoms may include nausea, vomiting, and fullness in the ear. In the early stages, hearing thresholds tend to be affected most in the low frequencies, while later stages may bring permanent deafness affecting the entire spectrum. Fluctuating thresholds require bracketing of audiometric readings until stabilized. Studies show incidence of Meniere's to be approximately 80% of cases unilateral and 20% cases bilateral19. Episodes may last from a few minutes to several days. The pathogenesis of Meniere's is found first in the quantitative imbalance of the cochlear-vestibular fluids, perilymph and endolymph. Separating the two fluids is the Reissner's Membrane. When the resorption of the potassium-rich endolymph fluid is impeded, a build-up of pressure (hydrops) occurs, sometimes causing the Reissner's membrane to rupture, and the mixing of the two asimilar fluids. This can lead to a more generalized and permanent form of the disease, leaving in its wake deafness, severe tinnitus, diplacusis (cochlear distortion), recruitment (abnormal loudness growth), and general vestibular dysfunction (vertigo).

Flag #5: Unilateral hearing loss of sudden or recent onset within the previous 90 days

Much of what has been covered in flags #3 and #4 applies to this section. Many pathologies of the ear appear unilaterally. Trauma and disease are generally unilateral depending upon the degree of exposure bilaterally. Cases that appear suddenly (defined in the regulation as within 90 days from onset) should be medically assessed before proceeding with auditory rehabilitation.

Flag #6: Audiometric air-bone gap equal to or greater that 15 dB at .5KHz, 1KHz, and 2KHz

While an air-bone gap of only 15 dB at 500Hz may not seem important in the overall scheme of things, when it also extends to 1,000Hz and 2,000Hz, a significant medically treatable condition may exist.

For instance, a simple Eustachian tube blockage or irritation such as found in a mild inhalant allergy or change of altitude (air pressure), can easily produce an air-bone gap of 15dB or greater at the relatively low frequency of 500Hz. Even barometric pressure changes have been found to cause similar affects in individuals. But, in each of these cases, involvement of the mid and high frequencies may indicate a deeper, more permanent problem. Some manifestations that may cause such an air-bone gap are:

  • Closure of the tragus or atresia of the external ear.
  • Obstructions in the external meatus such as: accumulated cerumen, exudates and debris accumulation, foreign object, otitis externa, fungus, pre-and cancerous growths, osseous formations, collapsed canal, or some mandible abnormalities.
  • At the tympanic membrane: perforation, post-infection or surgical scar tissue, thickening from tympanosclerosis, extreme flaccidness, disarticulation, or fluid, cholesteatoma, glomus tumor, or air pressure arising from Eustachian tube dysfunction.
  • Within the middle ear: disruption of impedance transformation or immobilized ossicles, otosclerosis, disarticulation, tensor tympani or stapedial muscle abnormalities, disruption of differential transfer at the oval or round windows, or fluid accumulation, otitis media, mastoiditis, cholesteatoma, glomus tumor, or again unequalized air pressure.

Flag #7: Visible evidence of significant cerumen accumulation/foreign body in the ear canal

Until the advent of high-definition video otoscopy, this provision of the regulation has been the main focus of otoscopic discovery in dispensing practice. But as one may see from the foregoing, cerumen accumulation is only one of a multitude of possible concerns20.

"Impacted" cerumen presents several challenges:

  • Conductive hearing loss, often accompanied by objective tinnitus, chronic cough (vagus), tearing eyes, interaural attenuation, and/or complaints of occlusion. If cochlear hearing is otherwise normal, the audiometric pattern is quite pronounced in the lows (usually about 40-60dB), rising to near normal in the highs. In cases of sloping of those with high frequency sensorineural impairment, air conduction thresholds tend to be "flat" in configuration.
  • Obstructed otoscopy of the canal and tympanic membrane.
  • Inability to perform impedance audiometry, acoustic reflex, electronystagmography (ENG), otoacoustic emissions, probe mic, and other tests in the clinical battery.
  • An accurate ear impression cannot be taken.
  • The use of a hearing aid is impossible or impractical.
  • Other pathologies may be obscured, causing delay in treatment.
  • "Significant" (but not impacted) cerumen accumulation may present these challenges:

  • While thresholds may not shift per se, other complications may occur, such as erroneous probe mic and tympanometry results, and a loss of natural ear canal resonance.
  • Obstructed view of the canal and TM landmarks, incomplete otoscopy.
  • Occlusion or fullness may still be a factor in some individuals exhibiting a sensitive vagus (Xth Cranial) reflex
  • Interaural attenuation, if traces of cerumen adhere to the tympanic plexus region of the pars tensa.
  • Difficulty in taking a proper ear impression, causing mechanical impaction.
  • Other pathologies may go undetected.

Flag #8: Pain or discomfort in the ear

In determining course of action with this flag, careful and informed judgment must be exercised. For instance, a number of spurious neurological artifacts unrelated to otological status can be identified by patients as "pain" or "discomfort". Examples are: dental oversensitivity, TMJ, sinus allergy, and facial nerve artifact, any of which could be mistaken for pain in the ear. These often have cross-action with ear-related nerves at either the mandible or tympanic plexus of the tympanic membrane.

Having said this, however, it is important to note that even these reports can and probably should be reported if they are not already under the care of a physician. The evaluator should always inquire deeper as to past history of the complaint, as well as note if it has been medically evaluated, by whom, and the course of treatment.

To determine correlation between reports of pain or discomfort and actual otological events, visual assessment should also be made for presence of swelling, redness, exudates, etc. Pain arising from the trigeminal (jaw, teeth, gums) could as easily result from mandibular or orthodontic abnormalities, neighboring sinuses and lymph glands (facial), or a host of contusions, swellings, and infections only peripherally proximate to ear anatomy. Sinus allergy can cause an "earache", etc.

Pain, nevertheless, is a motivating factor for patients to seek help. And though its management is generally outside the scope of practice of dispensing professionals, medical referral is often needed, because serious ear and non-ear related disease or pathologies might exist. On the other hand, serious ear disease, trauma, or acquired abnormality can also be the source of the complaint, and should certainly be referred for immediate medical assessment

An Opportunity to Build Interdisciplinary Teamwork

In the spirit of the FDA Hearing Aid Rule of 1977, one of the most important intentions of its framers was the building of cooperative community teams among hearing healthcare professionals21. Certainly, consumers of hearing healthcare come out better when local health professionals work together in best meeting their needs.

Two current initiatives---America's Hearing Healthcare Team Initiative and the BHI Physician Referral Development Program---are just two of several major efforts to instill greater cooperation between the various disciplines. The FDA Hearing Aid Rule of 1977 was designed to assure the "glue" that will bring hearing health professionals together and foster that kind of teamwork. The focus is, as always, on the well being of the patient, with each member of the team working toward providing the best possible outcome.

Dr. Chartrand serves as director of research for DigiCare Hearing Research & Rehabilitation, and as instructor for the International Institute for Hearing Instruments Studies and the American Academy of Audioprosthology. Correspondence: P.O. Box 706, Rye, CO 81069, or by faxing (719)676-6882, digicarenet@aol.com This e-mail address is being protected from spambots. You need JavaScript enabled to view it .


1. U.S. Food & Drug Administration Rules and Regulations Regarding Hearing Aid Devices: Professional and Patient Labeling and Conditions for Sale, Part IV, Federal Registers, 9286-9296, February 15, 1977

2. U.S. Department of Health & Human Services, Title 21 Code of Federal Regulations: Part 801-Medical Device Labeling, 4/1/91

3. Bove, C., Administrative Meeting of the Enforcement Division of the U.S. Food & Drug Administration, Silver Spring, MD, (1993).

4. Author's September, 1993 meeting with Division of Compliance Operations (HFK-116) to determine what constitutes appropriate compliance with waiver provision, Silver Spring, MD, (1993).

5. Hearing Review, Annual Survey, June, (2000).

6. Becker, W., Naumann, H.H., and Pfaltz, C.R., Ear, Nose and Throat Diseases, ed. Buckingham, R.A., New York: Theime Medical Publishers, Inc., pp. 134-136, (1989).

7. Jafek, B.W., Murrow, B.W., ENT Secrets, 2nd edition, Philadelphia: Hanley & Belfus,Inc., pp. 55-56, (2001).

8. Doyle, T.N., and Hoffman, J.E., "General Medical Considerations in Audiology", Jack Katz, ed., Handbook of Clinical Audiology, 3rd edition, Baltimore: Williams & Wilkins, pp. 39-47, (1989)

9. Newby, H.A., and Popelka, G.R., Audiology, 5th edition, Englewood Cliffs, NJ: Prentice-Hall, Inc., pp. 64-66, 71, (1985)

10. Chartrand, M.S., "Video Otoscopy Observations Utilizing Miracell Botanicals", Rye, CO: DigiCare Hearing Research & Rehabilitation, (2002).

11. Davis, W.E., "The external and middle ear", in Otolaryngology-Head and Neck Surgery: Principles and Concepts, Templar, J., and Dais, W.E., ed., St. Louis: Ishiyaku EuroAmerica, Inc., pp. 34-36, (1987)

12. Wallach, J., Interpretation of Diagnostic Tests: A Synopsis of Laboratory Medicine, 4th edition, Boston; Little Brown & Company, (1986).

13. Fishman, M.C., Hoffman, A.R., Klauser, R.D., and Thaler, M.S., Medicine, 4th ed., Philadelphia: Lippincott-Raven, (1996).

14. Northern, J.L., and Downs, M.P., Hearing in Children, 4th edition, Philadelphia: Lippincott Williams & Wilkins, (1991). 15. Habif, T.P., Clinical Dermatology, 2nd edition, St. Louis: C.V. Mosby Company, pp. 28-31, (1990)

16. National Institutes of Health, Office of Medical Allications Research, Consensus Statement on Acoustic Neuroma, Vol. 9, No. 4, Bethesda, MD, 1991.

17. Chartrand, M.S., Hearing Instrument Counseling, 2nd edition, Livonia, MI: International Institute for Hearing Instruments Studies, pg. 106, (1999).

18. DeGowin, R.L, DeGowin & DeGowin's Diagnostic Examination, 5th ed., New York: MacMillan Publishing Company, (1987).

19. Pulec, J., "Meniere's Disease", Hearing Disorders, 2nd edition, ed. Northern, J., Boston:Little, Brown, and Company, (1984).

20. Chartrand, M.S. & Chartrand, G.A., Nuts & Bolts in Hearing Aid Practice, continuing education course, Livonia, MI: International Institute for Hearing Instruments Studies, (2002).

21. Author's discussion with two of the original 1977 FDA panel members regarding the intent of the hearing aid rule at Tri-State Convention, Portland, OR, (1988).