IHS RED FLAGS Webinar PPT 2 - International Hearing Societyihsinfo.org/IhsV2/Education/pdf/FDA-Red-Flags.pdf7/29/2014 2 Housekeeping This presentation is being recorded CE credit is

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Welcome to

FDA Red Flags

Presenter:Chris Gustafson, AAS, ACA, BC‐HIS Evergreen Hearing Center, [email protected]

Fran VincentMarketing & Membership

Manager

Carrie PedersenProject Supervisor

IHS Organizers:

Note:

This presentation highlights recognized principles commonly found

in the legal arena, but in no way connotes nor should be considered as legal advice. It is recommended you consult your legal counsel for specific advice regarding legal matters that may be pertinent to you.

No relationship exists that represents a potential conflict of interest or special business relationship between the International Hearing Society and Chris Gustafson and Evergreen hearing Center or any of

its principals or employees.

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Housekeeping

This presentation is being recorded

CE credit is available! Visit ihsinfo.org for details

Note taking handouts are available at ihsinfo.org on the webinar page. Feel free to download now!

Agenda

The importance of the FDA and FTC Red flags

How FDA Red Flags relate to a series of medical conditions

FTC Red Flags and how they relate to marketing and policy

Q&A (enter your questions in the Question Box any time)

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THE FDA RED FLAGS

AND WHY ARE THEY SO IMPORTANT

The FDA RED FLAGS

1. Visible congenital or traumatic deformity of the ear

2. Active drainage from the ear in the past 90 days

3. Sudden loss within the past 90 day

4. Reported acute or chronic dizziness

5. Unilateral hearing loss of sudden or recent onset within

90 days

1. Air‐bone gap greater than 15dB at 500, 1 & 2k

2. Reported pain or discomfort

3. Excessive cerumen or foreign body in the ear

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#1 Visible congenital or traumatic deformity of the ear

Whenever we see an ear that is deformed, whether it is congenital, (meaning from birth), or acquired, which has occurred since birth or from trauma:

Identify through observation

Question the patient

Refer the patient on to a physician for medical clearance


Congenital Deformities

The term congenital means conditions that has existed since birth

Developmental

Deprivation

Disease processes

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Congenital Deformities

Microtia – abnormally small ears

Atresia – a congenital absence or complete closure of the ear canal or absence of the external auditory meatus.

This may be accompanied by undeveloped or under‐developed middle ear ossicles.


Acquired Deformities

Exostosis –

Bony growths arising from the surface of the bone within the bony portion of the ear canal

This results from prolonged exposure to cold water.

This can result in the narrowing or closure of the canal near the tympanic membrane.

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Osteoma –

This is a single benign tumor resembling cortical bone occurring at the tympanomastoid structure line that tends to have a narrow base.

Again, this can result in the narrowing or closure of the canal near the tympanic membrane.



Traumatic Deformity –

We are apt to see more of this as the veterans come into our offices as they have been exposed to violent explosions, extreme noise or embedment of a foreign object. Other trauma‐induced conditions may result from a blow to the head or result in cauliflower ear.

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Disease induced deformities may include:

Benign or malignant tumors,

External or middle ear cholesteatoma

Melanoma Mastoiditis ‐ and Mastoidectomy These deformities may be the result of previous surgeries such as a mastoidectomy. Often time, this may be overlooked with a hand held otoscope where video‐otoscopy may be more revealing.

Your patient history questionnaire should reveal this fact

#2 Active drainage from the ear in the past 90 days

Suppurative Otitis Media –

That is an acute or chronic Otitis Media with infected fluid or suppuration and inflammation of the middle ear with infected fluid.

This is usually most evident to the dispenser from the odor at the ear or on the earmold.

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Staphylococcus – These bacteria is one of the most common forms of acute or chronic external otitis.

With extreme cases of Staphylococcus;

the external meatus may close entirely.

There may be edema (swelling due to abnormal accumulation of fluid), exudates (an infected fluid substance discharged from the cells or blood vessels ‐ pus).


Staphylococcus – The patient will report having pain at or near the ear. Staphylococcus usually responds well to antibiotics.

This may be more prevalent with swimmers.

It is more common in hot and humid climates.

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Staphylococcus – These bacteria is one of the most common forms of acute or chronic external otitis.

With extreme cases of Staphylococcus;

the external meatus may close entirely.

There may be edema (swelling due to abnormal accumulation of fluid), exudates (an infected fluid substance discharged from the cells or blood vessels ‐ pus).


Otomycosis – This is an infection due to a fungus in the external auditory canal. The most common complaint is itching.

Cerumen has a pH of 4 to 5 and so suppresses both bacterial and fungal growth. Aquatic sports, including swimming and surfing, are particularly associated because repeated exposure to water results in removal of cerumen and drying of the external auditory canal.

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#3 Sudden loss within the past 90 days

Any reported sudden or rapidly progressive hearing loss should set that little red flag waving in the back of our minds.


The causes of a sudden loss may be from trauma, infection, disease, cochlear stroke, acoustic neuroma, ototoxicity or allergies.

In some cases with prompt medical attention, the loss may be reversed. So refer the patient immediately.

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Trauma –

Head injuries resulting in

temporal bone fracture

concussion

direct injuries to middle or inner ear

barotrauma (drastic air pressure changes)

These are common with water skiing and scuba diving accidents


influenza

scarlet fever

whooping cough

meningoencephalitis

viral cochleitis

mumps

measles

chicken pox

diphtheria

herpes zoster otitis

Viral Disease

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Bacterial Disease

Meningitis

Bacterial labyrinthitis


Case in Point The patient claimed her hearing aid died.

But . . .

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Aminoglycosides

Aminoglycosides are a class of antibiotics used in treating infections caused by gram negative aerobic bacteria. All of these are ototoxic, and to some degree these are most vestiblotoxic.


Aminoglycosides

• amikacin

• gentamycin

• kanamycin

• livodomycin

• neomycin

• netilmycin

• sisomycin

• streptomycin

• tobramycin

• So, basically –

• Any of the mycin family drugs.

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Other Ototoxic Drugs

salicylates (aspirin)

iodine

sulfa drugs

quinine


Tumors of the Middle and Inner Ear

glomus tumor

osteoma

middle ear carcinoma

cholesteatoma

acoustic neuroma

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#4 Reported acute or chronic dizziness

First, we must understand the difference between dizziness and vertigo. In either case, these patients should be referred to a physician for immediate investigation.


Dizziness is a general term referring to an inability to maintain normal balance may be described as with nausea, hyperventilation, asphyxia or faintness, or light‐headedness due to circulatory problems or the sensation of spinning.

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Vertigo is a vestibular symptom affecting spatial nystagmus, which the patient reports to having a spinning sensation or senses the environment spinning around.


The causes might be the result of

Medication

Serious oto‐pathological illness vestibular dysfunction

acoustic neuroma

viral cochleitis

cochlear stroke

or Meniere's Disease

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Meniere's Disease or endolymphatic hydrops

This is pathology affecting the inner ear and results in a sensorineural hearing loss, tinnitus and vertigo and a sensation of ear fullness.

These symptoms may appear separately or simultaneously.

The hearing loss can fluctuate usually affecting the lower frequencies at first and spreading to all frequencies as time elapses.

#5 Unilateral hearing loss of sudden or recent onset within 90 days

Trauma and disease are generally unilateral in nature and should be referred to a physician prior to proceeding with auditory rehabilitation.

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#5 Unilateral hearing loss of sudden or recent onset within 90 days

Some of the causes can include:

Meniere's disease

Acoustic neuroma

Perilymphatic Fistula

Trauma

Autoimmune Disease

Perforation of the Tympanic Membrane

Cholesteatoma

Otitis media

#6 Air‐bone gap greater than 15dB at 500, 1 & 2k Hz

When air‐bone gap of 15dB or greater occurs at 500Hz, 1,000Hz and 2,000Hz, it indicates that there is a potentially significant medically treatable condition.

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Some causes of an air‐bone gap are:

In the outer ear and canal –

• Closure of the tragus

• Collapsed canal

• Atresia of the external ear

• Obstructions in the external auditory canal

• Accumulated cerumen or other debris

• Foreign object

• External otitis

• Fungus

• Pre‐and cancerous growths


At the tympanic membrane:

Perforation

Post‐infection or surgical scar tissue

Thickening of the TM from tympanosclerosis

Extreme flaccidness

Fluid

Cholesteatoma

Glomus tumor

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Within the middle ear:

Otosclerosis

Disarticulation

Otitis media

Mastoiditis

Cholesteatoma

Glomus tumor

#7 Reported pain or discomfort

The patient may report to having pain in and around the ear which may indeed be related to the ear or it may be as a result of mandibular joint (TMJ) or orthodontic abnormalities such as dental oversensitivity or sinus problems.

These should be reported unless they are under the current care of a physician or dentist.

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#7 Reported pain or discomfort

With visual assessment we should be able to determine the presence of swelling, the absence of the cone of light on the TM, redness or drainage in the ear canal.

Serious ear disease, trauma, or acquired abnormalities may also be the cause.

All, of which, should raise that red flag and be referred for immediate medical treatment.

#8 Excessive cerumen or foreign body in the ear

Impacted cerumen may result in:

Conductive hearing loss

Increased incidence of Tinnitus

Chronic cough

Tearing eyes

Interaural attenuation

Complaints of occlusion

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Depending on the sensorineural hearing loss, the audiometric pattern may be worse in the low frequencies with normal SN hearing to a flat loss configuration with a high frequency hearing loss.



Obstructed otoscopy of the canal and tympanic membrane.

Inability to perform impedance audiometry and acoustic reflexes

Inaccurate Audiometric test results

Inability to perform probe mic measurements

An accurate ear impression cannot be taken

The use of a hearing aid may cause excessive feedback or reduced gain

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"Significant," but not impacted, cerumen accumulation may result in:

Loss of natural ear canal resonance

Inaccurate Tympanometry results

Inaccurate probe mic measurements

Obstructed view of the canal and TM landmarks

Cerumen adhering to the tympanic membrane may cause Interaural attenuation and elevated hearing thresholds

Taking an ear impression may cause increased cerumen impaction

FTC RED FLAGSAND WHAT IT MEANS TO THE DISPENSER

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FTC RED FLAGS

According to the Federal Trade Commission

“Our mission”: To prevent business practices that are anticompetitive, deceptive, or unfair to consumers

The Federal Trade Commission works for consumers to prevent fraudulent, deceptive, and unfair business practices and to provide information to help spot, stop, and avoid them.

FTC RED FLAGS

Expert Endorsements

If an ad claims the endorser is an expert, the endorser must be qualified as an expert

Endorsements must be supported by actual exercise of expertise in evaluating the product

Comparison claims must be based on the expert’s evaluation

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FTC RED FLAGS

Endorsements

Focus is on the consumer’s perception of whether the message is an “endorsement” Fundamental question is whether the relationship between the advertiser and the speaker is objectively such that the speaker’s statement can be considered “sponsored by the advertiser”

If it is, then an endorsement

FTC RED FLAGS

Examples – Expert Endorsements

Hearing aid ad where endorser is referred to as a “doctor” implies she is a medical doctor; ad must make clear the nature and limits of endorser’s expertise.

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FTC RED FLAGS

Examples – General Considerations

• False and misleading – Doctor claims product is “clinically proven to work” even though she knows the clinical study has serious flaws

• False and misleading – Company pays a blogger to try new product and write a review; company is liable for any claims blogger makes about product and blogger is liable for misleading or unsubstantiated claims and is liable if she fails to disclose clearly and conspicuously that she is being paid

FTC RED FLAGS

ADVERTISING

If you take a manufacturer’s ad and change it, you need to send it back to the manufacturer for approval before you print and publish the ad.

You, may be liable as well as the manufacturer, if the ad is not accurate!

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FTC RED FLAGS

Example of Unsubstantiated and False Claims

Dahlberg, Inc. (1995) Hearing aid manufacturer claimed product would enable persons to distinguish and understand speech sounds in group or noisy situations, would restore natural hearing, and could reverse, halt or delay hearing loss progression

FTC concluded claims were unsubstantiated and false Failure to disclose material fact that person may not receive any significant benefit from any hearing aid Violation of a 1976 FTC order Settlement of $2.75 million

FTC RED FLAGS

Example of Unsubstantiated and False Claims

Media Maverick, Inc. (2004)

Marketer of metal bracelet that was allegedly “electro‐polarized” claimed product relieved pain; product was promoted on 30‐minute informercials and on the internet

FTC concluded claims were unsubstantiated and false Clinical testing showed product was no better than placebo

Settlement of $400,000

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FTC RED FLAGS

Providers who allow deferred payments must comply with the FTC Rulings by August 1, 2012

Interim Final Rule Narrows the Circumstances Under Which Creditors Are Covered

For Release

November 30, 2012

FTC RED FLAGS

Under the Rule, Red Flag Programs must have four parts. First, the Program must include reasonable policies and procedures to identify signs – or “red flags” – of identity theft in the day‐to‐day operations of the business.

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FTC RED FLAGS

Second, the Program must be designed to detect the red flags of identity theft identified by the business.

FTC RED FLAGS

Third, the Program must set out the actions the business will take upon detecting red flags.

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FTC RED FLAGS

Finally, because identity theft is an ever‐changing threat, a business must re‐evaluate its program periodically to reflect new risks from this crime.

FTC RED FLAGS

Case in Point

John Doe comes in to buy

Educate your staff and keep your programs current

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References

FDA

Singular’s Illustrated Dictionary of Audiology

Patient.co.uk

WebMD Health Search

The FDA Red Flags Video Otoscopy Observation and Referral

By Max Stanley Chartrand, PhD, BC‐HIS

www.fda.gov/medicaldevices/deviceregulationandguidance

Meg Gustafson. MS, FAAA

References

FTC ‐

www.ftc.gov/opa/2013/06/redflags.shtm

Google search FTC Red Flags

HIA Annual Meeting

Jeffrey N. GibbsHyman, Phelps & McNamara, P.C.

Washington, DC

[email protected]

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Questions

Enter your question in the Question Box on your webinar dashboard

THANK YOU FOR ATTENDING!

Contact Chris Gustafson:

[email protected]

For more info on obtaining a CE credit for this webinar, visit www.ihsinfo.org

Documents

IHS RED FLAGS Webinar PPT 2 - International Hearing Societyihsinfo.org/IhsV2/Education/pdf/FDA-Red-Flags.pdf7/29/2014 2 Housekeeping This presentation is being recorded CE credit is