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FDA Red Flags 7/29/2014 Welcome to FDA Red Flags Presenter: Chris Gustafson, AAS, ACA, BC‐HIS Evergreen Hearing Center, Owner [email protected] IHS Organizers: Fran Vincent Carrie Pedersen Marketing & Membership Project Supervisor Manager 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. 1 7/29/2014 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) 2 7/29/2014 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 3 7/29/2014 #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 #1 Visible congenital or traumatic deformity of the ear Congenital Deformities The term congenital means conditions that has existed since birth . Developmental . Deprivation . Disease processes 4 7/29/2014 #1 Visible congenital or traumatic deformity of the ear 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. #1 Visible congenital or traumatic deformity of the ear 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. 5 7/29/2014 #1 Visible congenital or traumatic deformity of the ear Acquired Deformities . 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. #1 Visible congenital or traumatic deformity of the ear Acquired Deformities . 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. 6 7/29/2014 #1 Visible congenital or traumatic deformity of the ear Acquired Deformities . 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. 7 7/29/2014 #2 Active drainage from the ear in the past 90 days . 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). #2 Active drainage from the ear in the past 90 days . 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. 8 7/29/2014 #2 Active drainage from the ear in the past 90 days . 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). #2 Active drainage from the ear in the past 90 days . 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. 9 7/29/2014 #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. #3 Sudden loss within the past 90 days . 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. 10 7/29/2014 #3 Sudden loss within the past 90 days . 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 #3 Sudden loss within the past 90 days Viral Disease . influenza . scarlet fever . mumps . whooping . measles cough . chicken pox . meningoence . diphtheria phalitis . herpes zoster otitis . viral cochleitis 11 7/29/2014 #3 Sudden loss within the past 90 days Bacterial Disease . Meningitis . Bacterial labyrinthitis #3 Sudden loss within the past 90 days . Case in Point . The patient claimed her hearing aid died. But . 12 7/29/2014 #3 Sudden loss within the past 90 days 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. #3 Sudden loss within the past 90 days Aminoglycosides • amikacin • sisomycin • gentamycin • streptomycin • kanamycin • tobramycin • livodomycin • So, basically – • neomycin • Any of the mycin • netilmycin family drugs. 13 7/29/2014 #3 Sudden loss within the past 90 days Other Ototoxic Drugs . salicylates (aspirin) . iodine . sulfa drugs . quinine #3 Sudden loss within the past 90 days Tumors of the Middle and Inner Ear . glomus tumor . osteoma . middle ear carcinoma . cholesteatoma . acoustic neuroma 14 7/29/2014 #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. #4 Reported acute or chronic dizziness . 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. 15 7/29/2014 #4 Reported acute or chronic dizziness . Vertigo is a vestibular symptom affecting spatial nystagmus, which the patient reports to having a spinning sensation or senses the environment spinning around. #4 Reported acute or chronic dizziness The causes might be the result of . Medication . Serious oto‐pathological illness . vestibular dysfunction . acoustic neuroma . viral cochleitis . cochlear stroke . or Meniere's Disease 16 7/29/2014 #4 Reported acute or chronic dizziness 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. 17 7/29/2014 #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. 18 7/29/2014 #6 Air‐bone gap greater than 15dB at 500, 1 & 2k Hz Some causes of an air‐bone gap are: In the outer ear and canal – • Accumulated cerumen • Closure of the tragus or other debris • Collapsed canal • Foreign object • Atresia of the external • External otitis ear • Fungus • Obstructions in the • Pre‐and cancerous external auditory canal growths #6 Air‐bone gap greater than 15dB at 500, 1 & 2k Hz At the tympanic membrane: .
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