The ConfirMEE - Ear Effusion detection and characterization system is a non-invasive diagnostic device used to detect fluid in the middle ear.  An additional key feature of the product is that it will provide an indication of the viscosity of any middle ear fluid, which has in previous research been correlated to the level and type of infection.  With this information, the primary care physician can make more informed decisions about the appropriate course of treatment, including whether or not to prescribe antibiotics.  This in turn should lead to a reduction in unnecessary antibiotic use.

The device is intended to be a cost-effective, portable and easy to use system that can be utilized by primary health care physicians in their offices.  This will provide a unique and accurate tool for pediatricians and general family practice physicians to aid in this common and critical diagnosis.

The current practice of detecting middle ear infections is far from optimal.  At the early stage of the disease, the most common method is a visual examination (otoscopy) of the eardrum and ear canal.  The diagnostic decision is based on the observed degree of redness and inflammation.  Visual examinations do not provide exact information regarding the cause of the inflammation (infection or other).  This consequently leads, in many cases, to the unwarranted prescription of antibiotics.  It is believed that up to 80% of antibiotic prescriptions for common ear problems may be unnecessary.  Over-medication of antibiotics for common ear problems is believed to be a leading cause for development of antibiotic resistant bacteria in children.  The Center for Disease Control (CDC) has begun issuing recommendations for more cautious issuance of prescriptions of antibiotics in an efforts to prevent this problem and are strongly encouraging means to reduce unnecessary prescriptions, such as development of new diagnostic methods for accurately detecting infections.

If the symptoms or inflammation persist, the patient is referred to a specialist, who will generally employ tympanometry for a more accurate assessment of the presence of the effusion in the middle ear.  Tympanometry uses pressure and audible signals to measure the compliance of the tympanic membrane.  It is not indicated for small infants, is very sensitive to physician technique, and has reported accuracies of only 50 to 80%, depending on clinician experience.  A positive indication from tympanometry usually leads to myringotomy, or the incision and placement of tubes through the eardrum.

Otosonic’s ConfiMEE Ear Effusion Monitor technology, which relies on ultrasonic pulses that penetrate the tympanic membrane and are reflected off the back of the ear in the presence of fluids, will provide diagnostic accuracy.  Additionally, it will provide an indication of the viscosity of the fluid, something no existing device can currently provide.

ConfirMEE White Paper

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Kids Health
http//kidshealth.org/parent/infections/bacterial_viral/otitis_media.html

National Institutes of Health
http://www.nidcd.nih.gov/health/hearing/otitismedia.asp

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