5-2019-1271

Tympacifier Detection of acute otits media (Ear infection)

Acute Otitis Media (AOM) is the most common bacterial infectious disease in children
worldwide with a approximately 709 million cases per year. AOM is currently diagnosed by
otoscopy which suffers from low specificity with approximately 40% of correctly-diagnosed
cases. The limitation in diagnostic methods, along with the fear of severe complications
when not treating AOM, causes overdiagnosis of AOM and overuse of antibiotics. The
above yields a growing need for an innovative and efficient technological solution to
accurately diagnose AOM.
SOLUTION / PRODUCT
The Tympacifier’s diagnostic solution is based on the neural electrophysiology of taste and
its interpretation by the brain. Taste sensation is carried from the tongue to the brain by
the Chorda Tympani Nerve (CTN) which passes through the middle ear (at the ipsilateral
side of the tongue). In a unilateral AOM, the inflammation in the diseased ear impairs the
CTN conductivity in compare to the healthy ear, therefore affecting the taste signal pattern
reaching the brain. The Tympacifier’s system is composed of a) pacifier with miniature
stimulation electrodes, b) an EEG electrode for brain sensing (placed behind the ear) and c)
a dedicated mobile application for the analysis and diagnostic of the diseased ear. The system
operates by applying a bilateral electrical stimulation to the tongue to generate two taste
sensation signals. It then analyzes and compares the brain response of the two taste signals.
The signal travels from the diseased ear is identified and the system displays the result.
COMPETITION
Although AOM is highly common, diagnostic tools are limited. Today, the leading method
for AOM diagnosis is an otoscopic examination, in which the physician looks for visual
properties of the tympanic membrane. These methods are cumbersome, subjective,
operator-dependent and don’t provide the sufficient specificity and accuracy results. Newer
methods which are based on visual diagnostic and ultrasound are becoming available, yet
are still subjective and highly defendant on the operator.
EXECUTION PLAN
1st year objectives are to further research the brain response to taste, develop a
prototype and validate the system with healthy volunteers. 2nd year objectives are to
further develop the product and validate the product in a clinical first-in-man study to
assess the performance.
THE TEAM / RELEVANT EXPERIENCE
A seasoned team with relevant expertise in medical affairs, physiology, product
development and clinical research:
 Prof. Mickey Scheinowitz, Ph.D, Biomedical Engineering – Head of BioMedTech
program, TAU
 Ari DeRowe, M.D. ENT Specialist, Director, Pediatric Otolaryngology Unit, Tel-
Aviv Medical Center
 Tal Barkai, M.D. Intern (B.Sc. in Brain Science)
 Linor Klein, M.D. Intern (B.Sc in Computer Science)

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