80% of all children have ear infections before the age of three, which represents 16M annual episodes in the US alone. 20-30% of children have an average of 6 recurrences before the age of seven. Ear infections are the most common cause for a sick child visit to the doctor and accounts for half of all pediatric antibiotics. The World Health Organization attributes 28K annual deaths to complications resulting from ear infections.
The Unmet Need
Watchful waiting for 48-72 hours leaves the child in pain and generates significant parental stress as well as social burden and indirect cost due to time lost from school and parental work. The new American Academy of Pediatrics guidelines reinforces watchful waiting which is the norm in Europe. However, watchful waiting also exposes the child to potential complications such as mastoiditis and meningitis.
The use of systemic antibiotics with children has been tied to disruption of the microbiome which results in autoimmune disorders such as food and other allergies, asthma as well as digestive disorders such as inflamed bowel disease and obesity.
Ear ventilation tubes are recommended for children after 3-4 rounds of antibiotics in 6-12 months. However, tube insertion requires general anesthesia which results in a 2.5 times increase in the prevalence of childhood ADHD.
