I-Corps: A New Delivery Technology for Treating Chronic Eustachian Tube Dysfunction and Otitis Media with Effusion

The broader impact/commercial potential of this I-Corps project is the development of minimal-invasive, cost effective, and reliable way of treating eustachian tube dysfunction (ETD) and otitis media with effusion (OME). OME is one of the leading causes of medical consultations and the most frequent reason for antibiotic prescription and surgery in children resulting in over $5 billion annual expenditures in the United States.

In the US, each year nearly 700,000 children have tympanostomy tubes inserted because of chronic middle ear fluid and frequent ear infections. Treatment-resistant children with ETD/OME are affected by conductive hearing loss, language development issues, poor school performance, and are much more likely to have chronic middle ear problems in adulthood.

The problem is equally concerning for many adults who continue to suffer from ETD despite available surgical treatments. ETD/OME is one of the main reasons for office visits in the USA and is estimated to affect 11 million US adults. Patients with chronic ETD (which occurs in ~11% of all ETD cases in the US) get frustrated and anxious about recurring visits for ETD/OME issues, while clinicians cannot provide effective care for these patients and insurance companies incur losses by reimbursing surgical procedures with limited efficacy.

This I-Corps project is based on the development of a technology for the treatment of the underlying causes of chronic eustachian tube dysfunction (ETD) and persistent effusions. Recognizing existing treatment limitations, the proposed technology is a non-invasive device for targeted delivery of medications into the eustachian tube (ET) pharyngeal opening.

The proposed approach has the potential to enhance outcomes for chronic ETD/otitis media with effusion (OME) patients from combining therapeutic action of formulations delivered into the ET (e.g., in reducing mucosal inflammation, hypersecretion, adhesion), and airflow and air pressure-assisted opening and insufflation of the ET. The hypothesis is that the approach may enhance particle deposition in the posterior region of the nasal cavity and enable formulation delivery to the ET orifice and lumen.

Local delivery into the ET potentially may be an efficient approach for treating underlying causes (e.g., mucosal inflammation) that contribute to chronic ETD and persistent effusions while minimizing systemic side effects. The proposed technology has the potential to become a new treatment for chronic ETD/OME.

This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.