Start Date
July 24, 2018
Primary Completion Date
December 1, 2020
Study Completion Date
January 1, 2021
EarPopper
The EP device is 510(K) regulated (510(K) Number K073401) as a non-surgical, non-drug related treatment for middle ear pressure problems. The device is based on the Politzer Maneuver, and works by opening the Eustachian tube by delivering a safe, constant stream of air into the nasal cavity. In clinical studies funded by the National Institutes of Health (Grant#: 5R44DC003613-03), the EarPopper has proven to be effective in reducing chronic middle ear effusions. By regularly aerating the middle ear, we hypothesize that the EarPopper device will be an effective prophylactic measure to reduce incidence of AOM in children with recurrent OM. The device delivers a jet of air pressure from the nozzle at 5.2PSI, at a volume velocity of 1,524mL/min.
Lenox Hill Hospital, New York
Lead Sponsor
Northwell Health
OTHER