Efficacy of the EarPopper Device in Children With Recurrent Otitis Media

NAWithdrawnINTERVENTIONAL
0
Timeline

Start Date

July 24, 2018

Primary Completion Date

December 1, 2020

Study Completion Date

January 1, 2021

Conditions
Recurrent Acute Otitis MediaAcute Otitis Media
Interventions
DEVICE

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.

Trial Locations (1)

10075

Lenox Hill Hospital, New York

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Northwell Health

OTHER

NCT03534219 - Efficacy of the EarPopper Device in Children With Recurrent Otitis Media | Biotech Hunter | Biotech Hunter