22 devices · GMDN 47542
A middle ear decompressor, positive pressure is a manual device designed to relieve symptoms caused by negative pressure in the middle ear by delivering controlled positive pressure to the Eustachian tube. It is used to counteract or prevent conditions such as fluid buildup behind the eardrum and is typically composed of a hand-operated inflator/deflator (like a balloon) connected to a nasal, oral, or facial applicator.
This category of device is intended for reusable use in home settings and is regulated as a medical device based on its mechanism of action and intended use. Regulatory classification and supply pathways depend on the specific jurisdiction and the device’s risk profile, but all devices in this category must meet applicable safety and performance requirements for non-invasive, pressure-modulating ear devices.
This category summary is AI-generated from the GMDN nomenclature and has not been verified by a human reviewer.