Device Dossier
Tube, tympanostomy
Device Dossier for Tube, tympanostomy (Tube, tympanostomy, Class IIb, sponsor Rhino Surgical). ARTG record, intended purpose, GMDN category — compiled by…
- GMDN category: Tube, tympanostomy
Intended purpose
Indication: Recurring seromucotympanon; effusion of the tympanic cavity of different anamnesis. Ventilation tubes are small implants for the ventilation of the middle ear which are inserted into the intended situs: lower frontal (ai) or lower rear (pi) quadrant of the membrane, creating a passage between the middle ear and outer auditory canal. The purpose of a ventilation tube is to ventilate and/or drain the tympanic cavity. Thus, the pathologically changed mucous tissue of the Middle ear can regenerate and serious changes of the middle ear can be avoided. Piercing the tympanic membrane, Minimal Ventilation Tubes primarily serve the temporary ventilation of the middle ear and only secondarily the drainage of the middle ear.