Device Dossier

Prosthesis, internal, valve, speech, tracheostomy

Device Dossier for Prosthesis, internal, valve, speech, tracheostomy (Prosthesis, internal, valve, speech, tracheostomy, Class IIa, sponsor Main…

Intended purpose

Used to provide an air shunt from the trachea to the esophagus for laryngectomy patients. Commonly called a voice prosthesis, the shunt has a flapper valve which stops secretions from entering the trachea while allowing air to move from the trachea to the esophagus to produce voice.

TGA Public Summary