A sterile device designed to be inserted into a surgically-created tracheo-oesophageal fistula after total laryngectomy by a clinician to provide the patient with voice restoration. It is inserted and replaced on an as needed basis by a speech pathologist or clinician. It has a double flange (one on the outside of the throat and one on the inside) to hold it in place and includes a one-way valve that protects the airway during swallowing and opens under positive pressure so that air crosses into the oesophagus to produce voice (speech rehabilitation). The user periodically cleans the device in situ. This is a single-use device.