Device typeTracheoesophageal speech valve, indwelling: A device designed to be inserted into a surgically-created tracheo-oesophageal fistula after total laryngectomy 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 patient periodically cleans the device in situ. Disposable devices associated with implantation/insertion may be included. This is a single-use device.
FDA categoryProsthesis, Laryngeal (Taub)
Device ID07331791010903
Catalog number8286
AvailabilityPrescription
Single useYes
SterileYes
MRI safetyMR Safe
Length12.5 Millimeter
SizeDiameter Outer - Fr 22.5