Device typeTracheoesophageal speech valve, non-indwelling: A non-sterile device designed to be inserted into a surgically-created tracheo-oesophageal fistula after total laryngectomy, following wound healing, to provide the patient with voice restoration. It is placed by the trained patient into the fistula. 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 removes this device periodically for cleaning. This is a reusable device.
FDA categoryProsthesis, Laryngeal (Taub)
Device ID07331791000362
Catalog number7114
AvailabilityPrescription
MRI safetyLabeling does not contain MRI Safety Information
Length12 Millimeter