DEVICE: InHealth Technologies; Blom-Singer (00813307014454)

A non-sterile, smooth, capsule-like device intended to house/cover a tracheoesophageal device (e.g., speech valve, fistula gauge) at the distal end of the introduction assembly, to enable atraumatic insertion of the device into the tracheoesophageal fistula (puncture). It is a synthetic polymer gelatinous casing intended to dissolve in situ for subsequent digestion; disposable devices intended to assist mounting may be included. It is intended to be used in the home and healthcare facility, and may be used in conjunction with a lubricant. This is a single-use device.

A hand-held manual instrument designed to assist in the non-surgical placement of a tracheoesophageal device (e.g., speech valve, speech valve occluder, fistula gauge/dilator). It is a synthetic polymer holder onto which the tracheoesophageal device is distally mounted and directed to the target site through the tracheostoma. It is intended to be used by the patient at home (for non-indwelling devices) and clinician in the healthcare facility (for indwelling devices). This is a single-use device.

A non-sterile device intended to be placed in a surgically-created tracheoesophageal fistula/puncture (usually for more than 30 days) to: 1) maintain its shape and patency following total laryngectomy; and 2) to prevent leakage of fluids from the oesophagus into the trachea. It is made of synthetic polymer and includes a double retention flange and a neck fastening strap; it is not intended to enable voice production. It is inserted through the tracheostoma and replaced by a clinician as needed (indwelling type); devices to assist placement may be included. This is a single-use device.