DEVICE: InHealth Technologies; Blom-Singer (00848253003443)

A noninvasive device designed to be fastened around the neck of a patient to secure a tracheostomy device (tube, button) in situ. It is typically in the form of a dedicated strap/collar intended to connect to the tracheostomy device, which is not included. This is a reusable device.

A non-sterile hollow device intended to maintain tracheostoma patency after laryngectomy to provide an airway for the patient and to prevent tracheostomal stenosis in the months following the procedure. It is a soft plastic or silicone curved tube, similar to a tracheostomy tube, contoured to fit the postoperative tracheal anatomy, and may have an inner cannula and be fenestrated to allow simultaneous use with a tracheoesophageal speech valve. It is held in place with a strap or band around the neck and is typically regularly removed and reinserted by the patient. This is a reusable device.

A one-piece, canister-like device that connects in-line with a patient's artificial airway [e.g., an endotracheal (ET) tube], to capture the patient's exhaled heat and moisture so that they can be used to heat and humidify therapeutic gases inspired by the patient; it does not include a microbial filter. Commonly known as a heat & moisture exchanger (HME) or an "artificial nose", it is used when the patient is subjected to extended periods of breathing dry gases such as during anaesthesia or intensive care ventilation. This is a single-use device.

A patch with a pressure-sensitive adhesive coating designed to be adhered to the skin to temporarily secure/affix a removable patient-worn ambulatory appliance (e.g., tracheostomy base plate, insulin infusion pump) to the body. It is made of synthetic polymer materials [e.g., polyurethane] and is available in various designs (e.g., round, slot, spiral, with a central opening to fit the wearable appliance). It is not intended to adhere an external aesthetic restoration prosthesis (e.g., artificial nose, breast prosthesis) to the skin surface. This is a single-use device.

A non-sterile flexible device designed to adhere to the skin around a tracheostoma to function as an anchor for a tracheostomal device (e.g., shower shield, hands-free speech valve). It is made of synthetic polymer and/or metal materials and is available in various forms (e.g., an annular disc with a slightly protruding hollow centre designed to accept the intended device, or a ring on a vertical support); it may include an adhesive backing or be intended to adhere with a separate medical adhesive or tape. This is a reusable device.

A non-sterile, waterproof, patient-worn device intended to cover a tracheal stoma or tracheostomy tube to prevent inhalation of water during showering. It is typically in the form of a waterproof bib worn around the patient’s neck. This is a reusable device intended for single-patient use.

A device intended to be temporarily inserted into the tracheal end of a tracheoesophageal speech valve (typically indwelling type) to prevent leakage of fluids from the oesophagus into the trachea during swallowing; it is not intended to enable voice production. It is a synthetic polymer plug that includes a neck fastening strap and may include dedicated devices intended to assist insertion. It may be placed by a healthcare professional or by the patient and is intended to remain in position until medical attention can be obtained. This is a reusable 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, 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 non-sterile hand-held device intended to be used for the in situ washing of an indwelling tracheoesophageal speech valve by water irrigation to remove organic matter (e.g., phlegm). It is in the form of a water-fillable squeeze bulb with a distal nozzle that is inserted through the tracheostoma into the central lumen of the valve; it is intended to be used routinely by a patient in the home. This is a reusable device.

A non-sterile hand-held device intended to be used to clean an in situ airway device (e.g., indwelling tracheoesophageal speech valve, laryngeal airway). It is inserted into the central lumen of the device and typically rotated multiple times to remove organic matter (e.g., phlegm); it may also be used to clean an airway device ex situ (i.e., once it has been removed from the patient). It is in the form of a flexible or rigid handle with distal soft or stiff bristles, fibres or spines, or a swab; it may be used in the home or healthcare facility. This is a reusable device.

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.