Description

The Blom-Singer Advantage Indwelling Voice Prosthesis is a specialized medical device designed to restore speech for individuals who have undergone a total laryngectomy. Developed by InHealth Technologies, this indwelling tracheoesophageal voice prosthesis is intended for adults requiring voice rehabilitation through tracheoesophageal puncture (TEP).

Key Features

• One-Way Silicone Valve: Equipped with a one-way silicone valve embedded with silver oxide, this device serves as a material preservative, potentially reducing the need for anti-fungal agents for some users.
• Retention and Insertion: Features an easy-fold esophageal retention flange and the Blom-Singer Gel Cap Insertion System, ensuring atraumatic insertion.
• Cleaning System: Includes a Brush and Flush Cleaning System with built-in safety features for effective maintenance.

Available Options

• Diameters: Available in two diameters, 16 French (Fr.) and 20 French (Fr.).
• Lengths: Comes in a range of lengths from 4 mm to 22 mm.
• Sterility: Offered in both sterile and non-sterile versions.

Each package includes a secondary placement kit comprising an inserter, flange introducer, gel caps, and lubricant.

Intended Use

This prosthesis is designed for clinician placement, not intended for patient self-insertion or removal. It is used to enable voice production by allowing air passage from the trachea to the esophagus while preventing food, fluids, and saliva from entering the windpipe. Indwelling prostheses like this one are generally longer-lasting and require less maintenance compared to non-indwelling types.

Maintenance and Care

Daily cleaning and leak checking are necessary using the provided cleaning brush and flush system. If dislodged, a dilator or catheter should be inserted until a clinician can replace it. Signs of malfunction include leakage or loss of voice quality, necessitating medical review.

Device Lifespan

Clinical studies indicate a median device lifespan of 67 days, with a range from 1 to 760 days. The mean device lifespan is 97 days, though individual patient factors and clinical circumstances may affect this.

Accessories

The Blom-Singer Plug Insert is available for temporary leakage prevention, offered in 16 Fr. and 20 Fr. sizes. It does not allow voicing and is intended for temporary use only.

Additional Information

This device is part of clinical studies evaluating the lifespan and performance of indwelling voice prostheses. While there is no consistent difference in voicing quality between indwelling and non-indwelling devices, indwelling types like this one require less maintenance and do not need a safety strap.