Description

The Blom-Singer Duckbill Voice Prosthesis is a specialized tracheoesophageal device designed to restore speech for individuals who have undergone a total laryngectomy. This non-indwelling, patient-changeable prosthesis empowers users by allowing them to manage insertion, removal, and cleaning independently, without the need for clinician assistance.

Key Features

• One-Way Slit Valve: Crafted from medical-grade silicone, the duckbill design functions as a one-way valve, opening under positive pressure during exhalation to facilitate speech and closing during swallowing to prevent aspiration of food, fluids, and saliva.
• Versatile Insertion Methods: The prosthesis supports both retrograde (through the mouth and throat) and anterograde (through the stoma) insertion methods, enhancing adaptability for individual anatomical needs.
• Non-Flanged Design: Equipped with a safety strap, the non-flanged design ensures secure placement and easy handling during self-replacement and maintenance.

Size and Compatibility

Available in various sizes, including diameters of 16 French and 18 French, and lengths ranging from 6 mm to 25 mm, the device accommodates diverse anatomical requirements. This flexibility is crucial for achieving optimal fit and function.

Maintenance and Longevity

Regular maintenance involves daily cleaning and flushing to prevent leakage and ensure continued functionality. The device's lifespan can vary significantly, influenced by factors such as diet, radiotherapy, and gastroesophageal reflux, with an average duration ranging from a few weeks to several months.

Training and Support

Speech and Language Therapists provide essential training for effective use and maintenance, helping users achieve relatively natural voice quality. The prosthesis allows for voice production by redirecting pulmonary air through the device into the esophagus, with users occluding the stoma manually or using hands-free valves.

Considerations

While the Blom-Singer Duckbill Voice Prosthesis offers significant benefits, it is not suitable for all patients. Proper assessment by healthcare professionals is necessary to determine compatibility. Potential challenges include leakage due to yeast or sediment buildup, which may require temporary plugs, and issues such as prosthesis degradation or fistulae growth.

Certifications

The device is associated with multiple quality and safety certifications, including ISO 9001:2015 and ISO 13485:2016, underscoring its commitment to high standards in medical device manufacturing. These certifications provide reassurance of the product's reliability and safety for users worldwide.