Total Voice Prosthesis System

Total Voice Prosthesis System Specification

Measurement Range
Available in Multiple Sizes

Instruments Type
Prosthetic Device

Accuracy
High Sealing Efficacy

Shelf Life
Up to 5 Years

Storage Instructions
Store in cool, dry place away from sunlight

Usage Type
Clinical/Hospital

Function
Enables Tracheoesophageal Speech

Features
Biocompatible, One-Way Valve, Easy to Insert, Leakproof, Long-life

Equipment Type
Total Voice Prosthesis System

Material
Medical Grade Silicone

Condition
New

Technology
Valve Prosthesis

Portable
Yes

Wall Mounted
No

Real-Time Operation
Yes

Noise Level
Silent Operation

Operating Type
Manual and Prosthetic

Use
Restores voice function after laryngectomy

Dimension (L*W*H)
Custom Sizes (e.g., 8-12 mm length)

Weight
Lightweight, <5g

Color
Translucent/Blue Marking

Manufacturer Standards
ISO 13485, CE Marked

End Connection Type
Flanged/collar-type

Radiopacity
Yes, X-ray detectable

Disposability
Single Use

Insertion Tool
Included with Kit

Patient Compatibility
Adult

Packaging
Individually Packed

Sterilization
Gamma Sterile or EO Sterile

Latex Content
Latex Free

About Total Voice Prosthesis System

Total Voice Prosthesis System

A total voice prosthesis system, also known as a tracheoesophageal voice prosthesis (TEP), is a medical device that helps individuals who have undergone a total laryngectomy to regain their ability to speak. This system is typically used after the removal of the voice box (larynx) due to cancer or other medical conditions.

The TEP system consists of a one-way valve that is surgically implanted between the trachea and the esophagus. The valve allows air to flow from the lungs through the esophagus, creating vibrations that produce sound. The user covers their stoma (the opening in the neck where the trachea is exposed) and exhales, directing the air through the valve into the throat. This process enables the creation of a voice.

There are different types of voice prostheses available, including both indwelling and non-indwelling devices. Indwelling prostheses are typically inserted by medical professionals and stay in place for a longer duration, while non-indwelling prostheses can be removed and replaced by the patient themselves. However, non-indwelling prostheses may have a shorter lifespan and require more frequent replacement.

The choice of which type of voice prosthesis to use depends on various factors, including the patients health, lifestyle, and personal preferences. Patients are often advised by their speech-language pathologist (SLP) to decide when and if a TEP is the right option for them. The prosthesis can be placed during the laryngectomy surgery or at a later time as a minor secondary procedure.

It is important to maintain the cleanliness of the voice prosthesis to prevent blockages and ensure proper functioning. Patients are usually trained by their SLP or medical professionals on how to clean and maintain their device.

Voice prostheses are manufactured by several companies, with popular brands including Blom-Singer, Adeva, Eska, MediTop, Heimomed, InHealth Technologies, and Atos Medical.

Reliable Speech Restoration Solution

Designed for adults post-laryngectomy, the Total Voice Prosthesis System enables clear and natural-sounding speech using advanced one-way valve technology. Its high sealing efficacy ensures optimal voice quality and prevents leaks, assuring reliable day-to-day voice performance. Custom sizing allows precise anatomical fitting, providing patients with renewed confidence and social engagement.

Safety, Quality, and Comfort Guaranteed

Manufactured according to ISO 13485 standards and CE marked, this prosthetic system delivers exceptional safety and performance. It is fabricated from latex-free, medical-grade silicone, ensuring biocompatibility and allergic reaction prevention. Gamma or EO sterilization and individual packaging promote safe handling, while the translucent with blue marking aids correct placement during insertion.

User-Friendly and Durable Design

With a lightweight, portable construction weighing less than 5g and no wall mounting required, the system is easy to store and transport. The included insertion tool simplifies the fitting process, making clinical application efficient. Engineered for longevity, the prosthesis maintains functional integrity for up to five years when properly stored, making it a practical solution for hospitals and clinics.

FAQ's of Total Voice Prosthesis System:

Q: How does the Total Voice Prosthesis System help restore voice after a laryngectomy?

A: The system uses a medical-grade silicone one-way valve to enable tracheoesophageal speech, effectively channeling air from the lungs to allow voice production after the removal of the larynx.

Q: What are the sterilization methods for this prosthesis, and why are they important?

A: This device is sterilized using gamma or EO sterilization procedures, which guarantee a high level of cleanliness and reduce infection risk during clinical application.

Q: When and where can the voice prosthesis system be used?

A: It is intended for clinical and hospital use immediately after the healing period post-laryngectomy in adults, and is suitable for use in both inpatient and outpatient settings.

Q: What is included in the Total Voice Prosthesis System kit?

A: Each kit contains the voice prosthesis (in the selected size) and an insertion tool, all sterile and individually packed for safe, single use.

Q: How is the prosthesis inserted, and does it require any special equipment?

A: Insertion is performed manually using the provided tool, guided by medical professionals. No wall-mounted equipment is needed, making it adaptable and convenient for clinical environments.

Q: What are the key benefits of using this prosthesis system?

A: Benefits include silent operation, lightweight and portable design, leakproof and accurate sealing, easy insertion, and long-lasting functionality up to five years.