Fluoroplastic Universal Middle Ear Prosthesis - Centered

• Head: The head plate or disk is the part that is placed against the tympanic membrane. It is designed to provide stability and support for the device.
• These devices can be made using fluoroplastic material. Fluoroplastic is a non-reactive and low-friction material that can be used for coating or lining certain parts of the device.

Design Benefit:

The Middle ear implants restores or improves the hearing ability by providing structural support to ossicular chain thereby maintaining stability of middle ear resulting in effective sound transmission which enhances speech perception.

Duration of Use: 

Long-term use (Normally intended for continuous use for more than 30 days) 

Intended Purpose: 

Middle ear implants are used to reconstruct, provide structural support to the ossicular chain (i.e., Incus, Malleus & Stapes) facilitating stability in the middle ear resulting in improved hearing.

Clinical Indications

• Immobility of ear bones (Malleus, Incus and Stapes). 
• Otosclerosis/congenital stapes fixation and malleus fixation. 
• Traumatic injury to the ossicles. 
• Chronic otitis media with conductive hearing loss. 
• Malformation of the middle ear. 
• Revision surgery due to insufficient hearing improvement as may be caused by prosthesis dislocation. 
• Revision operation on a mal-positioned prosthesis

Performance Characteristics

• Middle Ear Implants (MEIs) are medical devices designed to restore the function of the middle ear or enhances the conduction of sound in cases where there are pathologic changes affects the conductive hearing mechanism. 
• MEIs transmits sound effectively from the tympanic membrane to the inner ear. 
• MEIs should be securely fixed in place to ensure stability and long term functionality. 
• The MEIs replaces ear bones(stapes, incus, malleus) which are part of the natural ossicular chain. It's design facilitates secure attachment of the bones and oval window. 
• MEIs come in various sizes and shapes to accommodate the anatomical variations of the patients. The appropriate sizes and shapes should be selected to ensure a proper fit and optimal sound transmission.
• MEI remains stable within the middle ear and is capable of withstanding the mechanical stresses associated with normal middle ear function. 
• MEI are easy to insert during the surgical procedure. It has a smooth surface and a shape that allows for smooth insertion without causing trauma to the delicate structures of the middle ear.

Safety Information & Contraindications

Safety

• The device is for single use only. Do not re-sterilize or re-use.
• Do not re-sterile- if the device is resterilised, it may cause harm or infection to patient due to re-sterilization of the device.
• The ENT surgeon is encouraged to carefully choose Middle ear Implant size and material to meet the needs of each specific clinical situation, while minimizing adverse effects.
• Do not use if the packaging has been opened or damaged.
• The Titanium Middle Ear Implant have been determined to be MR conditional. Material is safe up to 1.5 T in Magnetic field.

Contraindications

• Acute otitis media, which can cause implant displacement 
• Acute and chronic infectious diseases 
• Known wound healing disorders
• Dislocated, fractured or fixed stapes footplate and hyper mobile stapes footplate (“Floating Footplate”) 
• Treatment with cytotoxic drugs or radiotherapy (e.g., for malignant tumour)
• Particular material allergy 
• General impairment of wound healing 
• Patient suffering from alcohol, drug, or nicotine abuse 
• Medical issues surrounding the middle ear implant surgery

Material: Fluoroplastic (1 Unit/Box, ETO Sterile)

All measurements are in mm