Donaldson

Ear Ventilation Tube is small tubular implant available in variety of materials including Titanium (Grade 2), Fluoroplastic, Fluoroplastic + Stainless Steel (304L) and Silicone. The material offers excellent physical, chemical, mechanical properties and is proved to be biocompatible with the body tissues. Different designs and sizes are available to satisfy various surgical techniques for insertion of implants into the middle ear.

Design Benefit:

Ear ventilation tubes restore hearing, prevent infections, and facilitate fluid drainage from the middle ear, ensuring sustained migration and extrusion resistance. This treatment maintains optimal air pressure between the outer and middle ear, effectively reducing the risk of fluid accumulation. Additionally, tympanostomy tubes are employed to keep the middle ear clear of effusion, further enhancing auditory health.

Duration of Use:

'Long term’ means normally intended for continuous use for more than 30 days.

Intended Purpose:

Ear Ventilation Tubes are intended for ventilation or drainage of fluids from the middle ear. A tympanostomy tube is surgically inserted through an incision (myringotomy) which is made in the tympanic membrane. The primary purpose of the device is to ventilate the middle ear, allowing a free exchange of air between the outer ear and the middle ear space equalizing the pressure on both sides of the membrane and thus facilitate the drainage of fluids from the middle ear space through the Eustachian tube into the external auditory canal. Ventilation also prevents fluid accumulation within the middle ear. A secondary purpose is to provide an alternate route for the exit of middle ear fluid.

Clinical Indications

The ENT surgeon must use medical judgement and consider the patient’s medical history prior to a decision to surgically insert a ventilation tube. Pathologic conditions for which ventilation tubes are indicated include but are not limited to:

• Chronic otitis media with effusion characterized as either serous, mucoid or purulent.
• Persistent SOM (serous otitis media) which do not responded to medical treatments.
• Recurrent AOM (acute otitis media) which fails to respond satisfactorily to alternative therapies. A patient with a history of high negative middle ear pressure, which may be associated with conductive hearing loss, otalgia, vertigo and/or tinnitus.
• Atelectasis resulting from retraction pocket of the tympanic membrane or Eustachian tube dysfunction.

Performance Characteristics

• Ear Ventilation Tubes are small tubular implants having many variants available in different sizes that are surgically inserted into the eardrum. This opening enables drainage of the middle ear, allows air to flow into the middle ear and provides an alternate route for the exit of middle ear fluids. Ear Ventilation Tube can help create a pathway for antibiotic drops which can travel directly into the ear aiding to treat the ear infection rapidly. Facilitates rapid fluid drainage.
• The easy holding of the tympanic membrane is significantly enhanced by the outer diameter. The device offers good extrusion resistance. Flange provides good migration and extrusion resistance Smaller inner flange facilitates insertion in smaller incision. It offers enhanced aeration into the middle ear.
• Notched Inner flange facilitates easier insertion through small incisions.
• It offers excellent secretion drainage and occlusion resistance.
• The device is easy to handle.

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 Ear Ventilation tube 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 Fluoroplastic and Silicone Ear Ventilation Tube have been determined to be MR safe.
• The Titanium Ear Ventilation Tube have been determined to be MR conditional. Material is safe up to 1.5 T in Magnetic field.
• The Fluoroplastic + SS Ear Ventilation Tube have been determined to be MR Unsafe.

Contraindications

Some conditions for which ventilation tubes may not be the therapy of choice include: Cases of otitis media which respond favorably to drug therapy alone Cases of otitis media in which, in the medical judgement of the ENT surgeon, a myringotomy alone or tympanocentesis will suffice as treatment for the condition. Patients with hypersensitivity to Titanium (applicable to implant made up of titanium)

Material : Fluoroplastic