Indications, Safety, and Warnings

Meniett Device

Indications

The Meniett Low-Pressure Pulse Generator is indicated for the symptomatic treatment of Ménière’s Disease. The therapeutic effect of the Meniett device is achieved by application of low frequency, low amplitude pressure pulses to the middle ear whereby inner ear endolymphatic fluid is assumed to be evacuated from the inner ear and thus the patient is relieved of the symptoms associated with the disease.

Precautions

Medical Electrical Equipment needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in this Guide.

Portable and mobile RF communications equipment can affect Medical Electrical Equipment. Use of accessories and cables other than those specified and sold by Medtronic Xomed may result in increased emissions and decreased immunity of this unit.

The Meniett^® should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the Meniett should be observed to verify normal operation in the configuration in which it will be used.

Ventilation Tubes

Indications

The surgeon must use medical judgment 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 serous, mucoid, or purulent.
• Recurrent acute otitis media which fails to respond satisfactorily to alternative therapies.
• A patient with a history of persistent 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.

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 involving chronic otitis media with effusion should not be treated by insertion of membrane style tubes.
• Cases of otitis media in which, in the medical judgment of the surgeon, a myringotomy alone or tympanocentesis will suffice as treatment for the condition.

Warnings

The surgeon is encouraged to carefully choose a tube size, style and material to meet the needs of each specific clinical situation, while minimizing adverse effects.

Larger tube diameters and increasing flange size may increase the chances of prolonged tube retention and/or residual perforation.

MAGNETIC RESONANCE IMAGING (MRI): (For metal ventilation tubes:)

Medtronic Xomed manufactures metal ventilation tubes only from titanium alloys and Austenitic medical grade stainless steel; however, slight magnetism can be characteristic of Austenitic stainless steel. While there are no known reports of MRI-related adverse effects to a patient due to any Medtronic Xomed ventilation tubes, caution is advised when administering MRI procedures. Caution is particularly advised when magnetic fields above 1.5 Tesla are used, as the effects at such levels have not been thoroughly studied. Additionally, image artifact can occur due to the material composition of the tube. Because of the potential for such artifact, alternative imaging techniques, such as CT scanning, should be considered.