for Invotec Distributors.

Otovent® Benefits and Clinical Study

Otovent® can prevent or treat Otitis Media and be an attractive alternative to surgery. Otovent treats many of the complications associated with negative ear pressure caused by Eustachian tube dysfunction.

• Frequent treatments are painless and regarded as “fun” by children
• Typically satisfying results early on; compliance is very high
• Effective without drugs and with no known side effects
• May avoid or delay recourse to surgery or ventilation tubes
• Very low treatment cost

A Proven Success in Clinical Study
For the period from June - December, 100 children were consecutively randomised to either Auto-Inflation using Otovent or to a control group. The children were between 3 and 10 years of age and were entered into the study having had secretory Otitis Media for at least three months, verified by tympanometry.

Tympanometry was repeated at two weeks after study entry. After two weeks of Auto-Inflation the tympanometric conditions were improved in 64%, unchanged in 34% and deteriorated in 2% of the ears. In the control group, tympanometric conditions were improved in 15%, unchanged in 75% and deteriorated in 14% of the ears.

Reference:
S-E Stangerup M.D., J. Sederberr - Olsen M.D., V. Balle M.D. Auto-Inflation as a treatment of Secretory Otitis Media Arch Otolaryngology 1992; 118: 149-154

Theoretical Risks
1) Pressure Induced Ear Perforation
The pressure created by these quality controlled and tested balloons is less than that usually producted by nose blowing or sneezing. It is significantly lower than that of the traditional Valsalva maneuver and no cases of perforation have been reported to date.
Patients should be cautioned to use only Otovent balloons, as party balloons may produce significantly higher pressure gradients.

2) Middle Ear Infections Caused by Otovent
The pathagenesis of the development of acute Otitis, according to the majority view, is hematogenic transport of the bacteria to the middle ear where negative pressure and fluid pedispone to infection.
In a study of 50 children aged between 3 and 10 years of age suffering from negative M.E.P. or tubal dysfunction, those in the Otovent treatment groupexperienced fewer episodes of Otitis Media than did the controls (1 month study duration).
During the treatment, 2% developed acute Otitis Media in the Otovent group compared to 5.5% in the control group. In the period after the treatment (2 weeks) no child in the Otovent group developed acute otitis compared to 6 .6% in the control group.

3) Aspiration of the Nose Piece or Balloon
Aspiration through the nose is physically imposible. If a child should inflate Otovent by mouth in spite of supervision, the risk of aspiration is much less than during inflation of an ordinary balloon without a nose piece. The nose piece and attached balloon are 12 cm long and are therefore easily removed, even by the child.
The balloons are manufactured and pressure tested to provide the correct inflation and deflation pressure for 10 uses (3-4 days)

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