A new device for treatment of persistent otitis media with effusion

Int J Pediatr Otorhinolaryngol. 2013 Dec;77(12):2063-70. doi: 10.1016/j.ijporl.2013.10.009. Epub 2013 Oct 22.


Objectives: Most children suffer from otitis media with effusion (OME) before starting school. Insertion of grommets into the eardrum for treatment of OME is one of the most common operations performed in childhood. The efficiency and compliance of treatment with a new non-invasive device was evaluated in children with bilateral OME with disease duration of at least 3 months.

Methods: A device for autoinflation was developed to enable a combined modified Valsalva and Politzer maneuver. Ten children, aged 3-8 years (mean: 5 years and 2 months) with OME tested the device for estimation of its ability to ventilate the middle ear. Another thirty-one children, with persistent bilateral OME for at least three months, were divided into a treatment and a control group. Twenty-one children (42 ears), aged 2-7 year (mean: 4 years and 6 months), participated as the treatment group and ten patients (20 ears), aged 3-7 years (mean: 4 years and 5 months), were included as controls. Tympanometry and otomicroscopy were performed at inclusion and at the end of the study.

Results: In the treatment group the middle ear pressure was normalized in 52% and improved in 31% of the ears with 7 children (33%) achieving bilateral and 8 (38%) unilateral normalization. In the control group the middle ear pressure was normalized in 15%, improved in 15% and deteriorated in 10% of the ears with one child (10%) achieving bilateral and one child (10%) unilateral normalization. Statistically significant differences (p < 0.001) were observed in the pressure difference and the tympanometry type changes between the treatment and the control group. Otomicroscopic examination revealed that the number of ears judged as OME was reduced by 62% in the treatment group in comparison with 20% in the control group. All children managed to perform the maneuver and no side effects were neither reported nor detected.

Conclusions: The device was efficient in ventilation of the middle ear with normalization or improvement of the negative middle ear pressure and otomicroscopic findings in young children with persistent OME.

Keywords: Autoinflation; Non-invasive conservative treatment; Otitis media with effusion; Politzer; Serous otitis media; Valsalva.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Acoustic Impedance Tests / methods
  • Case-Control Studies
  • Child
  • Child, Preschool
  • Chronic Disease
  • Equipment Design
  • Equipment Safety
  • Female
  • Humans
  • Insufflation / instrumentation*
  • Insufflation / methods
  • Male
  • Middle Ear Ventilation
  • Otitis Media with Effusion / diagnosis*
  • Otitis Media with Effusion / therapy*
  • Prognosis
  • Reference Values
  • Risk Assessment
  • Severity of Illness Index
  • Treatment Outcome