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A new device for treatment of persistent otitis media with effusion
Armin Bidarian-Moniri1, Maria-João Ramos, Ilídio Gonçalves
1Department of Otorhinolaryngology, Sahlgrenska University Hospital Gothenburg, Sweden; Department of Otorhinolaryngology, Centro Hospitalar Barlavento Algarvio Portimão, Portugal.
Insights
A new non-invasive device effectively treats otitis media with effusion (OME) in children by enabling middle ear autoinflation. This approach improved ear pressure and reduced OME cases, offering a safe alternative to surgery.
Area of Science:
- Pediatrics
- Otolaryngology
- Biomedical Engineering
Background:
- Otitis media with effusion (OME) is a common childhood condition requiring intervention.
- Grommet insertion is a frequent surgical treatment for persistent OME.
- A novel non-invasive device for middle ear autoinflation was developed.
Purpose of the Study:
- To evaluate the efficacy and compliance of a new non-invasive autoinflation device.
- To assess the device's ability to ventilate the middle ear in children with OME.
- To compare treatment outcomes with a control group.
Main Methods:
- A combined modified Valsalva and Politzer maneuver device was used.
- Thirty-one children with persistent bilateral OME were divided into treatment (n=21) and control (n=10) groups.
- Tympanometry and otomicroscopy were performed before and after the study period.
Main Results:
- The treatment group showed significant improvement in middle ear pressure (52% normalized, 31% improved) and a 62% reduction in OME.
- The control group had minimal improvement (15% normalized, 15% improved) and a 20% reduction in OME.
- Statistically significant differences (p < 0.001) were observed between groups; all children tolerated the device without side effects.
Conclusions:
- The autoinflation device is effective for middle ear ventilation in children with persistent OME.
- The device normalizes or improves negative middle ear pressure and otomicroscopic findings.
- This non-invasive method offers a safe and efficient treatment option for pediatric OME.
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.
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