Otitis Media With Effusion
Conditions
Brief summary
A feasibility study for evaluating efficacy and satisfaction is treated using a non-invasive device for middle ear ventilation. The study is designed to test the device's effectiveness by encouraging the evacuation of fluid from the middle ear, aid in hearing improvement, pain relief and assessment of patient satisfaction with the use of the device.
Interventions
DEVICENon-invasive device for middle ear ventilation
Daily use of the device
Sponsors
Yuinvent Innovations Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
4 Years to 10 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosed with ear fluids (OME) according to a doctor's examination for at least 4-6 weeks. There is a progressive hearing impairment and a matching tympanum. * In principle, these children (with OME and hearing impairment) meet the criteria and candidates for the analysis of inserting tubes of incontinence (buttons).
Exclusion criteria
* First encounter: acute ear infection or Proper Otoscopy * Second session: First review: Otoscopy / Timpneometry / Hearing test. * Parallel treatment: acupuncture - tubes insertion - discontinuation of follow-up - cessation of the experiment initiated by parents
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Middle ear values of Tympanometry | 10 weeks | Values will be compared to baseline values of Tympanometry |
| Middle ear ventilation evaluated by otoscopy | 10 weeks | Otoscopy evaluation of ear ventilation will be compared to baseline values |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Auditory test | 10 weeks | Values will be compared to baseline values of Auditory test |
Outcome results
None listed