A Non-invasive Device to Remove Fluid From the Middle Ear
Not Applicable
- Conditions
- Otitis Media With Effusion
- Interventions
- Device: Non-invasive device for middle ear ventilation
- Registration Number
- NCT03978195
- Lead Sponsor
- Yuinvent Innovations Ltd.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 40
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Treatment Non-invasive device for middle ear ventilation -
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Auditory test 10 weeks Values will be compared to baseline values of Auditory test