A Non-invasive Device to Remove Fluid From the Middle Ear

Yuinvent Innovations Ltd.40 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Otitis Media With Effusion

Interventions

Non-invasive device for middle ear ventilationDEVICE

Daily use of the device

Eligibility

Sex: ALLMin age: 4 YearsMax age: 10 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Middle ear values of Tympanometry

Values will be compared to baseline values of Tympanometry

Time frame: 10 weeks

Middle ear ventilation evaluated by otoscopy

Otoscopy evaluation of ear ventilation will be compared to baseline values

Time frame: 10 weeks

Secondary Outcomes

Auditory test

Values will be compared to baseline values of Auditory test

Time frame: 10 weeks

Data from ClinicalTrials.gov

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