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

Yuinvent Innovations

Status

Unknown

Conditions

Otitis Media With Effusion

Treatments

Device: Non-invasive device for middle ear ventilation

Study type

Interventional

Funder types

Industry

Identifiers

NCT03978195

0275-18-MMC (CLEAR OM R1)

Details and patient eligibility

About

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.

Enrollment

40 estimated patients

Sex

All

Ages

4 to 10 years old

Volunteers

No Healthy Volunteers

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