Efficacy of the EarPopper Device in Children With Recurrent Otitis Media

Efficacy of the EarPopper Device in Children With Recurrent Otitis Media: A Randomized Controlled Trial

This is a randomized controlled clinical trial evaluating the efficacy of the EarPopper device (EP) in the reduction of episodes of acute otitis media (AOM) in children with recurrent otitis media. The control arm will be observational. The intervention arm will have the EP used.

The hypothesis of this randomized controlled trial is that the EP device will be able to prophylactically decrease incidence of AOM in children with recurrent AOM. The secondary hypothesis is that the EP device will be able to decrease morbidity of AOM and severity of AOM in children with recurrent AOM (by measuring quality of life and associated endpoints).

The EP device is 510(K) regulated (510(K) Number K073401) as a non-surgical, non-drug related treatment for middle ear pressure problems such as: Middle ear fluid (Otitis Media with Effusion), Eustachian Tube Dysfunction, Temporary hearing loss, Ear pain and pressure caused by air travel, Ear fullness caused by colds, allergies and sinusitis.

This is a randomized, controlled, double blinded study. This is a randomized controlled clinical trial evaluating the efficacy of the EarPopper device (EP) in the reduction of episodes of acute otitis media (AOM) in children with recurrent otitis media. The control arm will be observational.

Patients will be followed up for a period of one year, and monthly telephone call interviews will be conducted.

All patients will receive the EarPopper device for participation in this trial (for the control arm, they will receive the device at the end of their study follow up).

INCLUSION CRITERIA

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

1. Provision of signed and dated informed consent form from parent, plus assent form (if age appropriate)
2. Stated willingness to comply with all study procedures and availability for the duration of the study
3. Male or female, aged 4-11
4. Diagnosed with recurrent AOM, defined as: least 2 episodes of AOM within the preceding year of date of screening
5. Must be able to follow directions to use EarPopper, or have a caregiver able to administer the device.
6. Patient must be currently free of middle ear effusion or current acute OM. This will be determined on physical examination during screening visit

EXCLUSION CRITERIA

An individual who meets any of the following criteria will be excluded from participation in this study:

1. Patient with chronic middle ear effusion.
2. Patients with potential complications or confounding conditions: asthma, chronic sinusitis, immunodeficiency, diabetes mellitus
3. Patient with cleft palate.