Otitis Treatment With OtoSight™ - Modification of Antibiotic Treatment Intervention in Children

For the Prospective Subjects

Inclusion Criteria:

• Pediatric subjects between 6 months and 17 years of age

• Pediatric subjects presenting for an office visit with ear-related pain (otalgia)/otic complaints/earache indicative of potential Otitis Media with Effusion (OME) or Acute Otitis Media (AOM)

• Pediatric subjects where otoscopy would traditionally be indicated

• Pediatric subjects whose parents or legally authorized representative (LAR) havesigned an informed consent

Exclusion Criteria:

• The parent or guardian who attends visits does not speak the same language as theirphysician

• Pediatric subjects enrolled in another clinical trial

• Pediatric subjects with:

• Signs of severe chronic illness (e.g., immunodeficiency, congenital heart disease,encephalopathy, pulmonary disease other than asthma, and disorder of the ear, noseand throat) or any clinically significant illness or condition that, in the opinionof the investigator, would prohibit the subject from participating in the trial

• Anatomical conditions that would affect their ability to undergo an otoscopy.

For the Retrospective Case Match Controls

Inclusion Criteria:

• Pediatric subjects between 6 months and 17 years of age (< 18 years old).

• Index visit took place 11 - 25 months prior to the Treatment match's Baseline Visit.

• Index visit was for an ear-related chief complaint.

• An otoscopic exam was completed at index visit.

• Subjects have a follow up visits (telehealth included) in the time period betweenthe index visit and firstTreatment subject's enrollment date.