In-Office Tympanostomy Tube Placement in Children (OTTER)
Condition: OME - Otitis Media With Effusion; AOM - Acute Otitis Media
MeSH terms: Otitis; Otitis Media; Otitis Media with Effusion
Intervention: Iontophoresis & tube placement; Tube placement
Intervention description: Subjects will receive active Tymbion iontophoresis and will have tubes placed in-office using the Tube Delivery System in all ears indicated for tube placement.; Subjects will have tubes placed in the OR using the Tube Delivery System in all ears indicated for tube placement.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Intervention model description: Pivotal cohort is single arm. Physician initial subjects evaluated in separate cohorts but not included in primary and secondary analyses.
Masking: None (Open Label)
Enrollment: 370.0
Sex: All
Minimum age: 6 Months
Maximum age: 12 Years
Healthy volunteers: No

Summary:

      A prospective, single-arm, multicenter study to evaluate effectiveness and safety of Tymbion
      iontophoresis and tympanostomy tube placement using the Tula Iontophoresis and Tube Delivery
      Systems for children in an office setting.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Males or females at least 6 months old through 12 years old at time of consent

          2. Indication for tympanostomy tube insertion per Clinical Practice Guideline

          3. Behavioral capacity and cooperative temperament to undergo an awake procedure, based
             on physician judgment (not applicable to OR Lead-In subjects)

          4. Subject's parent/guardian and subject are able and willing to comply with the protocol
             and attend all study visits

          5. Subject's parent/guardian and subject are able and willing to provide informed consent
             or assent as age appropriate

        Exclusion Criteria:

          1. Significantly atrophic, retracted, bimeric, monomeric or atelectatic tympanic membrane

          2. Perforated tympanic membrane

          3. Otitis externa

          4. Active or recent conditions of the tympanic membrane (eg, prior myringotomy with
             incomplete wound healing or re-epithelization)

          5. Hemotympanum

          6. Damaged/denuded skin in the auditory canal

          7. Cerumen impaction resulting in a significant amount of cleaning required to visualize
             the tympanic membrane potentially causing abrasion or irritation to the external ear
             canal

          8. Anatomy that precludes sufficient visualization of and access to the tympanic membrane

          9. Anatomy that necessitates tympanostomy tube placement in the posterior half of the
             tympanic membrane

         10. History of sensitivity or allergic reaction to lidocaine HCl, tetracaine, epinephrine,
             or any hypersensitivity to local anesthetics of the amide type, or any component of
             the anesthetic drug formulation (not applicable to OR Lead-In subjects)

         11. Familial history of insensitivity to lidocaine or other local anesthetics of the amide
             type (eg, history of inadequate anesthesia with dental numbing agents). (not
             applicable to OR Lead-In subjects)

         12. Electrically sensitive medical support systems (eg, pacemakers, defibrillators,
             cochlear implants)

         13. Other conditions that would preclude performing the study procedure including
             iontophoresis system ear plug incompatibility.

         14. Health conditions that, in the opinion of the investigator, would present undue risk
             to the subject, based on device/anesthetic drug product label warnings and
             precautions.

         15. Subject is 4 years or older and not able to complete all baseline assessments. Subject
             is younger than 4 years and not able to complete all baseline assessments, not
             including audiometry.