Adult Study to Evaluate Placement of Tympanostomy Tubes In-office (ADEPT)
Condition: Barotrauma;Ear; OME - Otitis Media With Effusion; AOM - Acute Otitis Media; Eustachian Tube Dysfunction
MeSH terms: Otitis; Otitis Media; Otitis Media with Effusion; Barotrauma
Intervention: Tymbion Iontophoresis and Tube Delivery System (TDS)
Intervention description: Subjects will receive active Tymbion iontophoresis and tube insertion using the Tube Delivery System in all ears indicated for tube placement.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      A prospective, multicenter study to evaluate effectiveness and safety of Tymbion
      iontophoresis and tympanostomy tube placement using the Tula iontophoresis and tube delivery
      systems for adults in an office setting.

      This study cohort is called Group B and includes tube placement. Protocol CPR007003 also
      included a first study group ('A', without tube placement) that was completed and described
      in a separate registration (NCT03119181).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Adults at least 18 years of age at time of consent

          2. Indication for tympanostomy tube insertion per Clinical Practice Guideline,or
             indicated for tympanostomy tube insertion due to barotrauma or Eustachian tube
             dysfunction per AAO-HNS Clinical Indicators.

          3. Subject is able and willing to comply with the protocol and attend all study visits.

          4. Subject is able and willing to provide informed consent.

          5. Subject is able to read and understand English.

        Exclusion Criteria by Ear:

          1. Significantly atrophic, retracted or retraction pocket at location of tube placement,
             bimeric, monomeric or atelectatic tympanic membrane.

          2. Perforated tympanic membrane.

          3. Otitis externa.

          4. Hemotympanum.

          5. Damaged/denuded skin in the auditory canal.

          6. 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.

          7. Notable ear discomfort experienced during audiologic or otoscopic examination.

          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.

             General Exclusion Criteria

         10. Pregnant or lactating females

         11. History of sensitivity or allergic reaction to lidocaine HCl, tetracaine, epinephrine,
             or any hypersensitivity to local anesthetics.

         12. Familial history of insensitivity to lidocaine or other local anesthetics of the amide
             type.

         13. Electrically sensitive medical support systems (eg, pacemakers, defibrillators,
             cochlear implants)

         14. Other conditions that would preclude performing the study procedure including
             iontophoresis system ear plug incompatibility.

         15. 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