Adult Study to Evaluate Placement of Tympanostomy Tubes In-office (ADEPT)

The objective for Group B in the study is to evaluate tolerability and safety of tympanostomy tube (TT) placement in adults following local anesthesia in a physician's clinic setting.

Group B will consist of 30 evaluable adults who require unilateral or bilateral tube insertion.

The iontophoresis system (IPS) will be used to facilitate anesthetic delivery to the tympanic membrane (TM). The lidocaine-based solution used for local anesthesia of the TM is Tymbion (2% lidocaine HCl/ 1:100,000 epinephrine).

Subjects will receive active Tymbion iontophoresis and will have tubes placed using the TDS in all ears indicated for tube placement. The subject will rate the pain upon TDS tube insertion using the VAS, and the pain score will be compared to a performance goal.

Safety will be evaluated post procedure and at a follow-up visit.

• Tymbion Iontophoresis and Tube Delivery System (TDS) (Combination product): Subjects will receive active Tymbion iontophoresis and tube insertion using the Tube Delivery System in all ears indicated for tube placement.

Primary outcomes

• Subject-reported Pain Score Following Tube Delivery System (TDS) Tube Placement Using the Visual Analogue Scale (VAS) by Subject Compared to a Performance Goal. [Day of procedure (Day 0)- Immediately after tube placement]: The VAS consists of a 100 millimeter (mm) line with a statement at each end representing the extreme limits of pain intensity where a score of 0 represents "No pain" and a score of 100 represents "The worst possible pain". Following TDS tube placement, the subject will report their post-tube placement ear discomfort for each ear undergoing tube placement using the VAS. For subjects treated bilaterally, the highest (worst) score reported will be used as the unit of analysis.

Sex: All, ages: 18 Years to any

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

Participant flow

Outcome results

• Subject-reported Pain Score Following Tube Delivery System (TDS) Tube Placement Using the Visual Analogue Scale (VAS) by Subject Compared to a Performance Goal. (Primary), Mean, millimeters: Tube Insertion Using Tube Delivery System (TDS) 9.4 +/- 15.7

Adverse events

Time frame: Procedure through 3-week post-procedure follow-up visit.

Other adverse events by term

• Study Protocol (PDF, 2017-05-02)
• Statistical Analysis Plan (PDF, 2017-06-26)

• David Yen, MD, Principal investigator, Specialty Physician Associates