Study to Compare Active Tymbion Iontophoresis to Sham Tymbion Iontophoresis for Anesthesia of the Tympanic Membrane
Condition: Healthy Volunteer
Intervention: Tymbion Lidocaine/epinephrine solution; Device: Iontophoresis System (IPS) with Drug: Tymbion lidocaine/epinephrine solution
Intervention description: The external ear canal will be filled with Tymbion drug solution; The external ear canal will be filled with Tymbion drug solution. The Iontophoresis System (IPS) will be used to deliver current to the Tymbion solution to facilitate drug penetration into the tympanic membrane (TM) tissue to anesthetize (numb) the TM
Intervention MeSH terms: Lidocaine; Epinephrine; Racepinephrine; Pharmaceutical Solutions; Epinephryl borate
Phase: Phase 2
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      A prospective, multicenter study to determine if active Tymbion iontophoresis is superior to
      sham Tymbion iontophoresis in providing anesthesia to the tympanic membrane (TM). The study
      will use the Tula iontophoresis systems for healthy adult volunteers in an office setting,
      called Group A of Protocol CPR007003.

      The protocol CPR007003 also includes a Group B study described in a separate Registration
      (NCT03197558).
    

Eligibility criteria:

        Key Inclusion/Exclusion Criteria

        Inclusion Criteria Group A:

          1. Healthy adults, 18-50 years old

          2. Subject is able and willing to comply with the protocol and attend all study visits

          3. Subject is able and willing to provide informed consent

          4. Subjects with air conduction hearing thresholds of 25 dB HL or better at standard
             frequencies up to 2000 Hz, and 45 dB or better at 4000 Hz.

          5. Subject is able to read and understand English

        Exclusion Criteria Group A:

          1. Pregnant or lactating females.

          2. Prior ear iontophoresis procedure

          3. Subjects with conductive hearing loss.

          4. Subjects with 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.

          5. Familial history of insensitivity to lidocaine or other local anesthetics of the amide
             type.

          6. Significantly atrophic, retracted, bimeric, monomeric or atelectatic tympanic
             membrane.

          7. Perforated tympanic membrane.

          8. Subjects with known history of ear surgery or TM condition that has the potential to
             affect the sensitivity of the TM

          9. Otitis externa.

         10. Damaged/denuded skin in the auditory canal.

         11. Subjects with electrically sensitive support systems

         12. Cerumen impaction resulting in a significant amount of cleaning required to visualize
             the tympanic membrane.

         13. Evidence of Otitis Media at day of procedure, or within the past three (3) months
             prior to procedure.

         14. Other conditions that would preclude performing the study procedure including 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.