Study to Compare Active Tymbion Iontophoresis to Sham Tymbion Iontophoresis for Anesthesia of the Tympanic Membrane

• Status: Completed
• Trial end date: 2017-05-11
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Tusker Medical
• Treatments: Epinephrine; Epinephryl borate; Lidocaine; Pharmaceutical Solutions; Racepinephrine

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.