Clinical Context

Ear infections can occur when there is persistent buildup of fluid behind the eardrum in the middle ear. Children more frequently experience ear infections than adults since their eustachian tubes are shorter and more horizontal during development.

Ear infections may improve in some cases without treatment while in others, antibiotics may be needed to resolve the infection. When ear infections become chronic or recurrent, tympanostomy (or ear) tubes may be recommended by healthcare professionals to improve airflow to the middle ear and prevent fluid accumulation. Traditionally, these hollow cylindrical tubes are inserted in the eardrum following a myringotomy, or surgical incision in the eardrum, while the child is under general anesthesia.

Device Description

The Tubes Under Local Anesthesia (Tula) System (Premarket Approval P190016) is a combination product approved in November 2019. It consists of an iontophoresis system, a tube delivery system, and a lidocaine hydrochloride 2% and epinephrine 1:100,000 (0.01 mg/mL) otic iontophoretic drug solution (TYMBION).

Indications for Use

The Tula System is intended to create a myringotomy and insert a tympanostomy tube using the Tula Tube Delivery System in pediatric (aged 6 months and older) and adult patients indicated to receive tympanostomy tubes. The Tula System is used to deliver a tympanostomy tube under local anesthesia induced using the Tula Iontophoresis System and TYMBION, a combination of an amide local anesthetic and an alpha- and beta-adrenergic agonist.

TYMBION, a combination of an amide local anesthetic and an alpha- and beta-adrenergic agonist, is indicated for the induction of local anesthesia of the tympanic membrane via iontophoresis using the Tula Iontophoresis System in pediatric (aged 6 months and older) and adult patients undergoing tympanostomy tube placement using the Tula Tube Delivery System; see Summary of Safety and Effectiveness Data (PDF).

Context of Clinical Outcome Assessment (COA) Use

The two primary effectiveness endpoints of the clinical investigation were procedural success and tube placement tolerability. A formal parent/caregiver preference study was conducted to help inform the performance goal for procedural success. Tube placement tolerability was assessed using a patient-reported outcome (PRO) instrument, the Faces Pain Scale-Revised.

The investigation also included additional exploratory effectiveness endpoints that evaluated:

• Post-procedure tolerability (Faces Pain Scale—Revised; PRO),
• Procedural tolerability assessed by a trained observer (Face, Legs, Activity, Cry, Consolability scale; observer-reported outcome, or ObsRO),
• Parental satisfaction with the procedure (structured parent/guardian survey).

Lessons Learned

Effectiveness of the Tula System was demonstrated through a combination of patient (parent) preference information, PROs, and ObsROs. Prior to conducting the clinical investigation, procedural success, a primary effectiveness endpoint, was defined using information from a formal patient (parent) preference study.

The PRO instrument assessing procedure tolerability was critical to evaluate the effectiveness of the combination product from the patient’s perspective. Additionally, ObsROs like those used in the clinical investigation of the Tula System can be particularly beneficial in cases where the patient is unable to report for themselves.