Peer to Peer Web-Based Conferences

The Tula© System enables the placement of ear tubes under local anesthesia in the office environment. The Peer-to-Peer Program will allow for ENT surgeons new to Tula to be able to speak with an experienced peer on the procedure, workflow, and best practices. This additional education offering is provided as a method to support the safe and effective use of Tula.

Each surgeon participant will be required to have completed the Tula System training, which requires a combination of a didactic presentation, device deployments, and a hands-on simulation of the procedure. After completion of this training, the HCP will be able to perform the Tula procedure on his or her patients but will have this Peer-to-Peer program as an option to augment their training. If requested, peer-to-peer calls with surgeon faculty via web-based technology will be arranged to share case experiences.

Surgeon Faculty:

Ritvik P. Mehta, MD
California Head & Neck Specialists
San Diego, CA

Dr. Ritvik Mehta received his medical degree from the University of California, San Diego School of Medicine. He then went on to Harvard Medical School where he completed his internship in General Surgery and residency in Otolaryngology / Head and Neck Surgery. Dr. Mehta chose to pursue advanced training in Facial Plastic and Reconstructive Surgery Facial Nerve Disorders during his fellowship at the Massachusetts Eye and Ear Infirmary / Harvard Medical School. He then went on to complete a second fellowship in Otology / Neurotology and Skull Base Surgery at the University of California, San Diego School of Medicine.

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 TYMBIONTM, a combination of an amide local anesthetic and an alpha and beta-adrenergic agonist. Contraindications include certain abnormal ear anatomy, sensitivity/allergy to lidocaine or other local anesthetics, and reliance on electrically sensitive medical implants such as a pacemaker. Risks may include but are not limited to, inadequate local anesthesia, dizziness, and common tympanostomy procedure risks. For full prescribing information, see the Tula IFU and TYMBION Drug Package Insert at Rx only.

Tula Peer to Peer Call Request Form

Under the federal “Sunshine Law”, all medical device and pharmaceutical manufacturers, including Smith+Nephew, are required to track and report payments and transfers of value provided to US-licensed physicians and teaching hospitals annually. The information must be submitted to the Centers for Medicare & Medicaid Services (CMS) by March 31. CMS then posts the reported data on their Open Payments website, which is a publicly available website. Smith+Nephew is committed to full compliance with the Sunshine law. In order to comply, we will report payments and transfers of value provided to US-licensed physicians including the following as required by the Sunshine Law:

*Transportation expenses
*Lodging or accommodations
*Other items that have an independent value
*Certain educational materials (e.g. medical textbooks and journal reprints; Smith+Nephew
published items are not reportable)

For more information on the Sunshine Law, please visit CMS National Physician Payment
Transparency Program Open Payments web page at