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https://www.accessdata.fda.gov/cdrh_docs/pdf10/K103595.pdf
Acciarent Tympanostomy Tube and Tympanostomy Tube Delivery System Technological The Tympanostomy Tube Delivery System is a mechanical device that Characteristics: can create a myringotomy and deliver the Acciarent Tympanostomy Tube. The Acciarent Tympanostomy Tube is provided pre-loaded in the subject device.
https://clinicaltrials.gov/ct2/show/results/NCT02150044
Acclarent Tympanostomy Tube Delivery System for the Treatment of Patients Requiring Tympanostomy Tube Insertion (inVENT2) The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
https://clinicaltrials.gov/ct2/show/NCT02150044
May 29, 2014 · Acclarent Tympanostomy Tube Delivery System for the Treatment of Patients Requiring Tympanostomy Tube Insertion (inVENT2) The safety and scientific validity of this study is the responsibility of the study sponsor and investigators.
https://www.jnjmedicaldevices.com/en-US/service-details/what-are-differences-between-acclarent-aera-and-ear-tubes
The ACCLARENT AERA ® Eustachian Tube Balloon Dilation System is intended to dilate the Eustachian tube for treatment of persistent Eustachian tube dysfunction in adults ages 18 and older.
http://www.io.nihr.ac.uk/wp-content/uploads/migrated/2740.e51265a9.AventaMeddevice.pdf
The TULA system by Acclarent Inc. is another tympanostomy tube delivery system that is currently in development for the placement of tympanostomy tubes in children with otitis media. The system is used to make an incision in the tympanic membrane and insert a pre-
https://www.healio.com/pediatrics/otolaryngology/news/online/%7B837403c5-3c19-4b93-b4f6-ac88f2d48b29%7D/fda-approves-ear-tube-delivery-system-that-uses-local-anesthesia
Nov 26, 2019 · The FDA approved a new delivery system for tympanostomy tubes for the treatment of otitis media that does not require general anesthesia. The Tubes Under Local Anesthesia (Tula) system is the first...
https://www.cadth.ca/tympanostomy-tube-insertion-system-children-otitis-media
Oct 08, 2014 · The TULA System (Acclarent, Inc., Menlo Park, California) is made up of two devices and coaching tools. 19 The TULA IONTOPHORESIS SYSTEM is a headset equipped with single-use earplugs. 20 Iontophoresis is a method to actively move charged drug molecules through the skin using low levels of electrical current. 20 Ear electrodes within the earplugs connect to a control unit to deliver …
https://www.ncbi.nlm.nih.gov/pubmed/26611339/
OBJECTIVES: Tympanostomy tube (tube) placement is the most common pediatric otolaryngologic surgery in the United States. Most surgeries are performed in an operating-room setting under general anesthesia due to the lack of tolerable and reliable local anesthesia methods suitable for pediatric patients, and concerns regarding myringotomy procedures in a mobile child.Author: Jacob W. Zeiders, Charles A. Syms, Mary T. Mitskavich, David M. Yen, Daniel T. Harfe, Ryan D. Shield...
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 ...
https://patents.google.com/patent/EP2453855B1/en
EP2453855B1 EP10735391.4A EP10735391A EP2453855B1 EP 2453855 B1 EP2453855 B1 EP 2453855B1 EP 10735391 A EP10735391 A EP 10735391A EP 2453855 B1 EP2453855 B1 EP 2453855B1 AuthorityAuthor: Greg Liu, Rohit Girotra, John H. Morriss, Julie D. Vrany, Hung V. Ha, Bryan Knodel, Jeffrey A. Walke...
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