Ear Tubes in the Office? FDA approves a New “Breakthrough” System

December 17, 2019

The US Food and Drug Administration has approved a new system for Tympanostomy Tubes in patients 6 months or older.  The so called “Tubes Under Local Anesthesia” (TULA) system, which uses a small electrical current to deliver local anesthetic, was tested in 222 pediatric patients.  The success rate was reported as 86% and 89% in children younger than 5 years old and from 5-12 years old respectively. These results supported the FDA awarding a “breakthrough device” designation, which requires that the device offers significant advantages and that availability of the device is in the best interest of patients.

EHC NOTE: The inexorable march of technology may represent a two-edged sword for the businesses of OR’s and anesthesia providers.  Some breakthroughs drive additional cases, while some technology has the potential to drive traditional business completely out of the OR environment.  The TULA system clearly resides in the latter category. While the description holds promise as a positive for patients, if widely adopted it could have a meaningful impact on the caseload at certain hospitals and ASC’s. 

Up to this point, in our experience, technology has added to the scope, scale and volume of cases most facilities are able to perform.  However, the impact varies dramatically between facilities and markets. As cost pressures and technological innovation continue, many simpler, less invasive procedures may be susceptible to disruption through non-invasive techniques.  Each facility (and anesthesia provider group) should assess their potential exposure and if possible, seek to diversify case exposure to include a meaningful percentage of cases which would be less likely to migrate en-masse to the physician office setting.