• Skip to primary navigation
  • Skip to main content
  • Skip to primary sidebar
  • Skip to footer
  • Advertise
  • Subscribe

MassDevice

The Medical Device Business Journal — Medical Device News & Articles | MassDevice

  • Latest News
  • Technologies
    • Artificial Intelligence (AI)
    • Cardiovascular
    • Orthopedics
    • Neurological
    • Diabetes
    • Surgical Robotics
  • Business & Finance
    • Wall Street Beat
    • Earnings Reports
    • Funding Roundup
    • Mergers & Acquisitions
    • Initial Public Offering (IPO)
    • Legal News
    • Personnel Moves
    • Medtech 100 Stock Index
  • Regulatory & Compliance
    • Food & Drug Administration (FDA)
    • Recalls
    • 510(k)
    • Pre-Market Approval (PMA)
    • MDSAP
    • Clinical Trials
  • Special Content
    • Special Reports
    • In-Depth Coverage
    • DeviceTalks
  • Podcasts
    • MassDevice Fast Five
    • DeviceTalks Weekly
    • OEM Talks
      • AbbottTalks
      • Boston ScientificTalks
      • DeviceTalks AI
      • IntuitiveTalks
      • MedtechWOMEN Talks
      • MedtronicTalks
      • Neuro Innovation Talks
      • Ortho Innovation Talks
      • Structural Heart Talks
      • StrykerTalks
  • Resources
    • About MassDevice
    • DeviceTalks
    • Newsletter Signup
    • Leadership in Medtech
    • Manufacturers & Suppliers Search
    • MedTech100 Index
    • Videos
    • Webinars
    • Whitepapers
    • Voices
Home » FDA clears expanded labeling for Preceptis Medical’s ear tube system

FDA clears expanded labeling for Preceptis Medical’s ear tube system

August 17, 2022 By Sean Whooley

Preceptis Medical Hummingbird TTS ear tubes pediatricPreceptis Medical announced earlier this week that the FDA cleared expanded indications for its Hummingbird tympanostomy tube system (TTS).

New labeling for the Hummingbird system for office-based pediatric ear tube procedures allows for in-office procedures in all children 6 months and older.

Previous FDA clearance allowed for the use in children between 6 months old and 24 months old, Maple Grove, Minnesota–based Preceptis said in a news release. The FDA originally cleared the system in 2020.

Seeking to up the game on ear tub procedures

The company designed the Hummingbird TTS to combine the separate tools and steps performed in standard ear tube procedures into one comprehensive device. It allows otolaryngologists, or ear, nose and throat specialists (ENTs) to make an incision and deliver an ear tube using a single pass in the office environment.

Preceptis said the device eliminates the need for fasting, general anesthesia, and an operating room and has demonstrated 98% success in the office setting. The procedure only requires a topical anesthetic, with parents allowed to be present with their child to provide any further comfort.

“This device has been a game changer for patients and families. Having their child’s ear tubes placed in a quick office visit is comforting to parents, and they have been happy with the results. We look forward to offering this procedure to even more eligible patients,” said Dr. Nathan Page, pediatric otolaryngologist at Phoenix Children’s, one of the nation’s largest pediatric health care systems.

Preceptis said that approximately 1 million children undergo ear tube procedures annually in U.S. operating rooms, meaning in-office placement using the Hummingbird system could save thousands of dollars per patient by shifting the location of the prcocedure.

The company has completed the initial launch of the Hummingbird TTS system and said it plans to “build on strong momentum and demand” through a larger commercial launch with eyes on further expanding access to its system down the line.

“Our goal when we started Preceptis was to provide a safe, simple, and less expensive ear tube procedure option to all families,” Preceptis CEO Steve Anderson said. “This final label expansion represents the work of many ENTs, clinical study coordinators, and team members, and I appreciate the trust parents put into Preceptis and our ENTs while participating in the study.”

Filed Under: 510(k), Food & Drug Administration (FDA), Otolaryngology/Ear, Nose & Throat (ENT), Regulatory/Compliance Tagged With: FDA, Preceptis Medical

More recent news

  • Breaking: Sequel to launch twiist automated insulin delivery system next month
  • Dexcom shares U.S. report on CGM benefits for type 2 diabetes
  • Data backs Medtronic MiniMed 780G for type 2, children as company seeks expanded indications
  • Endogenex data supports type 2 diabetes procedure
  • Ambu wins FDA clearance for first single-use cysto-nephroscope

About Sean Whooley

Sean Whooley is an associate editor who mainly produces work for MassDevice, Medical Design & Outsourcing and Drug Delivery Business News. He received a bachelor's degree in multiplatform journalism from the University of Maryland, College Park. You can connect with him on LinkedIn or email him at [email protected].

Primary Sidebar

“md
EXPAND YOUR KNOWLEDGE AND STAY CONNECTED
Get the latest med device regulatory, business and technology news.

DeviceTalks Weekly

See More >

MEDTECH 100 Stock INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.
MDO ad

Footer

MASSDEVICE MEDICAL NETWORK

DeviceTalks
Drug Delivery Business News
Medical Design & Outsourcing
Medical Tubing + Extrusion
Drug Discovery & Development
Pharmaceutical Processing World
MedTech 100 Index
R&D World
Medical Design Sourcing

DeviceTalks Webinars, Podcasts, & Discussions

Attend our Monthly Webinars
Listen to our Weekly Podcasts
Join our DeviceTalks Tuesdays Discussion

MASSDEVICE

Subscribe to MassDevice E-Newsletter
Advertise with us
About
Contact us

Copyright © 2025 · WTWH Media LLC and its licensors. All rights reserved.
The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media.

Privacy Policy