24-Hour Crisis Hotline: (877)SAFEGBC or (877)723-3422 Mental Health & Substance Abuse Issues

6502 Nursery Drive, Suite 100
Victoria, TX 77904
(361)575-0611
(800)421-8825
Fax: (361)578-5500

Medical Disorders
Resources
Basic InformationLookupsLatest News
Don't Want a 2nd Heart Attack? Lose the Belly FatHow to Keep Those Blood Vessels PumpingScreening for Chinese Coronavirus to Start at 3 Major Airports: CDCDo You Take Warfarin? Time of Day Might Not MatterHealth Tip: Signs of Food PoisoningSepsis Causes Far More Deaths Worldwide Than ThoughtMillennials Most Likely to Skip Flu Shot, Believe 'Anti-Vaxxer' Claims: PollResearchers Alter Mosquitoes to Resist Dengue InfectionMany Americans Are Inactive, With Southerners Faring WorseVirtual Reality Can Bring Real-Life PainAre Doctors Discarding 'Injured' Kidneys That Might Be Used for Transplant?Nerve Stimulation Therapy Could Cut Fibromyalgia PainWhich Obesity Surgery Is Right for You?Brake Dust Another Driver of Air PollutionWhat Works Best to Help Men With Overactive Bladder?More Studies Link Vaping to Asthma, COPDCertain Diabetes Meds May Lower Gout Risk, TooHeart Transplants From Donors With Hepatitis C May Be Safe: StudyClimate Change May Translate Into More Fatal InjuriesAll in the Timing: Many Get Knee Replacement Too Late or Too SoonHealth Tip: Preparing for an UltrasoundLow Levels of Key Blood Cells Could Signal Higher Death RiskGyms Are Fertile Ground for GermsTwo More Heartburn Meds Recalled Due to Possible CarcinogenZika Damage Showing Up in Babies Deemed 'Normal' at BirthHealth Tip: Coping With Winter NosebleedsHeart Disease May Up Risk of Kidney FailureFlu Cases Surge Early, Could a Tough Season Lie Ahead?Cluster of Unhealthy Risk Factors Could Raise Odds of Recurrent Blood ClotsAHA News: Worried About Dementia? Check This Blood Pressure NumberNew Study Reports Alarming Surge in E-Scooter AccidentsSo Long, 98.6: Average Human Body Temperature Is DroppingWhat Matters More for Obesity Risk, Genes or Lifestyle?Health Tip: Protect Yourself From Household ChemicalsOzone, Wood Smoke Raise Odds of COPD in Smokers and NonsmokersSmog May Be Bad for Your BonesEver Get a Rash from Your Skin Cream or Makeup? Here's WhyHealth Tip: 5 Eye Myths DebunkedHealth Tip: Allergic Reaction First AidTB Vaccine More Powerful When Given IntravenouslyGene Therapy May Be Long-Term Cure for Type of HemophiliaClots in Space: Astronaut's Blocked Vein Brings Medical InsightHealth Tip: Help Your Child Safely Lose WeightPatients Often Bring Undetected 'Superbug' to the Hospital: StudyExperimental Drug Could Be New Option Against ArthritisBanned for Decades, DDT and Dioxins Are Still Harming U.S. BabiesHealth Tip: When Bruising is a Red FlagAmericans Need to Tackle Youth Obesity: U.S. Task ForceFestive Foods Can Leave Those on Restricted Diets Out in the ColdHow You Can Be Overfat Without Being Overweight
Questions and AnswersLinks
Related Topics

Diabetes

FDA Approves First System to Insert Ear Tubes Under Local Anesthesia


HealthDay News
Updated: Nov 26th 2019

new article illustration

TUESDAY, Nov. 26, 2019 (HealthDay News) -- The U.S. Food and Drug Administration has approved the first tympanostomy tube delivery system that can be performed under local anesthesia in a physician's office, the agency announced Monday.

The Tubes Under Local Anesthesia (Tula) System is indicated for inserting tympanostomy tubes for the treatment of otitis media in adults and children ages 6 months and older. The system includes the anesthetic Tymbion, Tusker Medical tympanostomy tubes, and devices needed for delivery of the ear tubes and the anesthetic into the ear drum. The Tula System uses a small electrical current to deliver the local anesthetic into the ear drum before tube insertion.

Approval was based on data from 222 pediatric patients. Reported procedural success rates were 86 and 89 percent in children younger than 5 years and in children 5 to 12 years old, respectively. The most commonly reported adverse event was inadequate anesthesia during the procedure.

The Tula System is not indicated for patients younger than 6 months of age or patients with allergies to local anesthetics. Patients with preexisting issues with their eardrum, such as perforated eardrum, are also contraindicated for the Tula System.

Approval was granted to Tusker Medical.

More Information