- FDA said Monday it approved a breakthrough-designated device used to deliver a treatment for recurrent ear infections in both adults and children.
- Tympanostomy tubes, or ear tubes, may be inserted into the ear drum when antibiotics fail to effectively treat ear infections. The agency said the newly approved technology from ear, nose and throat medtech Tusker Medical is the first ear tube delivery system that can be used in young children with local anesthesia alone in a doctor's office.
- FDA granted the approval based on a study of 222 pediatric patients, wherein 86% of children younger than 5 years old had success with the procedure. That rate inched up to 89% in patients between the ages of 5 and 12.
FDA has decried a comparative dearth pediatric device approvals, particularly those indicated for young children.
The newly approved ear infection treatment device stood out to FDA for its potential to turn a procedure requiring general anesthesia at a hospital or surgery center into a simpler physician's office procedure necessitating only local anesthesia. The comparative ease of implementation could expand access to the treatment within a "susceptible patient population," Jeff Shuren, director of the Center for Devices and Radiological Health, said in a statement.
Antibiotics are commonly first-line treatment for ear infections, but when infections become a pattern, the placement of a small tube in the ear can be a next intervention. Tubes can ventilate the middle ear and prevent fluid buildup behind the eardrum.
Menlo Park, California-based company Tusker Medical's system is composed of an anesthetic, ear tubes and pieces used to deliver the drug and tubes into the ear drum. The Tula system, short for Tubes Under Local Anesthesia, uses a slight electrical current to channel the anesthetic into the ear drum before placing the tubes, FDA said.
Having won marketing authorization for the system, Tusker will likely look to target some of the approximately 1 million ear tube placement surgeries that take place in the U.S. each year, according to Boston Children's Hospital. More broadly, the National Institute on Deafness and Other Communication Disorders estimates five out of six children experience an ear infection by the time they're 3 years old.
Tusker Medical was formed in 2016 by life sciences fund Apple Tree Partners. The technology was spun out from Johnson & Johnson, which it initially gained in its acquisition of Acclarent in 2009.
The device is indicated for use in people as young as 6 months old. FDA said it should not be used in patients with allergies to certain local anesthetics, or those with a perforated eardrum or other pre-existing eardrum issues.
Other pediatric device go-aheads from FDA this year include premarket approval of a contact lens meant to slow progression of nearsightedness and a humanitarian device exemption for a Zimmer Biomet device for treatment of scoliosis in children and adolescents.