Tympanostomy tubes in children
Status: Decision completed
There are significant questions related to the use of tympanostomy tubes for the treatment of otitis media with effusion in children under the age of 16 regarding efficacy, safety, differential efficacy and safety in subgroups, and cost.
Primary criteria rankings
- Safety = Medium
- Efficacy = High
- Cost = Medium
- Draft key questions published: March 11, 2015
- Public comment period: March 11 - 25, 2015
- Final key questions Published: May 1, 2015
- Draft report published: August 3, 2015
- Public comment period: August 3 - September 4, 2015
- Final report published: October 16, 2015
- HTCC public meeting: November 20, 2015
Middle ear inflammation (otitis media) is one of the most common ailments of childhood, with a diagnostic frequency second only to upper respiratory infection. Otitis media can present as an ear infection (acute otitis media) or as fluid in the middle ear in the absence of an infection (otitis media with effusion). In some children, ear infections do not respond to antibiotic therapy or recur within a month of completing antibiotics (persistent otitis media). They may also recur within six to twelve months (recurrent otitis media).
Persistent or recurrent otitis media as well as chronic otitis media with effusion can lead to long-term hearing problems, frequent doctor visits, decreased quality of life for both the child and parent, as well as missed school and work. Further, hearing loss can lead to a number of developmental delays, including speech, language, and cognitive problems, the impact of which are likely even greater in children already at risk for developmental difficulties or delays (including those with conditions such as autism spectrum disorders, Down syndrome, among others).
Tympanostomy tube insertion is the primary surgical treatment for otitis media with or without effusion, and is performed in approximately 667,000 children each year. Tympanostomy tubes are small tubes that are inserted into the eardrum in order to allow the flow of both air and fluid between the middle and outer ear. Tube placement is performed under general anesthesia, and tubes typically fall out within 12 to 14 months.
Tympanostomy tubes may decrease the occurrence of otitis media, and may improve hearing and quality of life. Risks of tympanostomy tube insertion may include otorrhea, blockage of the tube lumen, granulation tissue formation, premature tube extrusion, and tube displacement. In addition, there are risks associated with use of general anesthesia. In the longer term, tympanostomy tubes may lead to changes in the eardrum as well as possible long-term hearing loss. Other treatment options include antibiotics or other medications such as steroids or mucolytics, myringotomy (eardrum incision), adenoidectomy, or autoinflation of the Eustachian tube. In addition, because otitis media often resolves spontaneously, especially within the first six months, and may not cause long-term hearing or developmental problems, watchful waiting or delayed tube placement may be considered.