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617

CHAPTER

Evidence and Guidelines: Tympanostomy TubesDavid E. Tunkel

64

Introduction ............................................................. 618Indications for Surgery ...................................................... 618

Risks and Sequelae of Tympanostomy Tubes .......... 624Follow-Up Issues ...................................................... 624References ................................................................. 625

618 Pediatric Otolaryngolog y-Head and Neck Surgery: A Clinical Reference Guide

InTRodUcTIon• Tympanostomy tube insertion is the most common ambulatory

surgical procedure in children in the U.S.• By age 3 years almost 7% of children will have tympanostomy tubes• 667,000 children <15 yrs old undergo tympanostomy tube

placement yearly• Most common indications for tubes are otitis media with effusion

and recurrent acute otitis media (most evidence and guidelines are for these diagnoses)

• Less common indications for tympanostomy tubes include complications of otitis media, structural changes of the tympanic membranes (eg, atelectasis), and barotrauma—limited knowledge exists to make evidence-based recommendations for these indications

• Although tympanostomy tube placement is common, controversies and differences of opinion remain about:1. Appropriate indications for tympanostomy tubes2. Possible overuse of tubes for recurrent acute otitis media or

middle ear effusions of short duration3. Appropriate perioperative care and long-term follow-up

Indications for Surgery

Acute otitis Media• Tympanostomy tubes do not have a role in treatment of

uncomplicated isolated acute otitis media• Tympanostomy tubes can be placed at the time of myringotomy

for children with complications of acute otitis media (facial nerve paralysis, mastoiditis, lateral sinus thrombosis, etc). Although no RCTs support this recommendation, surgical drainage of middle ear space is useful adjunct to medical therapy, and allows culture to direct medical therapy

Recurrent Acute otitis Media• Usually defined as 3 episodes in 6 months, or 4 episodes of otitis

media occurring over a year with 1 episode within 6 months of presentation

• Prior to 2013 few if any evidence-based guidelines recommended tympanostomy tubes for recurrent acute otitis media (includes U.S., Japan, Italy, others)

• AAP Clinical Practice Guideline on Acute Otitis Media published March 2013 contained an action statement that says clinicians

ChAPTeR 64 Evidence and Guidelines: Tympanostomy Tubes 619

may offer tympanostomy tubes for recurrent acute otitis media1 (Considered an “option” as supporting literature is scant)

• Cochrane review included only 2 studies which met inclusion criteria, and found tympanostomy tubes reduced the number of acute otitis media episodes by 1.5 in the first 6 months after surgery; long-term benefits of tubes have not been demonstrated2

• One systematic review found insufficient evidence that tympanostomy tubes had a beneficial effect for recurrent acute otitis media3

• Another systematic review found tympanostomy tube efficacy for reduction of recurrent acute otitis media similar to antibiotic prophylaxis, with the reduction of 1 episode of acute otitis media in the 6 months following surgery. estimated number needed to treat to prevent 1 episode of acute otitis media was between 2 and 54

• Large quality-of-life improvements have been demonstrated after placement of tympanostomy tubes, but these studies usually included mixed populations of children with acute otitis media, middle ear effusions, or both

• AAoHnS clinical Practice Guideline on Tympanostomy Tubes (Table 64–1) published July 2013 makes several recommendations about the use of tympanostomy tubes for recurrent acute otitis media:5

1. Clinicians should NOT perform tympanostomy tube insertion in children with a history of recurrent acute otitis media who do not have a middle ear effusion in at least 1 ear at the time of evaluation:a. The children in the control groups of antibiotic prophylaxis

trials for prevention of acute otitis media had no middle ear effusions on entry to the trial and had very favorable natural history, with most children experiencing less than 2 infections in the study period

b. Children with a history of recurrent acute otitis media and a normal examination at presentation may be “overdiagnosed”

2. Clinicians ShOULD offer tympanostomy tube insertion in children with history of recurrent acute otitis media who have middle ear effusion in 1 or both ears at the time of evaluationa. Trials that did not exclude children with middle ear effusion

suggest a modest reduction in number of episodes of acute otitis media after tympanostomy tubes

b. Although reduction of episodes of acute otitis media is the primary goal, tympanostomy tubes may reduce pain during episodes of acute otitis media and can allow treatment of otorrhea with ototopical antibiotics

620

Ta

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2013

;149

(sup

pl

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1–35

.


otitis Media with Effusion • Most common cause of hearing impairment in young children• Most middle ear effusions will resolve spontaneously• 2004 clinical Practice Guideline on oME (AAOhNS, AAP,

AAFP) proposed indications for surgery for otitis media with effusion and noted that tympanostomy tube placement was the preferred initial procedure6

1. Surgical candidacy was based on hearing status, associated symptoms, any developmental risk factors, and the chance of spontaneous resolution of the middle ear effusions

2. Candidates for tympanostomy tubes included children with effusions of 4 months duration or longer with hearing loss or other symptoms, children with effusions who were at risk for developmental problems, children who had structural abnormalities of the tympanic membrane or middle ear as well as otitis media with effusion

• Cochrane review from 2010 noted that available trials of tympanostomy tubes for otitis media with effusion showed small short-term improvements in hearing, but no effects on speech and language were evident7

• No trials of tympanostomy tubes specifically looked at “at-risk” children with developmental disabilities, underlying sensorineural hearing loss, established speech delay, etc

• 2013 AAoHnS tympanostomy tube clinical practice guideline provides several action statements about tympanostomy tubes for otitis media with effusion:8

1. Do not perform tympanostomy tube insertion for children with isolated episode of otitis media with effusion lasting less than 3 monthsa. Short-term effusions can occur after viral infection or acute

otitis media and often resolve without therapyb. Children considered “at risk” may need intervention for shorter

periods of effusion or hearing loss, but evidence does not exist as these children are excluded from most trials

2. Perform an age-appropriate hearing test for children with long-term middle ear effusions and/or before placing tympanostomy tubes

3. Offer tympanostomy tube insertion for children with bilateral middle ear effusions lasting at least 3 months and documented hearing difficultiesa. hearing difficulties may include abnormal audiometry, but

also can include observed hearing issues in the social and educational environment, caregiver concerns about hearing, etc


4. Tympanostomy tubes may be performed for children with long-term effusions in 1 or both ears and symptoms that are likely associated with the effusions, such as problems with balance, school performance issues, behavioral problems, ear discomfort, etca. Although placement of tympanostomy tubes for children

with middle ear effusions and hearing difficulties is a “recommendation,” this statement is considered an “option” as the supporting evidence is weaker

5. Tympanostomy tube insertion may be performed for “at risk” children with effusions that are unlikely to resolve or have persisted for more than 3 months, or have unilateral diseasea. At-risk children may need intervention more promptly and

more often than other children, but evidence is scant because these children are excluded from most trials, and thus this is an “option”

b. The AAOhNS guideline on tympanostomy tubes states that otitis media with effusion in the presence of a type B tympanogram is unlikely to spontaneously resolve—thus tubes are an option for “at-risk” children with middle ear effusions and type B tympanograms

• Who are these “at-risk” children: Children who likely will have increased consequence of hearing loss and other effects of otitis media1. “At-risk” group includes children with: Underlying hearing loss

not from otitis media with effusion, speech–language delays, autism, and other pervasive developmental disorders, craniofacial syndromes that include cognitive and communication delays, visual impairment, cleft palate, other developmental delays

2. “At-risk” children are rarely included in otitis media trials, yet they may have the greatest need for interventions, including tympanostomy tube insertion, for middle ear disease

• nIcE (national Institute for Health and clinical Excellence) guidelines on management of otitis media with effusion were published in 2008 from the United Kingdom9

1. Consider surgical intervention (tympanostomy tubes) for children with bilateral middle ear effusions for 3 months with a hearing level in the better hearing ear of 25–30 dB

2. Consider surgery for children who have persistent bilateral otitis media with effusion with a hearing loss less than 25–30 dB when there appears to be impact of hearing loss on developmental, social, or educational measures


3. Children with Down syndrome and suspected otitis media with effusion should be assessed by a multidisciplinary team, and hearing aids should be offered to those with hearing loss and middle ear effusions

4. Tympanostomy tubes can be considered as an alternative to hearing aids after considering the severity of the hearing loss, the age of the child, surgical risks, and the likelihood of early extrusion of the tubes

5. This guideline expressed concerns about the use of tympanostomy tubes as primary treatment of middle ear effusions in cleft palate patients as well

RISkS And SEqUElAE oF TyMPAnoSToMy TUbES

• Anesthesia risks include laryngospasm and bronchospasm, but general anesthesia is safe in young children with careful selection and preparation

• Mortality is likely extremely low, although estimates of anesthesia-related deaths in children undergoing a mix of surgical procedures range from 1:10,000 to 1:45,000

• Otorrhea is seen at some point in over 25% of children who have tympanostomy tubes.10 7% of children can experience recurrent otorrhea

• Persistent tympanic membrane perforation is seen in 1–6% of children after extrusion of the tube, and likely this complication is more frequent with long-term tympanostomy tubes such as T-tubes

• Tympanostomy tubes are associated with long-term tympanic membrane changes and hearing loss of small magnitude

• Tympanosclerosis, retractions, and atrophic areas are all seen more often on the tympanic membranes of individuals who have a history of tympanostomy tube placement

• Two longitudinal studies have demonstrated worsened hearing by up to 8 dB in children who had tympanostomy tubes years earlier when compared to the controls that did not have surgery

Follow-UP ISSUES• Children with tympanostomy tubes need otolaryngology follow-up

to assess benefits and to avoid and treat complications, but there is no consensus about the best schedule for such follow-up


• Postoperative hearing assessment should be performed in children with preoperative hearing deficit to document resolution of hearing loss

• Posttympanostomy tube otorrhea should be treated with topical antibiotic eardrops, without oral antibiotics1. Ototopicals have increased efficacy, treat organisms such as

Pseudomonas aeruginosa and Staphylococcus aureus, and have fewer systemic side effects when compared to most oral antibiotics used for otitis media

2. Children with complicated otorrhea, cellulitis of the ear, other bacterial infections such as sinusitis or pharyngitis, and children with impaired immune status may require systemic antibiotics when otorrhea occurs after tympanostomy tubes

• Routine prophylactic water precautions, such as use of earplugs or avoidance of swimming, are not indicated for most children after tympanostomy tube placement1. Several observational studies and 1 randomized controlled trial

have shown little if any benefit of routine use of ear plugs after tympanostomy tube placement

2. Some children may benefit and some circumstances may warrant the use of water precautions, including children with compromised immune systems or those children who experience otalgia or frequent otorrhea associated with swimming, deep water diving, or exposure to heavily contaminated water

• No specific recommendations can be made about the appropriate timing for removal of tympanostomy tubes that remain indwelling in the tympanic membrane1. Most favor removal of indwelling tubes in children who are no

longer otitis media-prone and have had tubes in place for more than 2 to 3 years, but there are no prospective studies on which to base these decisions

2. Treatment of the perforation at the time of tube removal can include tube removal alone (no treatment), freshening of the perforation, application of trichloroacetic acid or other chemicals, grafting of the perforation with paper, gelfilm, gelfoam, fat, fascia, or other materials. No prospective studies exist to select the optimal technique to encourage tympanic membrane closure

REFEREncES1. Lieberthal AS, Carroll Ae, Chonmaitree T, et al. Clinical practice

guideline; the diagnosis and management of acute otitis media. Pediatrics. 2013;131(3):e969–999.


2. McDonald S, Langton hewer CD, Nunez DA. Grommets (ventilation tubes) for recurrent acute otitis media in children. Cochrane Database Syst Rev. 2008;Oct 8(4):CD004741. Doi: 10.1002/14651858.CD004741.pub2.

3. hellstrom S, Groth A, Jorgensen F, et al. Ventilation tube treatment: a systematic review of the literature. Otolaryngol Head Neck Surg. 2011;145(3):383–395.

4. Lous J, Ryborg CT, Thomsen JL. A systematic review of the effect of tympanostomy tubes in children with recurrent acute otitis media. Int J Pediatr Otorhinolaryngol. 2011;75(9):1058–1061.

5. Rosenfeld RM, Schwartz SR, Pynnonen MA, et al. Clinical practice guideline: Tympanostomy tubes in children. Arch Otolaryngol Head Neck Surg. (in press, scheduled for July 2013).

6. Rosenfeld RM, Culpepper L, Doyle KJ, et al. Clinical practice guideline; otitis media with effusion. Otolaryngol Head Neck Surg. 2004;130:S95–118.

7. Browning GG, Rovers MM, Williamson I, Lous J, Burton MJ. Grommets (ventilation tubes) for hearing loss associated with otitis media with effusion in children. Cochrane Database Syst Rev. 2010;10;CD001801. DOI:10.1002/14651858.CD001801.pub3.

8. Rosenfeld RM, Schwartz SR, Pynnonen MA, et al. Clinical practice guideline: tympanostomy tubes in children. Arch Otolaryngol Head Neck Surg. (in press, scheduled for July 2013).

9. Khanna R, Lakhanpaul M, Bull PD. Guideline Development Group. Surgical management of otitis media with effusion in children; summary of NICe guidance. Clin Otolaryngol. 2008;33:600–608.

10. Kay DJ, Nelson M, Rosenfeld RM. Meta-analysis of tympanostomy tube sequelae. Otolaryngol Head Neck Surg. 2001;124:374–380.

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