Clinical UM Guideline

This document addresses myringotomy and tympanostomy tube insertion, which are procedures used to decompress and ventilate the middle ear when fluid builds up due to infection, trauma, or other conditions. Tympanostomy tubes are also known by other terms, including grommet, T-tube, ear tube, pressure equalization (PE) tube, vent, or myringotomy tube.

Note: For a high-level overview of this document, please see “Summary for Members and Families” below.

Medically Necessary:

The use of combined myringotomy and tympanostomy tube insertion is considered medically necessary for individuals who meet any of the following criteria:

1. Children or adults with recurrent acute otitis media (AOM) (more than 3 episodes in 6 months or more than 4 episodes in 12 months) with or without otitis media with effusion (OME) who have middle ear effusion at the time of assessment for tube candidacy; or
2. Children with unilateral or bilateral OME for greater than or equal to 3 months with hearing loss greater than 20 dB in one or both ears; or
3. Children with recurrent AOM or OME of any duration when the child is at risk for speech, language, or learning delay or disorder from OM based on baseline sensory, physical, cognitive, or behavioral factors including, but not limited to, the following:
   1. Confirmed speech or language delay or disorder.
   2. Autism spectrum disorder or other pervasive developmental disorder.
   3. Syndromes (for instance, Down) or craniofacial disorders that include cognitive, speech, or language delays.
   4. Intellectual disability, learning disorder, or attention-deficit/hyperactivity disorder.
   5. Blindness or uncorrectable visual impairment.
   6. Cleft palate, with or without associated syndrome;
      or
4. Children or adults with structural damage to the tympanic membrane (TM) or middle ear, such as cholesteatoma, chronic retraction of tympanic membrane or pars flaccida; or
5. Children or adults with barotitis (barotrauma); or
6. Children or adults with autophony due to patulous eustachian tube; or
7. Children or adults with middle ear dysfunction due to head and neck radiation or skull base surgery; or
8. Children or adults with a severe complication of acute otitis media including, but not limited to: meningitis, intracranial abscess, mastoiditis, or facial nerve paralysis; or
9. Adults with OME greater than 3 months and continued symptoms of aural pressure or hearing loss; or
10. Children or adults with persistent AOM despite at least 2 different courses of recommended empiric antibiotic therapy.

The use of myringotomy as a stand-alone procedure is considered medically necessary for individuals who meet one or more of the following criteria:

1. Neonates with otitis media who are either:
   1. 16 or fewer weeks of age for full term infants; or
   2. Premature infant whose adjusted age (actual age - # weeks premature) is less than 16 weeks;
      or
2. Individual with acute otitis media and an immunocompromising condition such as cancer chemotherapy or use of anti-rejection medications following a transplant; or
3. Individual who meets criteria for tympanostomy and tube insertion but for whom tube insertion is not feasible due to the degree of ear inflammation.

Not Medically Necessary:

The use of myringotomy alone is considered not medically necessary when the criteria above have not been met and for all other indications.

The use of combined myringotomy and tympanostomy tube insertion is considered not medically necessary when the criteria above have not been met and for all other indications.

This document describes clinical studies and expert recommendations, and explains whether certain treatments for ear problems, such as creating a small opening in the eardrum (called a myringotomy) or placement of small tubes through the ear drum (called a tympanostomy tube) to improve the airflow and fluid drainage, are appropriate. The following summary does not replace the medical necessity criteria or other information in this document. The summary may not contain all of the relevant criteria or information. This summary is not medical advice. Please check with your healthcare provider for any advice about your health.

Key Information.

Myringotomy and tympanostomy tube insertion are treatments used when fluid builds up behind the eardrum. This fluid buildup can be caused by infections, injury, or other problems. Myringotomy in combination with or without tympanostomy tubes are commonly used to help drain fluid buildup and air move in and out of the middle ear and keep it dry. These tubes are also called ear tubes, grommets, or PE (pressure equalization) tubes. Most often, these procedures are used in children, but adults can benefit too. In some cases, doctors may perform a myringotomy without inserting tubes, especially for very young infants, people with certain health conditions, or when the eardrum is too inflamed. The procedures are usually safe and help prevent ear infections, improve hearing, and reduce pain or pressure. Newer tools can let doctors place tubes in a clinic setting without needing general anesthesia. Like all medical procedures, these come with risks and should be used only when truly needed.

What the Studies Show

Tympanostomy tubes have been studied in many clinical trials. They can help children hear better in the short term, but the benefits may not last beyond a few months. Some studies show fewer ear infections after tube placement, but others find no big difference compared to medicine alone. One large trial showed no long-term difference in ear infection rates between kids who got tubes and those who had medical treatment.. Experts agree that tubes help when ear problems cause delays in speech or learning. However, using myringotomy alone (without a tube) is not well-studied and may not work as well. It may be used in newborns or people with serious health issues when tube placement is not possible. Tympanostomy tubes are now sometimes placed in doctors’ offices using special tools for older babies and adults, avoiding the risks of general anesthesia. This in-office option works well in people who are calm and have no ear problems that could interfere with the procedure.

When is Myringotomy or Tympanostomy Clinically Appropriate?

Myringotomy with tympanostomy tube insertion may be appropriate in these situations:

• Children or adults with repeated ear infections (3 in 6 months or 4 in 12 months) who still have fluid in the middle ear
• Children with fluid in one or both ears for at least 3 months and hearing loss over 20 dB
• Children with any length of ear fluid or infections and risks for speech or learning delays due to conditions like autism, Down syndrome, intellectual disability, cleft palate, or blindness
• Children or adults with damage to the eardrum or middle ear
• People with ear pain or damage from changes in pressure (such as barotrauma)
• People with hearing their own voice too loudly (autophony) due to an open eustachian tube
• People with ear problems due to radiation or skull surgery
• People with severe complications from ear infections, such as meningitis, brain abscess, mastoiditis, or facial paralysis
• Adults with ear fluid lasting more than 3 months and continued hearing loss or pressure
• People with ongoing ear infections that do not improve with at least two rounds of antibiotics

Myringotomy alone may be appropriate in these situations:

• Newborns with ear infections who are very young (younger than 16 weeks, adjusted for prematurity)
• People with ear infections and a weak immune system, such as those on chemotherapy
• People who meet criteria for tubes but cannot have them due to severe ear inflammation

When is this not Clinically Appropriate?

Myringotomy with or without tympanostomy tubes is not considered appropriate when none of the above conditions are met. The procedures should not be used for other reasons. Unnecessary procedures can lead to risks like ear discharge, scarring, or hearing problems. Studies show that tubes do not help in cases without ear fluid or when used for very short-term problems. Better studies are needed to know if myringotomy alone improves health.

(Return to Description)

The following codes for treatments and procedures applicable to this guideline are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

When services may be Medically Necessary when criteria are met:

When services are Not Medically Necessary:
For the procedure codes listed above when criteria are not met or for situations designated in the Clinical Indications section as not medically necessary.

Summary:

This document addresses the use of myringotomy and tympanostomy tube insertion for middle ear conditions requiring decompression or prolonged ventilation and summarizes updated evidence on clinical effectiveness, procedure approaches, and patient-selection considerations. The evidence base includes randomized trials, meta-analyses, and long-term cohort studies evaluating outcomes such as hearing improvement, recurrence of otitis media, quality of life, and adverse events. The Discussion incorporates professional guidance from the American Academy of Otolaryngology-Head and Neck Surgery (AAO-HNS), including updated statements from the 2022 clinical practice guideline on tympanostomy tubes in children, as well as recommendations from the American Academy of Pediatrics (AAP) regarding recurrent acute otitis media. Additional expert consensus from AAO-HNS is cited regarding in-office tympanostomy tube placement for appropriately selected individuals. This reflects a synthesis of clinical evidence and professional society recommendations relevant to the appropriate use of these procedures.

According to the AAO-HNS, myringotomy is defined as a surgical procedure in which a small incision is made in the tympanic membrane (ear drum) for the purpose of draining fluid or providing short-term ventilation. The procedure is also used to relieve pressure caused by excessive buildup of fluid or to drain pus from the middle ear. It is most commonly done as a treatment for OME but may also be considered as a treatment for ear trauma (including pressure-related barotrauma) and eustachian tube dysfunction.

Tympanostomy is a companion procedure to myringotomy and involves the insertion of a small tube into the eardrum through a myringotomy incision in order to keep the middle ear aerated for a prolonged period of time, and to prevent the accumulation of fluid in the middle ear. The procedure to place a tube involves myringotomy and is performed under local or general anesthesia. There are many different tube designs available on the market. The most commonly used type is shaped like a grommet. When it is necessary to keep the middle ear ventilated for a very long period, a "T"-shaped tube may be used, as these "T-tubes" can stay in place for 2-4 years.

The use of myringotomy and tympanostomy tube insertion has become a widely used and accepted method of treating various middle ear conditions in children and adults.

The AAO-HNS published an updated clinical practice guideline addressing the use of tympanostomy tubes in children (Rosenfeld, 2022). The recommendations are substantially unchanged from the previous guideline with the following exceptions:

• Statement 8 concerning at-risk children has expanded criteria to include children with intellectual disability, learning disorder, or attention-deficit/hyperactivity disorder.
• Statement 10 recommends against a tympanostomy with “long-term tubes as initial surgery for children who meet criteria for tube insertion unless there is a specific reason based on an anticipated need for prolonged middle ear ventilation beyond that of a short-term tube.”
• Statement 13 recommends against routinely prescribing postoperative antibiotic ear drops after tympanostomy tube placement.
• Statement 16, the guideline strongly recommends follow-up after tube placement and that the surgeon or designee should examine the ears of a child within 3 months of tympanostomy tube insertion.
• Statement 11, a new option notes that adenoidectomy may be performed “as an adjunct to tympanostomy tube insertion for children with symptoms directly related to the adenoids (adenoid infection or nasal obstruction) or in children aged 4 years or older to potentially reduce future incidence of recurrent otitis media or the need for repeat tube insertion.”

Additionally, this document provides the following recommendations related to criteria for tympanostomy tube placement:

• Statement 1. OME OF SHORT DURATION: Clinicians should not perform tympanostomy tube insertion in children with a single episode of OME of less than 3 months’ duration, from the date of onset (if known) or from the date of diagnosis (if onset is unknown).
• Statement 2. HEARING EVALUATION: Clinicians should obtain a hearing evaluation if OME persists for 3 months or longer OR prior to surgery when a child becomes a candidate for tympanostomy tube insertion.
• Statement 3. Clinicians should offer bilateral tympanostomy tube insertion to children with bilateral OME for 3 months or longer AND documented hearing difficulties.
• Statement 4. Clinicians may perform tympanostomy tube insertion in children with unilateral or bilateral OME for 3 months or longer (chronic OME) AND symptoms that are likely attributable, all or in part, to OME that include, but are not limited to, balance (vestibular) problems, poor school performance, behavioral problems, ear discomfort, or reduced quality of life.
• Statement 6. Clinicians should not perform tympanostomy tube insertion in children with recurrent AOM who do not have MEE in either ear at the time of assessment for tube candidacy.
• Statement 7. Clinicians should offer bilateral tympanostomy tube insertion in children with recurrent AOM who have unilateral or bilateral MEE at the time of assessment for tube candidacy.
• Statement 8. Clinicians should determine if a child with recurrent AOM or with OME of any duration is at increased risk for speech, language, or learning problems from otitis media because of baseline sensory, physical, cognitive, or behavioral factors.
• Statement 9. Clinicians may perform tympanostomy tube insertion in at-risk children with unilateral or bilateral OME that is likely to persist as reflected by a type B (flat) tympanogram or a documented effusion for 3 months or longer.
• Statement 10. The clinician should not place long-term tubes as initial surgery for children who meet criteria for tube insertion unless there is a specific reason based on an anticipated need for prolonged middle ear ventilation beyond that of a short-term tube.

These recommendations are based on multiple studies addressing the use of tympanostomy, which demonstrate a “preponderance of benefit over harm” (Broen, 1996; Casselbrant, 1992; Gebhart, 1981; Gonzales, 1986; Hellstrom, 2011; Iino, 1999; Lous, 2012; Mandel, 1989, 1992; Paradise, 2001, 2005; Ponduri, 2009; Rosenfeld, 2011, 2016; Rovers, 2001a, 2001b, 2005; Sheahan, 2002). Additionally, the authors acknowledged a moderate to low level of evidence supporting Statement 11. The statement reflects that the expected benefit of adjunctive adenoidectomy is only a potential benefit.

The AAP published their clinical practice guideline titled The Diagnosis and Management of Acute Otitis Media in 2013 (Lieberthal, 2013). This document includes the following Key Action Statement based on multiple studies (Casselbrant, 1992; Gebhart, 1981; Gonzales, 1986; Rosenfeld, 2000; Witsell, 2005):

Clinicians may offer tympanostomy tubes for recurrent AOM (3 episodes in 6 months or 4 episodes in 1 year, with 1 episode in the preceding 6 months). (Evidence Quality: Grade B, Rec. Strength: Option).

The use of myringotomy and tympanostomy tube insertion has become accepted as a treatment method for individuals with severe complication of acute otitis media such as meningitis, intracranial abscess, mastoiditis, or facial nerve paralysis. While there is little evidence addressing such treatment, there is wide agreement in the otolaryngology community supporting it. In such cases it is deemed prudent to use myringotomy and tympanostomy to prevent further progression of complications.

In 2017, Steele published the results of a meta-analysis investigating the effectiveness of tympanostomy tubes in children with chronic otitis media with effusion and recurrent acute otitis media. The analysis involved 54 publications, with 29 studies describing the results of 16 RCTs and another 24 studies reporting the results of 24 non-randomized controlled trials. The authors reported that children with chronic otitis media with effusion who were treated with tympanostomy tubes had a net decrease in mean hearing threshold vs. watchful waiting of 9.1 dB at 1 to 3 months and 0.0 dB at 12 to 24 months. They noted that children with recurrent acute otitis media may have fewer episodes after placement of tympanostomy tubes. Finally, they found that adverse events are associated with tympanostomy tube placement are poorly defined and reported. They concluded,

Tympanostomy tubes improve hearing at 1 to 3 months compared with watchful waiting, with no evidence of benefit by 12 to 24 months. Children with recurrent acute otitis media may have fewer episodes after tympanostomy tube placement, but the evidence base is severely limited. The benefits of tympanostomy tubes must be weighed against a variety of associated adverse events.

In 2021 Hoberman reported the results of an RCT involving 250 children between 6 and 35 months of age with recurrent AOM assigned to treatment with either tympanostomy tubes (n=129) or medical management (n=121). At the end of the 2-year follow-up period, 208 participants had completed the trial, with 13 (10%) participants in the tube group not undergoing their procedure. In the medical group, 54 (45%) participants subsequently underwent tube placement procedures; 35 (29%) of whom received tube placement according to protocol due to recurrence of AOM and 19 (16%) at the request of the parent. The authors reported their results using a per protocol analysis that included in the tube group the 35 participants from the medical group who underwent tube placement. The primary outcome, rate of occurrence of AOM during the study period, was not significantly different between groups (p=0.66). Similarly, no significant differences between groups were found with regard to secondary outcomes, including percentage of episodes of AOM categorized as ‘probably severe,’ the percentage of children who had protocol-defined diarrhea or medication-related diaper dermatitis, extent of antimicrobial resistance, quality of life, use of medical and nonmedical resources, or parental satisfaction with the treatment assignment. Significant differences were reported in favor of the tube group for fewer days per year with otitis-related symptoms other than tube otorrhea, and fewer days per year receiving systemic antimicrobial treatment (no p-values provided). In the medical group, 55 participants met treatment failure criteria. An analysis of this group found them to be younger at baseline than the 46 medical group participants who did not experience treatment failure nor underwent subsequent tube placement. The authors concluded, “Among children 6 to 35 months of age with recurrent acute otitis media, the rate of episodes of acute otitis media during a 2-year period was not significantly lower with tympanostomy-tube placement than with medical management.”

Almari (2024) conducted a meta-analysis to evaluate the effectiveness of tympanostomy with adenoidectomy versus tympanostomy alone in children with OME. Five studies were included in the analysis, which showed that tympanostomy with adenoidectomy significantly improves hearing levels in both ears compared to tympanostomy alone (SMD -0.17, 95% CI [-0.29, -0.05], p=0.005). However, the pooled results were not heterogeneous (p<0.25, F=24%). The authors concluded that tympanostomy with adenoidectomy improves hearing more than tympanostomy alone, but both treatments have similar effects on ear infection rates. Further prospective randomized trials are necessary to evaluate the overall health benefits and long-term outcomes of adding adenoidectomy to tympanostomy tube insertion.

McCoul et al. (2012) provide a well-described, initial validation of the Eustachian Tube Dysfunction Questionnaire (ETDQ-7) as a brief, disease-specific patient reported outcome (PRO) for adult eustachian tube dysfunction (ETD), showing acceptable internal consistency, good test-retest reliability, and strong discrimination between clearly defined ETD and non-ETD clinic participants. However, the small sample, use of tympanometry as an imperfect reference standard, and very high diagnostic accuracy suggest that ETDQ-7 should be viewed primarily as a symptom and outcome measure, not a definitive diagnostic test. Later studies generally support its validity, reliability, and responsiveness across BDET trials, but they also indicated more modest diagnostic performance and limitations in distinguishing ETD subtypes. Holm (2025) subsequently reported a prospective observational study of 75 adults with symptoms suggestive of ETD and objective signs of negative middle ear pressure using the ETDQ-7. Ventilation tube insertion was performed on the affected ears; ETDQ-7 and before and 1 month after ventilation tube insertion were compared to 75 healthy controls. The results showed that the mean ETDQ-7 score decreased from 31.9 to 15.8 (p<0.0001), remained stable on unaffected ears, and was 9.6 in controls. A minimal clinically important difference was achieved on all affected ears after ventilation tube insertion. A cut-off score of greater than 14.5 for diagnosing ETD yielded 100% sensitivity and 94.2% specificity for ETDQ-7. The study was limited by the use of negative middle ear pressure as a diagnostic standard for ETD, this could have inflated sensitivity and specificity, since ETDQ-7 captures symptoms while the reference standard captures only a subset of ETD presentations. Additionally, there was no sham or untreated ETD comparison arm and a short follow-up period of only 1-month after tube insertion. The authors concluded that the study presents encouraging evidence that ETDQ-7 is responsive to treatment, dependable, and capable of distinguishing ETD participants from healthy controls, but the diagnostic accuracy claims are likely inflated due to design limitations, particularly the use of healthy controls and a narrow objective definition of ETD. The results support ETDQ-7 as a symptom severity and outcome measure, not a definitive diagnostic tool. Longer-term follow-up, broader ETD phenotypes, methodologically rigorous design and ear-level scoring are needed to strengthen future evidence.

The procedure to place a tympanostomy tube is commonly performed in an operating room (OR) under general anesthesia. However, in 2019, a device intended to create a myringotomy and insert a tympanostomy tube under local anesthesia in a clinician’s office (Tula^® Tympanostomy System) was approved by the FDA. The device was approved for use in adults and in pediatric individuals aged 6 months and older. Soon after, a similar device, the Hummingbird^® Tympanostomy Tube System, was cleared for use in children 6-24 months old. Advantages of these devices include avoiding of the need for general anesthesia for tube placement. Risks may include inadequate local anesthesia, dizziness and other common tympanostomy procedure risks such as otorrhea and tympanosclerosis. Prospective, multicenter studies have demonstrated success rates of at least 90% for in-office tympanostomy tube procedures (Truitt, 2021; Zeiders, 2015). In selected individuals with AOM who have normal ear anatomy and can avoid excessive movement, the in-office procedure provides a reasonable alternative to inpatient tympanostomy tube insertion. The AAO-HNS concurs in their 2019 statement on in-office placement of tubes:

The position of the AAO-HNS is that tympanostomy tubes are safe and effective for managing otitis media in children who meet current guidelines for tube insertion [Rosenfeld 2013]. Although insertion of tympanostomy tubes in children is generally accomplished in the operating room under general anesthesia, insertion in the clinic in appropriately selected patients using shared decision making between clinicians and families can be appropriate.

The use of myringotomy alone is poorly studied in the medical literature. In most circumstances, there is no available evidence to demonstrate that the use of myringotomy without tube insertion has any incremental benefit over myringotomy with tube insertion for the treatment of OME or AOM; to the contrary, there is limited published literature indicating that it is inferior for these indications (Mandel, 1992). The use of tubes in conjunction with myringotomy in circumstances where myringotomy alone has been proposed adds longer-term benefits such as prolonged ventilation and drainage, and pressure release. Further, middle ear fluid cultures are generally considered unnecessary when planning or adjusting antibiotic choices, and could be accomplished via less invasive procedures, if required. However, there are some isolated circumstances where myringotomy alone may be warranted. Such circumstances may include when an individual’s tympanic membrane is inflamed to the point where tube placement is not possible or in neonates when tube placement presents too great a risk. Other instances for myringotomy alone may be presented in individuals who are immunocompromised and who may present with advanced OM requiring immediate treatment or to obtain cultures to identify the infectious agent.

Acute otitis media (AOM): Middle ear infection characterized by a history of acute onset of signs and symptoms, the presence of middle-ear effusion, and signs and symptoms of middle-ear inflammation.

Autophony: A condition characterized by an unusually loud hearing of a person's own voice and/or breathing.

Barotitis (barotrauma): Damage to the middle ear caused by pressure changes.

Eustachian Tube Dysfunction Questionnaire (ETDQ-7): A validated patient reported outcome measure used to assess the severity of symptoms related to EDT in adults based on a Likert scale. The questionnaire is used to help quantify how much ETD symptoms affect an individual’s daily life and provides a standardized way to diagnose ETD when combined with clinical findings, track symptom severity over time, and measure treatment response (McCoul, (2012).

Intra-cranial complication: In this instance, a problem such as an infection inside the skull, that is related to the otitis media.

Mastoiditis: An infection of the mastoid bone of the skull.

Myringotomy: A surgical procedure that creates a small hole in the eardrum.

Otitis media with effusion (OME): An ear condition characterized by the accumulation of fluid in the middle ear.

Pars flaccida: A part of the ear drum.

Patulous eustachian tube: A condition where the eustachian tube that runs from the middle ear to the nasopharynx, which is normally closed, stays intermittently open.

Retraction of tympanic membrane: A condition in which a part of the eardrum lies deeper within the ear than normal.

Tympanostomy tube: A small tube placed into a myringotomy incision to maintain the opening for prolong periods of time. Tympanostomy tubes are also known by other terms, including grommet, T-tube, ear tube, pressure equalization tube, vent, PE tube, or myringotomy tube.

Vestibular problems: Health conditions due to infection, inflammation, or damage to the vestibular system of the inner ear. This is usually characterized by balance problems.

Peer Reviewed Publications:

1. Alamri AA, Amoodi HA, Alsubaie SA, et al. Efficacy of adenoidectomy versus tympanostomy on the otitis media with effusion: a systematic review and meta-analysis. Afr J Paediatr Surg. 2024; 21(4):236-241.
2. Broen PA, Moller KT, Carlstrom J, et al. Comparison of the hearing histories of children with and without cleft palate. Cleft Palate Craniofac J. 1996; 33(2):127-133.
3. Casselbrant ML, Kaleida PH, Rockette HE, et al. Efficacy of antimicrobial prophylaxis and of tympanostomy tube insertion for prevention of recurrent acute otitis media: results of a randomized clinical trial. Pediatr Infect Dis J. 1992; 11(4):278-286.
4. Chowdhury CR, Ho JH, Wright A, et al. Prospective study of the effects of ventilation tubes on hearing after radiotherapy for carcinoma of nasopharynx. Ann Otol Rhinol Laryngol. 1988; 97(2 Pt 1):142-145.
5. Gonzalez C, Arnold JE, Woody EA, et al. Prevention of recurrent acute otitis media: chemoprophylaxis versus tympanostomy tubes. Laryngoscope. 1986; 96(12):1330-1334.
6. 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.
7. Hoberman A, Preciado D, Paradise JL, et al. Tympanostomy tubes or medical management for recurrent acute otitis media. N Engl J Med. 2021; 384(19):1789-1799.
8. Holm NH, Ovesen T. The Usefulness of ETDQ-7 Score in Assessing ETD. Clin Otolaryngol. 2025; 50(5):840-847.
9. Hornigold R, Morley A, Glore RJ, et al. The long-term effect of unilateral t-tube insertion in patients undergoing cleft palate repair: 20-year follow-up of a randomised controlled trial. Clin Otolaryngol. 2008; 33(3):265-268.
10. Iino Y, Imamura Y, Harigai S, Tanaka Y. Efficacy of tympanostomy tube insertion for otitis media with effusion in children with Down syndrome. Int J Pediatr Otorhinolaryngol. 1999; 49(2):143-149.
11. Ingels K, Rovers MM, van der Wilt GJ, Zielhuis GA. Ventilation tubes in infants increase the risk of otorrhoea and antibiotic usage. B-ENT. 2005; 1(4):173-176.
12. Johnston LC, Feldman HM, Paradise JL, et al. Tympanic membrane abnormalities and hearing levels at the ages of 5 and 6 years in relation to persistent otitis media and tympanostomy tube insertion in the first 3 years of life: a prospective study incorporating a randomized clinical trial. Pediatrics. 2004; 114(1):e58-67.
13. Kay DJ, Nelson M, Rosenfeld RM. Meta-analysis of tympanostomy tube sequelae. Otolaryngol Head Neck Surg. 2001; 124(4):374-380.
14. Koopman JP, Reuchlin AG, Kummer EE, et al. Laser myringotomy versus ventilation tubes in children with otitis media with effusion: a randomized trial. Laryngoscope. 2004; 114(5):844-849.
15. Le CT, Freeman DW, Fireman BH. Evaluation of ventilating tubes and myringotomy in the treatment of recurrent or persistent otitis media. Pediatr Infect Dis J. 1991; 10(1):2-11.
16. 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.
17. Mandel EM, Rockette HE, Bluestone CD, et al. Efficacy of myringotomy with and without tympanostomy tubes for chronic otitis media with effusion. Pediatr Infect Dis J. 1992; 11(4):270-277.
18. McCormick DP, Johnson DL, Baldwin CD. Early middle ear effusion and school achievement at age seven years. Ambul Pediatr. 2006; 6(5):280-287.
19. McCoul ED, Anand VK, Christos PJ. Validation of the Eustachian Tube Dysfunction Questionnaire (ETDQ-7). Laryngoscope. 2012; 122(5), 1137-1141.
20. Paradise JL, Dollaghan CA, Campbell TF, et al. Language, speech sound production, and cognition in three-year-old children in relation to otitis media in their first three years of life. Pediatrics. 2000; 105(5):1119-1130.
21. Paradise JL, Dollaghan CA, Campbell TF, et al. Otitis media and tympanostomy tube insertion during the first three years of life: developmental outcomes at the age of four years. Pediatrics. 2003a; 112(2):265-277.
22. Paradise JL, Feldman HM, Campbell TF, et al. Early versus delayed insertion of tympanostomy tubes for persistent otitis media: developmental outcomes at the age of three years in relation to prerandomization illness patterns and hearing levels. Pediatr Infect Dis J. 2003b; 22(4):309-314.
23. Paradise JL, Feldman HM, Campbell TF, et al. Tympanostomy tubes and developmental outcomes at 9 to 11 years of age. N Engl J Med. 2007; 356(3):248-261.
24. Ponduri S, Bradley R, Ellis PE, et al. The management of otitis media with early routine insertion of grommets in children with cleft palate—a systematic review. Cleft Palate Craniofac J. 2009; 46(1):30-38.
25. Rach GH, Zielhuis GA, van Baarle PW, van den Broek P. The effect of treatment with ventilating tubes on language development in preschool children with otitis media with effusion. Clin Otolaryngol Allied Sci. 1991; 16(2):128-132.
26. Rosenfeld RM, Bhaya MH, Bower CM, et al. Impact of tympanostomy tubes on child quality of life. Arch Otolaryngol Head Neck Surg. 2000; 126(5):585-592.
27. Rosenfeld RM, Jang DW, Tarashansky K. Tympanostomy tube outcomes in children at-risk and not at-risk for developmental delays. Int J Pediatr Otorhinolaryngol. 2011; 75(2):190-195.
28. Schilder AG, Van Manen JG, Zielhuis GA, et al. Long-term effects of otitis media with effusion on language, reading and spelling. Clin Otolaryngol Allied Sci. 1993; 18(3):234-241.
29. Schilder AG. Assessment of complications of the condition and of the treatment of otitis media with effusion. Int J Pediatr Otorhinolaryngol. 1999; 49 Suppl 1:S247-251.
30. Sheahan P, Blayney AW, Sheahan JN, Earley MJ. Sequelae of otitis media with effusion among children with cleft lip and/or cleft palate. Clin Otolaryngol Allied Sci. 2002; 27(6):494-500.
31. Steele DW, Adam GP, Di M, et al. Effectiveness of tympanostomy tubes for otitis media: a meta-analysis. Pediatrics. 2017; 139(6):e20170125.
32. Stenstrom R, Pless IB, Bernard P. Hearing thresholds and tympanic membrane sequelae in children managed medically or surgically for otitis media with effusion. Arch Pediatr Adolesc Med. 2005; 159(12):1151-1156.
33.  Truitt TO, Kosko JR, Nimmons GL, et al. In-office insertion tympanostomy tubes in children using single-pass device. Laryngoscope Investig Otolaryngol. 2021; 6(2):325-331.
34. van Dongen TM, van der Heijden GJ, Venekamp RP, et al. A trial of treatment for acute otorrhea in children with tympanostomy tubes. N Engl J Med. 2014; 370(8):723-733.
35. Witsell DL, Stewart MG, Monsell EM, et al. The Cooperative Outcomes Group for ENT: a multicenter prospective cohort study on the outcomes of tympanostomy tubes for children with otitis media. Otolaryngol Head Neck Surg. 2005; 132(2):180-188.
36. Xu YD, Ou YK, Zheng YQ, et al. The treatment for postirradiation otitis media with effusion: a study of three methods. Laryngoscope. 2008; 118(11):2040-2043.
37. Zeiders JW, Syms CA, Mitskavich MT, et al. Tympanostomy tube placement in awake, unrestrained pediatric patients: a prospective, multicenter study. Int J Pediatr Otorhinolaryngol. 2015; 79(12):2416-2423.

Government Agency, Medical Society, and Other Authoritative Publications:

1. American Academy of Family Physicians; American Academy of Otolaryngology-Head and Neck Surgery; American Academy of Pediatrics Subcommittee on Otitis Media With Effusion. Otitis media with effusion. Pediatrics. 2004; 113(5):1412-1429.
2. American Academy of Otolaryngology-Head and Neck Surgery. In-office placement of tubes in pediatric patients while awake. Adopted July 9, 2019. Available at: https://www.entnet.org/resource/in-office-placement-of-tubes-in-pediatric-patients-while-awake/. Accessed on December 5, 2025.
3. Browning GG, Rovers MM, Williamson I, et al. Grommets (ventilation tubes) for hearing loss associated with otitis media with effusion in children. Cochrane Database Syst Rev. 2010;(10):CD001801.
4. Lieberthal AS, Carroll AE, Chonmaitree T, et al. The diagnosis and management of acute otitis media. Pediatrics. 2013; 131(3):e964-e999.
5. MacKeith S, Mulvaney CA, Galbraith K, et al. Ventilation tubes (grommets) for otitis media with effusion (OME) in children. Cochrane Database Syst Rev. 2023; 11(11):CD015215.
6. National Institute of Allergy and Infectious Diseases (NIAID). Health Information. DOCK8 Immunodeficiency Syndrome. July 2022. Available at: https://www.niaid.nih.gov/sites/default/files/DOCK8-Factsheet.pdf. Accessed on December 5, 2025.
7. Rosenfeld RM, Shin JJ, Schwartz SR, et al. Clinical practice guideline: Otitis media with effusion (update). Otolaryngol Head Neck Surg. 2016; 154(1 Suppl):S1-S41.
8. Rosenfeld RM, Tunkel DE, Schwartz SR, et al. Clinical practice guideline: tympanostomy tubes in children (update). Otolaryngol Head Neck Surg. 2022; 166(1 Suppl):S1-S55.
9. Venekamp RP, Mick P, Schilder AG, Nunez DA. Grommets (ventilation tubes) for recurrent acute otitis media in children. Cochrane Database Syst Rev. 2018;(5):CD012017.

1. Centers for Disease Control (CDC). Ear infections Basics. April 17, 2024. Available at: https://www.cdc.gov/ear-infection/about/index.html. Accessed December 5, 2025.
2. National Institutes of Health (NIH). Ear tubes or antibiotics for repeat infections in children? May 25, 2021. Available at: https://www.nih.gov/news-events/nih-research-matters/ear-tubes-or-antibiotics-repeat-infections-children. Accessed on December 5, 2025.

Ear tube
Grommet
Hummingbird^® Tympanostomy Tube System
Myringotomy tube
PE tube
Pressure equalization tube
T-tube
Tula^® Tympanostomy System
Vent

The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

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