Clinical UM Guideline |
Subject: Myringotomy and Tympanostomy Tube Insertion | |
Guideline #: CG-SURG-46 | Publish Date: 04/10/2024 |
Status: Reviewed | Last Review Date: 02/15/2024 |
Description |
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.
Clinical Indications |
Medically Necessary:
The use of combined myringotomy and tympanostomy tube insertion is considered medically necessary for individuals who meet any of the following criteria:
The use of myringotomy as a stand-alone procedure is considered medically necessary for individuals who meet one or more of the following criteria:
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.
Coding |
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:
CPT |
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69420 | Myringotomy including aspiration and/or eustachian tube inflation |
69421 | Myringotomy including aspiration and/or eustachian tube inflation requiring general anesthesia |
69433 | Tympanostomy (requiring insertion of ventilating tube), local or topical anesthesia |
69436 | Tympanostomy (requiring insertion of ventilating tube), general anesthesia |
0583T | Tympanostomy (requiring insertion of ventilating tube), using an automated tube delivery system, iontophoresis local anesthesia |
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ICD-10 Procedure |
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099500Z | Drainage of right middle ear with drainage device, open approach |
09950ZZ | Drainage of right middle ear, open approach |
099600Z | Drainage of left middle ear with drainage device, open approach |
09960ZZ | Drainage of left middle ear, open approach |
099700Z | Drainage of right tympanic membrane with drainage device, open approach |
09970ZZ | Drainage of right tympanic membrane, open approach |
099800Z | Drainage of left tympanic membrane, with drainage device, open approach |
09980ZZ | Drainage of left tympanic membrane, open approach |
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ICD-10 Diagnosis |
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| All diagnoses |
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.
Discussion/General Information |
According to the American Academy of Otolaryngology-Head and Neck Surgery (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 in adults.
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 American Academy of Otolaryngology-Head and Neck Surgery (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. In 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. The guideline further offers a new option in Statement 11 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.” The authors acknowledged a moderate to low level of evidence supporting this statement. This statement reflects that the expected benefit of adjunctive adenoidectomy is only a potential. Prospective randomized trials are needed in order to determine whether adjunctive adenoidectomy provides a net health benefit compared to tympanostomy tube insertion alone. This document provides the following recommendations related to criteria for tympanostomy tube placement:
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).
The American Academy of Pediatrics (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):
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 and others 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 and colleagues 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 in during the study period, was found to not be 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. Some 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.”
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.
Definitions |
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.
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.
References |
Peer Reviewed Publications:
Government Agency, Medical Society, and Other Authoritative Publications:
Index |
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.
History |
Status | Date | Action |
Reviewed | 02/15/2024 | Medical Policy & Technology Assessment Committee (MPTAC) review. Revised Discussion and References sections. |
Reviewed | 08/10/2023 | MPTAC review. Added text to Discussion/General Information related to outpatient tympanostomy tube insertion. Updated References and Index sections. Updated Coding section; added 0583T; removed ICD-10-PCS codes 099780Z; 09978ZZ; 099880Z; 09988ZZ not applicable. |
Revised | 02/16/2023 | MPTAC review. Revised MN criteria to add individuals with “Intellectual disability, learning disorder, or attention-deficit/hyperactivity disorder.” Updated Discussion/General Information and References sections. |
Reviewed | 02/17/2022 | MPTAC review. Updated Rationale and References sections. |
Reviewed | 02/11/2021 | MPTAC review. Reformatted Coding section. |
Reviewed | 02/20/2020 | MPTAC review. Updated References section. |
Reviewed | 03/21/2019 | MPTAC review. Updated References section. |
Reviewed | 05/03/2018 | MPTAC review. The document header wording updated from “Current Effective Date” to “Publish Date.” Updated References section. |
Reviewed | 05/04/2017 | MPTAC review. Updated formatting in Clinical Indications section. Updated References sections. |
Reviewed | 05/05/2016 | MPTAC review. Updated Rationale and References sections. |
Revised | 11/05/2015 | MPTAC review. Revised medically necessary statement criteria 1 to add “who have middle ear effusion at the time of assessment for tube candidacy”. Removed ICD-9 codes from Coding section. |
Revised | 08/06/2015 | MPTAC review. Revised medically necessary indications to address additional indications for myringotomy and tympanostomy tube placement and myringotomy alone. Updated Discussion and References sections. |
Reviewed | 05/07/2015 | MPTAC review. Updated Discussion and References sections. |
New | 02/05/2015 | MPTAC review. Initial document development. |
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