Continuing Education Activity

Tympanostomy tube placement is a standard surgical procedure, particularly in children, to alleviate symptoms associated with middle ear effusion, recurrent acute otitis media, and persistent ear infections. Tympanostomy tubes improve hearing and reduce the risk of long-term complications by ventilating the middle ear and promoting fluid drainage. Tympanostomy tube insertion is typically performed under general anesthesia in children and local anesthesia in adolescents and adults. The procedure involves making a small incision in the tympanic membrane to insert the tube. The procedure is generally well-tolerated. Close monitoring following tympanostomy tube insertion is essential to the timely identification and management of complications and to ensure optimal outcomes.

This activity for healthcare professionals reviews the relevant anatomy, indications, contraindications, equipment needs, procedural steps, complications, and outcomes of tympanostomy tube insertion in children and adults. The activity also highlights the role of the interprofessional team in improving outcomes for patients undergoing this procedure.

Objectives:

• Identify patients who may benefit from tympanostomy tube placement based on their clinical history.

• Apply best practices when performing tympanostomy tube insertion.

• Identify and manage the common complications of tympanostomy tube insertion.

• Develop and implement effective interprofessional team strategies to improve outcomes for patients undergoing tympanostomy tube insertion.

Introduction

Tympanostomy tubes are small, cylindrical devices inserted into the eardrum to facilitate fluid drainage from the middle ear and equalize pressure between the middle ear and the external environment. This minor surgical procedure, often performed as an outpatient procedure under general anesthesia, is 1 of the most frequently performed surgeries in children. In the United States (US), tympanostomy tube insertion is the most common ambulatory surgery performed on children younger than 15 years, with nearly 667,000 cases performed in 2006.[1] More than 8% of all children in the US will undergo tympanostomy tube placement at least once by age 3 years; approximately 20% will require the insertion of a second set of tympanostomy tubes during their lifetime.[2][3] 

Tympanostomy tube insertion is primarily indicated for conditions such as recurrent acute otitis media (AOM), chronic otitis media with effusion (OME), and persistent middle ear infections that fail to respond to conservative management. Otitis media is the second-most common ailment diagnosed in children and is more prevalent in children younger than 7 years of age due to their comparatively underdeveloped immune systems and compromised eustachian tube function.[4] Tympanostomy tubes aim to alleviate symptoms, improve hearing, and prevent complications associated with prolonged middle ear fluid accumulation, such as conductive hearing loss and recurrent infections.

Anatomy and Physiology

A comprehensive understanding of the anatomy of the external ear and a detailed familiarity with the tympanic membrane (TM) and its adjacent structures are essential to safely inserting a tympanostomy tube.

External Ear

The external ear comprises the auricle or pinna, a funnel-shaped cartilaginous structure contiguous with the acoustic meatus and external auditory canal. The external auditory canal, measuring approximately 2.5 cm in length in adults, has a lateral cartilaginous and a medial bony segment. The TM is positioned at the medial aspect of the external auditory canal and forms a significant portion of the lateral wall of the middle ear space.

Tympanic Membrane

The TM is concave, thin, semitransparent, and pearly gray. It comprises 3 layers: an outer epithelial or ectodermal layer, a middle fibrous layer, and an inner mucosal or endodermal layer; the inner mucosal layer is continuous with the squamous lining of the middle ear cavity. The middle fibrous layer, comprised of an outer radial layer and a deeper circular layer, supports the skin of the external auditory canal laterally and the middle ear mucosa medially. The fibrous layer integrates laterally to form the annulus. The manubrium of the malleus is attached to the medial aspect of the TM; the tip of the malleus forms a small depression in the TM called the umbo. The thinner, superior portion of the TM is the pars flaccida, and the thicker inferior area is the pars tensa. The pars flaccida comprises the upper posterior quadrant of the TM, and the pars flaccida comprises its remainder. The total surface area of the TM in adults is approximately 85 mm²; only 55 mm² is mobile. The TM measures about 8.5 to 10 mm vertically and 8 to 9 mm horizontally.[5]

The lateral surface of the TM receives blood supply from the deep auricular branch of the maxillary artery. The medial surface is supplied by the auricular branch of the occipital artery and the anterior tympanic artery branch of the maxillary artery. Sensory innervation to the lateral surface of the TM is provided by the auriculotemporal branch of the mandibular nerve (cranial nerve [CN] V, V3), the auricular branch of the facial nerve (CN VII), the auricular branch of the vagus nerve (CN X), and the glossopharyngeal nerve (CN IX). The medial aspect of the TM is innervated by the glossopharyngeal nerve (CN IX).[6] 

Middle Ear

Medial to the TM is the middle ear space housing the ossicles: the malleus, incus, and stapes. The tympanic segment of the facial nerve traverses the middle ear space from anterior to posterior above the oval window and stapes. The nerve turns 90 degrees, runs inferiorly at the second genu, and runs through the mastoid portion of the temporal bone before exiting the temporal bone through the stylomastoid foramen. A branch of the facial nerve known as the chorda tympani runs from posterior to anterior behind the TM between the malleus and incus, exiting through the petrotympanic fissure. The chorda tympani joins the lingual nerve and gives a taste sensation to the anterior two-thirds of the tongue.

Indications

In 2022, the American Academy of Otolaryngology-Head and Neck Surgery published guidelines for tympanostomy tube insertion in children.[7] These guidelines are:

• Bilateral chronic OME for 3 months or longer AND documented hearing loss.
• Unilateral or bilateral OME for 3 months or longer (chronic OME) AND symptoms that are likely attributable, all or in part, to OME, including, but not limited to, balance (vestibular) problems, poor school performance, behavioral problems, ear discomfort, or reduced quality of life.
• Recurrent AOM with unilateral or bilateral middle ear effusion at the time of assessment for tube candidacy. Recurrent AOM is defined as 3 or more well-documented and separate AOM episodes in the last 6 months OR at least 4 well-documented and separate AOM episodes in the previous 12 months with at least 1 in the last 6 months.
• 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. Children with OME who are at risk for developmental delays or disorders are those with permanent hearing loss independent of OME, speech and language delay, developmental disorders including autism spectrum disorder, syndromes or craniofacial disorders which include cognitive, speech or language delays, blindness or an uncorrectable visual impairment, cleft palate, developmental delay, intellectual disability, learning disorder, or attention-deficit hyperactivity disorder.

Adenoidectomy may be performed as an adjunct to tympanostomy tube insertion for children with symptoms directly related to the adenoids, such as 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.[7][8][9] 

Unlike children, there are no set guidelines for tympanostomy tube placement in adults, which can slow referrals and delay definitive treatment. The indications for tympanostomy tubes in adults with eustachian tube dysfunction vary and depend upon the severity of symptoms and the likelihood of improvement. Indications for adult tympanostomy tube placement are less well-defined but include chronic eustachian tube dysfunction leading to chronic OME, a systemic infection of unknown etiology with fluid within the mastoid or middle ear space, or an atrophic, retracted, and flaccid drum.[10] 

Primary care practitioners should initiate medical management and obtain a preliminary baseline audiogram and tympanogram when treating chronic eustachian tube dysfunction in adults. After 3 to 12 months of maximal medical therapy, subsequent studies should be conducted to assess symptom severity and improvement. Surgical intervention becomes necessary if medical management fails to alleviate symptoms and follow-up studies indicate insufficient improvement. This approach ensures appropriate escalation to surgical intervention when indicated based on objective measures of treatment response.

Occasionally, a tympanostomy tube is needed during hyperbaric oxygen therapy to treat or prevent otic barotrauma.[11]

Contraindications

There are no absolute contraindications to tympanostomy tube placement. Patients with chronic OME or recurrent AOM who do not meet the indications for tympanostomy tube placement should be observed or treated with antibiotics as medically indicated. However, a tympanostomy tube may be placed based on the surgeon’s judgment only after thoroughly discussing the risks and benefits of the procedure with the patient or their caregiver.

Several anatomic variants may be considered relative contraindications to tympanostomy tube placement. These variants include but are not limited to the dehiscence of the facial nerve within the middle ear space or a dehiscence or aberrant course of the internal carotid artery within the middle ear cleft.[12]

Equipment

The equipment for tympanostomy tube placement typically includes:

• Operating microscope or 0° endoscope
• Ear specula
• Cup forceps
• Cerumen loops
• 3F, 5F, and 7F Fraiser suction tubes
• Myringotomy knife
• Alligator forceps
• Curved forceps
• Tympanostomy tube(s)
  • tympanostomy tubes are typically made of plastic, metal, hydroxyapatite, or silicone and are classified as short-term (6-12 months) or long-term (12 months or longer). Selecting a particular tympanostomy tube type or shape is a matter of preference, as numerous short- and long-term tympanostomy tube types exist with well-established results.[7]

Personnel

The personnel typically required for tympanostomy tube placement will vary with the procedural setting.

Operating Room

• Surgeon
• Surgical technician or operating room nurse
• Circulating or operating room nurse
• Anesthesia personnel

Clinic

• Surgeon
• Medical assistant or nurse

Preparation

For children undergoing tympanostomy tube placement as the only procedure, general anesthesia with mask ventilation alone is typically used. Conversely, general endotracheal anesthesia is used for children undergoing additional procedures, such as adenoidectomy or cleft palate repair.

In adolescent and adult patients, the procedure is often well tolerated in the clinic under local anesthesia, facilitated by topical lidocaine, phenol, or lidocaine injection.

Technique or Treatment

The ear canal and TM are visualized using an operating microscope with an appropriately sized ear speculum or 0° endoscope. Cerumen and squamous epithelium are removed to facilitate visualization and access to the TM. A myringotomy knife is used to make a 2-mm radial incision in the anteroinferior portion of the TM. A middle ear effusion, if present, may be aspirated using a 5F or 3F Fraiser tip suction. Saline irrigation can effectively remove thick mucoid effusions from the middle ear space.

The tympanostomy tube is placed through the myringotomy using alligator forceps. Proper positioning is ensured with a pick or right-angle clamp to enable visualization of the middle ear mucosa through the tube. Bleeding typically ceases spontaneously; oxymetazoline or a 1:1000 epinephrine solution can be topically applied to achieve hemostasis. Antibiotic drops are administered intraoperatively and continued for several days to maintain tube patency and minimize the risk of postoperative otorrhea.

Complications

Myringosclerosis, tympanosclerosis, and other TM changes are common following tympanostomy tube placement and do not require intervention.[13]

Complications

The complications following tympanostomy tube insertion tend to be mild and easily managed. These complications include but are not limited to:

Tympanostomy tube otorrhea: is the most common complication of tympanostomy tube placement and is seen in 16% of children within 4 weeks of surgery and 26% of children during the entire period the tube is in place.[13] Prompt administration of antibiotic ear drops following tube placement has demonstrated efficacy in averting tympanostomy tube otorrhea.[14] Ciprofloxacin or ofloxacin formulations are typically used and are comparable to combination antibiotic-steroid ear drops.[14] Notably, adherence to water precautions has been efficacious in preventing otorrhea following tympanostomy tube placement.[15]

Tympanostomy tube obstruction: occurs in 6% to 12% of patients. The management of obstructed tympanostomy tubes primarily involves empirical methods, including manual removal of the blockage or treatment with ear drops. Formulations include 5% sodium bicarbonate, 3% hydrogen peroxide, 0.33% acetic acid, or 0.9% sodium chloride drops; hydrogen peroxide is the least efficacious.[16]

Granulation tissue: occurs in approximately 4% of patients. The recommended initial treatment is antibiotic-steroid drops. However, contemplating tube removal is advisable to mitigate foreign body reactions in cases of persistent obstruction.[13]

Premature tube extrusion: typically occurs within a few months of tube placement. Patients should undergo reassessment to determine their eligibility for tube replacement.[13]

Tympanic membrane perforation after tympanostomy tube extrusion: occurs in 1% to 6% of patients but has been reported to be as high as 10%. This complication may require myringoplasty or a formal tympanoplasty.[17]

Tube displacement into the middle ear: is a rare complication that affects approximately 0.5% of patients. The tube may be left in situ, and the patient observed, or the tube can be removed if an inflammatory reaction ensues. The development of a perilymphatic fistula has been reported following tube displacement into the middle ear.[18] 

Retained tympanostomy tube: is characterized by its persistence in situ beyond 2 to 2.5 years following placement. Retained tubes are associated with otorrhea, chronic TM perforation, granulation tissue formation, and cholesteatoma development. Patients with retained tympanostomy tubes may be observed; granulation tissue or otorrhea may be treated with topical drops, provided they are not required persistently. Alternatively, tympanostomy tube removal with or without myringoplasty may be considered to prevent persistent TM perforation.[19]

Clinical Significance

Tympanostomy tube placement is the most frequently performed ambulatory surgery in children in the US. Tympanostomy tube insertion has been shown to improve the quality of life in children.[17] In patients with chronic OME, the prevalence of middle ear effusion is reduced by 33%, and average hearing is improved by 5 to 12 decibels.[20] Tympanostomy tube placement allows topical drops to be administered directly into the middle ear at higher concentrations and limits the use of systemic antibiotics in children.[4]

Enhancing Healthcare Team Outcomes

With tympanostomy tube placement being the most frequent ambulatory surgery performed in children, an interprofessional team approach is imperative to obtaining optimum outcomes for patients. Clinicians, including physicians, advanced practitioners, and specialists like otolaryngologists, play key roles in identifying, referring, and performing the procedure. Primary care practitioners are pivotal in recognizing patients eligible for tympanostomy tube placement and referring them to specialists. Enhancing awareness of clinical practice guidelines and indications for the procedure can facilitate improved interdisciplinary patient care and consistent expectations for patients and their caregivers when transitioning from primary care clinicians to otolaryngologists.[21][22]

Nurses play a central role in coordinating activities among various clinicians, assisting during the procedure, and providing counseling to patients and caregivers. Audiologists are essential in conducting necessary assessments like audiograms and tympanograms to identify candidates for tympanostomy tube placement or those requiring surveillance before referral to specialists. Following the procedure, close observation by all team members is vital to monitor for complications, tube extrusion, and the potential need for repeat tube placement. Collaborative efforts and open communication channels among healthcare professionals ensure comprehensive care delivery and optimal patient outcomes throughout the entire process.