Medical policy: Balloon dilation of the Eustachian tube

Número de política: MP 1.157

Fecha de entrada en vigor: 2/1/2026

Política

Balloon dilation of the Eustachian tube (BDET) for treatment of chronic obstructive Eustachian tube dysfunction may be considered medically necessary when ALL of the following criteria are met:

• The individual is an adult (age 18 years and older).
• The Eustachian tube dysfunction has been present for 3 months or longer (in one or both ears) and includes ALL of the following:
  • Aural fullness
  • Aural pressure
  • Significant, documented negative effects on quality of life and/or functional health status
• Comprehensive diagnostic assessment yields the findings of BOTH:
  • Abnormal tympanogram (Type B or C); AND
  • Abnormal tympanic membrane (retracted membrane, effusion, perforation, or any other abnormality identified on exam)
• Lack of improvement despite appropriate medical management (including nasal steroids, when indicated) of commonly occurring co-morbidities:
  • Allergic rhinitis
  • Rhinosinusitis
  • Laryngopharyngeal reflux
• Documented absence of other causes of aural fullness:
  • Temporomandibular joint disorders
  • Extrinsic obstruction of the Eustachian tube
  • Superior semi-circular canal dehiscence
  • Endolymphatic hydrops
• Improvement in symptoms of obstructive Eustachian tube dysfunction if tympanostomy tubes were placed and patent.
• Lack of patulous Eustachian tube dysfunction or other contraindications to the BDET procedure.
• Documented reversibility of the individual’s Eustachian tube dysfunction
• Continuous, not episodic symptoms (e.g., symptoms not occurring only in response to barochallenge such as pressure changes while flying)
• No history of a previous BDET procedure.

Balloon dilation of the Eustachian tube is considered investigational if the above criteria are not met. There is insufficient evidence to support a general conclusion concerning the health outcomes or benefits associated with this procedure.

Directrices de la política

Symptoms of obstructive Eustachian tube dysfunction may include aural fullness, aural pressure, otalgia, and hearing loss. Nearly all individuals will have aural fullness and aural pressure. Many individuals will have otalgia, but hearing loss may not be present in all individuals (e.g., patients with Type C tympanograms).

Contraindications to balloon dilation of the Eustachian tube

The following patients should not be considered for balloon dilation of the Eustachian tube:

• Individuals with patulous (ETD), which is suggested by symptoms of autophony of voice, audible respirations, pulsatile tinnitus, and/or aural fullness.
• Individuals with extrinsic reversible or irreversible causes of ETD including but not limited to:
  • craniofacial syndromes, including cleft palate spectrum;
  • neoplasms causing extrinsic obstruction of the Eustachian tube;
  • history of radiation therapy to the nasopharynx;
  • enlarged adenoid pads;
  • nasopharyngeal mass;
  • neuromuscular disorders that lead to hypotonia/ineffective Eustachian tube dynamic opening;
  • systemic mucosal or autoimmune inflammatory disease affecting the mucosa of the nasopharynx and Eustachian tube (e.g., Samter’s triad, Wegener’s disease, mucosal pemphigus) that is ongoing/active (i.e., not in remission).
• Individuals with aural fullness but normal exam and tympanogram.
• Individuals with chronic and severe atelectatic ears.

Reversibility of Eustachian tube dysfunction

Reversibility of ETD can be demonstrated by several means, including any of the following:

• The individual states that they are able to relieve the pressure by performing a Valsalva maneuver to “pop” their ears;
• Performing a Valsalva maneuver produces temporary improvement of the individual’s tympanogram to Type A tympanogram;
• Performing a Valsalva maneuver causes the individual’s middle ear to aerate, which is indicated by the provider visualizing lateral movement of the tympanic membrane on otoscopy.

Balloon dilation of the Eustachian tube used in combination with other procedures

• Individuals undergoing balloon dilation of the Eustachian tube (BDET) concurrent with sinus ostial dilation should meet the same diagnostic criteria for BDET as those undergoing BDET alone.
• Individuals with a middle ear effusion at the time of BDET may benefit from concurrent myringotomy with or without tympanostomy tube placement.

Cross-reference:

• MP 1.119 Balloon ostial dilation for the treatment of chronic rhinosinusitis and recurrent acute rhinosinusitis

Variaciones del producto

Esta política solo se aplica a ciertos programas y productos administrados por Capital Blue Cross y está sujeta a variaciones en los beneficios. Consulte la información adicional a continuación.

FEP PPO - Consulte el Manual de Políticas Médicas de FEP.

Descripción/Antecedentes

Eustachian tube function and dysfunction

The Eustachian tube connects the middle ear space to the nasopharynx. It ventilates the middle ear space to equalize pressure across the tympanic membrane, clears mucociliary secretions, and protects the middle ear from infection and reflux of nasopharyngeal contents. Normally, the tube is closed or collapsed and opens during swallowing, sneezing, or yawning. Eustachian tube dysfunction (ETD) occurs when the functional valve of the Eustachian tube fails to open and/or close properly. This failure may be due to inflammation or anatomic abnormalities. Symptoms of chronic obstructive ETD can include aural fullness, aural pressure, hearing loss, and otalgia. In milder cases, Eustachian tube dysfunction may only be apparent in situations of barochallenge (inability to equalize with rapid barometric pressure changes), with otherwise normal function in stable ambient conditions.

Diagnóstico 

Because the symptoms of ETD are nonspecific, clinical practice guidelines emphasize the importance of ruling out other causes of ETD with a comprehensive diagnostic assessment that includes patient-report questionnaires, history and physical exam, tympanometry, nasal endoscopy, and audiometry to establish a diagnosis.

Medical and surgical management of Eustachian tube dysfunction

Medical management of Eustachian tube dysfunction (ETD) is directed by the underlying etiology. Treatment of identified underlying conditions, such as systemic decongestants, antihistamines, or nasal steroid sprays for allergic rhinitis; behavioral modifications and/or proton pump inhibitors for laryngopharyngeal reflux; or treatment of mass lesions, may be useful in resolving ETD.

Patients who continue to have symptoms following medical management may be treated with surgery such as myringotomy with the placement of tympanostomy tubes or Eustachian tuboplasty. These procedures create an alternative route for ventilation of the middle ear space but do not address the functional problem at the Eustachian tube. There is limited evidence and no randomized controlled trials (RCTs) supporting use of these surgical techniques for this indication. Additionally, surgery may be associated with adverse events such as infection, perforation, and otorrhea. Tympanostomy tube placement may be a repeat procedure for the life of the patient, and the risk of complications from tympanostomy tubes increases with increasing numbers of tube placements and duration of tube placement.

Balloon dilation of the Eustachian tube

Balloon dilation is a tuboplasty procedure intended to improve the patency of the cartilaginous Eustachian tube to cause local dilation. During the procedure, a saline-filled balloon catheter is introduced into the Eustachian tube through the nose using a minimally invasive transnasal endoscopic method. Pressure is maintained for 2 minutes or less, after which the balloon is emptied and removed. The procedure is usually performed under general anesthesia.

Balloon dilation of the Eustachian tube can be done as a standalone procedure or in conjunction with other procedures such as adenoidectomy, intranasal surgery (e.g., septoplasty, turbinate procedures, or sinus surgery), surgery for obstructive sleep apnea or sleep disturbed breathing, and myringotomy with or without tympanostomy tube placement. This evidence review addresses balloon dilation of the Eustachian tube as a stand-alone procedure.

Regulatory status

Table 1. Devices cleared by the U.S. Food and Drug Administration

Multiple devices have been given a de novo 510(k) classification by the U.S. Food and Drug Administration (FDA) (class II, FDA product code: PNZ) (Table 1).

Rational

For individuals who have chronic obstructive Eustachian tube dysfunction despite medical management who receive balloon dilation of the Eustachian tube, the evidence includes RCTs, prospective observational studies, case series, and systematic reviews of these studies. Relevant outcomes are symptoms, change in disease status, quality of life, and treatment-related morbidity. Two 6-week randomized controlled trials found more improvement with balloon dilation plus medical management than medical management alone on patient-reported symptoms, ability to perform a Valsalva maneuver, proportion of patients with normalized tympanograms, and otoscopy findings. Durability of these effects was demonstrated at 52 weeks in the uncontrolled extension phase of both RCTs. No serious device- or procedure-related adverse events were reported through 52 weeks of follow up. Multiple observational studies and case series have reported that patients experienced improvement when comparing symptoms before and after balloon dilation. Las pruebas son suficientes para determinar que la tecnología da lugar a una mejora en el resultado neto para la salud.

Definiciones

N/D

Exención de responsabilidad

Las políticas médicas de Capital Blue Cross se utilizan para determinar la cobertura de tecnologías, procedimientos, equipos y servicios médicos específicos. Estas políticas médicas no constituyen asesoramiento médico y están sujetas a cambios según lo exija la ley o las pruebas clínicas aplicables de las directrices de tratamiento independientes. Los proveedores que brindan tratamiento son individualmente responsables de los consejos médicos y el tratamiento de los miembros. Estas pólizas no son una garantía de cobertura o pago. El pago de las reclamaciones está sujeto a la determinación del programa de beneficios del miembro y la elegibilidad en la fecha del servicio, y a la determinación de que los servicios son médicamente necesarios y apropiados. El procesamiento final de una reclamación se basa en los términos del contrato que se aplican al programa de beneficios de los miembros, incluidas las limitaciones y exclusiones de beneficios. Si un proveedor o miembro tiene alguna pregunta sobre esta política médica, debe comunicarse con Servicios para proveedores o Servicios para miembros de Capital Blue Cross.

Información de codificación

Nota: Es posible que esta lista de códigos no sea exhaustiva y que los códigos estén sujetos a cambios en cualquier momento. La identificación de un código en esta sección no denota cobertura, ya que la cobertura está determinada por los términos de la información de beneficios del miembro. Además, no todos los servicios cubiertos son elegibles para un reembolso por separado.

Covered when medically necessary:

Referencias

1. Schilder AG, Bhutta MF, Butler CC, et al. Eustachian tube dysfunction: consensus statement on definition, types, clinical presentation and diagnosis. Clin Otolaryngol. Oct 2015; 40(5): 407-11. PMID 26347263
2. Tucci DL, McCoul ED, Rosenfeld RM, et al. Clinical Consensus Statement: Balloon Dilation of the Eustachian Tube. Otolaryngol Head Neck Surg. Jul 2019; 161(1): 6-17. PMID 31161864
3. Norman G, Llewellyn A, Harden M, et al. Systematic review of the limited evidence base for treatments of Eustachian tube dysfunction: a health technology assessment. Clin Otolaryngol. Feb 2014; 39(1): 6-21. PMID 24438176
4. Poe DS, Hanna BM. Balloon dilation of the cartilaginous portion of the eustachian tube: initial safety and feasibility analysis in a cadaver model. Am J Otolaryngol. Mar-Apr 2011; 32(2): 115-23. PMID 20392533
5. Schroder S, Lehmann M, Ebmeyer J, et al. Balloon Eustachian tuboplasty: a retrospective cohort study. Clin Otolaryngol. Dec 2015; 40(6): 629-38. PMID 25867023
6. Froehlich MH, Le PT, Nguyen SA, et al. Eustachian Tube Balloon Dilation: A Systematic Review and Meta-analysis of Treatment Outcomes. Otolaryngol Head Neck Surg. Nov 2020; 163(5): 870-882. PMID 32482125
7. Aboueisha MA, Attia AS, McCoul ED, et al. Efficacy and safety of balloon dilation of eustachian tube in children: Systematic review and meta-analysis. Int J Pediatr Otorhinolaryngol. Mar 2022; 154: 111048. PMID 35085875
8. Poe D, Anand V, Dean M, et al. Balloon dilation of the eustachian tube for dilatory dysfunction: A randomized controlled trial. Laryngoscope. May 2018; 128(5): 1200-1206. PMID 28940574
9. Meyer TA, O'Malley EM, Schlosser RJ, et al. A Randomized Controlled Trial of Balloon Dilation as a Treatment for Persistent Eustachian Tube Dysfunction With 1-Year Follow-Up. Otol Neurotol. Aug 2018; 39(7): 894-902. PMID 29912819
10. Anand V, Poe D, Dean M, et al. Balloon Dilation of the Eustachian Tube: 12-Month Follow-up of the Randomized Controlled Trial Treatment Group. Otolaryngol Head Neck Surg. Apr 2019; 160(4): 687-694. PMID 30620688
11. Cutler JL, Meyer TA, Nguyen SA, et al. Long-term Outcomes of Balloon Dilation for Persistent Eustachian Tube Dysfunction. Otol Neurotol. Dec 2019; 40(10): 1322-1325. PMID 31385858
12. National Institute for Health and Care Excellence. Balloon dilation for chronic eustachian tube dysfunction. Interventional procedures guidance [IPG665]. December 2019.
13. National Institute for Health and Care Excellence. Interventional procedure overview of balloon dilation for chronic eustachian tube dysfunction.