Eustachian tube dysfunction (ETD) occurs when the functional valve of the eustachian tube fails to open and/or close properly. This failure is frequently due to inflammation and can cause symptoms such as muffled hearing, ear fullness, tinnitus, and vertigo. Chronic obstructive ETD can lead to hearing loss, otitis media, tympanic membrane perforation, and cholesteatomas. Balloon dilation of the eustachian tube (BDET) is a procedure intended to improve patency by inflating a balloon in the cartilaginous part of the eustachian tube to cause local dilation.
For individuals who have chronic obstructive ETD despite medical management who receive BDET, the evidence includes randomized controlled trials (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 RCTs 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 followup. Multiple observational studies and case series have reported that patients experienced improvement when comparing symptoms before and after balloon dilation. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.
Clinical input was sought to help determine whether the use of BDET for individuals with chronic obstructive ETD despite medical management would provide a clinically meaningful improvement in net health outcome and whether the use is consistent with generally accepted medical practice. In response to requests, clinical input was received from 4 respondents, including 1 specialty society-level response including physicians with academic medical center affiliation and 3 physician-level responses affiliated with an academic medical center identified by BCBSA.
For individuals who have chronic obstructive ETD who receive BDET, clinical input supports that this use provides a clinically meaningful improvement in net health outcome and indicates this use is consistent with generally accepted medical practice in a subgroup of appropriately selected patients using the following criteria:
Obstructive ETD for 3 months or longer in 1 or both ears that significantly affects quality of life or functional health status;
The patient has undergone a comprehensive diagnostic assessment; including history and physical exam, tympanometry if the tympanic membrane is intact, nasopharyngoscopy, and comprehensive audiometry; and
This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.
Balloon dilation of the eustachian tube (BDET) for treatment of chronic obstructive eustachian tube dysfunction (ETD) may be considered medically necessary under the following conditions:
Adults (age 22 years and older) with symptoms of obstructive ETD (aural fullness, aural pressure, otalgia, and/or hearing loss) for 12 months or longer in 1 or both ears that significantly affects quality of life or functional health status;
Aural fullness and pressure must be present (see Policy Guidelines).
AND
The individual has undergone a comprehensive diagnostic assessment; including patient-reported questionnaires, history and physical exam, tympanometry if the tympanic membrane is intact, nasal endoscopy, and comprehensive audiometry, with the following findings:
Abnormal tympanogram (Type B or C);
Abnormal tympanic membrane (retracted membrane, effusion, perforation, or any other abnormality identified on exam).
AND
Failure to respond to appropriate medical management of potential co-occurring conditions, if any, such as allergic rhinitis, rhinosinusitis, and laryngopharyngeal reflux, including 4 to 6 weeks of a nasal steroid spray, if indicated.
AND
Other causes of aural fullness such as temporomandibular joint disorders, extrinsic obstruction of the eustachian tube, superior semicircular canal dehiscence, and endolymphatic hydrops have been ruled out.
AND
If the individual had a history of tympanostomy tube placement, symptoms of obstructive ETD should have improved while tubes were patent.
AND
The individual does not have patulous ETD or another contraindication to the procedure (see Policy Guidelines).
AND
The individual's ETD has been shown to be reversible (see Policy Guidelines).
AND
Symptoms are continuous rather than episodic (e.g., symptoms occur only in response to barochallenge such as pressure changes while flying).
AND
The individual has not had a previous BDET procedure.
Balloon dilation of the eustachian tube is considered investigational if the above criteria are not met.
|
CPT |
69705 |
Nasopharyngoscopy, surgical, with dilation of eustachian tube (ie, balloon dilation); unilateral |
|
69706 |
Nasopharyngoscopy, surgical, with dilation of eustachian tube (ie, balloon dilation); Bilateral |
|
|
ICD-10-PCS |
097F4ZZ |
Dilation of Right Eustachian Tube, Percutaneous Endoscopic Approach |
|
097F8DZ |
Dilation of Right Eustachian Tube with Intraluminal Device, Via Nat. or Artificial Opening Endoscopic |
|
|
097F8ZZ |
Dilation of Right Eustachian Tube, Via Nat. or Artif Opening Endoscopic |
|
|
097G4ZZ |
Dilation of Left Eustachian Tube, Percutaneous Endoscopic Approach |
|
|
097G8DZ |
Dilation of Left Eustachian Tube with Intraluminal Device, Via Natural or Artificial Opening Endoscopic |
|
|
097G8ZZ |
Dilation of Left Eustachian Tube, Via Natural or Artificial Opening Endoscopic |
| ICD-10-CM | H68.001-H68.029 | Eustachian salpingitis code range |
| H69.80-H69.93 | Other specified and unspecified disorders of Eustachian tube code range | |
| H65.00-H65.93 | Nonsuppurative otitis media code range | |
| H66.001-H66.93 | Suppurative and & unspecified otitis media code range | |
| H67.1-H67.9 | Otitis media in diseases classified elsewhere code range | |
| H71.00-H71.93 | Cholesteatoma of middle ear code range | |
| H72.00-H72.93 | Perforation of tympanic membrane code range | |
| H90.0-H90.A32 | Conductive and sensorineural hearing loss code range | |
| H81.311-H81.49 | Peripheral and Central vertigo code range | |
| H91.01-H91.93 | Other and unspecified hearing loss code range |
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).
The following individuals should not be considered for balloon dilation of the eustachian tube:
Individuals with patulous eustachian tube dysfunction (ETD).
A diagnosis of patulous ETD 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 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 member’s middle ear to aerate, which is indicated by the provider visualizing lateral movement of the tympanic membrane on otoscopy.
Individuals with a middle ear effusion at the time of BDET may benefit from concurrent myringotomy with or without tympanostomy tube placement.
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.1, 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, ETD may only be apparent in situations of barochallenge (inability to equalize with rapid barometric pressure changes), with otherwise normal function in stable ambient conditions.2,
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.2,
Medical management of 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.3, 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 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.4,5,
Balloon dilation of the eustachian tube can be done as a stand alone 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 our without tympanostomy tube placement. This evidence review addresses balloon dilation of the eustachian tube as a stand alone procedure.
| Device | Manufacturer | Date Cleared | 510(k) No. | Indication |
| Acclarent Aera Eustachian Tube Balloon Dilation System | Acclarent, Inc. | 01/16/2018 | K171761; K230742 | Eustachian tube dilation |
| Xpress ENT Dilation System | Entellus Medical, Inc. | 04/05/2017 | K163509 | Eustachian tube dilation |
| Nuvent Eustachian Tube Dilation Balloon | Medtronic Xomed, Inc. | 08/16/2021 | K210841 | Eustachian tube dilation |
| Audion Et Dilation System | Entellus Medical, Inc. | 04/12/2022 | K220027 | Eustachian tube dilation |
| Vensure Balloon Dilation System | Fiagon GmbH | 05/26/2023 | K230065 | Eustachian tube dilation |
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).
