Medically Necessary Treatment
Balloon dilation of the Eustachian tube for treatment of chronic obstructive Eustachian tube dysfunction may be considered medically necessary when <strong>all</strong> of the following criteria are met:
ALL of the following
Age is consistent with the device-specific FDA approval.
The individual does not have patulous Eustachian tube dysfunction or another contraindication (see Policy Guidelines).
Symptoms have occurred for at least 12 months, including but not limited to aural fullness, aural pressure, otalgia, or hearing loss.>= 12 months
The individual does not have other causes of aural fullness, such as temporomandibular joint disorders, extrinsic obstruction of the Eustachian tube, superior semicircular canal dehiscence, or endolymphatic hydrops.
Symptoms are continuous rather than episodic, such as symptoms occurring only in response to baro-challenge (for example, pressure changes while flying).
Comprehensive diagnostic assessment documents ALL of the following findings
Abnormal tympanogram (Type B or C).
Abnormal tympanic membrane, including a retracted membrane, effusion, perforation, or any other abnormality identified on examination.
The individual has failed to respond to appropriate medical management of co-occurring conditions, including 4–6 weeks of a nasal steroid spray if indicated. Co-occurring conditions include but are not limited to allergic rhinitis, rhinosinusitis, and laryngopharyngeal reflux.4–6 weeks if nasal steroid indicated
ONE of the following is met
No history of tympanostomy tube placement.
History of tympanostomy tube placement with improved symptoms of obstructive Eustachian tube dysfunction while the tubes were patent.
ONE of the following is met
The individual is younger than 18 years old and is refractory to at least one surgical intervention, such as tympanostomy tubes.
The individual is age 18 years or older.
Not Medically Necessary
Balloon dilation of the Eustachian tube is considered not medically necessary when Criterion I is not met.
Criterion I, including all required eligibility and clinical selection criteria, is not met.
Investigational
Balloon dilation of the Eustachian tube is considered investigational for the following indications:
Any of the following
Repeat balloon dilation of the Eustachian tube.
There is enough research to show that balloon dilation of the Eustachian tube improves health outcomes in individuals with chronic signs and symptoms under certain circumstances. Additionally, clinical practice guidelines recommend the use of balloon dilation of the Eustachian tube for select individuals. Therefore, the use of balloon dilation of the Eustachian tube may be considered medically necessary for the treatment of Eustachian tube dysfunction when policy criteria are met.
The following individuals should not be considered for balloon dilation of the Eustachian tube:
Patulous Eustachian tube dysfunction. A diagnosis of patulous Eustachian tube dysfunction is suggested by symptoms of autophony of voice, audible respirations, pulsatile tinnitus, and/or aural fullness.
Extrinsic reversible or irreversible causes of Eustachian tube dysfunction, 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 or ineffective Eustachian tube dynamic opening; and ongoing or active systemic mucosal or autoimmune inflammatory disease affecting the mucosa of the nasopharynx and Eustachian tube, such as Samter's triad, Wegener's disease, or mucosal pemphigus.
Individuals with aural fullness but a normal examination and tympanogram.
Individuals with chronic and severe atelectatic ears.
Balloon dilation of the Eustachian tube is not medically necessary when the medically necessary policy criteria are not met, including when the individual does not meet the required individual selection criteria.
Balloon dilation of the Eustachian tube is considered investigational for repeat balloon dilation procedures and for any other indication.
The diagnosis of obstructive Eustachian tube dysfunction should not be made without a comprehensive and multifaceted assessment, including otoscopy, audiometry, and nasal endoscopy. Balloon dilation of the Eustachian tube is contraindicated for individuals diagnosed with patulous Eustachian tube dysfunction. Other potentially treatable causes of Eustachian tube dysfunction, including allergic rhinitis, rhinosinusitis, and laryngopharyngeal reflux, should be identified and medically managed before balloon dilation is offered.
Repeat balloon dilation procedures and indications other than treatment meeting the medically necessary criteria are investigational. There is not enough research to show that balloon dilation of the Eustachian tube improves health outcomes for people with any other indication or for repeat balloon dilation procedures.
Balloon dilation of the Eustachian tube is considered not medically necessary when Criterion I is not met, including when any required criterion for medically necessary treatment is absent.
Balloon dilation of the Eustachian tube is considered not medically necessary when policy criteria are not met because positive health outcomes have not been demonstrated for individuals who do not meet the individual selection criteria.