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Currentblue cross blue shield - south dakotaPolicy 08.01.25

Balloon Dilation of the Eustachian Tube

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Policy governing coverage and medical necessity criteria for balloon dilation of the eustachian tube for treatment of chronic obstructive eustachian tube dysfunction; applies to Blue Cross Blue Shield - South Dakota members and their treating providers.

Policy Summary

Payerblue cross blue shield - south dakota

PolicyBalloon Dilation of the Eustachian Tube

Policy CodePolicy 08.01.25

Change TypeNo material clinical or coverage changes

Effective DateApr 1, 2017

Last ReviewOct 1, 2025

Next Review DateN/A

Key ActionDocument chronic symptoms ≥3 months, failed appropriate medical management (e.g., 4–6 week nasal steroid trial when indicated), and objective findings (abnormal tympanogram or endoscopic evidence) to support approval.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

18+Adults eligible

3 monthsSymptom duration

3RCTs referenced

None reportedSerious adverse events

N=219 (425 ears)Pediatric pooled cohort

Coverage and Medical Necessity Criteria

inv-01: Medically Necessary Criteria

Covered when ALL of the following are met:

Age and symptoms: The individual is 18 years or older with symptoms of obstructive Eustachian tube dysfunction (eg, aural fullness, aural pressure, otalgia and/or hearing loss) present for 3 months or longer in one or both ears that affect quality of life or functional health status; aural fullness and pressure must be present.age >= 18; duration >= 3 months

Policy medically necessary criteria

Comprehensive diagnostic assessment: A comprehensive diagnostic assessment has been completed including patient-reported questionnaires, history and physical examination, tympanometry if the tympanic membrane is intact, nasal endoscopy, and comprehensive audiometry with either an abnormal tympanogram (Type B or C) or an abnormal tympanic membrane (retraction, effusion, perforation, or other abnormality).abnormal tympanogram (Type B or C) or abnormal TM

Policy medically necessary criteria

Policy Summary

Payerblue cross blue shield - south dakota

PolicyBalloon Dilation of the Eustachian Tube

Policy CodePolicy 08.01.25

Change TypeNo material clinical or coverage changes

Effective DateApr 1, 2017

Last ReviewOct 1, 2025

Next Review DateN/A

SourceLink

On This Page

Failed medical management: Failure to respond to appropriate medical management of potential co-occurring conditions (eg, allergic rhinitis, rhinosinusitis, laryngopharyngeal reflux), including 4 to 6 weeks of nasal steroid spray when indicated.trial of medical therapy completed (4-6 weeks if indicated)

Policy medically necessary criteria

Exclude alternative causes: Other causes of aural fullness (eg, temporomandibular joint disorders, extrinsic obstruction of the Eustachian tube, superior semicircular canal dehiscence, endolymphatic hydrops) have been ruled out.

Policy medically necessary criteria

Prior tympanostomy tube history: If the individual had prior tympanostomy tube placement, symptoms should have improved while tubes were patent.

Policy medically necessary criteria

Contraindications and symptom pattern: No patulous Eustachian tube or other contraindication to the procedure; symptoms are continuous rather than only episodic (not solely in response to barochallenge).

Policy medically necessary criteria

No prior BDET: The individual has not previously undergone balloon dilation of the Eustachian tube (BDET).

Policy medically necessary criteria

inv-02: Coverage Criteria (evidence-informed)

Covered when ALL of the following are met (based on populations and trial eligibility):

Population and symptom thresholds: Patient has chronic obstructive Eustachian tube dysfunction despite medical management with persistent symptoms (eg, ear fullness, recurrent baro-challenge, hearing loss, otalgia, tinnitus) and objective evidence such as abnormal tympanometry (Type B or C) and elevated ETDQ-7 (mean item score >= 2.1 or total >= 14.5).ETDQ-7 mean >=2.1 or total >=14.5; abnormal tympanogram

Matches trial inclusion criteria

Prior medical management per trials: Documented trial of medical management directed at identified etiologies (eg, treatment for rhinosinusitis; intranasal steroid for at least 4 weeks or at least one course of oral steroid when applicable; antihistamines, decongestants, reflux management) with persistent symptoms.>=4 weeks intranasal steroid or >=1 course oral steroid when applicable

Reflects comparators and lead-in requirements in RCTs

Objective baseline and follow-up assessments: Baseline and follow-up objective measures (tympanometry, otoscopy, ability to perform Valsalva) and symptom measures (ETDQ-7) are documented; initial follow-up at 4-6 weeks and durability follow-up at approximately 1 year or longer are recorded.follow-up >=1 year preferred

Based on outcomes and follow-up durations in trials and reviews

inv-03: Coverage when trial-aligned criteria met

Coverage aligns with the clinical trial eligibility used in RCTs when considering medical necessity:

Trial-consistent coverage criteria: All of the following: (1) persistent ETD symptoms despite prior medical management (eg, minimum 4 weeks daily intranasal steroid spray or at least one course of oral steroid), (2) objective evidence of abnormal middle-ear function such as abnormal tympanometry (Type B or C), and (3) adult patients matching RCT enrollment (studies enrolled ages >=18) or pediatric cases supported by observational data.

Derived from RCT inclusion criteria and study designs

inv-04: Pediatric coverage considerations

Pediatric evidence and considerations (observational):

Pediatric indications supported by observational studies: Observational pediatric studies report benefit for children with chronic otitis media with effusion or recurrent acute otitis media refractory to prior surgical treatment (eg, prior tympanostomy tubes and/or adenoidectomy), showing improved failure-free survival and tympanogram improvements; evidence is primarily retrospective cohorts and case series.

Evidence limited to observational data; RCTs not represented in these chunks

inv-05: Medical necessity criteria for BDET

Covered when ALL of the following are met:

Duration and assessment: Obstructive ETD for 3 months or longer in one or both ears that significantly affects quality of life or functional health status; comprehensive diagnostic assessment performed (history and physical exam, tympanometry if tympanic membrane intact, nasopharyngoscopy/dynamic nasal endoscopy, and comprehensive audiometry).duration >= 3 months

Per clinical input and AAO‑HNS guidance

Failed medical management of comorbidities: Failure to respond to appropriate medical management of potential co-occurring conditions (eg, allergic rhinitis, rhinosinusitis, laryngopharyngeal reflux), including a 4–6 week trial of nasal steroid spray when indicated.4-6 week nasal steroid trial if indicated

AAO‑HNS clinical consensus and clinical input

Contraindication—patulous ETD: Patients diagnosed with patulous Eustachian tube are contraindicated for BDET.

AAO‑HNS statement

inv-06: Medically necessary — adult obstructive ETD

Covered when ALL of the following are met:

Adult age and chronic signs: Patient is an adult (≥18 years) with chronic signs and symptoms of Eustachian tube obstruction for ≥3 months (eg, baro-challenge difficulty OR hearing loss/aural fullness relieved by auto-insufflation OR history of negative middle ear pressure/effusion).age >=18; duration >=3 months

Consistent with AAO‑HNS consensus and BCBS MA policy

Failed appropriate medical management: Failure to respond to appropriate medical management of co-occurring conditions, including a 4–6 week trial of nasal steroid spray when indicated.4-6 week nasal steroid trial if indicated

Consistent with guideline and trial comparators

Objective endoscopic or consistent history/physical: Objective pathological findings on dynamic endoscopic exam of the Eustachian tube OR if no visible pathologic findings, history and physical remain consistent with cartilaginous Eustachian tube obstruction.

Endoscopic evaluation recommended

Prior tympanostomy tube response: If prior tympanostomy tubes were placed, symptoms should have improved while tubes were patent (a trial of tubes is not required prior to BDET).

Documented improvement while tubes patent supports diagnosis

inv-07: Medical necessity criteria (adult OETD)

Covered when ALL of the following are met:

Adult with chronic obstruction: Adult (18+) with chronic signs/symptoms of Eustachian tube obstruction (eg, difficulty equilibrating pressure with baro-challenge OR hearing loss/aural fullness relieved by auto-insufflation OR history of negative middle ear pressure/effusion for ≥3 months).duration >=3 months

Adapted from BCBS MA policy and AAO‑HNS consensus

Prior management and trials: Failure to respond to appropriate medical management of co-occurring conditions including a 4–6 week nasal steroid spray for allergic rhinitis unless contraindicated.4-6 week trial when indicated

Reflects trial and guideline expectations

Objective evidence or consistent exam: Objective pathological findings on dynamic endoscopic exam of the Eustachian tube OR, if no visible findings, history and exam consistent with cartilaginous ET obstruction.

Endoscopy recommended

Tympanostomy tube history consideration: If prior tympanostomy tubes were placed, documentation that symptoms improved while tubes were patent; a tube trial is not required prior to BDET.

Documented response supports indication

inv-08: Supportive objective findings

Candidates should also have ALL of the following supportive features (preferable but some may be labeled 'possibly'):

Supportive objective findings: Reversible tympanic membrane retraction demonstrated by Valsalva or other maneuvers; chronic abnormal tympanogram findings for ≥3 months (Type B or Type C); possibly documented conductive hearing loss or conductive 'pad' on audiogram; nasopharyngoscopic findings showing accessible Eustachian tube orifices without extrinsic obstructing lesions; and possibly CT demonstrating safe bony coverage over the internal carotid artery on the side(s) planned for dilation.

Some items are supportive or 'possible' rather than absolute requirements

inv-09: Initial coverage criteria

Covered when ALL of the following are met (as supported by the clinical commentary in the document):

Adult selection and chronicity: Patient is an adult (document references >17 years as relevant scenario) with chronic or recurrent ETD evidenced by history and prior interventions consistent with persistent disease; pediatric use is cautioned and evidence is limited.adult age preferred; pediatric caution

Clinical commentary and reviewer opinion

Objective and historical evidence: Documented ETD complaints (eg, barotrauma, serous otitis media, adhesive otitis, atelectasis) with supporting tympanograms (Type B or C) or recurrent abnormal tympanograms; isolated normal tympanograms do not exclude if prior abnormal tracings and recurrent symptoms exist.

Clinical commentary

Prior management documentation: Documentation of failure or insufficiency of prior medical management including allergy and GERD/LPR management as clinically appropriate; note that intranasal steroids have level I evidence showing no benefit over placebo but documentation of prior efforts is expected.

Clinical commentary

Absence of contraindicating nasopharyngeal history: No history of cleft palate, prior nasopharyngeal radiation, or prior nasopharyngeal surgery (other than adenoidectomy or prior BDET).

Documented as exclusions in commentary

inv-10: Adjunctive procedure criteria

BDET may be performed concomitantly when clinically indicated:

Concomitant procedures allowed: BDET may be performed with adenoidectomy; intranasal surgery (eg, septoplasty, turbinate procedures, sinus surgery); surgery for obstructive sleep apnea; myringotomy with or without tympanostomy tube placement; tympanoplasty and/or mastoidectomy when clinically indicated.

Adjunctive procedures may reduce inflammatory burden and aid outcomes

Otologic adjunctive indications: Consider concomitant BDET with tympanoplasty in patients with poor long-term Eustachian tube function (eg, ≥2 sets of tympanostomy tubes over 2 years, adhesive otitis media with conductive loss or ossicular erosion, or 2nd-look tympanoplasty), where adding BDET may improve quality of life and reduce repeat otologic surgeries.

Specific otologic adjunctive scenarios cited in literature

inv-11: Initial therapy / coverage criteria

Covered when ALL of the following are met:

Symptom duration: Symptoms of obstructive Eustachian tube dysfunction have been present for ≥3 months.>= 3 months

Supported by document

Clinical manifestations: At least one of the following clinical manifestations: barochallenge (difficulty equilibrating pressure), hearing loss or aural fullness relieved by auto-insufflation, or history of negative middle ear pressure or middle ear effusion.1 of list

Supported by document

Comorbidity management: If a potentially causal comorbidity is present (eg, allergic rhinitis, rhinosinusitis, laryngopharyngeal reflux), there is documented failure to respond to appropriate medical management (eg, 4‑week trial of nasal steroid for allergic rhinitis; 4‑week trial of PPI/antacid for reflux).documented trial and failure

Specific examples given in document

Evaluation—dynamic endoscopy: Dynamic nasal endoscopy (including swallows and yawns) has been performed and documented; findings may show luminal pathology or, if absent, history and physical remain consistent with cartilaginous Eustachian tube obstruction.endoscopy documented

Supported by document

Tympanostomy tube history: If a tympanostomy tube was previously placed, documentation that it improved symptoms while patent (a trial of tubes is not required prior to BDET).if applicable

Document recommends but does not require prior tube trial

inv-12: Coverage criteria (not present in this section)

No criteria present: These excerpts do not contain specific coverage criteria, medical necessity rules, or decision trees; they are bibliographic and feasibility commentary.

See other policy sections for coverage logic.

This policy excludes individuals with patulous Eustachian tube dysfunction and those with extrinsic reversible or irreversible causes of ETD. Examples of excluded extrinsic causes include craniofacial syndromes (including cleft palate spectrum), neoplasms causing extrinsic obstruction of the Eustachian tube, prior radiation therapy to the nasopharynx, enlarged adenoid pads, nasopharyngeal masses, neuromuscular disorders leading to ET hypotonia, and active systemic mucosal or autoimmune inflammatory diseases affecting the nasopharynx/ET.

The evidence review and coverage considerations in this policy address balloon dilation of the Eustachian tube (BDET) as a stand-alone procedure. Concomitant or adjunctive procedures (for example adenoidectomy, septoplasty, turbinate procedures, sinus surgery, myringotomy/tympanostomy tubes) are acknowledged in the clinical discussion but are outside the scope of this standalone coverage assessment.

Clinical trials of BDET documented explicit exclusions. Study protocols excluded patients with patulous Eustachian tube, tympanic membrane perforation or ear tubes in place, internal carotid artery dehiscence, recent major head/neck surgery, pregnancy, and active acute otitis media — conditions not studied that may be treated as exclusions for coverage decisions.

The American Academy of Otolaryngology - Head and Neck Surgery clinical consensus and this policy state that BDET is contraindicated for patients diagnosed with patulous Eustachian tube, with symptoms such as autophony, audible respirations, or pulsatile tinnitus suggesting that diagnosis.

When the policy's medical necessity criteria are not met, BDET is considered investigational because available evidence is insufficient to demonstrate net health benefit. This investigational designation applies where trial-consistent eligibility (symptoms plus objective dysfunction and prior medical management) is not documented.

Summary of investigational/excluded scenarios: BDET is considered investigational or excluded for pediatric patients under 18 (in the U.S.), for patients with craniofacial syndromes, neoplasms causing extrinsic ET obstruction, and for those with ongoing systemic mucosal or autoimmune inflammatory disease affecting the nasopharynx/ET. Other exclusions include adults with aural fullness but normal exam and tympanogram, and patients with chronic severe atelectatic ears.

Specific patient histories and circumstances that should preclude consideration of BDET include history of cleft palate or prior cleft palate surgery, prior radiation therapy to the nasopharynx, and prior nasopharyngeal surgery (other than adenoidectomy or previous BDET). These histories are described as contraindications or reasons to avoid BDET due to likely extrinsic or structural contributors to ETD.

Mechanical pressure equalization devices (for example, patient‑inflated nasal balloons or electric pump insufflation devices) have been shown to provide only short-term benefit < 90 days and present compliance challenges; they are not supported as equivalent long‑term alternatives to BDET.

Within the provided excerpts there are sections that do not state additional explicit exclusions beyond those already listed; several bibliographic and procedural citations focus on feasibility and literature review rather than new exclusion criteria.

Per the policy, BDET is considered investigational (not covered) when the medical necessity criteria are not met — i.e., when documentation does not demonstrate the required chronicity, objective findings, and failed prior medical management used in trials and the policy's coverage criteria.

Use of BDET in populations or indications not represented in the cited evidence (for example, cases without documented prior medical management or without qualifying objective abnormalities) lacks supporting comparative data and is therefore unsupported by the evidence reviewed in this policy.

Situations with insufficient objective evidence — such as patients reporting ETD symptoms without abnormal tympanometry or without documentation of failed medical therapy — were not included in RCT eligibility and therefore may not meet coverage criteria based on the evidence.

The procedure is not indicated for patients who do not have chronic obstructive ETD refractory to medical treatment. NICE guidance and the policy emphasize that BDET is indicated only for chronic ETD that has failed appropriate medical management and is not effective for all patients.

Cases that meet the investigational or exclusion conditions summarized in this policy (for example craniofacial syndromes, neoplasms causing extrinsic obstruction, active systemic mucosal/autoimmune inflammatory disease, pediatric patients <18 years without FDA indication) are considered not medically necessary or excluded for BDET.

In particular, BDET is listed as investigational or excluded for patients with craniofacial syndromes, neoplasms causing extrinsic obstruction, and active systemic mucosal or autoimmune inflammatory diseases affecting the nasopharynx and Eustachian tube.

Pediatric use of BDET is approached with caution given limited evidence. The document and reviewers note sparse pediatric data and one reviewer suggested a conservative lower age threshold (expert opinion) of approximately 14 years, while FDA clearance for a specific device was expanded to ages 8–17 in December 2023 — highlighting the need for careful case selection and documentation in younger patients.

Mechanical pressure equalization devices are repeatedly cited but the evidence does not support their use for sustained management; benefits are typically short term (<90 days), and long‑term efficacy is unsupported.

The excerpts provided do not include any new or explicit 'not medically necessary' statements beyond those already captured; some bibliographic sections focus on trials, reviews, and feasibility rather than policy exclusions.

Coding and Billing

See Codes tablemixed

No codes listed

Regulatory device/product codesmixed

PNZ	FDA product code for ET dilation devices (class II)

Regulatory / Device Codesmixed

PNZ	FDA product code for eustachian tube dilation devices (class II de novo)

Covered CPT CodesCPT

69705	Nasopharyngoscopy, surgical, with dilation of eustachian tube (i.e., balloon dilation); unilateral.
69706	Nasopharyngoscopy, surgical, with dilation of eustachian tube (i.e., balloon dilation); Bilateral.
69799	Unlisted procedure, middle ear (may be utilized for balloon dilation of the eustachian tube [BDET]: Acclarent® Area Eustachian Tube Balloon Dilation System or XprESS™), Nuvent Eustachian Tube Dilation Balloon, Audion Et Dilation System, Vensure Balloon Dilation System.

HCPCS supply codeHCPCS

C1726

Catheter, balloon dilation, nonvascular (may be utilized for balloon dilation of the eustachian tube [BDET]: Acclarent® Area Eustachian Tube Balloon Dilation System or XprESS™), Nuvent Eustachian Tube Dilation Balloon, Audion Et Dilation System, Vensure Balloon Dilation System.

Covered CPT CodesCPTCovered

Category I CPT codes (BDET)

AMA added two new Category 1 CPT® codes for BDET effective Jan 1, 2021

Coding referencesmixed

CPT reference

Mentions AMA CPT Editorial Summary (September 2019) but does not list specific CPT codes in these chunks

inv-40: Symptom duration — minimum symptom duration

Minimum symptom durationSymptoms of obstructive Eustachian tube dysfunction for ≥ 3 months

Clinical contextApplies to symptoms in one or both ears that significantly affect quality of life or functional status (eg, barochallenge, aural fullness, hearing loss)

Documentation expectationRecord of symptom duration (≥3 months) in clinical notes and diagnostic testing

inv-41: Nasal steroid trial — duration when indicated

Recommended trial duration4–6 weeks of daily intranasal steroid spray when indicated (documented trial required prior to BDET)

When indicatedFor coexisting allergic rhinitis or other nasal inflammatory conditions as part of prior medical management

DocumentationRecord of medical management trial and lack of symptom resolution despite therapy

Prior Authorization, Documentation, and Billing Actions

Prior Authorization

Prior Approval

Prior approval: Not applicable per policy statement.

Prior Approval not required per policy header.

Prior Authorization

Prior authorization: clinical justification

Prior authorization should include clinical justification that the patient has chronic obstructive ETD refractory to medical therapy and baseline objective testing. Document symptom duration (≥3 months), impact on quality of life/functional status, and comprehensive diagnostic assessment (history/physical, patient-reported questionnaire such as ETDQ-7, tympanometry, nasal/nasopharyngeal endoscopy, and audiometry).

Document ETDQ-7 score (if used) and symptom descriptors (aural fullness, pressure, otalgia, hearing loss).
Record duration ≥3 months and that symptoms are continuous rather than episodic.

Billing Rule

Code reporting and prior authorization

Report appropriate procedure and supply codes and follow payer prior authorization processes. Use CPT codes 69705 (unilateral) and 69706 (bilateral) for nasopharyngoscopy with dilation of eustachian tube, CPT 69799 for unlisted middle ear procedures when applicable, and HCPCS C1726 for nonvascular balloon dilation catheter. Include place of service (office, outpatient, inpatient) and relevant ICD-10 diagnosis codes. Prior authorization may be required per payer processes.

Covered CPT: 69705, 69706; Unlisted: 69799.
HCPCS: C1726 (catheter, balloon dilation, nonvascular).
Include facility/place of service and supporting documentation with any prior authorization submission.

Step Therapy

Prior medical management requirement

Prior medical management requirement: document failure to respond to appropriate medical management of co-occurring conditions (e.g., allergic rhinitis, rhinosinusitis, laryngopharyngeal reflux). When indicated, a trial of nasal steroid spray for 4–6 weeks (some inputs note up to 12 weeks in certain expert responses) should be documented. Manage comorbidities appropriately before BDET.

Document dates, agents, doses, duration (e.g., intranasal steroid daily for 4–6 weeks or as clinically indicated).
If oral steroid course was used, document dates/dose and response.

Documentation Required

Preauthorization documentation expectations

Preauthorization documentation expectations: include evidence of chronic obstructive ETD (symptom history ≥3 months), results of baseline objective tests (abnormal tympanogram Type B or C, audiogram showing conductive loss if present), nasal/nasopharyngeal endoscopy findings (dynamic exam), prior tympanostomy tube history and response while tubes were patent, and documentation of failed medical management and exclusion of other causes.

Attach tympanometry and audiogram reports, nasal endoscopy documentation, ETDQ-7 or symptom questionnaire if used.
If prior tympanostomy tubes placed, document improvement of symptoms while tubes were patent.

Denial Risk

Procedure considered investigational

Procedure considered investigational when medical necessity criteria are not met. BDET is investigational (excluded) if selection criteria (age, chronicity, diagnostic findings, failed medical therapy) are not satisfied or in specific excluded populations (see contraindications/exclusions).

Investigational/excluded triggers include: pediatric patients <18 (unless FDA indication applies), craniofacial syndromes, neoplasms causing extrinsic obstruction, active systemic mucosal/autoimmune inflammatory disease, patients with aural fullness but normal exam/tympanogram, and adults with chronic severe atelectatic ears.

Documentation Required

Prior treatment and objective findings expected

Prior treatment and objective findings expected: confirmation of failed prior medical therapy (documented trials as above) and objective abnormal testing such as tympanometry Type B or C, abnormal/abnormal-appearing tympanic membrane (retraction, effusion, perforation), audiometry consistent with conductive hearing loss, and dynamic nasal endoscopy findings. If no endoscopic pathology, history and physical must remain consistent with cartilaginous ET obstruction.

Tympanogram: Type B or C documented.
Audiogram: conductive hearing loss when present.
Nasal endoscopy: dynamic findings or clear clinical correlation when absent.

Denial Risk

Contraindicating patient history

Contraindicating patient history: do not consider BDET for patients with patulous ETD or those with extrinsic causes not amenable to dilation (craniofacial syndromes including cleft palate spectrum, neoplasms causing obstruction, history of nasopharyngeal radiation or surgery [other than adenoidectomy], enlarged adenoids causing obstruction, nasopharyngeal mass, neuromuscular disorders causing ineffective opening). Also exclude patients with chronic severe atelectatic ears and those with aural fullness but normal exam/tympanogram.

Document absence of patulous ETD (autophony, audible respiration).
History of cleft palate, nasopharyngeal radiation/surgery are contraindications.

Denial Risk

Documentation gaps risk denial

Documentation gaps that risk denial: lack of documented failure of appropriate medical management (dates, agents, duration), missing baseline objective testing (tympanogram, audiogram, nasal endoscopy), absence of documented symptom chronicity (≥3 months), failure to rule out other causes of aural fullness, or incomplete records of prior tympanostomy tube response when applicable.

Ensure all test reports and treatment records are included with prior authorization to avoid denial.
Specify symptom onset dates and continuous vs episodic nature.

Note

No explicit procedural authorization or prior approval timeframe specified

No explicit procedural authorization timeframe or universal payer-specific prior authorization rule is stated in the source; follow Blue Cross Blue Shield - South Dakota payer processes for prior authorization submissions. Policy notes that prior approval is not applicable, but prior authorization processes and documentation expectations should be followed per payer.

Confirm with payer whether a prior authorization is required and what submission portal/forms to use.
Supply all required documentation even if formal prior approval is listed as not applicable.

Documentation Required

Required diagnostic documentation

Required diagnostic documentation: comprehensive diagnostic assessment including patient-reported questionnaires (ETDQ-7 when used), history and physical exam, tympanometry (if tympanic membrane intact), nasopharyngoscopy/nasal endoscopy with dynamic assessment (rest, swallow, yawn), and comprehensive audiometry.

Include copies of tympanograms, audiograms, and endoscopy reports/images where available.
Record dynamic endoscopy findings (inflammation, edema, hypertrophied tubal tonsil, reduced lumen opening) or state absence and clinical correlation.

Documentation Required

Required clinical documentation

Required clinical documentation: record baseline symptoms (aural fullness, pressure, otalgia, hearing loss), ETDQ-7 scores if used, duration of symptoms (≥3 months), continuous vs episodic pattern, prior interventions (tympanostomy tubes) and response, detailed medical management trials (medication name, dose, duration), and objective findings (abnormal tympanogram, abnormal otoscopy, audiogram).

If prior tympanostomy tubes were placed, document that symptoms improved while tubes were patent.
Note any reversible features demonstrated (e.g., ability to Valsalva with tympanogram improvement).

Documentation Required

Required clinical documentation to support appropriateness

Required clinical documentation to support appropriateness: history supporting chronic obstructive ETD (barochallenge, serous otitis media, adhesive otitis, history of negative middle ear pressure), objective improvements with Valsalva when applicable, abnormal tympanograms, audiometric evidence, nasopharyngoscopy findings, and documentation that other causes (TMJ disorder, superior semicircular canal dehiscence, endolymphatic hydrops, neoplasm) have been excluded.

Document any demonstrated reversibility tests (Valsalva) and their effects on tympanometry.
List tests used to exclude alternative diagnoses and their results.

Note

No specific documentation requirements in literature excerpts

No specific documentation requirements are provided for some literature citations and commentary; however, when using evidence citations in a prior authorization, include relevant literature references only as supplemental rationale and ensure clinical documentation meets the explicit diagnostic and treatment trial requirements above.

Do not substitute literature citations for missing patient-specific objective tests or treatment records.

Step Therapy

Conservative therapy expected before BDET

Conservative therapy expected before BDET: trials directed at underlying etiology are expected, including treatment of rhinosinusitis, allergic rhinitis (intranasal steroid spray for 4–6 weeks when indicated), decongestants/antihistamines as appropriate, and management of reflux. While intranasal steroids have mixed evidence, payers commonly expect documented trials prior to BDET.

Document type, dose, duration, and response to conservative therapies.
Note that evidence shows intranasal steroids may be no better than placebo but trials are still commonly expected prior to procedure.

Step Therapy

Required prior medical management

Required prior medical management (consolidated): manage co-occurring conditions and document a trial of nasal steroid when indicated (4–6 weeks commonly referenced; some expert inputs note up to 12 weeks). If contraindicated, document reason. Record any oral steroid courses and other therapies tried.

Specify duration (e.g., intranasal steroid daily for 4–6 weeks) and outcomes.
If medical management was contraindicated or not applicable, provide rationale.

Step Therapy

Required medical trial

Required medical trial: a documented trial of medical therapy directed at underlying etiology is expected prior to BDET (examples: 4–6 weeks of daily intranasal steroid for allergic rhinitis; appropriate antibiotics for bacterial rhinosinusitis; PPI or antacid therapy for reflux when indicated). Document nonresponse.

Include start/end dates and prescriber notes regarding lack of improvement.
If oral steroid course used as comparator (per some RCTs), document dose and response.

Step Therapy

Alternative/step therapy considerations

Alternative/step therapy considerations: tympanostomy tube placement remains an alternative; prior tube placement is not universally required before BDET, but if tubes were used, document that symptoms improved while tubes were patent. Mechanical pressure equalization devices and other dilation methods have less evidence.

Tympanostomy tubes may be appropriate primary or repeat therapy; document rationale if BDET chosen instead.
Trial of tympanostomy tubes is not mandatory prior to BDET.

Step Therapy

Medical therapy attempts prior to BDET

Medical therapy attempts prior to BDET: document specific attempts such as intranasal steroids (≥4 weeks), oral steroids (if used), decongestants, antihistamines, antibiotics for bacterial infection, and reflux therapy when indicated. Note that high-quality evidence does not demonstrate a consistently effective pharmacologic therapy for chronic obstructive ETD.

Record medication names, doses, duration, prescriber, and response.
State if certain therapies were contraindicated and why.

Step Therapy

Medical management trial required

Medical management trial required: demonstrate failure to respond to appropriate management of comorbidities if present (e.g., allergic rhinitis, rhinosinusitis, laryngopharyngeal reflux). Document clinical rationale for proceeding to BDET after these trials.

If comorbidities were present, include specialty consultations or treatment notes showing optimization and failure to improve ETD symptoms.

Note

No step therapy requirements specified

No step therapy requirements specified in some excerpts: while multiple expert responses reference trials of medical therapy (4–6 or up to 12 weeks) prior to BDET, there is no single uniform step-therapy pathway mandated by the source; follow payer-specific step therapy policies if present.

When in doubt, document reasonable trials of appropriate medical therapy and communicate with the payer regarding any specific step therapy requirements.

Definitions and Background

Eustachian tube dysfunction (ETD) occurs when the functional valve of the Eustachian tube fails to open and/or close properly, commonly because of inflammation. Symptoms include aural fullness, pressure, otalgia, tinnitus, vertigo, and sometimes hearing loss. Balloon dilation (BDET) is a transnasal endoscopic tuboplasty that dilates the cartilaginous Eustachian tube with a saline‑filled balloon (inflation ≤2 minutes) to improve patency and restore middle‑ear ventilation.

inv-79: Obstructive eustachian tube dysfunction (ETD) — definition and key features

DefinitionObstructive Eustachian tube dysfunction (ETD) occurs when the eustachian tube valve fails to open/close properly, often from inflammation, causing aural fullness, pressure, otalgia, tinnitus, or hearing loss

PathophysiologyFailure to ventilate middle ear leads to negative pressure, effusion, retraction, and potential hearing loss or cholesteatoma

AssessmentDiagnosis requires comprehensive assessment including otoscopy, audiometry, tympanometry, and nasal endoscopy

inv-80: Reversibility of ETD — criteria demonstrating reversibility (Valsalva etc.)

Demonstration methodsAbility to relieve pressure with a Valsalva maneuver (patient-reported ability to 'pop' ears)

Tympanogram change with ValsalvaPerforming Valsalva produces temporary normalization of the tympanogram to Type A

Otoscopy signVisualization of lateral tympanic membrane movement on otoscopy during Valsalva indicates reversibility

inv-81: ETDQ-7 — description and thresholds for abnormal scores

InstrumentETDQ-7: validated 7-item patient-reported questionnaire assessing ETD symptom severity

Abnormal thresholdsTotal score ≥ 14.5 or mean item score ≥ 2.1 indicates ETD

Normalization/MCIDNormalization often defined as mean item score < 2.1; MCID ≈ 0.5-point improvement

inv-82: Tympanometry types — Type A/B/C definitions

Type ANormal middle-ear and eustachian tube function (normal tympanogram)

Type BFlat tympanogram indicating poor tympanic membrane mobility (effusion or reduced compliance)

Type CTympanogram showing negative middle-ear pressure (Eustachian tube dysfunction)

inv-83: BDET procedure — procedural description (transnasal endoscopic insertion, balloon inflation ≤2 minutes)

Procedure descriptionTransnasal endoscopic insertion of a saline-filled balloon catheter into the cartilaginous Eustachian tube with inflation, pressure maintained ≤ 2 minutes, then deflation and removal

Approach and settingMinimally invasive transnasal endoscopic method, usually performed under general anesthesia; may be standalone or adjunctive

Adjunctive proceduresCan be performed with adenoidectomy, intranasal surgery, tympanostomy tubes, tympanoplasty when clinically indicated

inv-84: ETDQ-7 (trial usage) — ETDQ-7 usage in trials and normalization definition

Use in trialsETDQ-7 was used as a symptom outcome measure in RCTs and observational studies

Normalization definition in trialsNormalization commonly defined as mean item score < 2.1 (total < 14.5)

InterpretationMCID approximately a 0.5-point improvement in mean item score

inv-85: Normalized tympanogram (Type A) — outcome used as primary endpoint in RCTs

Outcome used in RCTsNormalization to a Type A tympanogram (return to normal middle-ear pressure/compliance) was used as a primary endpoint in randomized trials

MeaningType B or C tympanograms improving to Type A indicates objective restoration of middle-ear ventilation

DocumentationTympanometry results at baseline and follow-up (eg, 6 weeks, 12, 24, 52 weeks) support assessment of treatment effect

inv-86: Obstructive ETD candidate — general candidate description (Adults ≥18 with symptoms ≥3 months)

Basic candidate profileAdults aged ≥ 18 years with obstructive ETD in one or both ears for ≥ 3 months that significantly affects quality of life or function

Prior managementFailed appropriate medical management of co-occurring conditions (documented trials such as 4–6 week nasal steroid when indicated)

Diagnostic requirementsComprehensive diagnostic assessment including tympanometry, audiometry, nasal endoscopy (dynamic) and history/physical consistent with cartilaginous ET obstruction

inv-87: Contraindication — patulous ETD

ContraindicationPatulous Eustachian tube — BDET is contraindicated

Trial exclusionsTrials excluded patients with patulous ETD, tympanic membrane perforation or ear tubes in place

Clinical noteIntermittent or past history of patulous ETD may warrant caution; active patulous ETD is a clear exclusion

inv-88: OETD abbreviation — Obstructive Eustachian tube dysfunction

AbbreviationOETD = Obstructive Eustachian tube dysfunction

UsagePreferred terminology per AAO-HNS Clinical Consensus Statement

ContrastDistinct from patulous ETD (abnormally open tube) which is a contraindication to BDET

inv-89: BDET patient selection — selection criteria summary (symptoms ≥3 months, failed medical management)

Selection criteria summaryAdults with symptoms ≥ 3 months, comprehensive diagnostic evaluation, and failed appropriate medical management (eg, 4–6 week nasal steroid trial when indicated)

Objective findingsAbnormal tympanogram (Type B or C) or dynamic endoscopic evidence of cartilaginous ET pathology preferred

Tympanostomy tube historyIf prior tubes placed, symptoms should have improved while tubes were patent; trial of tubes not required

inv-90: Chronic obstructive ETD — definition requiring persistent signs/symptoms lasting at least 3 months

DefinitionChronic obstructive ETD: persistent signs/symptoms (eg, ear fullness, baro-challenge difficulty, hearing loss) lasting at least 3 months

Objective correlatesOften accompanied by negative middle-ear pressure or abnormal tympanogram (Type B or C)

RequirementDocumentation of chronicity (≥3 months) and failure of appropriate medical management for causal comorbidities

inv-91: Clinically meaningful outcomes — list of meaningful outcomes (tympanometry, otoscopy, hearing, PROMs)

Meaningful outcomes listNormalization or improvement in tympanometry (B/C → C or A), improved otoscopy (reduced TM retraction), improved conductive hearing, improved ETDQ-7 scores, and restored ability to Valsalva/tolerate barochallenge

Measurement methodsUse tympanometry, audiometry, otoscopy, and PROMs (ETDQ-7) to document clinically meaningful change

Trial endpointsRCTs used tympanogram normalization (Type A) and ETDQ-7 improvement as primary/secondary endpoints

inv-92: Balloon dilation of the Eustachian tube (BDET) — procedural summary

Procedure summaryBalloon dilation of the Eustachian tube (BDET) is a transnasal endoscopic tuboplasty that dilates the cartilaginous ET with a saline-filled balloon inflated for ≤2 minutes then deflated and removed

PurposeTargets underlying tubal dysfunction to improve middle-ear ventilation rather than provide temporary ventilation like tympanostomy tubes

Anesthesia and settingUsually under general anesthesia; can be standalone or combined with other procedures

inv-93: Tympanostomy tube — definition and role as alternative

DefinitionTympanostomy tube: an implant placed in the tympanic membrane to ventilate the middle ear and relieve negative pressure

Role vs BDETProvides temporary ventilation for the duration of tube patency; BDET aims to treat underlying ET dysfunction rather than bypass it

Clinical implicationImprovement while tubes were patent supports ETD diagnosis; tubes remain an alternative therapy

inv-94: Chronic obstructive ETD definition (symptoms ≥3 months with specific manifestations)

Chronic OETD definitionSymptoms ≥ 3 months evidenced by barochallenge difficulty, aural fullness or hearing loss relieved by auto-insufflation, or history of negative middle-ear pressure/effusion

Supporting requirementsFailure to respond to appropriate medical management of comorbidities (eg, 4-week nasal steroid for allergic rhinitis)

Diagnostic evaluationDynamic nasal endoscopy and tympanometry/audiometry as part of assessment

inv-95: Required pre-procedure evaluations — dynamic nasal endoscopy and documented trials of management for comorbidities

Required pre-procedure evaluationsDynamic nasal endoscopy (including swallows and yawns) with documentation of findings and trials of appropriate medical management for potential causal comorbidities

Diagnostic testingTympanometry (if TM intact), comprehensive audiometry, otoscopy, and nasopharyngoscopy should be completed

Purpose of evaluationsTo demonstrate objective pathology or, if absent, confirm history/exam consistent with cartilaginous ET obstruction

inv-96: Balloon Eustachian tuboplasty (BDET) — descriptive definition and mention of randomized trial contexts

Descriptive definitionBalloon Eustachian tuboplasty (BDET) uses a transnasal endoscopic saline-filled balloon catheter to dilate the cartilaginous portion of the Eustachian tube

Trial contextsDescribed and evaluated in randomized trials where primary endpoints included tympanogram normalization and ETDQ-7 improvement

Procedure stepsIntroduce catheter transnasally, inflate balloon (pressure maintained ≤2 minutes), deflate and remove