CurrentPremera BluecrossPolicy 7.01.84_PBC (07-01-2025)

Hearing Aids (Excludes Implantable Devices)

Defines coverage position for semi-implantable and fully implantable middle ear hearing aids (e.g., Vibrant Soundbridge, Maxum System, Esteem) — states these devices are considered investigational; provides device selection criteria, coding additions, age considerations, rationale and evidence summary. Excludes implantable devices from coverage (investigational) and notes benefit/contractual restrictions for acoustic hearing aids may apply.

Policy Summary

PayerPremera Bluecross

PolicyHearing Aids (Excludes Implantable Devices)

Policy CodePolicy 7.01.84_PBC (07-01-2025)

Change TypeCoding update; annual literature review

Effective DateJul 1, 2025

Next Review Date

Key ActionProviders should document that semi-implantable and fully implantable middle ear hearing aids are considered investigational per policy and include device-specific selection criteria and prior hearing aid experience if submitting for consideration; member benefit booklet/contract may restrict coverage for acoustic hearing aids

POLICY UPDATE CHANGES

Added new CPT codes 0951T–0955T to coding section effective 07/01/25

Annual review approved April 7, 2025; literature search through January 8, 2025

1Coverage stance (investigational devices)

3New CPT/HCPCS codes added

18Minimum age (FDA-labeled devices)

Coverage Summary

This policy defines the coverage position for semi-implantable and fully implantable middle ear hearing aids and is effective 2025-07-01. Coverage stance: Not covered — investigational / cosmetic (coverage_stance = not_covered_cosmetic). Affected devices referenced in the policy include the Vibrant Soundbridge, Maxum System, and Esteem.

Policy overview

Policy number7.01.84_PBC (07-01-2025)

Effective date2025-07-01

Last review2025-05-01

StatusCURRENT

Minimum FDA age for devices18 years

Medical Necessity / Investigational Determinations

Medical Necessity / Investigational Determination

Coverage determination for semi-implantable and fully implantable middle ear hearing aids:

Semi-implantable and fully implantable middle ear hearing aids are considered investigational (unproven) and not covered
Middle ear implantable and semi-implantable hearing aids require additional larger studies; current evidence insufficient to determine safety and effectiveness

Evidence summary: Insufficient — available evidence is limited to single-arm interventional studies, systematic reviews, and observational series with small sample sizes and median follow-up <5 years; surgical risks and uncertainties about whether these devices provide clinically meaningful benefit over adequate external acoustic hearing aids remain. A ClinicalTrials.gov search in January 2025 identified no ongoing or unpublished trials likely to influence the policy.

Device-specific FDA Indications (Informational)

Device-specific FDA indications (informational only)

Selection criteria and FDA labeling referenced for specific devices (not coverage approval):

Device labeling / selection criteria

Vibrant Soundbridge: Pure-tone air-conduction thresholds within specified frequency limits (see Table 1); word recognition score >= 50% using recorded material; normal middle ear anatomy; psychologically and motivationally suitable with realistic expectations>= 50% word recognition; frequency-specific limits per Table 1
See Table 1 for frequency-specific lower and upper limits
Maxum System: Indicated for adults >= 18 years with moderate-to-severe sensorineural hearing loss who desire an alternative to an acoustic hearing aid; recommended prior experience with appropriately fitted hearing aidsAge >= 18 years; prior hearing aid experience recommended
Informational only (FDA labeling)
Esteem device: Indicated for adults >= 18 years with stable bilateral sensorineural hearing loss (moderate 40-70 dB to severe 71-90 dB by pure-tone average); unaided speech discrimination >= 40%; normal middle ear anatomy and tympanic membrane; normally functioning eustachian tube; adequate space on HRCT; minimum 30 days experience with appropriately fit hearing aidsUnaided speech discrimination >= 40%; Age >= 18 years; minimum 30 days hearing aid experience
Informational only (FDA labeling)

Threshold summary

Vibrant Soundbridge selection limitsFrequency-specific pure-tone air-conduction thresholds per Table 1 (frequency-dependent lower and upper dB limits)

Vibrant Soundbridge word recognition>= 50% (recorded material)

Esteem speech discrimination (unaided)>= 40%

Esteem minimum age>= 18 years

Maxum minimum age>= 18 years

Minimum hearing aid experience (Esteem)>= 30 days with appropriately fit hearing aids

General minimum prior hearing aid experienceRecommended prior experience with appropriately fitted hearing aids

Coding (CPT / HCPCS / Historical)

New CPT codes effective 2025-07-01 (implantable middle ear hearing implant procedures)CPT

0951T	Totally implantable active middle ear hearing implant; initial placement; including mastoidectomy, placement of and attachment to sound processor (new code effective 07/01/25)
0952T	Totally implantable active middle ear hearing implant; revision or replacement; with mastoidectomy and replacement of sound processor (new code effective 07/01/25)
0953T	Totally implantable active middle ear hearing implant; revision or replacement; without mastoidectomy and replacement of sound processor (new code effective 07/01/25)
0954T	Totally implantable active middle ear hearing implant; replacement of sound processor only, with attachment to existing transducers (new code effective 07/01/25)
0955T	Totally implantable active middle ear hearing implant; removal, including removal of sound processor and all implant components (new code effective 07/01/25)

HCPCS codes related to semi-implantable devicesHCPCS

S2230	Implantation of magnetic component of semi-implantable hearing device on ossicles in middle ear
V5095	Semi-implantable middle ear hearing prosthesis

Historical / removed codes referenced in historymixed

69799	Removed CPT code (not applicable to policy as of 05/01/19)
L8613	HCPCS code removed previously as not applicable to this policy

Billing note: Added new CPT codes 0951T–0955T effective 07/01/25.

Provider Actions / Billing Guidance

Billing Rule

Use updated CPT/HCPCS codes for implantable middle ear hearing procedures

0951T
0952T
0953T
0954T
0955T
S2230
V5095
For DOS on or after 2025-07-01, report new CPT codes 0951T–0955T and use HCPCS S2230 or V5095 as applicable.

Documentation Required

Document device is investigational and rationale

Providers should document that semi-implantable and fully implantable middle ear hearing aids are considered investigational per policy and include device-specific selection criteria and prior hearing aid experience if submitting for consideration; member benefit booklet/contract may restrict coverage for acoustic hearing aids.

Documentation Required

Age documentation per FDA labeling

Document that candidate is >= 18 years of age to align with FDA-approved indications for addressed devices.

Background and Evidence Summary

Background and evidence details: Semi-implantable and fully implantable middle ear hearing aids (examples: Vibrant Soundbridge, Maxum System, Esteem) are alternatives to external acoustic hearing aids. Evidence types include single-arm interventional studies, systematic reviews, and observational series. Limitations of the evidence include small numbers of participants, short median follow-up (<5 years), and predominance of noncomparative designs. Surgical risks are inherent to implantation procedures. Overall, the evidence is insufficient to conclude a net health benefit compared with external acoustic hearing aids.

Evidence summary

Evidence sufficiencyInsufficient — limited sample sizes, single-arm studies, median follow-up <5 years; unable to determine improvement in net health outcomes

Clinical trials search (ClinicalTrials.gov)No ongoing or unpublished trials identified as of January 2025 likely to influence policy

Definition: Moderate-to-severe sensorineural hearing loss — per policy hearing-loss categories based on pure-tone average: moderate 40-60 dB; severe 60-80 dB (policy references degrees and device-specific ranges).