CurrentPremera BluecrossPolicy N/A

Semi‑implantable and Fully‑implantable Middle Ear Hearing Aids

Defines the coverage stance and criteria for semi‑implantable and fully‑implantable middle ear hearing aids for adults, and informs providers when these devices may be considered or are investigational.

Policy Summary

PayerPremera Bluecross

PolicySemi‑implantable and Fully‑implantable Middle Ear Hearing Aids

Policy CodePolicy N/A

Change TypeTechnical/coding update (no material clinical changes)

Effective DateJul 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization and document audiometric thresholds and word recognition scores when billing implantable middle ear device codes.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

0951T-0955T, S2230, V5095New CPT/HCPCS codes listed

18+ yrsAge indication

2FDA‑approved device families

1Fully implantable named

Coverage Criteria for Middle Ear Implantable Hearing Aids

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Policy stance: Semi-implantable and fully implantable middle ear hearing aids are considered investigational

Device examples: Vibrant Soundbridge, Maxum, Esteem

Age indication: Device use is consistent with FDA labeling for adultsage >= 18

FDA labeling indicates devices are intended for adults 18 years of age or older

Clinical evidence: Available evidence does not demonstrate sufficient improvement in net health outcomes compared with external acoustic hearing aids

Evidence limited to single-arm studies and observational series with median follow-up < 5 years

Coverage criteria (summary)

Covered when aligned with FDA labeling and applicable policy criteria (as maintained by the payer); devices approved by FDA are intended for adults 18 years or older with moderate to severe sensorineural hearing loss.

FDA-labeled device coverage: Device is FDA-approved and used in adults 18 years or older with moderate to severe sensorineural hearing loss as per device labeling.age >= 18

Vibrant Soundbridge (MPV) and Esteem (OAF) FDA approvals cited

Device-specific selection criteria: Audiometric and anatomic selection criteria per device labeling are documented.

Examples: pure-tone air-conduction thresholds within device-specific limits (see Table 1) and minimum unaided word recognition (>=50% for Vibrant Soundbridge; Esteem requires >=40% unaided speech discrimination); normal middle ear anatomy and other device-specific requirements (e.g., CT to confirm space for Esteem).

Investigational or non-FDA-approved devices: Devices that are not FDA-approved are considered investigational and are not covered under this policy.N/A

Example: Carina did not have FDA approval at time of document; trials conducted under IDEs

The policy considers semi‑implantable and fully implantable middle ear hearing aids to be investigational and therefore not covered as established therapies. Examples cited in the policy include the Vibrant Soundbridge, Maxum System, and the Esteem device, all of which are discussed in the regulatory and evidence sections as implantable middle ear hearing devices whose use is not considered standard of care under this policy.

The evidence base—consisting of single‑arm interventional studies submitted to the FDA, systematic reviews, and observational series—is limited in size and duration. Although some studies suggest implantable middle ear hearing aids may improve hearing relative to conventional external acoustic hearing aids, the available data are insufficient to demonstrate an improvement in net health outcomes compared with external acoustic hearing aids.

Coding and Clinical Eligibility Parameters

Covered CPT Codes (listed)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 CodesHCPCS

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

Regulatory and CPT codes referencedmixed

MPV	FDA product code for semi-implantable devices (Vibrant Soundbridge)
OAF	FDA product code for Esteem fully implantable hearing system
0951T	New CPT code added to policy
0952T	New CPT code added to policy
0953T	New CPT code added to policy
0954T	New CPT code added to policy
0955T	New CPT code added to policy

Pure-tone air-conduction threshold limits (Table 1)

0.5 kHzLower limit 30 dB; Upper limit 65 dB

1.0 kHzLower limit 40 dB; Upper limit 75 dB

1.5 kHzLower limit 45 dB; Upper limit 80 dB

2.0 kHzLower limit 45 dB; Upper limit 80 dB

3.0 kHzLower limit 50 dB; Upper limit 85 dB

4.0 kHzLower limit 50 dB; Upper limit 85 dB

Word recognition / speech discrimination thresholds

Vibrant Soundbridge word recognition>= 50% using recorded material

Esteem unaided speech discrimination>= 40% unaided speech discrimination

Documentation noteWord recognition scores required per device labeling (recorded material for Vibrant Soundbridge)

Provider Actions, Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for implantable middle ear device procedures. Providers must obtain authorization prior to scheduling or performing procedures coded with the following CPT and HCPCS codes.

0951T, 0952T, 0953T, 0954T, 0955T (CPT)
S2230, V5095 (HCPCS)

Denial Risk

Policy Deletion / Replacement Risk

This policy was deleted and replaced with InterQual criteria for dates of service on or after July 2, 2020; providers should be aware of the deletion/replacement risk when submitting claims and confirming coverage for historical dates of service.

Policy deletion effective 07/02/2020; InterQual criteria apply for dates of service on or after 07/02/2020

Documentation Required

FDA Labeling and Device Use

FDA labeling and device-specific approvals state these implantable middle ear devices are intended for use in adults (≥18 years) with moderate-to-severe sensorineural hearing loss who desire an alternative to acoustic hearing aids. FDA indications and manufacturer labeling (e.g., Vibrant Soundbridge, Maxum System, Esteem) emphasize prior experience with appropriately fitted acoustic hearing aids and specific audiometric selection criteria.

Use limited to adults ≥18 years per FDA labeling
Devices intended for individuals who desire an alternative to acoustic hearing aids
Manufacturer labeling recommends prior experience or trial with appropriately fitted acoustic hearing aids
Selection may require documentation of pure‑tone thresholds and word recognition scores as outlined in device labeling

Note

Verify Member Benefits

Providers must verify member benefits and any plan-specific coverage limitations by consulting the member benefit booklet or contacting customer/member service before scheduling services. Coverage may vary by contract and this policy does not apply to Medicare Advantage.

Verify coverage and benefit limits with member’s plan prior to authorization
This policy is a guide; member contracts determine coverage
Contact member services for plan-specific questions

Background

Semi‑implantable and fully implantable middle ear hearing aids transduce sound directly to the ossicles and are positioned as alternatives to external acoustic hearing aids for adults who desire another option. Semi‑implantable devices (for example, the Vibrant Soundbridge and Maxum System) use an implanted transducer with external sound processor components, while fully implantable systems (for example, Esteem) have all components implanted. The policy notes that FDA labeling for approved devices is intended for adults ≥18 years with moderate to severe sensorineural hearing loss, but also highlights limited trial sizes and follow‑up and that the overall evidence does not establish a net health benefit over external acoustic hearing aids.

Definitions

Semi-implantable middle ear hearing aid — components

Implanted componentsMagnetic component implanted onto ossicles; receiver implanted;

External processorExternal sound processor worn on scalp over receiver and held by magnet (Soundbridge) or processor resting over external ear (Maxum)

Device exampleVibrant Soundbridge (MED-EL) and Maxum System

Fully-implantable middle ear hearing aid — components

Implanted sensor, processor, driverAll components (sensor, sound processor, and driver) implanted and connected to ossicles

Transduction methodUses piezoelectric transduction (sensor at incus head to driver at stapes)

Device exampleEsteem Implantable Hearing System (Envoy Medical), FDA product code OAF

Device with external components and implanted transducer

DefinitionDevice with implanted transducer/receiver attached to ossicles plus an external sound processor (worn externally) — semi-implantable device

ExampleVibrant Soundbridge (processor worn externally over implanted receiver)

FunctionExternal processor amplifies and sends signals to implanted receiver which transduces to electromagnetic energy to vibrate ossicles

Device entirely implanted under the skin (fully implantable)

DefinitionDevice entirely implanted under the skin with no external components (sensor, processor, and driver all implanted)

ExampleEsteem Implantable Hearing System (fully implantable)

Clinical noteIntended for adults ≥18 years with stable bilateral sensorineural hearing loss per FDA labeling