CurrentBlue Cross Blue Shield - MassachusettsPolicy 480

Semi-implantable and fully implantable middle ear hearing aids

BCBSMA Medical Policy #480 defines coverage and authorization requirements for semi-implantable and fully implantable middle ear hearing aids for Commercial and Medicare products, states these devices are investigational and not covered as outpatient services, and requires precertification for inpatient procedures.

Policy Summary

PayerBlue Cross Blue Shield - Massachusetts

PolicySemi-implantable and fully implantable middle ear hearing aids

Policy CodePolicy 480

Change TypeClarified codingannual review (references updated)

Effective Date

Next Review Date

Key ActionPrecertification/preauthorization is required for all products if implantation of semi- or fully implantable middle ear hearing aids is performed in the inpatient setting.

SourceLink

POLICY UPDATE CHANGES

5/2024: Clarified coding table.

4/2026: Annual policy review; references updated; policy statements unchanged.

2Investigational HCPCS codes listed

1Investigation/not covered outpatient

1Precertification required (inpatient)

Coverage Summary

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This policy addresses semi- and fully implantable middle ear hearing aids (for example, Vibrant Soundbridge, Maxum System, and the Esteem Implantable Hearing System) as alternatives to external acoustic hearing aids. FDA approvals exist for specific semi-implantable and fully implantable devices. The clinical evidence—comprising single-arm studies submitted to the FDA, systematic reviews, and observational series—suggests possible hearing improvement for some patients but is limited in patient numbers and follow-up and is insufficient to demonstrate a net health benefit compared with external hearing aids.

Scope summaryBCBSMA Medical Policy #480 defines coverage and authorization requirements for semi-implantable and fully implantable middle ear hearing aids for Commercial and Medicare products; devices are investigational and not covered as outpatient services; precertification required for inpatient procedures.

SubjectSemi-implantable and fully implantable middle ear hearing aids

Policy number480

StatusCURRENT

Last review date2026-04

Confidence0.95

Medical-Necessity Criteria

Coverage Determination

Policy statements for Commercial and Medicare members:

ALL of the following

Semi-implantable and fully implantable middle ear hearing aids are INVESTIGATIONAL.
For outpatient settings, these devices are not a covered service for Commercial Managed Care (HMO and POS), Commercial PPO and Indemnity, Medicare HMO Blue, and Medicare PPO Blue members.
For inpatient settings, precertification/preauthorization IS REQUIRED for all products if the procedure is performed inpatient.

Not Covered / Investigational

Coverage stance: Semi- and fully implantable middle ear hearing aids are considered investigational and not covered for outpatient services (Commercial Managed Care, Commercial PPO and Indemnity, Medicare HMO Blue, and Medicare PPO Blue). For operational detail and criteria, refer to the policy’s coverage determination/criteria group which specifies investigational status, outpatient noncoverage, and an inpatient precertification requirement. The policy states precertification/preauthorization is required when the procedure is performed inpatient.

Provider Actions

Prior Authorization

Inpatient precertification requirement

Precertification/preauthorization is required for all products if implantation of semi- or fully implantable middle ear hearing aids is performed in the inpatient setting.

Denial Risk

Outpatient noncoverage

Claims for semi-implantable and fully implantable middle ear hearing aids performed outpatient for Commercial Managed Care, Commercial PPO and Indemnity, Medicare HMO Blue, and Medicare PPO Blue members are not covered and may be denied.

S2230
V5095

Documentation Required

Coding and contract verification

Providers should report services using the most up-to-date procedure, revenue, and diagnosis codes and verify member contract benefits to determine applicability of coverage.

Background & Evidence

Semi-implantable devices (eg, Vibrant Soundbridge and Maxum System) and one fully implantable device (Esteem Implantable Hearing System) have received FDA approval for specific indications. Semi-implantable devices include an implanted magnetic component attached to the ossicles, a receiver, and an external sound processor; the fully implantable Esteem system uses an implanted sensor, processor, and driver with piezoelectric transduction to stimulate the ossicles.

Policy evidence summary: The evidence is insufficient to determine that semi- and fully implantable middle ear hearing aids improve net health outcome—trials include limited numbers of patients with median follow-up under 5 years, and available studies are primarily single-arm, observational, or systematic reviews with small sample sizes.

Term	Definition
Normal hearing	Detection of sound at or below 20 decibels (dB).
[{"text":"Degree of hearing loss (ASHA)","status":""},{"text":"Mild 20-40 dB; moderate 40-60 dB; severe 60-80 dB; profound 65 80 dB.","status":""}]