Cochlear Implant Replacement (external components)
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Criteria and documentation requirements for prior-authorized replacement of cochlear implant external components for Wellmark Blue Cross and Blue Shield members; applies to providers requesting coverage for replacement devices.
No material clinical or coverage changes in this revision.
Coverage Criteria for Replacement Cochlear Implant Components
Medically Necessary — Covered when ALL of the following are met
Covered when ALL of the following are met:
Replacement is also considered medically necessary if a change in the individual's medical condition makes the present unit non-functional and improvement is expected with a replacement unit.
Indication: lack of hearing aid benefit evidenced by low speech perception scores
Indication-related criteria (lack of hearing aid benefit):
Testing conditions referenced include live-voice testing (e.g., ~70 dB SPL) and assessment at relevant frequencies (example: 4000 Hz).
Audiologic candidacy thresholds (partial) — regulatory/audiologic thresholds referenced
Regulatory/audiologic candidacy thresholds referenced (examples):
Exact numeric threshold applied depends on patient age/test specified in the full regulatory context; document the specific test and percent-correct score.
Trial of amplification/CROS — device-trial requirement (partial)
Prior trial of amplification or alternative routing required (examples):
Document duration and device type (hearing aid or CROS) and provide aided speech-recognition test results from the ear to be implanted.
The replacement of cochlear implant external components that is requested solely to obtain better technology or for improved aesthetics is excluded and considered not medically necessary.
No additional explicit exclusions are stated in the referenced regulatory excerpts; the document instead provides threshold and testing details for determining medical necessity.
The referenced text does not list explicit exclusions in these passages but indicates non-eligibility when specified audiologic thresholds (for example, open-set word recognition percentages) or required device-trial experiences are not documented or met.
Use of a single external processor to serve bilateral cochlear implants is noted as a clinical limitation: no single processor for bilateral cochlear implantation has been approved by the FDA, and single-processor approaches do not provide binaural benefit and may impair sound localization and increase signal-to-noise ratio.
Replacement of external cochlear implant components is considered not medically necessary when the stated medical-necessity criteria are not met or when replacement is requested solely for upgraded technology or cosmetic reasons.
The policy’s indication requirements hinge on demonstration of limited hearing-aid benefit by aided speech perception testing; therefore, patients with aided speech perception scores above the cited low thresholds (for example, better than ≤5% or <12% where age-appropriate) would not meet the policy definition of lack of benefit.
Implantation or replacement would be considered not medically necessary if qualifying open-set word-recognition thresholds are not met or documented. Examples referenced in the regulatory text include scores of <30% on an open-set test or <12% on difficult open-set/monosyllabic lists for certain pediatric age groups.
Procedure and Component Coding
| No codes listed |
| 69949 | Unlisted procedure, inner ear [when specified as implantation of hybrid cochlear device] |
| L8615 | Headset/headpiece for use with cochlear implant device, replacement |
| L8616 | Microphone for use with cochlear implant device, replacement |
| L8617 | Transmitting coil for use with cochlear implant device, replacement |
| L8618 | Transmitter cable for use with cochlear implant device or auditory osseointegrated device, replacement |
| L8619 | Cochlear implant external speech processor and controller, integrated system, replacement |
| L8627 | Cochlear implant, external speech processor, component, replacement |
| L8628 | Cochlear implant, external controller component, replacement |
| L8629 | Transmitting coil and cable, integrated, for use with cochlear implant device, replacement |
| L8699 | Prosthetic implant, not otherwise specified [when specified as hybrid cochlear device, including all internal and external components] |
Prior Authorization, Documentation, and Billing Actions
Prior authorization: speech perception documentation
Prior approval is required. Include objective speech-perception test results (aided and unaided) with the prior authorization request. Documentation should show developmentally appropriate open-set or monosyllabic word lists (e.g., CNC, PBK) with scores for the ear to be implanted or replaced.
- Provide audiometric thresholds and aided speech-perception (open-set) scores.
- Include date the device was received and manufacturer warranty information showing the current device is not under warranty.
Authorization tied to audiologic thresholds
Authorization decisions are tied to specific audiologic thresholds and documented speech-recognition performance. Requests should demonstrate that the individual meets the policy’s audiologic and speech-recognition thresholds (for example, poor open-set word-recognition scores as described below) and that replacement is expected to improve function.
- Document pre-authorization audiologic thresholds and aided word-recognition percentages in the ear to be implanted or replaced.
- State the expected functional improvement with a replacement device.
Word-recognition threshold not met
If the documented word-recognition scores do not meet the policy’s required thresholds (for example, not showing <12% or <30% on the applicable open-set measures where specified), the request risks denial.
- Failure to demonstrate qualifying low open-set word-recognition scores (as required by age/measure) may result in denial.
- If aided speech perception scores exceed the policy thresholds, include rationale for why replacement is still medically necessary.
Speech test documentation risk
Not documenting qualifying speech-recognition test results, or omitting the specific test name, raw score, test conditions (ear tested, aided/unaided), and date, increases the likelihood of denial. Provide full test reports with interpretation.
- Include test name (e.g., CNC, PBK), percent correct, ear tested, aided vs unaided condition, and test date.
- Report if developmentally appropriate test materials were used for children.
Required documentation
Provide complete objective documentation to support medical necessity for replacement. Required items include device receipt date, manufacturer warranty showing device is not under warranty, objective evidence device is non-repairable, and evidence device use was daily until malfunction.
- Date device was received.
- Manufacturer warranty information indicating the device is not under warranty.
- Audiologist documentation describing why the device is non-repairable/malfunctioning.
- Statement that the device was used daily until malfunction and is interfering with activities of daily living.
- Evidence there is no loss, abuse, or neglect of the device.
- Documentation of patient compliance with device use and anticipated continued benefit.
Documented speech perception test results
Document speech-perception test results using developmentally appropriate monosyllabic/open-set lists in the ear to be implanted; report percent-correct scores and test conditions.
- Use appropriate word lists (e.g., CNC, PBK) for age and development.
- Report open-set percent-correct scores for the ear to be implanted/replaced and indicate aided vs unaided performance.
Audiologic testing and device experience
Audiologic testing must include aided speech-recognition testing and documentation of trials with appropriate alternative devices when applicable. Record the duration and outcomes of any hearing-aid or CROS trials.
- Include aided and unaided audiograms and speech-recognition testing.
- Document trials of appropriately fitted hearing aids or CROS devices (typically at least 1 month) and the limited benefit observed.
- State whether alternative amplification provided functional improvement and include measured scores.
Required test and device-use documentation
Record open-set percent scores, PBK or equivalent test notation, and prior device-use history. For children and adults, include the specific scores that demonstrate limited benefit from hearing aids or other strategies.
- Open-set percent-correct scores and the specific test used (e.g., PBK for children).
- Notation of duration of hearing-aid or CROS use (e.g., ≥1 month) and summary of benefit (limited vs meaningful).
- Documentation that replacement is not solely for upgraded technology or aesthetics and that device is non-repairable.
Use appropriate CPT and HCPCS codes when reporting services
Report services and replacement components using the CPT and HCPCS codes listed in the policy. Use unlisted procedure code 69949 when specifying implantation of a hybrid cochlear device and the appropriate L‑series HCPCS codes for external components and replacements.
- Use CPT codes appropriate to the surgical service; when implanting a hybrid cochlear device specify 69949 (unlisted procedure, inner ear) as indicated.
- Use HCPCS L8615–L8629 and L8699 for external speech processors, components, transmitting coils/cables, microphones, and prosthetic implants as applicable.
Evidence of trial and limited benefit from appropriately fitted hearing aids
Provide evidence of a trial and limited benefit from an appropriately fitted hearing aid or alternative amplification before implantation/replacement when required by the policy. Document the trial details and measured outcomes.
- Document at least a 1‑month trial of an appropriately fitted hearing aid or CROS when policy criteria require it.
- Include aided speech-recognition scores demonstrating limited benefit despite the trial.
Trial of alternative hearing strategies
When applicable, document attempts at alternative hearing strategies (e.g., CROS, bilateral hearing aids) and their outcomes prior to approving replacement. Include objective speech-recognition scores showing limited benefit from these strategies.
- Describe alternative strategies tried (CROS, bilateral hearing aids) and duration of use.
- Supply objective aided speech-recognition data showing limited benefit from alternatives.
Clinical Background and Rationale
Cochlear implants restore hearing for individuals with severe-to-profound sensorineural hearing loss by providing direct electrical stimulation to the auditory nerve. The system comprises external components (microphone, speech processor, transmitter coil and cables) and internal components (antenna and electrode array). Revisions or replacement of external components may be required when devices fail, are non-repairable, or no longer function to support activities of daily living.
Definitions and Abbreviations
Policy Revision History
Policy renewed after annual review (February 2025).
Policy revised following annual review (April 2024).
Policy revised after an interim review (May 2023).
Policy revised following annual review (April 2023).
Policy renewed following annual review (September 2022).
FDA premarket approval (PMA) granted for hybrid cochlear implant systems: Nucleus Hybrid L24 in 2014 with later expanded approval in 2022; Med-El EAS system received expanded PMA in 2016 (regulatory details referenced).
Policy originally created (October 2015).
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