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DESCRIPTIONCochlear implant is a device for individuals with severe to profound hearing loss who only receive limited benefit from amplification with hearing aids. A cochlear implant provides direct electrical stimulation to the auditory nerve, bypassing the usual transducer cells that are absent or nonfunctional in deaf cochlea. The basic components of a cochlear implant include both external and internal components. The external components include a microphone, an external sound processor, and an external transmitter. The internal components are implanted surgically and include an internal receiver implanted within the temporal bone, and an electrode array that extends from the receiver into the cochlea through a surgically created opening in the round window of the middle ear.
Sounds that are picked up by the microphone are carried to the external sound processor, which transforms sound into coded signals that are then transmitted transcutaneously to the implanted internal receiver. The receiver converts the incoming signals to electrical impulses that are then conveyed to the electrode array, ultimately resulting in stimulation of the auditory nerve.
Several cochlear implants are commercially available in the United States, the Nucleus family of devices, manufactured by Cochlear Corporation; the Clarion family of devices, manufactured by Advanced Bionics; the Med El Combi 40+ device, manufactured by Med El. Over the years, subsequent generations of the various components of the devices have been approved by the U.S. Food and Drug Administration (FDA), focusing on improved electrode design and speech-processing capabilities. Furthermore, smaller devices and the accumulating experience in children have resulted in broadening of the selection criteria to include children as young as 12 months. The FDA-labeled indications for currently marketed electrode arrays are summarized below.
FDA Approval Status of Currently Marketed Cochlear Electrodes
*The Clarion CII Bionic Ear System is composed of a Clarion HiFocus electrode in conjunction with a next generation internal transmitter. Cochlear Hybrid™ (Cochlear, Inc.) is an electro-acoustic stimulation device currently undergoing clinical trials and as of September 2009 has not received FDA approval.
In March 2014, FDA approved the Nucleus® Hybrid™ L24 Cochlear Implant System (Cochlear Corporation, Centennial, CO) through the premarket approval process.(1) This system is a hybrid cochlear implant and hearing aid, with the hearing aid integrated into the external sound processor of the cochlear implant. It is indicated for unilateral use in patients aged 18 years and older who have residual low-frequency hearing sensitivity and severe to profound high-frequency sensorineural hearing loss, and who obtain limited benefit from appropriately fit bilateral hearing aid. The electrode array inserted into the cochlea is shorter than conventional cochlear implants. According to the FDA’s premarket approval notification, labeled indications for the device include:
Other hybrid hearing devices have been developed but do not have FDA approval, including the Med El® EAS Hearing Implant System
While cochlear implants have typically been used unilaterally, in recent years, interest in bilateral cochlear implantation has arisen. The proposed benefits of bilateral cochlear implants are to improve understanding of speech in noise and localization of sounds. Improvements in speech intelligibility may occur with bilateral cochlear implants through binaural summation; i.e., signal processing of sound input from 2 sides may provide a better representation of sound and allow one to separate out noise from speech. Speech intelligibility and localization of sound or spatial hearing may also be improved with head shadow and squelch effects, i.e., the ear that is closes to the noise will be received at a different frequency and with differenct intensity, allowing one to sort out noise and identify the direction of sound. Bilateral cochlear implantation may be performed independently with separate implants and speech processors in each ear or with a single processor. There is, of course, a substantial risk of a second surgery, infection, facial nerve damage, reduced vestibular function and destruction of the inner ear with a second implant and there is only marginal hearing improvement going from one to two implants. However, no single processor for bilateral cochlear implantation has been FDA approved for use in the United States. Additionally, single processors do not provide binaural benefit and may impair sound localization and increase the signal to noise ratio received by the cochlear implant.
POLICYUnilateral or bilateral cochlear implantation of a U.S. Food and Drug Administration (FDA) approved cochlear implant device may be considered medically necessary in patients age 12 months and older with bilateral severe-to-profound pre-or post-lingual (sensorineural) hearing loss defined as a hearing threshold of pure-tone average of 70 dB (decibels) hearing loss or greater at 500 HZ (hertz), 100 HZ and 2000 Hz, and have shown limited or no benefit from hearing aids.
Cochlear implantation as a treatment for patients with unilateral hearing loss with or without tinnitus is considered investigational.
Cochlear implantation with a hybrid cochlear implant/hearing aid device that includes the hearing aid integrated into the external sound processor of the cochlear implant, including but not limited to the Nucleus® Hybrid™ L24 Cochlear Implant System, is considered investigational.
Upgrades of an existing, functioning external system to achieve aesthetic improvement, such as smaller profile components or a switch from a body-worn, external sound processor to a behind-the-ear (BTE) model, are considered not medically necessary.
Note: Auditory Brain Stem Implant, designed to restore hearing in patients with neurofibromatosis who are deaf secondary to removal of bilateral acoustic neuromas, is not addressed in this policy.
POLICY EXCEPTIONSFederal Employee Program (FEP) may dictate that all FDA-approved devices, drugs or biologics may not be considered investigational and thus these devices may be assessed only on the basis of their medical necessity.
POLICY GUIDELINESBilateral cochlear implantation should be considered only when it has been determined that the alternative of unilateral cochlear implant plus hearing aid in the contralateral ear will not result in a binaural benefit; i.e., in those patients with hearing loss of a magnitude where a hearing aid will not produce the required amplification.
Hearing loss is rated on a scale based on the threshold of hearing. Severe hearing loss is defined as a bilateral hearing threshold of 70-90 dB and profound hearing loss is defined as a bilateral hearing threshold of 90 dB and above.
In adults, limited benefit from hearing aids is defined as scores 50% correct or less in the ear to be implanted on tape recorded sets of open-set sentence recognition. In children, limited benefit is defined as failure to develop basic auditory skills, and in older children, <30% correct on open-set tests.
A post-cochlear implant rehabilitation program is necessary to achieve benefit from the cochlear implant. The rehabilitation program consists of 6 to 10 sessions that last approximately 2½ hours each. The rehabilitation program includes development of skills in understanding running speech, recognition of consonants and vowels, and tests of speech perception ability.
Contraindications to cochlear implantation may include deafness due to lesions of the eighth cranial nerve or brain stem, chronic infections of the middle ear and mastoid cavity or tympanic membrane perforation. The absence of cochlear development as demonstrated on CT scans remains an absolute contraindication.
Hybrid cochlear implant devices that include a hearing aid integrated into the external sound processor of the cochlear implant are considered investigational because the available evidence does not demonstrate that hybrid devices improve outcomes compared with standard cochlear implants.
Investigative service is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized by certifying boards and/or approving or licensing agencies or published peer review criteria as standard, effective medical practice for the treatment of the condition being treated and as such therefore is not considered medically necessary.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
POLICY HISTORY7/1992: Approved by Medical Policy Advisory Committee (MPAC)
12/30/1999: Policy Guidelines updated
9/21/2001:Policy rewritten to be reflective of Blue Cross Blue Shield Association policy # 7.01.05, Code Reference section updated, CPT code 92507, 92510 added
11/2001: Reviewed by MPAC; revisions approved
4/18/2002: Type of Service and Place of Service deleted
5/29/2002: Code Reference section updated, CPT code 69949 added, HCPCS L8619, V5269, V5273, V5299, V5336, V5362, V5363 added
3/6/2003: Code Reference section updated, CPT code 92601, 92602, 92603, 92604 added
7/15/2004: Reviewed by MPAC, bilateral cochlear implantation considered investigational, Description section aligned with BCBSA policy # 7.01.05, definition of investigational added Policy Guidelines, Sources updated
10/5/2004: Code Reference section updated, CPT code 69949 deleted, CPT 92507 description revised, CPT 92508 added, ICD-9 procedure code 20.96, 20.97, 20.99, 95.49 added, ICD-9 diagnosis code range 389.10-389.18 listed separately, ICD-9 diagnosis 389.7 added, HCPCS L8619 note added, HCPCS V5269, V5273, V5299, V5336, V5362, V5363 deleted
3/22/2005: Code Reference section updated, CPT code 92510 description revised, HCPCS L8615, L8616, L8617, L8618 with Note: "See POLICY GUIDELINES for information regarding replacement of the external component of the cochlear implant" and effective date of 1/1/2005 added.
11/15/2005: HCPCS codes K0731, K0732, L8620 added
03/10/2006: Coding updated. CPT4 / HCPCS 2006 revisions added to policy
03/13/2006: Policy reviewed, no changes
09/13/2006: Coding updated. ICD9 2006 revisions added to policy
12/27/2006: Code Reference section updated per the 2007 HCPCS revisions
3/27/2007: Policy reviewed, no changes to policy statement. Bilateral cochlear implantation added to Policy Guidelines section
06/26/2007: Policy statement updated; bilateral cochlear implantation changed from investigational to may be considered medically necessary
7/19/2007: Reviewed and approved by MPAC
9/18/2007: Code reference section updated. ICD-9 2007 revisions added to policy
1/7/2009: Policy reviewed, policy section partially rewritten and clarified.
3/12/2010: Code Reference section updated. New HCPCS codes L8627, L8628 and L8629 added to covered table.
04/26/2010: Policy description updated regarding devices. Policy statements modified for clarity; intent unchanged. Contraindications to cochlear implantation added to the policy guidelines. FEP verbiage added to the Policy Exceptions section. Deleted outdated references from the Sources section. Removed deleted CPT code 92510 from the codes table as this code was deleted on 12/31/2005.
08/02/2011: Policy reviewed; no changes.
07/17/2012: Policy reviewed; no changes.
05/08/2013: Removed deleted CPT code 92510 from the Code Reference section.
11/15/2013: Policy statement updated to add the following: Cochlear implantation as a treatment for patients with unilateral hearing loss with or without tinnitus is considered investigational. Deleted the following unilateral hearing loss ICD-9 diagnosis codes from the Code Reference section: 389.13, 389.15, and 389.17.
09/15/2014: Policy statement updated to state that cochlear implantation with a hybrid cochlear implant/hearing aid device that includes the hearing aid integrated into the external sound processor of the cochlear implant, including but not limited to the Nucleus® Hybrid™ L24 Cochlear Implant System, is considered investigational. Policy guidelines and policy description udpated regarding hybrid devices.
08/25/2015: Code Reference section updated for ICD-10.
SOURCE(S)Blue Cross Blue Shield Association policy # 7.01.05
CODE REFERENCEThis may not be a comprehensive list of procedure codes applicable to this policy.
The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document.