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Printer Friendly Version Cochlear Implants

Cochlear Implants

 

DESCRIPTION

Cochlear 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

Clarion HiFocus*

Nucleus 24

Nucleus 24 Contour

Med El Combi 40

Children: 12 mo - 18 yr; profound hearing loss

Children: 18 - 24 mo; profound hearing loss

Children: 12 mo - 18 yr; profound hearing loss

Children: 18 mo - 18 yr; profound, hearing loss

Adults: Postlingual profound hearing loss

Older children: 2 - 17 yr; severe to profound loss

Older children: severe to profound loss

Adults: Bilateral severe to profound loss

 

Adults: Severe to profound loss pre- and postlingually

Adults: Severe to profound loss pre- and postlingually

 

*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.

While cochlear implants have typically been used monolaterally, 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.

 

POLICY

Unilateral 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.

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 EXCEPTIONS

Federal 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 GUIDELINES

Bilateral 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.

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 HISTORY

7/1992: 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.

 

SOURCE(S)

Blue Cross Blue Shield Association policy # 7.01.05

 

CODE REFERENCE

This is not intended to be a comprehensive list of codes. Some covered procedure codes have multiple descriptions.

The code(s) listed below are ONLY covered if the procedure is performed according to the "Policy" section of this document.

Covered Codes

Code Number

Description

CPT-4

69930

Cochlear device implantation, with or without mastoidectomy

69949

Unlisted procedure, inner ear

92507

Treatment of speech, language, voice, communication, and/or auditory processing disorder; individual)

92508

Treatment of speech, language, voice, communication, and/or auditory processing disorder (includes aural rehabilitation); group, two or more individuals

92601

Diagnostic analysis of cochlear implant, patient under 7 years of age; with programming

92602

Diagnostic analysis of cochlear implant, patient under 7 years of age; subsequent reprogramming

92603

Diagnostic analysis of cochlear implant, age 7 years or older; with programming

92604

Diagnostic analysis of cochlear implant, age 7 years or older; subsequent reprogramming

ICD-9-Procedure

20.96

Implantation or replacement of cochlear prosthetic device, not otherwise specified

20.97

Implantation or replacement of cochlear prosthetic device, single channel

20.98

Implantation of replacement of cochlear prosthetic multiple channel device

20.99

Other operations on middle and inner ear

95.49

Other nonoperative procedures related to hearing

ICD-9-Diagnosis:

389.10

Sensorineural hearing loss, unspecified

389.11

Sensory hearing loss, bilateral

389.12

Neural hearing loss, bilateral

389.13 

Neural hearing loss, unilateral

389.14 

Central hearing loss 

389.15

Sensorineural hearing loss, unilateral

389.16

Sensorineural hearing loss, asymetrical

389.17 

Sensory hearing loss, unilateral

389.18 

Sensorineural hearing loss, bilateral 

389.7

Deaf, nonspeaking, not elsewhere classifiable

HCPCS

L8614

Cochlear device, includes all internal and external components

L8615

Headset/headpiece for use with cochlear implant device, replacement

Note: See  POLICY GUIDELINES for information regarding replacement of the external component of the cochlear implant

L8616

Microphone for use with cochlear implant device, replacement

Note: See  POLICY GUIDELINES for information regarding replacement of the external component of the cochlear implant

L8617

Transmitting coil for use with cochlear implant device

Note: See POLICY GUIDELINES for information regarding replacement of the external component of the cochlear implant

L8618

Transmitter cable for use with cochlear implant device, replacement

Note: See POLICY GUIDELINES for information regarding replacement of the external component of the cochlear implant

L8619

Cochlear implant external speech processor, replacement

Note: See  POLICY GUIDELINES for information regarding replacement of the external component of the cochlear implant.

L8623

Lithium Ion battery for use with cochlear implant device speech processor, other than ear level, replacement, each

L8624

Lithium Ion battery for use with cochlear implant device speech processor, ear level, replacement, each 

L8627

Cochlear implant, external speech processor, component, replacement (new 1-1-2010)

Note: See POLICY GUIDELINES for information regarding replacement of the external component of the cochlear implant

L8628

Cochlear implant, external controller component, replacement (new 1-1-2010)

Note: See POLICY GUIDELINES for information regarding replacement of the external component of the cochlear implant

L8629

 Transmitting coil and cable, integrated, for use with cochlear implant device, replacement (new 1-1-2010)

Note: See POLICY GUIDELINES for information regarding replacement of the external component of the cochlear implant

 

 

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