| MP 7.01.05 | Cochlear Implant | |
| Medical Policy | ||
| Section Surgery |
Original Policy Date 12/1/95 |
Last Review Status/Date Reviewed with literature search/4:2008 |
| Issue 4:2008 |
Return to Medical Policy Index |
Disclaimer
Our medical policies are designed for informational purposes only and are not an authorization, or an explanation of benefits, or a contract. Receipt of benefits is subject to satisfaction of all terms and conditions of the coverage. Medical technology is constantly changing, and we reserve the right to review and update our policies periodically.
Description
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; and the Med El Combi 40+ device, manufactured by Med El Corporation. 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 labeled indications from the FDA 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 Adults: postlingual profound hearing loss |
Children: 18–24 mo; profound hearing loss Older children: 2–17 yr; severe to profound loss Adults: severe to profound loss pre- and postlingually |
Children: 12 mo–18 yr profound hearing loss Older children: severe to profound loss Adults: severe to profound loss pre- and postlingually |
Children: 18 mo-18 yr; profound hearing loss Adults: bilateral severe to profound hearing loss |
*The Clarion CII Bionic Ear System is composed of a Clarion HiFocus electrode in conjunction with a next generation internal transmitter.
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 closest to the noise will be received at a different frequency and with different 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. However, no single processor for bilateral cochlear implantation has been approved by the FDA for use in the United States. In addition, single processors do not provide binaural benefit and may impair sound localization and increase the signal to noise ratio received by the cochlear implant.
Note: Auditory brain stem implant, designed to restore hearing in patients with neurofibromatosis who are deaf secondary to removal of bilateral acoustic neuromas is addressed in a separate policy (No. 7.01.83).
Policy
An FDA-approved cochlear implant and associated aural rehabilitation may be considered medically necessary in patients 1 year and older with severe to profound pre- or postlingual hearing loss, defined as a hearing threshold of 70 decibels (dB) or above, and have shown limited benefit from hearing aids.
Bilateral cochlear implantation may be considered medically necessary.
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.
Next generation devices have typically offered a marginal improvement over previous devices, such that replacement of the internally implanted components is not routinely performed and thus may be considered medically necessary only in the small subset of patients who have an inadequate response to existing components. 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.
In 2003, CPT established a range of codes (92601, 92602, 92603, 92604, 92605 & 92606) to define a variety of postoperative evaluative and therapeutic services related to cochlear implants. Codes 92601 and 92603 describe postoperative analysis and fitting of previously placed external devices, connection to cochlear implant, and programming of the stimulator. Codes 92602 and 92604 describe subsequent sessions for measurement and adjustment of the external transmitter and re-programming of the internal stimulator.
Benefit Application
BlueCard/National Account Issues
The issue of upgrading components of a cochlear implant or bilateral cochlear implantation may be best addressed contractually.
Some facilities may negotiate a global fee for the implantation of the device and the associated aural rehabilitation. However, charges for rehabilitation may be subject to individual contractual limitations.
Rationale
Cochlear implants are recognized effective treatment of sensorineural deafness, as noted in a 1995 National Institutes of Health Consensus Development conference, which offered the following conclusions (1):
- Cochlear implantation has a profound impact on hearing and speech reception in postlingually deafened adults with positive impacts on psychological and social functioning.
- The results are more variable in children. Benefits are not realized immediately but rather are manifested over time, with some children continuing to show improvement over several years.
- Prelingually deafened adults may also benefit, although to a lesser extent than postlingually deafened adults. These individuals achieve minimal improvement in speech recognition skills. However, other basic benefits, such as improved sound awareness, may meet safety needs.
- Training and educational intervention are fundamental for optimal postimplant benefit.
- Cochlear implants in children under 2 years old are complicated by the inability to perform detailed assessment of hearing and functional communication. However, a younger age of implantation may limit the negative consequences of auditory deprivation and may allow more efficient acquisition of speech and language. Some children with postmeningitis hearing loss under the age of 2 years have received an implant due to the risk of new bone formation associated with meningitis, which may preclude a cochlear implant at a later date.
While use of a monolateral cochlear implant in patients with severe to profound hearing loss has become standard clinical practice, bilateral cochlear implantation has been less common. A review of the peer-reviewed literature on MEDLINE from the period of 1995 through March 2006 identified several reports on patients with bilateral cochlear implants. (2-14) These reports evaluated small numbers of patients and provided limited outcome information. In the reports published thus far, most, but not all, patients reported very slight to modest improvements in sound localization and speech intelligibility with bilateral cochlear implants, especially with noisy backgrounds but not necessarily in quiet environments. When reported, the combined use of binaural stimulation improved hearing by only a few decibels or percentage points. This improvement appears marginal, and may not outweigh the significant risks of a second implantation. In addition, similar binaural results can be achieved with a contralateral hearing aid, assuming the contralateral ear has speech recognition ability. (15)
Several issues need to be resolved through additional studies before bilateral cochlear implantation should be used routinely in patients with severe to profound hearing loss. Patient selection criteria needs to be identified to determine in which patients the brain will be able to integrate bilateral electrical stimulation and when benefit with bilateral cochlear implants can be expected, e.g., pre- or postlingual patients, age, duration of hearing loss, the etiology and physiology of the hearing loss, and number of auditory nerve fibers surviving. In addition, bilateral implantation poses twice the risk of unilateral implantation including surgical risk, infection, facial nerve damage, reduced vestibular function, and destruction of the inner ear. While the potential to restore cochlear function is not foreseeable in the near future (there is current research to restore hearing by stimulating cochlear hair cell regrowth), destruction of the cochlea eliminates this possibility, which is especially of concern in children. Thus, there is little evidence about the benefits and outcomes of bilateral cochlear implants and also concerns about risks of bilateral implantation.
2007 Update
A literature review through December 2006 identified a number of new studies that were relevant to this policy. Sharma and Dorman report that central auditory pathways are “maximally plastic” for a period of about 3.5 years. (16) Stimulation delivered within this period results in auditory evoked potentials that reach normal values in 3 to 6 months. However, when stimulation occurs after 7 years, changes occur within 1 month, but then have little to no subsequent change. Sharma and Dorman also reported on auditory development in 23 children with unilateral or bilateral implants. (17) In 1 child who received a bilateral device with later (after age 7) implantation of the second ear, the auditory responses in the second device were similar to that seen in “late-implanted” children.
A number of studies have reported benefits for patients with a unilateral cochlear implant (CI) with hearing aid (HA) in the opposite ear (CI-HA). Ching reported on 21 adults who used unilateral cochlear implant and a contralateral hearing aid. (18) Binaural benefits were seen for at least one measure for their patients; measures included speech recognition, sound localization, and functional performance. Ching and colleagues subsequently reported on 29 children and 21 adults with unilateral cochlear implant and a contralateral hearing aid. (19) They noted that both children and adults derived binaural advantages related to sentence perception in noise. Also, children and adults localized sound better with bilateral inputs. In another report, Holt concluded that children who used CI-HA benefited from combining the acoustic input, particularly in background noise. (20)
A number of studies have also reported results with bilateral cochlear implants. Litovsky reported that 9 of 13 (70%) children with bilateral cochlear implants discriminated source separations of ≤20 degrees and 7 of 9 performed better when using bilateral (vs. unilateral) devices. (21) Schoen and colleagues reported that bilateral cochlear implants were able to restore spatial hearing in 11 cochlear implant patients. (22) Litovsky and colleagues reported on a multicenter prospective study of 37 adults with post-linguistic bilateral hearing loss. (23) Bilateral benefit (speech understanding in quiet and noise) was seen in 32 of the 34 subjects. The authors indicate that the 3dB improvement in signal to noise ratio noted in the study would result in an average improvement of 28% in speech understanding and that this improvement could be crucial. Questionnaire data (subjects used only the “best” unilateral device for 3 weeks) also indicated that bilateral users perceived their performance to be better than when using a single device. Ricketts and colleagues reported on 16 similar adults with postlinguistic bilateral hearing loss. (24) They found a small but significant advantage with bilateral implants for speech recognition in noise. While a training effect was noted over time for a subset of patients followed up to 17 months, a consistent bilateral advantage was noted. Ramsden and colleagues reported on 30 adults in England who had bilateral cochlear implants and received their second implant a mean of 3 years after the first. (25) At 9 months, a significant (12.6%, p < 0.001) binaural advantage was seen for speech and noise from the front. They were not able to predict when the second ear would be the better performer. Sequential implantation with long delays between ears resulted in poor second ear performance for some of their subjects. Kuhn-Inacker reported on a group of 39 European children who had bilateral cochlear implants. (26) From qualitative and quantitative data, they concluded that bilateral implants improve the children’s communicative behavior, especially in complex listening situations.
The potential to restore cochlear function is not foreseeable in the near future (there is current research to restore hearing by stimulating cochlear hair cell regrowth), but destruction of the cochlea eliminates this possibility. However, if implantation of cochlear implants is believed to be most beneficial at a younger age, when the nervous system is “plastic,” this potential development seems too far in the future to benefit young children who are current candidates for a cochlear implant.
In summary, these studies show consistent improvement in speech reception (especially in noise) and in sound localization with bilateral devices. These are important attributes. Studies also suggest that earlier implantation may be preferred. Based on these new studies, bilateral cochlear implants have been shown to provide important benefits.
2008 Update
The policy was updated with a literature review using MEDLINE from January 2007 through February 2008. None of the articles identified lead to a change in the policy statement. A number of additional publications report on the benefits of bilateral cochlear implantation in both children and adults. (27-30) One study by Luntz reported results similar to those reported above (18-20), about the binaural benefits of unilateral cochlear implant and contralateral hearing aid. (31) The policy statements are unchanged.
References:
- 1995 NIH Consensus Conference: Cochlear Implants in Adults and Children: www.odp.od.nih.gov/consensus/cons/068statement.htm.
- Long CJ, Eddington DK, Colburn HS et al. Binaural sensitivity as a function of interaural electrode position with a bilateral cochlear implant user. J Acoust Soc Am 2003; 114(3):1565-74.
- van Hoesel RJ, Tyler RS. Speech perception, localization, and lateralization with bilateral cochlear implants. J Acoust Soc Am 2003; 113(3):1617-30.
- Au DK, Hui Y, Wei WI. Superiority of bilateral cochlear implantation over unilateral cochlear implantation in tone discrimination in Chinese patients. Am J Otolaryngol 2003; 24(1):19-23.
- Vermeire K, Brokx JP, Van de Heyning PH et al. Bilateral cochlear implantation in children. Int J Pediatr Otorhinolaryngol 2003; 67(1):67-70.
- Thai-Van H, Gallego S, Truy E et al. Electrophysiological findings in two bilateral cochlear implant cases: does the duration of deafness affect electrically evoked auditory brain stem responses? Ann Otol Rhinol Laryngol 2002; 111(11):1008-14.
- Schon F, Muller J, Helms J. Speech reception thresholds obtained in a symmetrical four-loudspeaker arrangement from bilateral users of MED-EL cochlear implants. Otol Neurotol 2002; 23(5):710-4.
- Muller J, Schon F, Helms J. Speech understanding in quiet and noise in bilateral users of the MED-EL COMBI 40/40+ cochlear implant system. Ear Hear 2002; 23(3):198-206.
- Van Hoesel R, Ramsden R, Odriscoll M. Sound-direction identification, interaural time delay discrimination, and speech intelligibility advantages in noise for a bilateral cochlear implant user. Ear Hear 2002; 23(2):137-49.
- Gantz BJ, Tyler RS, Rubinstein JT et al. Binaural cochlear implants placed during the same operation. Otol Neurotol 2002; 23(2):169-80.
- Tyler RS, Gantz BJ, Rubinstein JT et al. Three-month results with bilateral cochlear implants. Ear Hear 2002; 23(1 suppl):80S-89S.
- Truy E, Ionescu E, Ceruse P et al. The binaural digisonic cochlear implant: surgical technique. Otol Neurotol 2002; 23(5):704-9.
- Mawman DJ, Ramsden RT, O'Driscoll M et al. Bilateral cochlear implantation—a case report. Adv Otorhinolaryngol 2000; 57:360-3.
- Lawson DT, Wilson BS, Zerbi M et al. Bilateral cochlear implants controlled by a single speech processor. Am J Otol 1998; 19(6):758-61.
- Morera C, Manrique M, Ramos A et al. Advantages of binaural hearing provided through bimodal stimulation via a cochlear implant and a conventional hearing aid: a 6-month comparative study. Acta Otolaryngol 2005; 125(6):596-606.
- Sharma A, Dorman MF. Central auditory development in children with cochlear implants: clinical implications. Adv Otorhinolaryngol 2006; 64:66-88.
- Sharma A, Dorman MF, Kral A. The influence of a sensitive period on central auditory development in children with unilateral and bilateral cochlear implants. Hear Res 2005; 203(1-2):134-43.
- Ching TY, Incerti P, Hill M. Binaural benefits for adults who use hearing aids and cochlear implants in opposite ears. Ear Hear 2004; 25(1):9-21.
- Ching TY, Incerti P, Hill M et al. An overview of binaural advantages for children and adults who use binaural/bimodal hearing devices. Audiol Neurootol 2006; 11(suppl 1):6-11.
- Holt RF, Kirk KI, Eisenberg LS et al. Spoken word recognition development in children with residual hearing using cochlear implants and hearing aids in opposite ears. Ear Hear 2005; 26(4 suppl):82S-91S.
- Litovsky RY, Johnstone PM, Godar S et al. Bilateral cochlear implants in children: localization acuity measures with minimum audible angle. Ear Hear 2006; 27(1):43-59.
- Schoen F, Mueller J, Helms J et al. Sound localization and sensitivity to interaural cues in bilateral users of the Med-El Combi 40/40+ cochlear implant system. Otol Neurotol 2005; 26(3):429-37.
- Litovsky R, Parkinson A, Arcaroli J et al. Simultaneous bilateral cochlear implantation in adults: a multicenter clinical study. Ear Hear 2006; 27(6):714-31.
- Ricketts TA, Grantham DW, Ashmead DH et al. Speech recognition for unilateral and bilateral cochlear implant modes in the presence of uncorrelated noise sources. Ear Hear 2006; 27(6):763-73.
- Ramsden R, Greenham P, O’Driscoll M et al. Evaluation of bilaterally implanted adult subjects with the nucleus 24 cochlear implant system. Otol Neurotol 2005; 26(5):988-98.
- Kuhn-Inacker H, Shehata-Dieler W, Muller J et al. Bilateral cochlear implants: a way to optimize auditory perception abilities in deaf children? Int J Pediatr Otorhinolaryngol 2004; 68(10):1257-66.
- Scherf F, van Deun L, van Wieringen A et al. Hearing benefits of second-side cochlear implantation in two groups of children. Int J Pediatr Otorhinolaryngol 2007; 71(12):1855-63.
- Grantham DW, Ashmead DH, Ricketts TA et al. Horizontal-plane localization of noise and speech signals by postlingually deafened adults fitted with bilateral cochlear implants. Ear Hear 2007; 28(4):524-41.
- Galvin KL, Mok M, Dowell RC. Perceptual benefit and functional outcomes for children using sequential bilateral cochlear implants. Ear Hear 2007; 28(4):470-82.
- Buss E, Pillsbury HC, Buchman CA et al. Multicenter U.S. bilateral MED-EL cochlear implantation study: speech perception over the first year of use. Ear Hear 2008; 29(1):20-32.
- Luntz M, Yehudai N, Shpak T. Hearing progress and fluctuations in bimodal-binaural hearing users (unilateral cochlear implants and contralateral hearing aid). Acta Otolaryngol 2007; 127(10):1045-50.
|
Codes |
Number |
Description |
| CPT | 69930 | Cochlear device implantation, with or without mastoidectomy |
| 92507 | Treatment of speech, language, voice, communication, and/or auditory processing disorder | |
| 92510 | Aural rehabilitation following cochlear implant | |
| 92601 | Diagnostic analysis of cochlear implant, patient under 7 years of age; with programming | |
| 92602 | ; subsequent programming | |
| 92603 | Diagnostic analysis of cochlear implant, age 7 years or older; with programming | |
| 92604 | ; subsequent reprogramming | |
| 92605 | Evaluation for prescription of non-speech-generating augmentative and alternative communication device. | |
| 92606 | Therapeutic services for the use of non-speech-generating device, including programming and modification | |
| 92607 | Evaluation for prescription for speech-generating augmentative and alternative communication device, face-to-face with the patient; first hour | |
| 92608 | ; each additional 30 minutes | |
| 92609 | Therapeutic services for the use of speech generating device, including programming and modification | |
| 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 or replacement of cochlear prosthetic multiple-channel device | |
| ICD-9 Diagnosis | 389.10–389.18 | Sensorineural hearing loss code range Note: ICD-9 does not classify according to degree of hearing loss and/or deafness |
| HCPCS | L8614 | Cochlear device/system |
| L8615, L8616, L8617, L8618, L8619 | Code range for replacement components of cochlear implant device/system | |
| L8621, L8622, L8623, L8624 | Code range for replacement batteries used with cochlear implant device/system | |
| Type of Service | Surgery | |
| Place of Service | Inpatient | |
Index
Cochlear Implant
Implant, Cochlear
Policy History
| Date | Action | Reason |
| 12/01/95 | Add to Surgery section | New policy |
| 07/31/97 | Replace policy | Reviewed with changes; revised description |
| 11/01/98 | Replace policy | Policy reviewed; new devices added |
| 08/15/01 | Replace policy | Policy reviewed: new devices and FDA approval status added |
| 07/12/02 | Replace policy | Policy reviewed; new FDA-approved device added (Med El Combi 40+) |
| 12/18/02 | Replace policy | Update CPT code only |
| 12/17/03 | Replace policy | Policy reviewed by consensus without literature review; no changes in policy |
| 04/16/04 | Replace policy | Discussion of bilateral cochlear implants and its investigational status added |
| 06/27/05 | Replace policy | Literature review update for the period of 2004 through May 2005; policy statement unchanged |
| 04/25/06 | Replace policy | Literature review update for the period of May 2005 through March 2006; reference number 15 added. Policy statement unchanged. Code table updated. |
| 02/15/07 | Replace policy | Policy updated with literature review through December 2006. Policy statement changed to indicate bilateral cochlear implants are medically necessary. Reference numbers 16-26 added. |
| 04/17/07 | Replace policy – correction only | Policy statement on bilateral implants “is considered” corrected to “may be considered” |
| 04/09/08 | Replace policy | Policy updated with literature review; no changes in policy statements. Reference numbers 27 – 31 added. |
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