Download 7.01.05 Cochlear Implant

MEDICAL POLICY
POLICY
RELATED POLICIES
POLICY GUIDELINES
CODING
DESCRIPTION
SCOPE
BENEFIT APPLICATION
RATIONALE
REFERENCES
APPENDIX
HISTORY
Cochlear Implant
Number
7.01.05
Effective Date
May 1, 2017
Revision Date(s) 05/01/17; 01/01/17; 10/07/16; 10/01/16; 12/15/15; 07/14/15;
07/14/14; 08/12/13; 08/14/12; 08/09/11; 04/13/10; 05/13/08;
04/10/07; 08/08/06; 08/09/05; 07/13/04; 05/11/04; 05/13/03;
03/11/03; 10/08/02; 10/09/01; 01/04/99; 11/03/98; 01/97
Replaces
N/A
Policy
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Bilateral Hearing Loss
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 with bilateral severe to profound pre-lingual
or post-lingual sensorineural hearing loss (see Policy Guidelines) when the following criteria are met:
 The patient has a hearing threshold of pure-tone average (PTA) of 70 dB (decibels) hearing loss or
greater at 500 Hz (hertz), 1,000 Hz, and 2,000 Hz, AND
 The patient has tried standard hearing aids but had limited or no benefit from their use.
Unilateral Hearing Loss
Cochlear implantation as a treatment for patients with unilateral hearing loss, with or without tinnitus, is
considered investigational.
Upgrades
Upgrade of an existing internal and/or external cochlear system component is considered not medically
necessary when the current device is working.
Replacements
Replacement of an external cochlear component (speech controller or speech processor) may be considered
medically necessary only in a small subset of patients when:
 The processor is not working or broken and cannot be repaired or replaced under a manufacturer’s
warranty.
OR
 Replacement is needed because the patient’s condition has changed to the extent that the current
processor is inadequate and no longer meets the functional needs for activities of daily living, and
improvement is expected with a replacement device.
Hybrid Cochlear Implant/Hearing Aid
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 (eg, the Nucleus® Hybrid™ L24 Cochlear Implant
System) may be considered medically necessary for patients ages 18 years and older when ALL of the following
criteria are met:
 Bilateral severe-to-profound high-frequency sensorineural hearing loss with residual low-frequency
hearing sensitivity; AND
 Receive limited benefit from appropriately fit bilateral hearing aids; AND
 Have the following hearing thresholds:
o
Low-frequency hearing thresholds no poorer than 60 dB hearing level up to and including 500 Hz
(averaged over 125, 250, and 500 Hz) in the ear selected for implantation; AND
o
Severe to profound mid- to high-frequency hearing loss (threshold average of 2000, 3000, and
4000 Hz ≥75 dB hearing level) in the ear to be implanted; AND
o
Moderately severe to profound mid- to high-frequency hearing loss (threshold average of 2000,
3000, and 4000 Hz ≥60 dB hearing level) in the contralateral ear; AND
o
Aided consonant-nucleus-consonant word recognition score from 10% to 60% in the ear to be
implanted in the preoperative aided condition and in the contralateral ear will be equal to or
better than that of the ear to be implanted but not more than 80% correct.
Related Policies
[TOP]
1.01.528
Hearing Aids (Excludes Implantable Devices)
7.01.84
Semi-Implantable and Fully Implantable Middle Ear Hearing Aids
7.01.547
Implantable Bone Conduction and Bone-Anchored Hearing Aids
Policy Guidelines
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Limited benefit from hearing aids
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 to 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 of 50% or less correct on tape-recorded sets of
open-set sentence recognition in the ear to be implanted.
In children, limited benefit is defined as failure to develop basic auditory skills, and in older children, scores of
30% or less correct on open-set tests.
Bilateral cochlear implantation
Bilateral cochlear implantation (CI) should be considered only when it has been determined that the use of a
cochlear implantation in one ear plus a hearing aid in the opposite ear will not improve hearing in both ears (ie,
the hearing loss is considered severe to profound and a hearing aid will not deliver the required amplification of
sound).
Post- cochlear implantation rehabilitation
A post cochlear implant rehabilitation program is necessary to learn the skills to achieve benefit from the cochlear
implant. The rehabilitation program consists of 6 to 10 sessions that last approximately 2.5 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
Contraindications to cochlear implantation may include:
 Absence of cochlear development as demonstrated on a computed tomography (CT) scan
 Cochlear ossification, may prevent electrode insertion
 Deafness due to lesions of the eighth cranial (acoustic) nerve, central auditory pathway or brain stem
 Infections, active or chronic, of the external or middle ear; or mastoid cavity
 Tympanic membrane perforation.
Children less than 12 months of age
The cochlear device is FDA labeled only for use in children 12 months of age and older. In certain situations, offlabel use for CI may be considered before 12 months of age for severe bilateral hearing loss as defined in the
policy statement. Each request for CI for children less than 12 months of age should be reviewed on an individual
basis. One example situation is post-meningitis when cochlear ossification may prevent implantation. Another
example is in children with a strong family history of profound hearing impairment/loss, when establishing a
precise diagnosis is less uncertain. (See Rationale)
Reasonable Useful Life Expectancy for External Cochlear Implant Parts
Parts
Batteries - Disposable
Batteries - Rechargeable
External speech processor
Life Expectancy
60 hours (1-3 days)
1 year or more
3 years or longer
Headpieces/microphones
1-2 years
Comments
Replaced as needed
Many will last longer than 1 year
Manufacturer’s warranty is usually 3 years.
The component may last longer depending
on care & maintenance.
May last longer depending on care &
maintenance.
Adapted from Gift of Hearing Foundation (GOHF). http://www.giftofhearingfoundation.org/cochlear/FAQ.htm. Accessed April 2017.
Coding
69930
L8614
L8615
L8619
CPT
Cochlear device implantation, with or without mastoidectomy
HCPCS
Cochlear device, includes all internal and external components
Headset/headpiece for use with cochlear implant device, replacement
Cochlear implant external speech processor and controller, integrated system, replacement
Description
[TOP]
A cochlear implant is a device for treatment of severe-to-profound hearing loss in individuals who get only limited
benefit from sound 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 the deaf cochlea.
Background
The basic structure of a cochlear implant includes 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. The parts outside the ear send sounds to the parts implanted inside the 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.
Regulatory Status
Several cochlear implants are commercially available in the United States and are manufactured by Cochlear
Corp., Advanced Bionics, and the Med El Corp. Over the years, subsequent generations of the various
components of the devices have been approved by FDA, focusing on improved electrode design and speechprocessing 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
FDA for currently marketed implant devices are summarized in Table 1. FDA Product Code: MCM.
Table 1. Cochlear Implant Systemsa Approved by the Food and Drug Administration
Variables
Predicate
devices
Indications
Adults
Children
Manufacturer and Currently Marketed Cochlear Implants
Advanced Bionics®
Cochlear® Nucleus 5*
Med El® Maestro
HiResolution Bionic Ear System
(Sonata or Pulsar)
(HiRes 90K)
Clarion Multi-Strategy or HiFocus CII
Nucleus 22, 24, Freedom with
Combi 40+ (P000025)
Bionic Ear (P940022)
Contour (P840024)
 ≥18 y
 Postlingual onset of
severe to profound bilateral
sensorineural HL
(≥70 dB)
 Limited benefit from appropriately fitted
hearing aids, defined as scoring ≤50%
on a test of open-set HINT sentence
recognition
 12 mo to 17 y of age
 Profound bilateral sensorineural
deafness (>90 dB)
 Use of appropriately fitted hearing aids
for at least 6 mo in children 2-17y or at
least 3 mo in children 12-23 mo
 Lack of benefit in children <4 y defined
as a failure to reach developmentally
appropriate auditory milestones (eg,
spontaneous response to name in quiet
or to environmental sounds) measured
using IT-MAIS or MAIS or <20% correct
on a simple open-set word recognition
test (MLNT) administered using
monitored live voice (70 dB SPL)
 Lack of hearing aid benefit in children
>4 y defined as scoring <12% on a
difficult open-set word recognition test
(PBK test) or <30% on an open-set
sentence test (HINT for Children)
administered using recorded materials
in the soundfield (70 dB SPL)
 ≥18 y
 Pre-, peri-, or postlingual onset of
bilateral sensorineural HL, usually
characterized by:
o Moderate-to-profound hearing
loss in low frequencies; and
o Profound (≥90 dB HL) HL in midto-high speech frequencies
 Limited benefit from binaural
hearing aids (≤50% sentence
recognition in ear to be implanted)
25 mo to 17 y 11 mo
 Severe to profound bilateral
sensorineural HL
 MLNT scores ≤30% in best-aided
condition in children 25 mo to 4 y
11 mo
 LNT scores ≤30% in best-aided
condition in children
5 y to 17 y and 11 mo
12-24 mo
 Profound sensorineural HL
bilaterally
 Limited benefit from appropriate
binaural hearing aids
 ≥18 y
 Severe to profound
bilateral sensorineural
HL (≥70 dB)
 ≤40% correct HINT
sentences with
best-sided listening
condition
 12 mo to 18 y with
profound sensorineural HL (≥90 dB)
 In younger children,
little or no benefit is
defined by lack of
progress in the
development of simple
auditory skills with
hearing aids over a 3
to 6-mo period
 In older children, lack
of aided benefit is
defined as <20%
correct on the MLNT or
LNT, depending on
child’s cognitive ability
and linguistic skills
 A 3- to 6-mo trial with
hearing aids is
required if not
previously experienced
HINT: Hearing in Noise Test; HL: hearing loss; IT-MAIS: Infant-Toddler Meaningful Auditory Integration Scale; LNT: Lexical Neighborhood
Test; MAIS: Meaningful Auditory Integration Scale; MLNT: Multisyllabic Lexical Neighborhood Test; PBK: Phonetically Balanced-Kindergarten;
SPL: sound pressure level.
a
The external Nucleus 5 sound processor is not a part of the recall. Advanced Bionics HiRes90K was voluntarily recalled in November 2010
and given FDA-approval for reentry to market the device in September 2011. Cochlear Ltd. voluntarily recalled the Nucleus CI500 range in
September 2011 for device malfunction in the CI512 implant.
*The FDA website is the resource for the most up to date approvals of accessories and technology related to the Nucleus cochlear implant
system. (http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P970051S129). Accessed February 2017.
Hybrid Cochlear Implant System
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:
 Preoperative hearing in the range from normal to moderate hearing loss (HL) in the low frequencies
(thresholds no poorer than 60 dB HL up to and including 500 Hz).
 Preoperative hearing with severe to profound mid- to high-frequency hearing loss (threshold average of
2000, 3000, and 4000 Hz ≥75 dB HL) in the ear to be implanted.
 Preoperative hearing with moderately severe to profound mid- to high-frequency hearing loss (threshold
average of 2000, 3000, and 4000 Hz ≥60 dB HL) in the contralateral ear.
 Consonant-Nucleus-Consonant (CNC) word recognition score between 10% to 60% (inclusively) in the
ear to be implanted in the preoperative aided condition and in the contralateral ear equal to or better than
that of the ear to be implanted but not more than 80% correct.
Other hybrid hearing devices have been developed but do not have FDA approval, including the Med El® EAS
Hearing Implant System.
Bilateral Cochlear Implants
Although cochlear implants have typically been used unilaterally, interest in bilateral cochlear implantation has
arisen in recent years. The proposed benefits of bilateral cochlear implants are to improve understanding of
speech occurring in noisy environments and localization of sounds. Improvements in speech intelligibility with
bilateral cochlear implants may occur through binaural summation (ie, signal processing of sound input from 2
sides may provide a better representation of sound and allow the individual to separate noise from speech).
Speech intelligibility and localization of sound or spatial hearing may also be improved with head shadow and
squelch effects (ie, the ear that is closest to the noise will receive it at a different frequency and with different
intensity, allowing the individual 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 a
single processor may be used. However, no single processor for bilateral cochlear implantation has been
approved by 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.
Scope
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Medical policies are systematically developed guidelines that serve as a resource for Company staff when
determining coverage for specific medical procedures, drugs or devices. Coverage for medical services is subject
to the limits and conditions of the member benefit plan. Members and their providers should consult the member
benefit booklet or contact a customer service representative to determine whether there are any benefit limitations
applicable to this service or supply. This medical policy does not apply to Medicare Advantage.
Benefit Application
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Some facilities may negotiate a global fee for the implantation of the device and the associated auditory
rehabilitation. However, charges for rehabilitation services may be subject to individual contractual limitations.
A cochlear implant is a surgically implanted hearing device. The implanted receiver and electrode system device
and implantation surgery should be reimbursed under the medical benefit.
Hearing aids may be excluded by contract. See Scope.
Rationale
[TOP]
This policy was originally created in 1995 and was updated regularly with searches of the MEDLINE database.
The most recent literature search was performed through December 20, 2016. The following is a summary of the
key literature to date.
Cochlear Implantation for Bilateral Sensorineural Hearing Loss
Cochlear Implantation in Adults: Unilateral Stimulation
Cochlear implants are recognized as an effective treatment of sensorineural deafness, as noted in a 1995
National Institutes of Health Consensus Development conference, which offered the following conclusions(2):
 Cochlear implantation has a profound impact on hearing and speech reception in postlingually deafened
adults with positive impacts on psychological and social functioning.
 Pre-lingually deafened adults may also benefit, although to a lesser extent than post-lingually 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 post implant benefit.
The effectiveness of cochlear implants has been evaluated in several systematic reviews and technology
assessments, both from the United States and abroad. In 2009, Bond et al authored a technology assessment in
the United Kingdom to investigate the clinical and cost-effectiveness of unilateral cochlear implants (using or not
using hearing aids) and bilateral cochlear implants compared with a single cochlear implant (unilateral or
unilateral plus hearing aids) for severely to profoundly deaf children and adults.(3) The clinical effectiveness
review included 33 articles, 2 of which were randomized controlled trials (RCTs) (deaf children, n=1513; adults,
n=1379). They used 62 different outcome measures and overall evidence was of moderate to poor quality. (The
authors’ summary of the effectiveness of bilateral cochlear implants and cochlear implants in children are
summarized in the following appropriate sections.) The authors concluded, “Unilateral cochlear implantation is
safe and effective for adults and children and likely to be cost-effective in profoundly deaf adults and profoundly
and prelingually deaf children.”
Bond et al published 2 other systematic reviews on the clinical and cost-effectiveness of unilateral cochlear
implants, first focusing on children in 2009(4) and then adults in 2010(5) Both were conducted with a literature
review that identified 1580 titles and abstracts on cochlear implants. In the 2010 review, the authors identified 9
studies that met their inclusion criteria addressing implantation in adults(5); all were methodologically weak and
too heterogeneous to perform a meta-analysis. However, the authors concluded that there is sufficient, consistent
evidence demonstrating positive benefits with unilateral cochlear implants in severely to profoundly hearing
impaired adults when compared with acoustic hearing aids or no hearing support.
In January 2009, the National Institute for Health and Care Excellence (NICE) released technology appraisal
guidance 166, Cochlear Implants for Children and Adults With Severe to Profound Deafness.(6) This guidance
was based on this technology assessment report by Bond et al.(3)
The NICE guidance includes the following recommendations:
1. “Unilateral cochlear implantation is recommended as an option for people with severe to profound
deafness who do not receive adequate benefit from acoustic hearing aids…
2. For purposes of this guidance, severe to profound deafness is defined as hearing only sounds that are
louder than 90 dB HL [hearing level] at frequencies of 2 and 4 kHz without acoustic hearing aids.
Adequate benefit from acoustic hearing aids is defined for this guidance as: for adults, a score of 50% or
greater on Bamford-Kowal-Bench (BKB) sentence testing at a sound intensity of 70 dB SPL [sound
pressure level].
3. Cochlear implantation should be considered for adults only after an assessment by a multidisciplinary
team. As part of the assessment [implant candidates] should also have had a valid trial of an acoustic
hearing aid for at least 3 months (unless contraindicated or inappropriate).”
In April 2011, a technology assessment was completed by the Tufts Evidence-based Practice Center for the
Agency for Health Care Research and Quality (AHRQ) on the effectiveness of cochlear implants in adults.(7) This
assessment examined 22 studies with 30 or more patients and concluded that while the studies reviewed were
rated as poor to fair quality, unilateral cochlear implants are effective in adults with sensorineural hearing loss.
Pre- and post-cochlear implant scores on multisyllable tests and open-set sentence tests demonstrated significant
gains in speech perception whether or not a contralateral hearing aid was used along with the cochlear implant.
Additionally, the assessment found generic and disease-specific health-related quality of life (QOL) improved with
unilateral cochlear implants. However, the available evidence was insufficient to draw conclusions on
improvements in open-set sentence test scores (ie, >40% and ≤50% or >50% and ≤60%), and any relationship
between preimplantation patient characteristics and outcomes (eg, age, duration of hearing impairment, Hearing
in Noise Test [HINT] scores and pre- or post-linguistic deafness).
In 2013, Gaylor et al. published an update to the AHRQ technology assessment.(8) Sixteen (of 42) studies
published through May 2012 were of unilateral cochlear implants. Most unilateral implant studies showed a
statistically significant improvement in mean speech scores, as measured by open-set sentence or multisyllable
word tests; meta-analysis of 4 studies revealed a significant improvement in cochlear-implant relevant QOL after
unilateral implantation (standard mean difference, 1.71; 95% confidence interval [CI], 1.15 to 2.27). However,
these studies varied in design, and there was considerable heterogeneity observed across studies.(8) Similarly, a
2012 systematic review of 11 studies by Bittencourt et al also concluded cochlear implants improved hearing
outcomes over conventional hearing aids in patients with severe to profound postlingual deafness.(9)
In 2011, Berrettini et al. published results of a systematic review of cochlear implant effectiveness in adults.(10)
Included in the review were 8 articles on unilateral cochlear implants in advanced age patients. All of the studies
reported benefits with cochlear implantation, despite advanced age at time of implant (age 70 years or older). In 6
studies, results were not significantly different between younger and older patients. However, 2 studies reported
statistically significant inferior perceptive results (eg, HINT and consonant nucleus consonant test) in older
patients. This systematic review also examined 3 studies totaling 56 adults with prelingual deafness who received
unilateral cochlear implants. The authors concluded unilateral cochlear implants provided hearing and QOL
benefits in prelingually deaf patients, but results were variable.
Cochlear Implantation in Adults: Bilateral Stimulation
While use of unilateral cochlear implants in patients with severe to profound hearing loss has become a wellestablished intervention,(7) bilateral cochlear implantation is becoming more common. Many publications have
reported 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 a few decibels or percentage points.
The 2009 Bond et al. technology assessment on the clinical and cost-effectiveness of cochlear implants made the
following conclusions on the evidence related to bilateral cochlear implants in adults.(3) The strongest evidence
for an advantage from bilateral over unilateral implantation was for understanding speech in noisy conditions. The
comparison of bilateral with unilateral cochlear implants plus an acoustic hearing aid was limited by small sample
sizes and poor reporting. The authors concluded, “There are likely to be overall additional benefits from bilateral
implantation, enabling children and adults to hold conversations more easily in social situations.”
In 2009, the NICE technology appraisal guidance noted above(6) indicates:
1. “Simultaneous bilateral cochlear implantation in adults is recommended as an option for people with
severe to profound deafness who do not receive adequate benefit from acoustic hearing aids … [and] …
who are blind or who have other disabilities that increase their reliance on auditory stimuli as a primary
sensory mechanism for spatial awareness.
2. Sequential bilateral cochlear implantation is not recommended as an option for people with severe to
profound deafness.
3. For purposes of this guidance, severe to profound deafness is defined as hearing only sounds that are
louder than 90 dB HL at frequencies of 2 and 4 kHz without acoustic hearing aids. Adequate benefit from
acoustic hearing aids for adults is defined for this guidance as: for adults, a score of 50% or greater on
Bamford-Kowal-Bench (BKB) sentence testing at a sound intensity of 70 dB SPL.
4. Cochlear implantation should be considered for … adults only after an assessment by a multidisciplinary
team. As part of the assessment … [implant candidates] should also have had a valid trial of an acoustic
hearing aid for at least 3 months (unless contraindicated or inappropriate).”
Crathorne et al published an update of the NICE systematic review in 2012.(11) The objective was to evaluate the
clinical and cost-effectiveness of bilateral multichannel cochlear implants compared with unilateral cochlear
implantation alone or in conjunction with an acoustic hearing aid in adults with severe-to-profound hearing loss. A
literature search was updated through January 2012. Nineteen studies conducted in the United States and
Europe were included in this update; 6 had been included in the original NICE review. Two studies were RCTs
with waiting-list controls, 10 were prospective pre/post repeated-measure or cohort designs, 6 were crosssectional in design, and 1 was an economic evaluation. All studies compared bilateral with unilateral implantation,
and 2 compared bilateral implants with a unilateral implant plus acoustic hearing aid. The studies selected were of
moderate-to-poor quality, including the 2 RCTs. Meta-analyses could not be performed due to heterogeneity
between studies in outcome measures and study designs. However, all studies reported that bilateral cochlear
implants improved hearing and speech perception. One RCT found a significant binaural benefit over the first ear
alone for speech and noise from the front (12.6%, p<0.001) and when noise was ipsilateral to the first ear (21%,
p<0.001); another RCT found a significant benefit for spatial hearing at 3 months postimplantation compared with
preimplantation (mean difference, 1.46; p<0.01). QOL results varied, showing bilateral implantation might improve
QOL in the absence of worsening tinnitus.
Van Schoonhoven et al. independently published a systematic review in 2013 as an update to the original NICE
review.(12) As with the Crathorne review, all studies (N=19, published through March 2011) showed a significant
bilateral benefit in localization over unilateral cochlear implantation. Similarly, meta-analyses could not be
performed due to the heterogeneity of the studies and the level of evidence of the included studies, which was of
moderate-to-poor quality.(12)
The 2011 AHRQ technology assessment, noted earlier, completed by the Tufts Evidence-based Practice Center
on the effectiveness of cochlear implants in adults examined 16 studies on bilateral cochlear implantation of fairto-moderate quality published since 2004.(7) The assessment concluded bilateral cochlear implants provide
greater benefits in speech perception test scores, especially in noise, when compared with unilateral cochlear
implants (with or without contralateral hearing aids). Significant binaural head shadow benefits were noted along
with some benefit in binaural summation, binaural squelch effects, and sound localization with bilateral cochlear
implants. However, it was unclear if these benefits were experienced under quiet conditions, although benefits
increased with longer bilateral cochlear implant usage indicating a need for longer term studies. Hearing-specific
QOL could not be assessed because only 1 study evaluated this outcome. Additionally, the evidence available on
simultaneous bilateral implantation was found to be insufficient, although gains were experienced in speech
perception using open-set sentences or multisyllable tests compared with unilateral cochlear implants or unilateral
listening conditions. The assessment noted longer term studies are needed to further understand the benefits with
bilateral cochlear implantation and identify candidacy criteria given the risks of a second surgery and the
destruction of the cochlea preventing future medical intervention.
The update by Gaylor et al. to the assessment previously reported showed improvement across 13 studies in
communication-related outcomes with bilateral implantation compared with unilateral implantation and additional
improvements in sound localization compared with unilateral device use or implantation only.(8) The risk of bias
varied from medium to high across studies. Based on results from at least 2 studies, QOL outcomes varied across
tests after bilateral implantation; meta-analysis was not performed because of heterogeneity in design between
the studies.
In the 2011 Berrettini et al. review of cochlear implant effectiveness in adults (noted earlier), 13 articles on
bilateral cochlear implants were reviewed.(10) Sound localization improved with bilateral cochlear implants
compared with monaural hearing in 6 studies. Significant improvements in hearing in noise and in quiet
environments with bilateral implants compared with unilateral implants were reported in 10 studies and 7 studies,
respectively. Five of the studies reviewed addressed simultaneous implantation, 5 studies reviewed sequential
implantation, and 3 studies included a mix of simultaneous and sequential implantation. However, no studies
compared simultaneous with sequential bilateral implantation results, and no conclusions could be made on the
timing of bilateral cochlear implantation. Smulders et al. also examined the timing of bilateral cochlear
implantation in a systematic review of 11 studies; 5 studies addressed postlingually deafened adults and 7 studies
addressed prelingually deafened children (discussed next).(13) One study on adults showed a delay in the timing
of the second implantation resulted in poorer outcomes in quiet environments. Nevertheless, all studies reported
benefits with bilateral implants, but all studies were considered to be of poor quality and with a high risk of bias.
Since the publication of the systematic reviews described above, additional comparative studies (eg, Blamey et al
[2015])(14) and case series (eg, Harkonen et al [2015])(15) have reported on outcomes after bilateral cochlear
implantation. For example, in a 2016 prospective observational study including 113 patients with postlingual
hearing loss, of whom 50 were treated with cochlear implants and 63 with hearing aids, cochlear implant
recipients’ depression scores improved from preimplantation to 12 months posttreatment (Geriatric Depression
Scale score improvement, 31%; 95% CI, 10% to 47%).(16)
Cochlear Implantation in Pediatrics
Similar to the adult population, the evidence related to the use of cochlear implants in children has been
evaluated in several systematic reviews and technology assessments.
The 2009 Bond technology assessment on cochlear implants made the following observations regarding cochlear
implantation in children: All studies in children that compared 1 cochlear implant with nontechnologic support or
an acoustic hearing aid reported gains on all outcome measures.(3) Weak evidence showed greater gain from
earlier implantation (before starting school). The 2009 NICE guidance noted earlier,(6) included the following
recommendations for children:
1. “Unilateral cochlear implantation is recommended as an option for people with severe to profound
deafness who do not receive adequate benefit from acoustic hearing aids…
2. Simultaneous bilateral cochlear implantation is recommended as an option for … [children] with severe
to profound deafness who do not receive adequate benefit from acoustic hearing aids…
3. Sequential bilateral cochlear implantation is not recommended as an option for people with severe to
profound deafness.
4. For purposes of this guidance, severe to profound deafness is defined as hearing only sounds that are
louder than 90 dB HL at frequencies of 2 and 4 kHz without acoustic hearing aids. [For children,
adequate benefit from acoustic hearing aids is defined for this guidance as … speech, language and
listening skills appropriate to age, developmental stage, and cognitive ability.
5. Cochlear implantation should be considered for children only after an assessment by a multidisciplinary
team. As part of the assessment, children … should also have had a valid trial of an acoustic hearing aid
for at least 3 months (unless contraindicated or inappropriate).”
As also noted earlier, Bond et al published 2 systematic reviews on the clinical and cost-effectiveness of unilateral
cochlear implants, first focusing on children in 2009(4) and subsequently focusing on adults in 2010.(5) Both
reviews were conducted with a literature search that identified 1580 titles and abstracts on cochlear implants. In
the 2009 review, the authors identified 15 studies that met their inclusion criteria addressing cochlear implantation
in children.(4) The authors found the studies available were methodologically weak and too heterogeneous to
perform a meta-analysis. However, they concluded there is sufficient, consistent evidence demonstrating positive
benefits with unilateral cochlear implants in severely to profoundly hearing impaired children when compared with
acoustic hearing aids or no hearing support.
Cochlear Implant Timing in Pediatrics
The optimal timing of cochlear implantation in children is of particular interest given the strong associations
between hearing and language development. While there is current research investigating the ability to restore
hearing by stimulating cochlear hair cell regrowth, cochlear implantation damages the cochlea and eliminates this
possibility. However, the potential to restore cochlear function is not foreseeable in the near future. If cochlear
implantation is believed to be most beneficial at a younger age, when the nervous system is “plastic,” the potential
for cochlear hair cell regrowth seems too far in the future to benefit young children and should not be a deterrent
to current candidates for a cochlear implant. A number of studies have evaluated the effect of age of implantation
on hearing outcomes after cochlear implantation in children.
As reported by Sharma and Dorman, central auditory pathways are “maximally plastic” for a period of about 3.5
years, making a case for earlier cochlear implantation of children with hearing impairment.(17) Stimulation
delivered before about 3.5 years of age results in auditory evoked potentials that reach normal values in 3 to 6
months. However, when stimulation occurs after 7 years of age, changes occur within 1 month, but then have little
to no subsequent change. Sharma et al observed this result when they reported on auditory development in 23
children with unilateral or bilateral implants.(18) In 1 child who received a bilateral device with implantation of the
second ear after age 7 years, the auditory responses in the second ear were similar to that seen in “lateimplanted” children.
In 2011, Forli et al. conducted a systematic review of 49 studies on cochlear implant effectiveness in children that
addressed the impact of age of implantation on outcomes.(19) Heterogeneity of studies precluded performance of
a meta-analysis. Early implantation was examined in 22 studies, but few studies compared outcomes of
implantations performed before 1 year of age to implantations performed after 1 year of age. Studies suggest
improvements in hearing and communicative outcomes in children receiving implants before 1 year of age,
although it is not certain whether these improvements are related to duration of cochlear implant usage rather
than age of implantation. However, the reviewers noted hearing outcomes have been shown to be significantly
inferior in patients implanted after 24 to 36 months. Finally, 7 studies were reviewed that examined cochlear
implant outcomes in children with associated disabilities. In this population, cochlear implant outcomes were
inferior and occurred more slowly but were considered to be beneficial.
As previously noted, the 1995 National Institutes of Health Consensus Development conference concluded
cochlear implants are recognized as an effective treatment of sensorineural deafness.(2) This conference offered
the following conclusions regarding cochlear implantation in children:
 Cochlear implantation has variable results in children. Benefits are not realized immediately but rather
are manifested over time, with some children continuing to show improvement over several years.
 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.
Studies published since the above systematic reviews suggest that cochlear implant removal and reimplantation
(due to device malfunction or medical/surgical complications) in children is not associated with worsened hearing
outcomes.(20)
Specific Indications for Cochlear Implantation in Pediatrics
Several systematic reviews have evaluated outcomes after cochlear implantation for specific causes of deafness
and in subgroups of pediatric patients. In a 2011 systematic review of 38 studies, Black et al. sought to identify
prognostic factors for cochlear implantation in pediatric patients.(21) A quantitative meta-analysis was not able to
be performed due to study heterogeneity. However, the following 4 prognostic factors consistently influenced
hearing outcomes:
 age at implantation,
 inner ear malformations,
 meningitis,
 connexin 26 (a genetic cause of hearing loss).
Pakdaman et al conducted a systematic review of cochlear implants in children with cochleovestibular anomalies
in 2012.(22) Anomalies included inner ear dysplasia such as large vestibular aqueduct and anomalous facial
nerve anatomy. Twenty-two studies were reviewed (total N=311 patients). The authors found implantation surgery
was more difficult and speech perception was lower in patients with severe inner ear dysplasia. However,
heterogeneity in the studies limited interpretation of these findings.
In 2013, Eze et al published a systematic review comparing outcomes for cochlear implantation among children
with and without developmental disability.(23) The authors noted that while approximately 30% to 40% of children
who receive cochlear implants have developmental disability, evidence about outcomes in this group is limited.
Their review included 13 studies that compared receptive or expressive language outcomes in children with
cochlear implants with and without developmental disability. The included studies were heterogeneous in terms of
comparator groups and outcome measures, precluding data pooling and meta-analysis. In a structured systematic
review, the authors reported that 7 of the eligible studies demonstrated a significantly poor outcome with cochlear
implantation in children with developmental disability, while the remaining studies reported no significant
difference in outcomes between the 2 groups.
Auditory Neuropathy Spectrum Disorder
Humphriss et al. published a systematic review evaluating outcomes after cochlear implantation among pediatric
patients with auditory neuropathy spectrum disorder (ANSD), a sensorineural hearing disorder characterized by
abnormal auditory brainstem response with preserved cochlear hair cell function as measured by otoacoustic
emissions testing.(24) The authors identified 27 studies that included an evaluation of cochlear implantation in
patients with ANSD, including 15 noncomparative studies, 1 that compared children with ANSD who received a
cochlear implant with children with ANSD with hearing aids, and 12 that compared children with ANSD who
received a cochlear implant with children with severe sensorineural hearing loss who received a cochlear implant.
Noncomparative studies were limited in that most (11/15) did not include a measure of speech recognition before
cochlear implantation. Among the comparative studies, those comparing cochlear implantation to “usual care,”
typically a hearing aid, provide the most information about effectiveness of cochlear implantation among patients
with ANSD; the 1 small study that used this design found no significant differences between the groups. Overall,
the authors suggest that further RCT evidence is needed.
In a 2015 systematic review, Fernandes et al evaluated 18 published studies and 2 dissertations that reported
hearing performance outcomes for children with ANSD and cochlear implants.(25) Studies included 4
nonrandomized controlled studies considered high quality, 5 RCTs considered low quality, and 10 clinical
outcome studies. Most studies (n=14) compared the speech perception in children with ANSD and cochlear
implants with the speech perception in children with sensorineural hearing loss and cochlear implants. Most of
these studies concluded that children with ANSD and cochlear implants developed hearing skills similar to those
with sensorineural hearing loss and cochlear implants; however, these types of studies do not allow comparisons
of outcomes between ANSD patients treated with cochlear implants and those treated with usual care.
Cochlear Implantation in Infants Younger than 12 Months
While currently available cochlear implants have FDA labeling for only children older than 12 months, earlier
diagnosis of congenital hearing loss with universal hearing screening has prompted interest in cochlear
implantation in children younger than 12 months.
In 2010, Vlastarakos et al conducted a systematic review of studies on bilateral cochlear implantation in a total of
125 children implanted before age 1.(26) For this off-label indication, the authors noted follow-up times ranged
from a median duration of 6 to 12 months. While results seemed to indicate accelerated rates of improvement in
implanted infants, the evidence available is limited and of lower quality.
A number of small studies from outside the United States have reported results on cochlear implantation in infants
younger than 12 months old. For example, in a study from Australia, Ching et al (2009) published an interim
report on early language outcomes among 16 children implanted prior to 12 months of age, compared with 23
who were implanted after 12 months of age (specific timing implantation was not provided).(27) The results
demonstrated that children who received an implant before 12 months of age developed normal language skills at
a rate comparable with normal-hearing children, while those implanted later performed at 2 standard deviations
below normal. Reviewers noted that these results were preliminary, because there is a need to examine the effect
of multiple factors on language outcomes and the rate of language development. Similarly, in a study from Italy,
Colletti (2009) reported on findings from 13 infants who had implants placed before 12 months of age.(28) The
procedures were performed between 1998 and 2004. In this small study, the rate of receptive language growth for
these early-implant infants overlapped with scores of normal-hearing children. This overlap was not detected for
those implanted at 12 to 23 or 24 to 36 months of age. Subsequently, Colletti et al (2011) reported on 10-year
results among 19 infants with cochlear implants received between the ages of 2 and11 months (early implantation
group) compared with 21 children implanted between the ages of 12 and 23 months and 33 children implanted
between the ages of 24 and 35 months. (29) Within the first 6 months postimplantation, there were no significant
differences among groups in Category of Auditory Performance testing, but patients in the infant group had
greater improvements than older children at the 12-month and 36-month testing.
A more recent (2016) prospective study of 28 children with profound sensorineural hearing loss who were
implanted early with cochlear implants (mean age at device activation, 13.3 months) reported that these children
had social and conversational skills in the range of normal-hearing peers 1 year after device activation.(30)
Cochlear Implantation in Children: Bilateral Stimulation
In a 2014 systematic review, Lammers et al. summarized the evidence on the effectiveness of bilateral cochlear
implantation compared with unilateral implantation among children with sensorineural hearing loss.(31) The
authors identified 21 studies that evaluated bilateral cochlear implantation in children, with no RCTs identified.
Due to a limited number of studies, heterogeneity in outcomes and comparison groups and high risk for bias in
the studies, the authors were unable to perform pooled statistical analyses, so a best-evidence synthesis was
performed. The best-evidence synthesis demonstrated that there is consistent evidence indicating the benefit of
bilateral implantation for sound localization. One study demonstrated improvements in language development,
although other studies found no significant improvements. The authors noted that the currently available evidence
consists solely of cohort studies that compare a bilaterally implanted group with a unilaterally implanted control
group, with only 1 study providing a clear description of matching techniques to reduce bias.
In 2010, Sparreboom et al. conducted a systematic review of bilateral cochlear implants in children with severe-toprofound deafness.(32) Due to the heterogeneity of the studies identified, the authors were unable to perform a
meta-analysis. A qualitative review of the studies found binaural ability takes time to develop; bilateral cochlear
implants seem to provide better speech perception over unilateral implants; and delays in implanting the second
cochlear implant seem to decrease speech perception in quiet and decrease or eliminate the potential for binaural
summation. The author concluded while bilateral cochlear implants provide benefits of bilateral hearing in
children, further research is needed.
As noted, Smulders et al. examined the timing of sequential bilateral cochlear implantation in a systematic review
of 11 studies; 5 studies addressed postlingually deafened adults (previously discussed), and 7 studies addressed
prelingually deafened children.(13) Sound localization was not affected by second implantation delay in any study
of the studies on children, but delays in second implantation resulted in poorer outcomes in quiet environments in
1 study and poorer outcomes in noise in 2 studies. However, all studies were considered to be of poor quality and
with a high risk of bias.
Several publications not included in the Lammers and Sparreboom systematic reviews have evaluated bilateral
cochlear implants in children. These studies, ranging in size from 91 to 961 patients, generally report improved
speech outcomes with bilateral implantation, compared with unilateral implantation.(33-36) In another
retrospective case series of 73 children and adolescents who underwent sequential bilateral cochlear implantation
with a long (>5 year) interval between implants, performance on the second implanted side was worse than the
primary implanted side, with outcomes significantly associated with the interimplant interval.(37)
Section Summary
Multiple trials of cochlear implantation in patients with bilateral sensorineural hearing loss, although in varying
patient populations, have consistently demonstrated improvements in speech recognition in noise and improved
sound localization.
Cochlear Implantation for Unilateral Hearing Loss
As noted, a number of potential benefits to binaural hearing exist, including binaural summation, which allows
improved signal detection threshold, and sound localization. The potential benefits from binaural hearing have
prompted interest in cochlear implantation for patients with unilateral hearing loss.
Systematic Reviews
In 2014, Vlastarakos et al published a systematic review of the evidence related to cochlear implantation for
single-sided deafness and/or unilateral tinnitus.(38) The authors included 17 studies (total N=108 patients),
including prospective and retrospective comparative studies, case series, and case reports. The authors reported
that sound localization is improved after cochlear implantation, although statistical analysis was not included in
some of the relevant studies. In most patients (95%), unilateral tinnitus improved. The authors note that most of
the studies included had short follow-up times, and evaluation protocols and outcome measurements were
heterogeneous.
In 2015, van Zon et al. published another systematic review of studies evaluating cochlear implantation for singlesided deafness or asymmetric hearing loss.(39) The authors reviewed 15 studies, 9 of which (n=112 patients)
were considered high enough quality to be included in data review. The authors identified no high-quality studies
of cochlear implantation in this population. Data were not able to be pooled for meta-analysis due to high
between-study heterogeneity, but the authors conclude that studies generally report improvements in sound
localization, QOL scores, and tinnitus after cochlear implantation, with varying results for speech perception in
noise.
In 2014, Blasco and Redleaf published a systematic review and meta-analysis of studies evaluating cochlear
implantation for unilateral sudden deafness.(40) The review included 9 studies with a total of 36 patients. In
pooled analysis, subjective improvement in tinnitus occurred in 96% of patients (of 27 assessed), subjective
improvement in speech understanding occurred in 100% of patients (of 16 assessed), and subjective
improvement in sound localization occurred in 87% of patients (of 16 assessed). However, the small number of
patients in which each outcome was assessed limits conclusions that may be drawn.
Case Series
Several individual studies have reported on outcomes for cochlear implantation for single-sided deafness since
the publication of the systematic reviews described above.
The longest follow-up was reported by Mertens et al (2015), in a case series with structured interviews, including
23 individuals who received cochlear implants for single-sided deafness with tinnitus.(41) Eligible patients had
either single-sided deafness or asymmetric hearing loss and ipsilateral tinnitus. Subjects had a mean 8 years of
experience with their cochlear implant (range, 3-10 years). Tinnitus symptoms were assessed by structured
interview, visual analog scale (VAS), and the Tinnitus Questionnaire (TQ; a validated scale). Patients
demonstrated improvements in VAS score from baseline (mean score, 8) to 1 month (mean score: 4; p<0.01 vs
baseline) and 3 months (mean score, 3; p<0.01 vs baseline) after the first fitting. TQ scores improved from
baseline to 3 months post fitting (55 vs 31, p<0.05) and were stable for the remainder of follow-up.
In 2015, Arndt et al reported outcomes for 20 children who underwent cochlear implantation for single-sided
deafness, which represented a portion of their center’s cohort of 32 pediatric patients with single-sided deafness
who qualified for cochlear implants.(42) Repeated-measure analyses of hearing data sets were available for 13
implanted children, excluding 5 who had undergone surgery too recently to be evaluated and 2 children who were
too young to be evaluated for binaural hearing benefit. There was variability in the change in localization ability
across the tested children. Self- or child-reported hearing benefit was measured with the Speech, Spatial and
Qualities of Hearing Scale. Significant improvements were reported on the child and parent evaluations for the
scale’s total hearing score and 3 subcategories: speech hearing, spatial hearing, hearing quality.
In 2017, Sladen et al retrospectively reviewed prospectively collected data of short-term (6-month) follow-up for
23 adults and children with single-sided deafness from a variety of mechanisms who received a cochlear
implant.(43) In the implanted ear, CNC word recognition improved significantly from preimplantation to 3 months
postactivation (p=0.001). However, for AzBio sentence understanding in noise (+5 dB signal-to-noise), there was
no significant improvement from preimplantation to 6 months postactivation.
In a prospective repeated-measures cohort study that included 20 subjects with single-sided deafness implanted
with cochlear implants (15 of whom had reached 6-month follow-up), Sladen et al (2016) reported on speech
recognition and QOL.(44) Pure-tone audiometry improved with air conduction in the implanted ear. CNC scores in
quiet improved from 4.8% in the preoperative period to 42.3% at the 6-month postactivation check in patients who
reached that follow-up.
Also in 2016, Rahne et al reported on a retrospective review of 4 children and 17 adults with single-sided
deafness treated with cochlear implants and followed for 12 months.(45) Sound localization with aided hearing
improved from preimplantation for all individuals. The speech recognition threshold in noise (signal-to-noise) ratio
improved from -1.95 dB (CI off, SD=2.7 dB) to -4.0 dB after 3 months (SD=1.3 dB; p<0.05), with continued
improvements through 6 months.
Earlier, smaller studies, such as those reported by Arndt et al (2011)(46) with 11 adult patients, and by Hansen et
al (2013)(47) with 29 patients, reported improvements in hearing ability compared with baseline for implanted
subjects.
Cochlear Implant for Tinnitus Relief in Patients With Unilateral Deafness
The application of cochlear implants for tinnitus relief in patients with unilateral deafness has also been described.
Studies of cochlear implants in patients with bilateral hearing loss, which is often associated with tinnitus, have
reported improvements in tinnitus. For example, van Zon et al (2016) reported on a prospective study focusing on
tinnitus perception conducted as a part of a multicenter RCT comparing unilateral with bilateral cochlear
implantation in patients with severe bilateral sensorineural hearing loss.(48) This analysis included 38 adults
enrolled from 2010-2012 and randomized to simultaneous bilateral or unilateral cochlear implants. At 1 year
postimplantation, both unilaterally and bilaterally implanted patients had significant decreases in score on the
Tinnitus Handicap Inventory (THI; a validated scale): change in score of 8 to 2 (p=0.03) and from 22 to 12
(p=0.04) for unilaterally and bilaterally implanted patients, respectively. Bilaterally implanted patients had a
significant decrease in TQ: change in score of 20 to 9 (p=0.04).
Based on observations about tinnitus improvement with cochlear implants, several studies have reported on
improvements in tinnitus after cochlear implantation in individuals with unilateral hearing loss. In the meta-analysis
by Vlastarakos et al (2014) described above, for example, unilateral tinnitus improved in most patients (95%).(38)
Ramos Macias et al (2015) reported results of a prospective multicenter study with repeated measures related to
tinnitus, hearing, and QOL, among 16 individuals with unilateral hearing loss and severe tinnitus who underwent
cochlear implantation.(49) All patients had a severe tinnitus handicap (THI score ≥58%). Eight (62%) of the 13
patients who completed the 6-month follow-up visit reported a lower tinnitus handicap on the THI score. Perceived
loudness/annoyingness of the tinnitus was evaluated with a 10-point VAS. When the cochlear implant was on,
tinnitus loudness decreased from 8.4 preoperatively to 2.6 at the 6-month follow-up; 11 of 13 patients reported a
change in score of 3 or more.
Van de Heyning et al published a study in 2008 of 21 patients with unilateral hearing loss accompanied by severe
tinnitus for at least 2 years. Patients underwent cochlear implants at a university center in Belgium.(50) Three (of
21) patients showed complete tinnitus relief, whereas most demonstrated a significant reduction in tinnitus
loudness based on a VAS (2 years after implantation, 2.5; before implantation, 8.5).
Tavora-Vieira et al reported results of a prospective case series that included 9 postlingually deaf subjects with
unilateral hearing loss, with or without tinnitus in the ipsilateral ear, with functional hearing in the contralateral ear,
who underwent cochlear implantation.(51) Speech perception was improved for all subjects in the “cochlear
implant on” state compared with the “cochlear implant off” state, and subjects with tinnitus generally reported
improvement.
Section Summary
The available evidence for the use of cochlear implants in improving outcomes for patients with unilateral hearing
loss, with or without tinnitus, is limited by small sample sizes, short follow-up times and heterogeneity in
evaluation protocols and outcome measurements.
Hybrid Cochlear Implantation
A concern about traditional cochlear implants is that the implantation process typically destroys any residual
hearing, particularly for hearing in the low-frequency ranges. Newer devices have used a shorter cochlear
electrode in combination with a hearing aid-like amplification device to attempt to mitigate the damage to the
cochlea and permit residual hearing.
In March 2014, FDA approved Nucleus® Hybrid™ L24 Cochlear Implant System for use through the premarket
approval process. According to FDA’s Summary of Safety and Effectiveness Data, the approval was based on 2
clinical studies conducted outside of the United States and 1 pivotal study of the Hybrid L24 device conducted
under investigational device exemption.(1)
The pivotal trial was a prospective, multicenter, 1-arm, nonrandomized, nonblinded, repeated-measures clinical
study among 50 subjects at 10 U.S. sites. Results were reported in FDA documentation and in peer-reviewed
form by Roland et al (2016).(52) Eligible patients were selected based on having severe high-frequency
sensorineural hearing loss (≥70 dB hearing level averaged over 2000, 3000, and 4000 Hz) with relatively good
low-frequency hearing (≤60 dB hearing level averaged over 125, 250, and 500 Hz) in the ear selected for
implantation.
Performance was compared pre- and postimplant within each subject; outcomes were measured at 3, 6, and 12
months postoperatively. The study tested 2 coprimary efficacy hypotheses: (1) that outcomes on CNC, a measure
of word recognition and (2) AzBio sentences in noise presented through the hybrid implant system would be
better at 6 months postimplantation than preoperative performance using a hearing aid.
All 50 subjects enrolled underwent device implantation and activation. One subject had the device explanted and
replaced with a standard cochlear implant between the 3- and 6-month follow-up visits due to profound loss of
low-frequency hearing; an additional subject was explanted before the 12-month follow-up visit, and 2 additional
subjects were explanted after 12 months. For the 2 primary effectiveness end points, CNC word-recognition score
and AzBio sentence-in-noise score, there were significant within-subject improvements from baseline to 6-month
follow-up. The mean improvement in CNC word score was 35.8% (95% CI, 27.8% to 43.6%); for AzBio score, the
mean improvement was 32.0% (95% CI, 23.6% to 40.4%) For safety outcomes, 65 adverse events were reported,
most commonly profound/total loss of hearing (occurring in 44% of subjects) with at least 1 adverse event
occurring in 34 subjects (68%).
Lenarz et al. reported results of a prospective multicenter European study evaluating the Nucleus Hybrid™ L24
system.(53) The study enrolled 66 adults with bilateral severe-to-profound high-frequency hearing loss. At 1 year
postoperatively, 65% of subjects had significant gains in speech recognition in quiet, and 73% had significant
gains in noisy environments. Compared with the cochlear implant hearing alone, residual hearing significantly
increased speech recognition scores.
Hearing Benefit With Shorter Cochlear Array
The Nucleus Hybrid L24 system was designed with a shorter cochlear implant with the intent of preserving lowfrequency hearing. A potentially relevant question is whether a shorter implant is associated with differences in
outcomes, although studies addressing this question do not directly provide evidence about hybrid implants
themselves. Gifford et al compared hearing outcomes pre- and postimplantation for 44 adult cochlear implant
recipients with preserved low-frequency hearing in 2 test conditions: cochlear implant plus low-frequency hearing
in the contralateral plus low-frequency hearing in the contralateral ear (bimodal condition) and cochlear implant
plus low-frequency hearing in both ears (best-aided condition).(54) They reported that there were small but
statistically significant differences in improvements in adaptive sentence recognition and speech recognition in a
noisy “restaurant” environment, suggesting that the presence of residual hearing is beneficial.
In 2014, Santa Maria et al published a meta-analysis of hearing outcomes after various types of hearingpreservation cochlear implantation, which included implantation of hybrid devices, cochlear implantation with
surgical techniques designed to preserve hearing, and the use of postoperative systemic steroids.(55) The study
included 24 studies, but only 2 focused specifically on a hybrid cochlear implant system, and no specific benefit
from a hybrid system was reported.
Causon et al (2015) evaluated factors associated with cochlear implant outcomes in a meta-analysis of articles
published from 2003 to 2013, which reported on pure tone audiometry measurements pre- and post-cochlear
implantation.(56) Twelve studies with available audiometric data (total N=200 patients) were included. The
authors applied a formula to attempt to standardize degree of hearing preservation after cochlear implant,
described as the HEARRING consensus statement formula, which calculates a percentage of hearing
preservation at a specific frequency band, which is scaled to the preoperative audiogram by dividing the change
in hearing by the difference between the maximum measurable threshold and the preoperative hearing threshold.
The association of a variety of patient- and surgery-related factors, including insertion depth, and improvement in
low-frequency hearing were evaluated. In this analysis, insertion depth was not significantly associated with lowfrequency residual hearing.
In a retrospective review that included 10 subjects implanted with a cochlear implant with either a standard
electrode (n=12) or the Nucleus Hybrid L24 electrode (n=10), loss of acoustic hearing to the severe-profound
level occurred in a higher proportion of patients who received a standard electrode (58% vs 30%).(57)
Since the publication of the Santa Maria and Causon studies, which evaluated factors associated with cochlear
implant outcomes, additional studies have attempted to evaluate whether shorter cochlear arrays are more likely
to preserve hearing.
Section Summary
Prospective and retrospective studies using a single-arm, within-subjects comparison pre- and postintervention
suggest that a hybrid cochlear implant system is associated with improvements in hearing of speech in quiet and
noise. For patients who have high-frequency hearing loss but preserved low-frequency hearing, the available
evidence suggests that a hybrid cochlear implant improves speech recognition better than a hearing aid alone.
Some studies have suggested that a shorter cochlear implant insertion depth may be associated with preserved
residual low-frequency hearing, although there is uncertainty about the potential need for reoperation following a
hybrid cochlear implantation if there is loss of residual hearing.
Summary of Evidence
For individuals who have bilateral sensorineural hearing loss who receive cochlear implant(s), the evidence
includes randomized controlled trials (RCTs) and multiple systematic reviews and technology assessments.
Relevant outcomes are symptoms, functional outcomes, and treatment-related mortality and morbidity. The
available studies have reported improvements in speech reception and quality-of-life measures. And, although the
available RCTs and other studies measured heterogeneous outcomes and included varying patient populations,
the findings are consistent across multiple studies and settings. In addition to consistent improvement in speech
reception (especially in noise), studies showed improvements in sound localization with bilateral devices. Studies
have also suggested that earlier implantation may be preferred. The evidence is sufficient to determine
qualitatively that the technology results in a meaningful improvement in the net health outcome.
For individuals who have unilateral sensorineural hearing loss who receive cochlear implant(s), the evidence
includes prospective and retrospective studies reporting within-subjects comparisons and systematic reviews of
these studies. Relevant outcomes are symptoms, functional outcomes, and treatment-related mortality and
morbidity. Given the natural history of hearing loss, pre- and postimplantation comparisons may be appropriate for
objectively measured outcomes. However, the available evidence for the use of cochlear implants in improving
outcomes for patients with unilateral hearing loss, with or without tinnitus, is limited by small sample sizes, short
follow-up times, and heterogeneity in evaluation protocols and outcome measurements. The evidence is
insufficient to determine the effects of the technology on health outcomes.
For individuals who have high-frequency sensorineural hearing loss with preserved low-frequency hearing who
receive a hybrid cochlear implant that includes a hearing aid integrated into the external sound processor, the
evidence includes prospective and retrospective studies using single-arm, within-subjects comparison pre- and
postintervention and systematic reviews. Relevant outcomes are symptoms, functional outcomes, and treatmentrelated mortality and morbidity. The available evidence has suggested that a hybrid cochlear implant system is
associated with improvements in hearing of speech in quiet and noise. The available evidence has also
suggested that a hybrid cochlear implant improves speech recognition better than a hearing aid alone. Some
studies have suggested that a shorter cochlear implant insertion depth may be associated with preserved residual
low-frequency hearing, although there is uncertainty about the potential need for reoperation after a hybrid
cochlear implantation if there is loss of residual hearing. The evidence is insufficient to determine the effects of
the technology on health outcomes.
Ongoing and Unpublished Clinical Trials
Some currently unpublished trials that might influence this policy are listed in Table 2.
Table 2. Summary of Key Trials
NCT No.
Ongoing
NCT02204618
NCT00960102
NCT02075229
NCT02203305
Unpublished
NCT01256229
Trial Name
Planned
Enrollment
Completion
Date
Cochlear Implantation in Single Sided Deafness and Asymmetrical
Hearing Loss: a Cost/Utility Study
Children's Bilateral Cochlear Implantation in Finland: a Prospective,
Controlled, Multicenter Study (FinBiCI)
A Proposal to Evaluate Revised Indications for Cochlear Implant
Candidacy for the Adult CMS Population
Cochlear Implantation in Cases of Single-Sided Deafness
150
Aug 2017
40
Dec 2017
90
Jun 2018
(ongoing)
Dec 2018
Outcomes in Children With Developmental Delay and Deafness: A
Prospective, Randomized Trial
303
30
Sep 2016
(completed)
NCT: national clinical trial.
Clinical Input Received through Physician Specialty Societies and Academic Medical
Centers
While the various physician specialty societies and academic medical centers may collaborate with and make
recommendations during this process, through the provision of appropriate reviewers, input received does not
represent an endorsement or position statement by the physician specialty societies or academic medical centers,
unless otherwise noted.
2016 Input
In response to requests, input was received from 2 specialty societies, one of which provided 4 responses and
one of which provided 3 responses, and 3 academic medical centers while this policy was under review in 2016.
Clinical input focused on the use of hybrid cochlear implants. Input was consistent that the use of a hybrid
cochlear implant/hearing aid device that includes the hearing aid integrated into the external sound processor of
the cochlear implant improves outcomes for patients with high-frequency hearing loss but preserved lowfrequency hearing.
2010 Input
In response to requests, input was received from 2 physician specialty societies and 4 academic medical centers
while this policy was under review in 2010. In addition, unsolicited input was received from a specialty society.
Most of those providing input supported the use of cochlear implants in infants younger than 12 months of age;
many of those supporting this use noted that there are major issues determining hearing level in infants of this
age group, and others commented that use could be considered in these young infants in certain situations only.
Those providing input were divided in their comments regarding the medical necessity of upgrading functioning
external systems; some agreed with this and others did not.
Practice Guidelines and Position Statements
The American Academy of Otolaryngology-Head and Neck Surgery
The American Academy of Otolaryngology-Head and Neck Surgery has a position statement on cochlear implants
that was revised in 2014. The Academy “considers unilateral and bilateral cochlear implantation as appropriate
treatment for adults and children with severe to profound hearing loss. Based on extensive literature
demonstrating that clinically selected adults and children can significantly perform better with two cochlear
implants rather than one, bilateral cochlear implantation is accepted medical practice.”(58)
Agency for Health Care Research and Quality
In April 2011, a technology assessment for the Agency for Health Care Research and Quality (AHRQ) on the
effectiveness of cochlear implants in adults.(7) The assessment conclusions are noted within the body of this
policy.
National Institute for Health and Care Excellence
In January 2009, the National Institute for Health and Care Excellence (NICE) released technology appraisal
guidance 166, Cochlear Implants for Children and Adults With Severe to Profound Deafness, which includes
recommendations for use of unilateral and bilateral cochlear implants in children and adults as noted within the
body of this policy.(6)
National Institutes of Health
Cochlear implants are recognized as an effective treatment of sensorineural deafness, as noted in a 1995
National Institutes of Health (NIH) Consensus Development conference, which offered the following conclusions
(2):
 Cochlear implantation has a profound impact on hearing and speech reception in post-lingual deafened
adults with positive impacts on psychological and social functioning.
 Pre-lingual deafened adults may also benefit, although to a lesser extent than post-lingual 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 post-implant benefit.
The conference offered the following conclusions regarding cochlear implantation in children:
 Cochlear implantation has variable results in children. Benefits are not realized immediately but rather
are manifested over time, with some children continuing to show improvement over several years.
 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 post meningitis 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.
U.S. Preventive Services Task Force Recommendations
Not applicable.
Medicare National Coverage
Existing national coverage states(59):
“…cochlear implantation may be covered for treatment of bilateral pre- or-post-linguistic, sensorineural,
moderate-to-profound hearing loss in individuals who demonstrate limited benefit from amplification” which
“is defined by test scores of less than or equal to 40% correct in the best-aided listening condition on taperecorded tests of open-set sentence cognition.”
Coverage for cochlear implants may also be provided when the patient has
“hearing test scores of greater than 40% and less than or equal to 60% only when the provider is
participating in, and patients are enrolled in, either an FDA-approved category B investigational device
exemption clinical trial as defined at 42 CFR 405.201, a trial under the Centers for Medicare & Medicaid
(CMS) Clinical Trial Policy as defined at section 310.1 of the National Coverage Determinations Manual, or a
prospective, controlled comparative trial approved by CMS as consistent with the evidentiary requirements
for National Coverage Analyses and meeting specific quality standards.”
References
[TOP]
1. Food and Drug Administration. Approval Letter: Nucleus Hybrid L24 Cochlear Implant System -P130016. 2014; http://www.accessdata.fda.gov/cdrh_docs/pdf13/P130016a.pdf. Accessed April 2017.
2. Cochlear Implants in Adults and Children. NIH Consensus Statement Online 1995 May 15-17;13 (2):1-30
(Archived); http://consensus.nih.gov/1995/1995CochlearImplants100html.htm. Accessed April 2017.
3. Bond M, Mealing S, Anderson R, et al. The effectiveness and cost-effectiveness of cochlear implants for
severe to profound deafness in children and adults: a systematic review and economic model. Health
Technol Assess. Sep 2009;13(44):1-330. PMID 19799825
4. Bond M, Elston J, Mealing S, et al. Effectiveness of multi-channel unilateral cochlear implants for
profoundly deaf children: a systematic review. Clin Otolaryngol. Jun 2009;34(3):199-211. PMID
19531168
5. Bond M, Elston J, Mealing S, et al. Systematic reviews of the effectiveness and cost-effectiveness of
multi-channel unilateral cochlear implants for adults. Clin Otolaryngol. Apr 2010;35(2):87-96. PMID
20500577
6. National Institute for Health and Care Excellence (NICE). Cochlear Implants for Children and Adults With
Severe to Profound Deafness [TA166]. 1999 January; http://www.nice.org.uk/TA166. Accessed April
2017.
7. Raman G, Lee J, Chung M, et al. Effectiveness of Cochlear Implants in Adults with Sensorineural
Hearing Loss. Technology Assessment Report. 2011 April;
http://www.cms.gov/Medicare/Coverage/DeterminationProcess/downloads/id80TA.pdf. Accessed April
2017.
8. Gaylor JM, Raman G, Chung M, et al. Cochlear implantation in adults: a systematic review and metaanalysis. JAMA Otolaryngol Head Neck Surg. Mar 2013;139(3):265-272. PMID 23429927
9. Bittencourt AG, Ikari LS, Della Torre AA, et al. Post-lingual deafness: benefits of cochlear implants vs.
conventional hearing aids. Braz J Otorhinolaryngol. Apr 2012;78(2):124-127. PMID 22499380
10. Berrettini S, Baggiani A, Bruschini L, et al. Systematic review of the literature on the clinical effectiveness
of the cochlear implant procedure in adult patients. Acta Otorhinolaryngol Ital. Oct 2011;31(5):299-310.
PMID 22287821
11. Crathorne L, Bond M, Cooper C, et al. A systematic review of the effectiveness and cost-effectiveness of
bilateral multichannel cochlear implants in adults with severe-to-profound hearing loss. Clin Otolaryngol.
Oct 2012;37(5):342-354. PMID 22928754
12. van Schoonhoven J, Sparreboom M, van Zanten BG, et al. The effectiveness of bilateral cochlear
implants for severe-to-profound deafness in adults: a systematic review. Otol Neurotol. Feb
2013;34(2):190-198. PMID 23444466
13. Smulders YE, Rinia AB, Rovers MM, et al. What is the effect of time between sequential cochlear
implantations on hearing in adults and children? A systematic review of the literature. Laryngoscope. Sep
2011;121(9):1942-1949. PMID 22024849
14. Blamey PJ, Maat B, Baskent D, et al. A retrospective multicenter study comparing speech perception
outcomes for bilateral implantation and bimodal rehabilitation. Ear Hear. Jul-Aug 2015;36(4):408-416.
PMID 25695925
15. Harkonen K, Kivekas I, Rautiainen M, et al. Sequential bilateral cochlear implantation improves working
performance, quality of life, and quality of hearing. Acta Otolaryngol. May 2015;135(5):440-446. PMID
25677966
16. Choi JS, Betz J, Li L, et al. Association of using hearing aids or cochlear implants with changes in
depressive symptoms in older adults. JAMA Otolaryngol Head Neck Surg. Jul 01 2016;142(7):652-657.
PMID 27258813
17. Sharma A, Dorman MF. Central auditory development in children with cochlear implants: clinical
implications. Adv Otorhinolaryngol. 2006;64:66-88. PMID 16891837
18. 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. May 2005;203(1-2):134-143. PMID
15855038
19. Forli F, Arslan E, Bellelli S, et al. Systematic review of the literature on the clinical effectiveness of the
cochlear implant procedure in paediatric patients. Acta Otorhinolaryngol Ital. Oct 2011;31(5):281-298.
PMID 22287820
20. Sterkers F, Merklen F, Piron JP, et al. Outcomes after cochlear reimplantation in children. Int J Pediatr
Otorhinolaryngol. Jun 2015;79(6):840-843. PMID 25843784
21. Black J, Hickson L, Black B, et al. Prognostic indicators in paediatric cochlear implant surgery: a
systematic literature review. Cochlear Implants Int. May 2011;12(2):67-93. PMID 21756501
22. Pakdaman MN, Herrmann BS, Curtin HD, et al. Cochlear implantation in children with anomalous
cochleovestibular anatomy: a systematic review. Otolaryngol Head Neck Surg. Feb 2012;146(2):180190. PMID 22140206
23. Eze N, Ofo E, Jiang D, et al. Systematic review of cochlear implantation in children with developmental
disability. Otol Neurotol. Oct 2013;34(8):1385-1393. PMID 24005167
24. Humphriss R, Hall A, Maddocks J, et al. Does cochlear implantation improve speech recognition in
children with auditory neuropathy spectrum disorder? A systematic review. Int J Audiol. Jul
2013;52(7):442-454. PMID 23705807
25. Fernandes NF, Morettin M, Yamaguti EH, et al. Performance of hearing skills in children with auditory
neuropathy spectrum disorder using cochlear implant: a systematic review. Braz J Otorhinolaryngol. JanFeb 2015;81(1):85-96. PMID 25458263
26. Vlastarakos PV, Proikas K, Papacharalampous G, et al. Cochlear implantation under the first year of
age--the outcomes. A critical systematic review and meta-analysis. Int J Pediatr Otorhinolaryngol. Feb
2010;74(2):119-126. PMID 19896223
27. Ching TY, Dillon H, Day J, et al. Early language outcomes of children with cochlear implants: interim
findings of the NAL study on longitudinal outcomes of children with hearing impairment. Cochlear
Implants Int. 2009;10 Suppl 1:28-32. PMID 19067433
28. Colletti L. Long-term follow-up of infants (4-11 months) fitted with cochlear implants. Acta Otolaryngol.
Apr 2009;129(4):361-366. PMID 19153846
29. Colletti L, Mandala M, Zoccante L, et al. Infants versus older children fitted with cochlear implants:
performance over 10 years. Int J Pediatr Otorhinolaryngol. Apr 2011;75(4):504-509. PMID 21277638
30. Guerzoni L, Murri A, Fabrizi E, et al. Social conversational skills development in early implanted children.
Laryngoscope. Sep 2016;126(9):2098-2105. PMID 26649815
31. Lammers MJ, van der Heijden GJ, Pourier VE, et al. Bilateral cochlear implantation in children: a
systematic review and best-evidence synthesis. Laryngoscope. Jul 2014;124(7):1694-1699. PMID
24390811
32. Sparreboom M, van Schoonhoven J, van Zanten BG, et al. The effectiveness of bilateral cochlear
implants for severe-to-profound deafness in children: a systematic review. Otol Neurotol. Sep
2010;31(7):1062-1071. PMID 20601922
33. Broomfield SJ, Murphy J, Emmett S, et al. Results of a prospective surgical audit of bilateral paediatric
cochlear implantation in the UK. Cochlear Implants Int. Nov 2013;14 Suppl 4:S19-21. PMID 24533758
34. Sarant J, Harris D, Bennet L, et al. Bilateral versus unilateral cochlear implants in children: a study of
spoken language outcomes. Ear Hear. Jul-Aug 2014;35(4):396-409. PMID 24557003
35. Escorihuela Garcia V, Pitarch Ribas MI, Llopez Carratala I, et al. Comparative study between unilateral
and bilateral cochlear implantation in children of 1 and 2 years of age. Acta Otorrinolaringol Esp. Nov 26
2015. PMID 26632253
36. Friedmann DR, Green J, Fang Y, et al. Sequential bilateral cochlear implantation in the adolescent
population. Laryngoscope. Aug 2015;125(8):1952-1958. PMID 25946482
37. Illg A, Giourgas A, Kral A, et al. Speech comprehension in children and adolescents after sequential
bilateral cochlear implantation with long interimplant interval. Otol Neurotol. Jun 2013;34(4):682-689.
PMID 23640090
38. Vlastarakos PV, Nazos K, Tavoulari EF, et al. Cochlear implantation for single-sided deafness: the
39.
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54.
55.
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58.
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60.
outcomes. An evidence-based approach. Eur Arch Otorhinolaryngol. Aug 2014;271(8):2119-2126. PMID
24096818
van Zon A, Peters JP, Stegeman I, et al. Cochlear implantation for patients with single-sided deafness or
asymmetrical hearing loss: a systematic review of the evidence. Otol Neurotol. Feb 2015;36(2):209-219.
PMID 25502451
Blasco MA, Redleaf MI. Cochlear implantation in unilateral sudden deafness improves tinnitus and
speech comprehension: meta-analysis and systematic review. Otol Neurotol. Sep 2014;35(8):1426-1432.
PMID 24786540
Mertens G, De Bodt M, Van de Heyning P. Cochlear implantation as a long-term treatment for ipsilateral
incapacitating tinnitus in subjects with unilateral hearing loss up to 10 years. Hear Res. Oct 15
2015;331:1-6. PMID 26433053
Arndt S, Prosse S, Laszig R, et al. Cochlear implantation in children with single-sided deafness: does
aetiology and duration of deafness matter? Audiol Neurootol. 2015;20 Suppl 1:21-30. PMID 25999052
Sladen DP, Frisch CD, Carlson ML, et al. Cochlear implantation for single-sided deafness: A multicenter
study. Laryngoscope. Jan 2017;127(1):223-228. PMID 27346874
Sladen DP, Carlson ML, Dowling BP, et al. Early outcomes after cochlear implantation for adults and
children with unilateral hearing loss. Laryngoscope. Oct 12 2016. PMID 27730647
Rahne T, Plontke SK. Functional Result After Cochlear Implantation in Children and Adults With Singlesided Deafness. Otol Neurotol. Oct 2016;37(9):e332-340. PMID 27631656
Arndt S, Aschendorff A, Laszig R, et al. Comparison of pseudobinaural hearing to real binaural hearing
rehabilitation after cochlear implantation in patients with unilateral deafness and tinnitus. Otol Neurotol.
Jan 2011;32(1):39-47. PMID 21068690
Hansen MR, Gantz BJ, Dunn C. Outcomes after cochlear implantation for patients with single-sided
deafness, including those with recalcitrant Meniere's disease. Otol Neurotol. Dec 2013;34(9):1681-1687.
PMID 24232066
van Zon A, Smulders YE, Ramakers GG, et al. Effect of unilateral and simultaneous bilateral cochlear
implantation on tinnitus: a prospective study. Laryngoscope. Apr 2016;126(4):956-961. PMID 26255618
Ramos Macias A, Falcon Gonzalez JC, Manrique M, et al. Cochlear implants as a treatment option for
unilateral hearing loss, severe tinnitus and hyperacusis. Audiol Neurootol. 2015;20 Suppl 1:60-66. PMID
25997672
Van de Heyning P, Vermeire K, Diebl M, et al. Incapacitating unilateral tinnitus in single-sided deafness
treated by cochlear implantation. Ann Otol Rhinol Laryngol. Sep 2008;117(9):645-652. PMID 18834065
Tavora-Vieira D, Marino R, Krishnaswamy J, et al. Cochlear implantation for unilateral deafness with and
without tinnitus: a case series. Laryngoscope. May 2013;123(5):1251-1255. PMID 23553411
Roland JT, Jr., Gantz BJ, Waltzman SB, et al. United States multicenter clinical trial of the cochlear
nucleus hybrid implant system. Laryngoscope. Jan 2016;126(1):175-181. PMID 26152811
Lenarz T, James C, Cuda D, et al. European multi-centre study of the Nucleus Hybrid L24 cochlear
implant. Int J Audiol. Dec 2013;52(12):838-848. PMID 23992489
Gifford RH, Dorman MF, Skarzynski H, et al. Cochlear implantation with hearing preservation yields
significant benefit for speech recognition in complex listening environments. Ear Hear. Jul-Aug
2013;34(4):413-425. PMID 23446225
Santa Maria PL, Gluth MB, Yuan Y, et al. Hearing preservation surgery for cochlear implantation: a
meta-analysis. Otol Neurotol. Dec 2014;35(10):e256-269. PMID 25233333
Causon A, Verschuur C, Newman TA. A retrospective analysis of the contribution of reported factors in
cochlear implantation on hearing preservation outcomes. Otol Neurotol. Aug 2015;36(7):1137-1145.
PMID 25853614
Friedmann DR, Peng R, Fang Y, et al. Effects of loss of residual hearing on speech performance with the
CI422 and the Hybrid-L electrode. Cochlear Implants Int. Sep 2015;16(5):277-284. PMID 25912363
American Academy of Otolarygology-Head and Neck Surgery Foundation. Position Statement on
Bilateral Cochlear Implants. 2014 revision; http://www.entnet.org/Practice/policyCochlearImplants.cfm.
Accessed April 2017.
Centers for Medicare and Medicaid (CMS). National Coverage Determination (NCD) Pub. 100.3, section
50.3 Cochlear Implantation. https://www.cms.gov/Medicare/Coverage/Coverage-with-EvidenceDevelopment/Cochlear-Implantation-.html. Accessed April, 2017.
Blue Cross Blue Shield Association. Cochlear Implant. Medical Policy Reference Manual. Policy No.
7.01.05, 2017.
Appendix
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N/A
History
[TOP]
Date
01/97
11/03/98
01/04/99
10/09/01
10/08/02
03/11/03
05/13/03
05/11/04
07/13/04
08/09/05
02/06/06
06/09/06
08/08/06
04/10/07
05/13/08
04/13/10
08/09/11
08/24/11
02/09/12
06/26/12
08/20/12
09/25/12
10/18/12
08/12/13
03/11/14
03/21/14
05/15/14
07/14/14
07/14/15
Reason
Add to Surgery Section - New Policy
Replace Policy - Revised Description and Policy Guidelines
Replace Policy - Policy reviewed; new devices added.
Replace Policy - Policy reviewed; new devices and FDA approval status added.
Replace Policy - Policy reviewed; new FDA-approved device added (Med E1 Combi 40+).
Replace Policy - Policy Benefit Application section added. No change to Policy Statement.
Replace Policy - Update CPT code only.
Replace Policy - Policy reviewed without literature review; no change to policy statement.
Replace Policy - Policy reviewed; discussion of bilateral cochlear implants and its investigational
status added.
Replace Policy - Policy reviewed with literature search; policy statement unchanged.
Codes updated - No other changes.
Disclaimer and Scope update - No other changes.
Replace Policy - Policy updated with literature review; no change in policy statement.
Replace Policy - Policy updated with literature review. Policy statement changed to indicate
bilateral cochlear implants are medically necessary. Reference numbers added.
Replace Policy - Policy updated with literature search; no change to the policy statement.
References and codes added.
Replace Policy - Policy updated with literature search. Policy statements modified for clarity, intent
unchanged. References and codes added.
Replace Policy – Policy updated with literature review; Rationale section and references
reorganized. No changes in policy statements. Reference numbers 3-4, 6, 12, 16-17 added;
numerous references to early, small studies removed. ICD-10 codes added to policy.
Benefit Application updated.
The CPT codes 92605 and 92606 were removed from the policy.
Related Policies update; title for 7.01.84 has been changed.
Replace policy. Clarification statement added to the policy guidelines second paragraph: In
addition, unique clinical circumstance may justify individual consideration for implantation before 12
months of age, based on review of applicable medical records to verify the other pediatric criteria
noted in this policy are met. Rationale section revised based on literature review through April
2012. Reference numbers 7-9, 13 and 22-24 added. Other references renumbered. CPT codes
92605 and 92606 added. Policy statements unchanged.
Update Coding Section – ICD-10 codes are now effective 10/01/2014.
Update Related Policies – 7.01.03 renumbered to 7.01.547.
Replace policy. Policy statement added: cochlear implantation as a treatment for patients with
unilateral hearing loss with or without tinnitus is considered investigational. Rationale updated
based on literature review through May 2013. References 7, 10, 11, 28-32 added; others
renumbered/removed. Policy statement changed as noted.
Coding Update. Remove codes 20.96, 20.97, and 20.98 per ICD-10 mapping project; these codes
are not utilized for adjudication of policy.
Update Related Policies. Add 1.01.528
Coding update. CPT codes 92607 and 92608 removed from the policy; these codes address the
evaluation portion; this policy is specific to the device and evaluation is not addressed herein.
Annual Review. Policy statement added that cochlear implantation with a hybrid cochlear implant/
hearing aid system is considered investigational. Rationale section reorganized and policy updated
with literature review through April 4, 2014. References reorganized, numbers 1, 20, 21, 27, 29, 3032, 36-40 added, others renumbered/removed. Policy statement changed as noted. Coding update:
Remove CPT codes 92507-92606 & 92626-92633 from policy. Remove ICD-9 and ICD-10
diagnosis codes and ICD-10-PCS codes.
Annual Review. Policy updated with literature review through April 19, 2015; references 17, 23-24,
36-37, and 45 added. Policy statements unchanged. CPT codes 92626, 92627, 92630 and 92633
12/12/15
10/01/16
10/07/16
01/01/17
05/01/17
removed; these are codes fall under the rehabilitation benefit. HCPCS codes L8616, L8617, L8618,
L8621, L8622, L8623 and L8624 removed; these are for replacement and do not fall within the
scope of the policy.
Policy statement formatted to differentiate between different types of hearing loss/implants.
Annual Review, changes approved September 13, 2016. Policy updated with results of clinical
input. Policy statement changed to indicate that cochlear implantation with a hybrid cochlear
implant/hearing aid system is considered medically necessary for patients meeting criteria. CPT
codes 92601-92606, 92609 removed; these are not supportive of policy intent.
Update coding section. Changed code L8328 to L8628. Removed paragraph regarding codes
92601-92606, and 92609 as they were removed from policy.
Interim review, changes approved December 13, 2016. Removed age limit for policy statement
about cochlear implants for bilateral hearing loss; added statement about replacement of cochlear
implant components. Policy guidelines about individual review consideration for implantation in
children under 12 months of age added. RUL table for cochlear implant components added to
Policy Guidelines.
Annual review, changes approved April 11, 2017. Policy updated with literature review through
December 20, 2016; references 16 and 43-45 added. Coding updated; removed HCPCS codes
L8627, L8628, and L8629. Policy statements unchanged.
Disclaimer: This medical policy is a guide in evaluating the medical necessity of a particular service or treatment. The Company adopts
policies after careful review of published peer-reviewed scientific literature, national guidelines and local standards of practice. Since medical
technology is constantly changing, the Company reserves the right to review and update policies as appropriate. Member contracts differ in
their benefits. Always consult the member benefit booklet or contact a member service representative to determine coverage for a specific
medical service or supply. CPT codes, descriptions and materials are copyrighted by the American Medical Association (AMA).
©2017 Premera All Rights Reserved.
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037338 (07-2016)
Oromoo (Cushite):
Beeksisni kun odeeffannoo barbaachisaa qaba. Beeksisti kun sagantaa
yookan karaa Premera Blue Cross tiin tajaajila keessan ilaalchisee
odeeffannoo barbaachisaa qabaachuu danda’a. Guyyaawwan murteessaa
ta’an beeksisa kana keessatti ilaalaa. Tarii kaffaltiidhaan deeggaramuuf
yookan tajaajila fayyaa keessaniif guyyaa dhumaa irratti wanti raawwattan
jiraachuu danda’a. Kaffaltii irraa bilisa haala ta’een afaan keessaniin
odeeffannoo argachuu fi deeggarsa argachuuf mirga ni qabaattu.
Lakkoofsa bilbilaa 800-722-1471 (TTY: 800-842-5357) tii bilbilaa.
Français (French):
Cet avis a d'importantes informations. Cet avis peut avoir d'importantes
informations sur votre demande ou la couverture par l'intermédiaire de
Premera Blue Cross. Le présent avis peut contenir des dates clés. Vous
devrez peut-être prendre des mesures par certains délais pour maintenir
votre couverture de santé ou d'aide avec les coûts. Vous avez le droit
d'obtenir cette information et de l’aide dans votre langue à aucun coût.
Appelez le 800-722-1471 (TTY: 800-842-5357).
Kreyòl ayisyen (Creole):
Avi sila a gen Enfòmasyon Enpòtan ladann. Avi sila a kapab genyen
enfòmasyon enpòtan konsènan aplikasyon w lan oswa konsènan kouvèti
asirans lan atravè Premera Blue Cross. Kapab genyen dat ki enpòtan nan
avi sila a. Ou ka gen pou pran kèk aksyon avan sèten dat limit pou ka
kenbe kouvèti asirans sante w la oswa pou yo ka ede w avèk depans yo.
Se dwa w pou resevwa enfòmasyon sa a ak asistans nan lang ou pale a,
san ou pa gen pou peye pou sa. Rele nan 800-722-1471
(TTY: 800-842-5357).
Deutsche (German):
Diese Benachrichtigung enthält wichtige Informationen. Diese
Benachrichtigung enthält unter Umständen wichtige Informationen
bezüglich Ihres Antrags auf Krankenversicherungsschutz durch Premera
Blue Cross. Suchen Sie nach eventuellen wichtigen Terminen in dieser
Benachrichtigung. Sie könnten bis zu bestimmten Stichtagen handeln
müssen, um Ihren Krankenversicherungsschutz oder Hilfe mit den Kosten
zu behalten. Sie haben das Recht, kostenlose Hilfe und Informationen in
Ihrer Sprache zu erhalten. Rufen Sie an unter 800-722-1471
(TTY: 800-842-5357).
Hmoob (Hmong):
Tsab ntawv tshaj xo no muaj cov ntshiab lus tseem ceeb. Tej zaum
tsab ntawv tshaj xo no muaj cov ntsiab lus tseem ceeb txog koj daim ntawv
thov kev pab los yog koj qhov kev pab cuam los ntawm Premera Blue
Cross. Tej zaum muaj cov hnub tseem ceeb uas sau rau hauv daim ntawv
no. Tej zaum koj kuj yuav tau ua qee yam uas peb kom koj ua tsis pub
dhau cov caij nyoog uas teev tseg rau hauv daim ntawv no mas koj thiaj
yuav tau txais kev pab cuam kho mob los yog kev pab them tej nqi kho mob
ntawd. Koj muaj cai kom lawv muab cov ntshiab lus no uas tau muab sau
ua koj hom lus pub dawb rau koj. Hu rau 800-722-1471
(TTY: 800-842-5357).
Iloko (Ilocano):
Daytoy a Pakdaar ket naglaon iti Napateg nga Impormasion. Daytoy a
pakdaar mabalin nga adda ket naglaon iti napateg nga impormasion
maipanggep iti apliksayonyo wenno coverage babaen iti Premera Blue
Cross. Daytoy ket mabalin dagiti importante a petsa iti daytoy a pakdaar.
Mabalin nga adda rumbeng nga aramidenyo nga addang sakbay dagiti
partikular a naituding nga aldaw tapno mapagtalinaedyo ti coverage ti
salun-atyo wenno tulong kadagiti gastos. Adda karbenganyo a mangala iti
daytoy nga impormasion ken tulong iti bukodyo a pagsasao nga awan ti
bayadanyo. Tumawag iti numero nga 800-722-1471 (TTY: 800-842-5357).
Italiano (Italian):
Questo avviso contiene informazioni importanti. Questo avviso può contenere
informazioni importanti sulla tua domanda o copertura attraverso Premera
Blue Cross. Potrebbero esserci date chiave in questo avviso. Potrebbe
essere necessario un tuo intervento entro una scadenza determinata per
consentirti di mantenere la tua copertura o sovvenzione. Hai il diritto di
ottenere queste informazioni e assistenza nella tua lingua gratuitamente.
Chiama 800-722-1471 (TTY: 800-842-5357).
日本語 (Japanese):
この通知には重要な情報が含まれています。この通知には、Premera Blue
Cross の申請または補償範囲に関する重要な情報が含まれている場合があ
ります。この通知に記載されている可能性がある重要な日付をご確認くだ
さい。健康保険や有料サポートを維持するには、特定の期日までに行動を
取らなければならない場合があります。ご希望の言語による情報とサポー
トが無料で提供されます。800-722-1471 (TTY: 800-842-5357)までお電話
ください。
Română (Romanian):
Prezenta notificare conține informații importante. Această notificare
poate conține informații importante privind cererea sau acoperirea asigurării
dumneavoastre de sănătate prin Premera Blue Cross. Pot exista date cheie
în această notificare. Este posibil să fie nevoie să acționați până la anumite
termene limită pentru a vă menține acoperirea asigurării de sănătate sau
asistența privitoare la costuri. Aveți dreptul de a obține gratuit aceste
informații și ajutor în limba dumneavoastră. Sunați la 800-722-1471
(TTY: 800-842-5357).
한국어 (Korean):
본 통지서에는 중요한 정보가 들어 있습니다. 즉 이 통지서는 귀하의 신청에
관하여 그리고 Premera Blue Cross 를 통한 커버리지에 관한 정보를
포함하고 있을 수 있습니다. 본 통지서에는 핵심이 되는 날짜들이 있을 수
있습니다. 귀하는 귀하의 건강 커버리지를 계속 유지하거나 비용을 절감하기
위해서 일정한 마감일까지 조치를 취해야 할 필요가 있을 수 있습니다.
귀하는 이러한 정보와 도움을 귀하의 언어로 비용 부담없이 얻을 수 있는
권리가 있습니다. 800-722-1471 (TTY: 800-842-5357) 로 전화하십시오.
Pусский (Russian):
Настоящее уведомление содержит важную информацию. Это
уведомление может содержать важную информацию о вашем
заявлении или страховом покрытии через Premera Blue Cross. В
настоящем уведомлении могут быть указаны ключевые даты. Вам,
возможно, потребуется принять меры к определенным предельным
срокам для сохранения страхового покрытия или помощи с расходами.
Вы имеете право на бесплатное получение этой информации и
помощь на вашем языке. Звоните по телефону 800-722-1471
(TTY: 800-842-5357).
ລາວ (Lao):
ແຈ້ ງການນ້ີ ມີຂ້ໍ ມູ ນສໍາຄັ ນ. ແຈ້ ງການນ້ີ ອາດຈະມີຂ້ໍ ມູ ນສໍາຄັ ນກ່ ຽວກັ ບຄໍາຮ້ ອງສະ
ໝັ ກ ຫື ຼ ຄວາມຄຸ້ ມຄອງປະກັ ນໄພຂອງທ່ ານຜ່ ານ Premera Blue Cross. ອາດຈະມີ
ວັ ນທີສໍາຄັ ນໃນແຈ້ ງການນີ້. ທ່ ານອາດຈະຈໍາເປັນຕ້ ອງດໍາເນີນການຕາມກໍານົ ດ
ເວລາສະເພາະເພື່ອຮັ ກສາຄວາມຄຸ້ ມຄອງປະກັ ນສຸ ຂະພາບ ຫື ຼ ຄວາມຊ່ ວຍເຫື ຼ ອເລື່ອງ
ຄ່ າໃຊ້ ຈ່ າຍຂອງທ່ ານໄວ້ . ທ່ ານມີສິດໄດ້ ຮັ ບຂ້ໍ ມູ ນນ້ີ ແລະ ຄວາມຊ່ ວຍເຫື ຼ ອເປັນພາສາ
ຂອງທ່ ານໂດຍບໍ່ເສຍຄ່ າ. ໃຫ້ ໂທຫາ 800-722-1471 (TTY: 800-842-5357).
ភាសាែខម រ (Khmer):
េសចកត ីជូនដំណឹងេនះមានព័ត៌មានយា៉ងសំខាន់។ េសចកត ីជូនដំណឹងេនះរបែហល
ជាមានព័ត៌មានយា៉ងសំខាន់អំពីទរមង់ែបបបទ ឬការរា៉ប់រងរបស់អនកតាមរយៈ
Premera Blue Cross ។ របែហលជាមាន កាលបរ ិេចឆ ទសំខាន់េនៅកនុងេសចកត ីជូន
ដំណឹងេនះ។ អន ករបែហលជារតូវការបេញច ញសមតថ ភាព ដល់កំណត់ៃថង ជាក់ចបាស់
នានា េដើមបីនឹងរកសាទុកការធានារា៉ប់រងសុខភាពរបស់អនក ឬរបាក់ជំនួយេចញៃថល ។
អន កមានសិទធិទទួ លព័ត៌មានេនះ និងជំនួយេនៅកនុងភាសារបស់អនកេដាយមិនអស
លុយេឡើយ។ សូ មទូ រស័ពទ 800-722-1471 (TTY: 800-842-5357)។
ਪੰ ਜਾਬੀ (Punjabi):
ਇਸ ਨੋਿਟਸ ਿਵਚ ਖਾਸ ਜਾਣਕਾਰੀ ਹੈ. ਇਸ ਨੋਿਟਸ ਿਵਚ Premera Blue Cross ਵਲ ਤੁਹਾਡੀ
ਕਵਰੇਜ ਅਤੇ ਅਰਜੀ ਬਾਰੇ ਮਹੱ ਤਵਪੂਰਨ ਜਾਣਕਾਰੀ ਹੋ ਸਕਦੀ ਹੈ . ਇਸ ਨੋਿਜਸ ਜਵਚ ਖਾਸ ਤਾਰੀਖਾ
ਹੋ ਸਕਦੀਆਂ ਹਨ. ਜੇਕਰ ਤੁਸੀ ਜਸਹਤ ਕਵਰੇਜ ਿਰੱ ਖਣੀ ਹੋਵੇ ਜਾ ਓਸ ਦੀ ਲਾਗਤ ਜਿਵੱ ਚ ਮਦਦ ਦੇ
ਇਛੁੱ ਕ ਹੋ ਤਾਂ ਤੁਹਾਨੂੰ ਅੰ ਤਮ ਤਾਰੀਖ਼ ਤ ਪਿਹਲਾਂ ਕੁੱ ਝ ਖਾਸ ਕਦਮ ਚੁੱ ਕਣ ਦੀ ਲੋ ੜ ਹੋ ਸਕਦੀ ਹੈ ,ਤੁਹਾਨੂੰ
ਮੁਫ਼ਤ ਿਵੱ ਚ ਤੇ ਆਪਣੀ ਭਾਸ਼ਾ ਿਵੱ ਚ ਜਾਣਕਾਰੀ ਅਤੇ ਮਦਦ ਪ੍ਰਾਪਤ ਕਰਨ ਦਾ ਅਿਧਕਾਰ ਹੈ ,ਕਾਲ
800-722-1471 (TTY: 800-842-5357).
‫( فارسی‬Farsi):
‫اين اعالميه ممکن است حاوی اطالعات مھم درباره فرم‬. ‫اين اعالميه حاوی اطالعات مھم ميباشد‬
‫ به تاريخ ھای مھم در‬.‫ باشد‬Premera Blue Cross ‫تقاضا و يا پوشش بيمه ای شما از طريق‬
‫شما ممکن است برای حقظ پوشش بيمه تان يا کمک در پرداخت ھزينه‬. ‫اين اعالميه توجه نماييد‬
‫شما حق‬. ‫ به تاريخ ھای مشخصی برای انجام کارھای خاصی احتياج داشته باشيد‬،‫ھای درمانی تان‬
‫ برای کسب‬.‫اين را داريد که اين اطالعات و کمک را به زبان خود به طور رايگان دريافت نماييد‬
‫( تماس‬800-842-5357 ‫ تماس باشماره‬TTY ‫ )کاربران‬800-722-1471 ‫اطالعات با شماره‬
.‫برقرار نماييد‬
Polskie (Polish):
To ogłoszenie może zawierać ważne informacje. To ogłoszenie może
zawierać ważne informacje odnośnie Państwa wniosku lub zakresu
świadczeń poprzez Premera Blue Cross. Prosimy zwrócic uwagę na
kluczowe daty, które mogą być zawarte w tym ogłoszeniu aby nie
przekroczyć terminów w przypadku utrzymania polisy ubezpieczeniowej lub
pomocy związanej z kosztami. Macie Państwo prawo do bezpłatnej
informacji we własnym języku. Zadzwońcie pod 800-722-1471
(TTY: 800-842-5357).
Português (Portuguese):
Este aviso contém informações importantes. Este aviso poderá conter
informações importantes a respeito de sua aplicação ou cobertura por meio
do Premera Blue Cross. Poderão existir datas importantes neste aviso.
Talvez seja necessário que você tome providências dentro de
determinados prazos para manter sua cobertura de saúde ou ajuda de
custos. Você tem o direito de obter esta informação e ajuda em seu idioma
e sem custos. Ligue para 800-722-1471 (TTY: 800-842-5357).
Fa’asamoa (Samoan):
Atonu ua iai i lenei fa’asilasilaga ni fa’amatalaga e sili ona taua e tatau
ona e malamalama i ai. O lenei fa’asilasilaga o se fesoasoani e fa’amatala
atili i ai i le tulaga o le polokalame, Premera Blue Cross, ua e tau fia maua
atu i ai. Fa’amolemole, ia e iloilo fa’alelei i aso fa’apitoa olo’o iai i lenei
fa’asilasilaga taua. Masalo o le’a iai ni feau e tatau ona e faia ao le’i aulia le
aso ua ta’ua i lenei fa’asilasilaga ina ia e iai pea ma maua fesoasoani mai ai
i le polokalame a le Malo olo’o e iai i ai. Olo’o iai iate oe le aia tatau e maua
atu i lenei fa’asilasilaga ma lenei fa’matalaga i legagana e te malamalama i
ai aunoa ma se togiga tupe. Vili atu i le telefoni 800-722-1471
(TTY: 800-842-5357).
Español (Spanish):
Este Aviso contiene información importante. Es posible que este aviso
contenga información importante acerca de su solicitud o cobertura a
través de Premera Blue Cross. Es posible que haya fechas clave en este
aviso. Es posible que deba tomar alguna medida antes de determinadas
fechas para mantener su cobertura médica o ayuda con los costos. Usted
tiene derecho a recibir esta información y ayuda en su idioma sin costo
alguno. Llame al 800-722-1471 (TTY: 800-842-5357).
Tagalog (Tagalog):
Ang Paunawa na ito ay naglalaman ng mahalagang impormasyon. Ang
paunawa na ito ay maaaring naglalaman ng mahalagang impormasyon
tungkol sa iyong aplikasyon o pagsakop sa pamamagitan ng Premera Blue
Cross. Maaaring may mga mahalagang petsa dito sa paunawa. Maaring
mangailangan ka na magsagawa ng hakbang sa ilang mga itinakdang
panahon upang mapanatili ang iyong pagsakop sa kalusugan o tulong na
walang gastos. May karapatan ka na makakuha ng ganitong impormasyon
at tulong sa iyong wika ng walang gastos. Tumawag sa 800-722-1471
(TTY: 800-842-5357).
ไทย (Thai):
ประกาศนี ้มีข้อมูลสําคัญ ประกาศนี ้อาจมีข้อมูลที่สําคัญเกี่ยวกับการการสมัครหรื อขอบเขตประกัน
สุขภาพของคุณผ่าน Premera Blue Cross และอาจมีกําหนดการในประกาศนี ้ คุณอาจจะต้ อง
ดําเนินการภายในกําหนดระยะเวลาที่แน่นอนเพื่อจะรักษาการประกันสุขภาพของคุณหรื อการช่วยเหลือที่
มีค่าใช้ จ่าย คุณมีสิทธิที่จะได้ รับข้ อมูลและความช่วยเหลือนี ้ในภาษาของคุณโดยไม่มีค่าใช้ จ่าย โทร
800-722-1471 (TTY: 800-842-5357)
Український (Ukrainian):
Це повідомлення містить важливу інформацію. Це повідомлення
може містити важливу інформацію про Ваше звернення щодо
страхувального покриття через Premera Blue Cross. Зверніть увагу на
ключові дати, які можуть бути вказані у цьому повідомленні. Існує
імовірність того, що Вам треба буде здійснити певні кроки у конкретні
кінцеві строки для того, щоб зберегти Ваше медичне страхування або
отримати фінансову допомогу. У Вас є право на отримання цієї
інформації та допомоги безкоштовно на Вашій рідній мові. Дзвоніть за
номером телефону 800-722-1471 (TTY: 800-842-5357).
Tiếng Việt (Vietnamese):
Thông báo này cung cấp thông tin quan trọng. Thông báo này có thông
tin quan trọng về đơn xin tham gia hoặc hợp đồng bảo hiểm của quý vị qua
chương trình Premera Blue Cross. Xin xem ngày quan trọng trong thông
báo này. Quý vị có thể phải thực hiện theo thông báo đúng trong thời hạn
để duy trì bảo hiểm sức khỏe hoặc được trợ giúp thêm về chi phí. Quý vị có
quyền được biết thông tin này và được trợ giúp bằng ngôn ngữ của mình
miễn phí. Xin gọi số 800-722-1471 (TTY: 800-842-5357).