Cochlear Implants 2016: Advances in Candidacy, Technology, and Outcomes, Factors That Drive the Expansion of Pediatric Cochlear Implant Candidacy Cochlear implant candidacy and outcomes have advanced reflecting technology improvements, early identification, and better linkage between the surgical intervention and follow-up care. Children and adults with a range of hearing losses and other issues are now benefitting importantly from traditional cochlear implants as well as hybrid and auditory brainstem implants. ... Article
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Article  |   June 24, 2016
Cochlear Implants 2016: Advances in Candidacy, Technology, and Outcomes, Factors That Drive the Expansion of Pediatric Cochlear Implant Candidacy
Author Affiliations & Notes
  • Teresa A. Zwolan
    Department of Otolaryngology, Cochlear Implant Program, University of Michigan, Ann Arbor, MI
  • Donna L. Sorkin
    American Cochlear Implant Alliance, McLean, VA
  • Disclosures
    Disclosures ×
  • Financial: Teresa A. Zwolan is a Clinical Professor and Director at the University of Michigan Cochlear Implant Program. Donna L. Sorkin is the Executive Director of the American Cochlear Implant Alliance.
    Financial: Teresa A. Zwolan is a Clinical Professor and Director at the University of Michigan Cochlear Implant Program. Donna L. Sorkin is the Executive Director of the American Cochlear Implant Alliance.×
  • Nonfinancial: Some of this research has been previously presented at the American Speech-Language-Hearing Association Convention in 2015. Teresa A. Zwolan and Donna L. Sorkin have previously published in this subject area.
    Nonfinancial: Some of this research has been previously presented at the American Speech-Language-Hearing Association Convention in 2015. Teresa A. Zwolan and Donna L. Sorkin have previously published in this subject area.×
Article Information
Hearing Aids, Cochlear Implants & Assistive Technology / Part 1
Article   |   June 24, 2016
Cochlear Implants 2016: Advances in Candidacy, Technology, and Outcomes, Factors That Drive the Expansion of Pediatric Cochlear Implant Candidacy
Perspectives of the ASHA Special Interest Groups, June 2016, Vol. 1, 21-28. doi:10.1044/persp1.SIG9.21
History: Received January 25, 2016 , Revised May 16, 2016 , Accepted May 17, 2016
Perspectives of the ASHA Special Interest Groups, June 2016, Vol. 1, 21-28. doi:10.1044/persp1.SIG9.21
History: Received January 25, 2016; Revised May 16, 2016; Accepted May 17, 2016

Cochlear implant candidacy and outcomes have advanced reflecting technology improvements, early identification, and better linkage between the surgical intervention and follow-up care. Children and adults with a range of hearing losses and other issues are now benefitting importantly from traditional cochlear implants as well as hybrid and auditory brainstem implants.

Age and Early Identification
When it comes to identification of, and follow-up for, pediatric cochlear implant (CI) candidates, “the earlier the better” is always the best motto. This is true whether a child is born with profound hearing loss or develops a significant hearing loss shortly after birth. A number of researchers have documented that children who are born with bilateral, severe-to-profound hearing loss derive the greatest benefit from cochlear implantation when intervention is provided prior to 12 months of age (Dettman et al., 2016) and when the implant is provided prior to the age of 18 months (Niparko et al., 2010).
Early clinical trials focused on demonstrating safety and efficacy of cochlear implants, and resulting indications were strict. The success of these early clinical trials led to a reduction in the approved age at implantation from 2 years to 18 months in 1998, and then to 12 months of age in 2000 for a child with profound hearing loss. At the same time, indications were expanded to include children with a bilateral, severe-to-profound sensorineural hearing loss for children 24 months of age and older. A summary of changes that have taken place in CI indications is provided in Table 1.
Table 1. Historical Expansion of FDA Guideline for Cochlear Implantation*
Historical Expansion of FDA Guideline for Cochlear Implantation* ×
Criteria 1985 1990 1998 2000 2014
Age of Implantation Adults '18 yrs + Adults & Children 2 yrs + Adults & Children 18 months + Adults & Children 12 months + Adults only for Hybrid
Onset of hearing loss Post-linguistic • Post-linguistic adults • Adults & Children Pre-& Post- Linguistic • Adults & Children Pre- & Post-Linguistic • Adults & Children
• Pre- & Post-linguistic children Pre- & Post-Linguistic
Degree of hearing loss Profound Profound • Severe-Profound Adults • Severe-Profound Patients 2 yrs + • Nucleus Hybrid: Normal-to-moderate in low frequencies
• Profound Children • Profound Children <2 years • Severe-Profound loss in mid to high frequencies
• Adults: Bilateral moderate to profound hearing loss in the low frequencies and profound (≥90 dB HL) loss in mid-to-high frequencies
Speech scores 0% 0% 40% or less • Sentence score 50% or less in ear to be implanted, 60% or less in the best aided condition • CNC word score >10%, but less than 60% in ear to be implanted;
• <80% CNC words in contralateral ear
* Based upon candidacy criteria for the Nucleus Cochlear Implant System, which has the broadest CI candidacy of the three cochlear implant devices approved for use in the US by the FDA. The first data row indicates which age demographic had a change in candidacy in that year.
Based upon candidacy criteria for the Nucleus Cochlear Implant System, which has the broadest CI candidacy of the three cochlear implant devices approved for use in the US by the FDA. The first data row indicates which age demographic had a change in candidacy in that year.×
Table 1. Historical Expansion of FDA Guideline for Cochlear Implantation*
Historical Expansion of FDA Guideline for Cochlear Implantation* ×
Criteria 1985 1990 1998 2000 2014
Age of Implantation Adults '18 yrs + Adults & Children 2 yrs + Adults & Children 18 months + Adults & Children 12 months + Adults only for Hybrid
Onset of hearing loss Post-linguistic • Post-linguistic adults • Adults & Children Pre-& Post- Linguistic • Adults & Children Pre- & Post-Linguistic • Adults & Children
• Pre- & Post-linguistic children Pre- & Post-Linguistic
Degree of hearing loss Profound Profound • Severe-Profound Adults • Severe-Profound Patients 2 yrs + • Nucleus Hybrid: Normal-to-moderate in low frequencies
• Profound Children • Profound Children <2 years • Severe-Profound loss in mid to high frequencies
• Adults: Bilateral moderate to profound hearing loss in the low frequencies and profound (≥90 dB HL) loss in mid-to-high frequencies
Speech scores 0% 0% 40% or less • Sentence score 50% or less in ear to be implanted, 60% or less in the best aided condition • CNC word score >10%, but less than 60% in ear to be implanted;
• <80% CNC words in contralateral ear
* Based upon candidacy criteria for the Nucleus Cochlear Implant System, which has the broadest CI candidacy of the three cochlear implant devices approved for use in the US by the FDA. The first data row indicates which age demographic had a change in candidacy in that year.
Based upon candidacy criteria for the Nucleus Cochlear Implant System, which has the broadest CI candidacy of the three cochlear implant devices approved for use in the US by the FDA. The first data row indicates which age demographic had a change in candidacy in that year.×
×
Early Intervention
Early identification provides the opportunity to begin the process of intervention for hearing loss during the first weeks of life. The initiation of universal newborn hearing screening in the United States, and in most developed countries throughout the world, is one factor that has made 12 months of age for implantation an attainable goal for growing numbers of young children born with hearing loss. Newborn hearing screenings provide a vehicle through the health care system for prompt delivery of information to families, which makes it possible for them to have their child move forward with cochlear implantation at an early age, should they wish to do so. Prior to the initiation of widespread newborn hearing screenings, the average age of identification of pediatric hearing loss was 20 months (Halpin, Smith, Widen, & Chertoff, 2010; Sininger et al., 2009). Given this identification timeframe, 3 years of age was previously considered an early age for a prelingually deafened child to receive a CI.
Because of the advantages seen in speech and language acquisition, CI clinicians typically encourage families to move forward with CI surgery by the age of 12 months if the child is an appropriate candidate. Most employer-based health insurance policies, as well as state Medicaid programs, require that a child be 1 year of age at the time of implantation, consistent with current FDA indications. Some families and clinicians have successfully pursued CI surgery prior to the age of 12 months, making the case to insurance companies that implantation can be safely performed in children less than 12 months of age if performed by an experienced surgical team (Waltzman & Roland, 2005).
Residual Hearing
Another factor that impacts CI outcomes, and thus drives the expansion of CI candidacy, is the child's level of pre-operative residual hearing. Initially, FDA indications for children specified they have a bilateral, profound hearing loss to receive a CI. Over time, research demonstrated that children with residual hearing in the severe to profound range who received cochlear implants performed significantly better on auditory skill tests than children who utilized traditional amplification. Hence, in the year 2000, the FDA guidelines were broadened to include children with more residual hearing, and now include children with bilateral severe-to-profound sensorineural hearing loss if they are over the age of 24 months. Also in 2000, indications for adults were expanded to include those with a moderate to profound hearing loss. In 2014, the Nucleus Hybrid received FDA approval for adults, and the indications included adults with normal-to-moderate low frequency hearing combined with a severe-to-profound hearing loss in the high frequencies. Candidacy for the hybrid also included a statement indicating that candidates should score between 10 and 60% correct in the ear to be implanted and less than 80% correct on the CNC Monosyllabic Words test in the contralateral ear. A summary of such changes is provided in Table 1.
Regardless of age, research has shown that individuals who have greater preoperative residual hearing tend to have better outcomes (Dowell, Hollow, & Winton, 2004; Niparko et al., 2010). Two additional groups of researchers (Dettman et al., 2004; Fitzpatrick, McCrae, & Schramm, 2006) demonstrated that when children do not meet CI candidacy requirements at birth (i.e., the hearing loss is not profound), hearing aid use and auditory experience positively impact post-operative outcomes once an implant is obtained.
Therapy Options
Prior to the initiation of newborn hearing screenings, children with hearing loss often experienced significant delays in their speech and language skills. Extensive one-on-one therapy with speech-language pathologists (SLPs) and/or teachers of the deaf was used to try to catch the speech and language skills of late-identified children up to that of their peers with typical hearing. Unfortunately, many such children experienced life-long delays in their intelligibility and spoken language skills.
Fortunately, therapies have evolved over the years and have facilitated expansions in CI candidacy. An example of a contemporary form of therapy is “parent-centered therapy,” which focuses on mentoring the parents or other caregivers, and rarely entails a professional working with a child without a parent present. Such therapies stress the importance of appropriate hearing assistive technology (HAT) and require families to take an active role in teaching language to their children in a natural way that is more akin to what typically occurs in a home environment. Parents, grandparents, and siblings are now more involved with teaching young children with hearing loss about the world around them.
Changes in Hearing Status
Since hearing loss can be progressive, educators and clinicians should be proactive about conducting ongoing assessments of a child's hearing. A child with hearing loss who uses traditional amplification may initially develop spoken language and later experience declines in hearing that make him or her a candidate for a CI. Parents may be unaware of the negative ramifications such declines in hearing have on the child's spoken language and educational achievements, which may cause them to resist moving forward with cochlear implantation. Thus, in order to avoid severe delays, it is important for families to receive comprehensive information about the benefits of implantation when a child's hearing loss progresses. Providing such children with continued access to meaningful sound with a CI can positively impact the child's speech, language, and educational outcomes.
Improved Technology and Surgery
Expansion in candidacy has been further driven by dramatic improvements in CI technology and surgical approaches. Some electrode arrays are now designed to preserve residual hearing and to keep more neural structures intact. One example of this is the Nucleus Hybrid device, which has the most lenient FDA-approved indications yet. This device is designed to provide acoustic and electric sound processing for individuals with significant low-frequency residual hearing and severe-to-profound high-frequency hearing loss (Roland, Gantz, Waltzman, Parkinson, & Multicenter Clinical Trial Group, 2016). FDA indications for this device have been described above and are summarized in Table 1.
Many patients who meet indications for a Nucleus Hybrid device have low frequency hearing that falls in the normal to mild hearing loss range, and many demonstrate sentence recognition scores that exceed the maximum score indicated for more traditional electrode arrays (i.e., >60% correct). FDA approval of the hybrid came about following completion of a lengthy clinical trial that included 50 adult patients who were implanted at a variety of centers across the United States (Roland et al., 2016). Testing in this clinical trial differed from traditional measures in several ways. For the first time, adult candidacy was based on a word recognition score, rather than a sentence recognition score. Although sentence testing was performed, stimuli were not presented in quiet but were, instead, presented at a +5 dB signal to noise ratio. Post-operative testing was performed using just the CI, the CI plus the acoustic component in the implanted ear (CI+EA), and the CI+EA plus the hearing aid in the contralateral ear (bimodal). This enabled the investigators to demonstrate an overall improvement in hearing when compared to the participants' best aided pre-operative condition. Additionally, the clinical trial included the self-assessment measure of the Speech, Spatial, and Qualities of Hearing Questionnaire (Gatehouse & Noble, 2004).
Similarly, MED-EL (n.d.)  recently completed a clinical trial to evaluate an electro-acoustic device, referred to as the MED-EL EAS. Criteria for inclusion in the EAS trial were similar to those for the Nucleus Hybrid study; patients were required to have a mild-to-moderate low frequency loss sloping to a profound loss in the higher frequencies paired with a monosyllabic word recognition score less than or equal to 60% correct in the best aided condition.
The internal devices of the Nucleus Hybrid and the MED-EL EAS vary in size and thickness when compared with traditional electrode arrays. If hearing is preserved, the externally worn speech processors include an acoustic component that can be used to amplify low-frequency sounds while the speech processor simultaneously provides mid- to-high-frequency information via electrical stimulation of the electrode array. The results of both clinical trials indicate that provision of acoustic and electric stimulation enhances the sound quality and the speech recognition skills of patients who utilize these devices, particularly when test stimuli are presented in the presence of background noise. Other recent advances in sound processor technology include enhancements in music quality, telephone communication, and connectivity to Bluetooth and streaming devices.
Improved Outcomes
Clinical trials with the Nucleus Hybrid and MED-EL EAS have facilitated changes in the way clinicians evaluate and consider patients for CI candidacy. First, results with these devices demonstrate that patients with preoperative residual hearing and greater preoperative speech recognition skills can receive improved hearing from a CI; particularly when electric-acoustic hearing is combined with use of a hearing aid in the contralateral ear (Roland et al., 2016). These clinical trial results demonstrate the value of preserving residual hearing with cochlear implants, which is, incidentally, also possible with other electrode arrays (Arnoldner et al., 2010; Hassepass et al., 2015; Hunter et al., 2016; Skarzynski et al., 2016; Sweeney et al., 2016; Wanna et al., 2015). The ability to preserve portions of the cochlea increases the likelihood that clinicians will recommend a CI to patients who have more residual hearing than they would have in the past, even if the patient does not meet criteria for a hybrid device. This is because new electro-acoustic sound processor technologies are not limited for use with hybrid patients; patients with preserved low frequency hearing who received non-hybrid arrays also may benefit from this technology.
Second, the Hybrid and EAS clinical trials included more difficult test materials than those traditionally used with CI recipients. Gifford, Shallop, & Peterson (2008)  found that traditional measures, such as HINT sentences in quiet, often resulted in ceiling effects and did not agree with other test measures. As a result, the Minimum Speech Test Battery (MSTB) was developed in 2011 as a tool for evaluating implant candidacy in adults. The MSTB includes a recommended battery that contains AzBio Sentences in quiet, AzBio sentences in noise at either +5 or +10 dB signal to noise ratio, CNC Monosyllabic Words in quiet (Peterson & Lehiste, 1962), and the BKB SIN test (Etymotic Research, 2005). Recently, a group of professionals convened to develop a MSTB for children. As with the adult MSTB, this battery will include a recommendation to present recorded materials, and it will include an assessment of speech in noise. It will additionally include an assessment of speech recognition at a reduced presentation level of 45 dBA (Uhler, K. personal communication, April 2016).
Necessary Considerations
There are both advantages and disadvantages associated with modifying current CI test batteries. Inclusion of additional test measures provides greater insight into the strengths and weaknesses of the listener. However, such modification seems to have resulted in greater confusion among CI centers regarding what presentation level should be used, which test procedures should be used, and if/when test stimuli should be presented in quiet or in noise. Additionally, there seems to be increased confusion among non-CI professionals regarding when it is appropriate to refer an adult or child for a CI evaluation.
Several responsibilities come about when one decides to administer more difficult test materials to evaluate candidacy for a CI. One responsibility is a need to clearly define the test protocol used to determine candidacy, and another responsibility is a need to follow protocols consistently with all patients, regardless of the patient's insurer. It is the clinician's responsibility to counsel patients and their families about the potential risks and benefits of cochlear implantation. Additionally, clinicians should look closely at variables that affect the decision to recommend the implant, including the anticipated outcome, the patient's quality of life, bilateral hearing aid benefit, cognitive status, and speech and language skills. Therefore, it is more important than ever to involve other professionals in the pre-operative decision-making process, such as psychologists, counselors, and speech-language pathologists.
Expansion in Pediatric Cochlear Implant Candidacy Does Not Necessarily Equal Increased Access and Use
Utilization Rates
Despite these recent changes in CI candidacy and the well-documented benefit and cost effectiveness of cochlear implantation for children and adults, utilization rates for CIs in the United States remain quite low. This is especially true for the pediatric population when compared with other developed countries of the world. Utilization by children in the United States who have the hearing profile of a CI candidate is estimated to be 50% compared with pediatric utilization rates of 90% or greater in European countries that have newborn hearing screening and well-established CI programs in place (Sorkin & Buchman, 2015). Adult CI utilization in the United States is even poorer, and is estimated to be 5–7% of eligible individuals, which is comparable to other developed countries of the world (Sorkin & Buchman, 2015).
The main reasons people who could benefit from a CI do not receive one include low awareness of CIs and the absence of a robust referral network. In most developed countries with CI programs in place, children with profound hearing loss are identified as CI candidates through newborn hearing screening programs. These children enter the early intervention system promptly, and parents receive information on the full range of treatment options for their child in a timely manner. This is in contrast to parents of children identified with lesser degrees of hearing loss, who report that they are not consistently provided with information on CIs when selecting a communication option for their children (Sorkin & Zwolan, 2008). Rather than delivering comprehensive, evidenced-based information on language development options, the United States' system tends to be heavily influenced by the individual state agencies' approaches to deafness, as well as by the beliefs of the individual early intervention professional working with the family. This is quite different from the referral process in Europe and in certain other areas of the world, most notably Australia, where an estimated 98% of children age 3 and under who are deemed candidates for a cochlear implant receive one (Sorkin & Buchman, 2015).
Utilization of CIs by adults with the appropriate audiological profile is low everywhere—even in countries with high pediatric utilization. This is attributed to the lack of screening for adults and the fact that many hearing aid dispensers and audiologists are unfamiliar with current CI indications and outcomes. Despite the fact that audiologists play an important role in providing information to patients, anecdotal information provided by adults indicates that individuals with severe to profound hearing loss (who are using hearing aids) are not being consistently referred to CI centers for evaluation. Given that more residual hearing and shorter periods of deafness are associated with better CI outcomes, it is critical that hearing health care professionals proactively provide information about cochlear implants to their patients. Clinicians should encourage consideration of a CI evaluation for any patient with moderate-to-profound hearing loss whose aided comprehension scores meet, or are close to, the candidacy criteria noted above.
Misperceptions Regarding Utilization
There is a perception that cochlear implantation is not commonly covered by health insurance in the United States and that this is the reason for low utilization. In the United States, private (employer-based) insurance, as well as public health programs, typically cover the implant device, the related surgical costs, and audiological and other therapeutic follow-up (Sorkin, 2013). Coverage is available from an estimated 90% of employer plans, as well as Medicare and Medicaid; hence, insurance does not appear to play a significant role in CI under-utilization.
Audiologists, SLPs, and other professionals involved in hearing and general health care of children and adults with moderate-to-profound hearing loss need to play a key role in improving public knowledge and perceptions about cochlear implantation. Unfortunately, most children born with profound hearing loss are still implanted after the 12–18 month “window of opportunity” for optimal performance with a CI (P. Trautwein, Cochlear Americas, personal communication, April, 2016). Additionally, most adults wait an average of 12 years to receive a CI once they become candidates (Balkany et al., 2007; Parkinson et al., 2002). Thus, it appears there is great room for improvement in regards to the timely provision of information to patients and their families regarding cochlear implants.
In summary, many positive changes in CI outcomes have been facilitated by newborn hearing screening and earlier identification of hearing loss in children. This now routine practice has made it possible for deaf children to be identified soon after birth, to be fit with hearing aids soon after identification, and to begin the process of being evaluated for a CI early so they can receive intervention around their first birthday. It is essential for audiologists and other hearing health care professionals to be familiar with current candidacy guidelines and implantation options, as they are the key players for referring clients of all ages to cochlear implant centers in a timely manner. The ASHA web site has more information on cochlear implants (http://www.asha.org/public/hearing/Cochlear-Implant/) and it is an excellent source of information for audiologists, SLPs, parents, and adult clients. Other information, such as new developments and recent changes in candidacy, can be found on the websites of the three manufacturers who have FDA-approved devices: www.advancedbionics.com, www.cochlear.com, and www.medel.com. Additionally, Information regarding current studies to expand criteria can be obtained at www.clinicaltrials.gov.
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Table 1. Historical Expansion of FDA Guideline for Cochlear Implantation*
Historical Expansion of FDA Guideline for Cochlear Implantation* ×
Criteria 1985 1990 1998 2000 2014
Age of Implantation Adults '18 yrs + Adults & Children 2 yrs + Adults & Children 18 months + Adults & Children 12 months + Adults only for Hybrid
Onset of hearing loss Post-linguistic • Post-linguistic adults • Adults & Children Pre-& Post- Linguistic • Adults & Children Pre- & Post-Linguistic • Adults & Children
• Pre- & Post-linguistic children Pre- & Post-Linguistic
Degree of hearing loss Profound Profound • Severe-Profound Adults • Severe-Profound Patients 2 yrs + • Nucleus Hybrid: Normal-to-moderate in low frequencies
• Profound Children • Profound Children <2 years • Severe-Profound loss in mid to high frequencies
• Adults: Bilateral moderate to profound hearing loss in the low frequencies and profound (≥90 dB HL) loss in mid-to-high frequencies
Speech scores 0% 0% 40% or less • Sentence score 50% or less in ear to be implanted, 60% or less in the best aided condition • CNC word score >10%, but less than 60% in ear to be implanted;
• <80% CNC words in contralateral ear
* Based upon candidacy criteria for the Nucleus Cochlear Implant System, which has the broadest CI candidacy of the three cochlear implant devices approved for use in the US by the FDA. The first data row indicates which age demographic had a change in candidacy in that year.
Based upon candidacy criteria for the Nucleus Cochlear Implant System, which has the broadest CI candidacy of the three cochlear implant devices approved for use in the US by the FDA. The first data row indicates which age demographic had a change in candidacy in that year.×
Table 1. Historical Expansion of FDA Guideline for Cochlear Implantation*
Historical Expansion of FDA Guideline for Cochlear Implantation* ×
Criteria 1985 1990 1998 2000 2014
Age of Implantation Adults '18 yrs + Adults & Children 2 yrs + Adults & Children 18 months + Adults & Children 12 months + Adults only for Hybrid
Onset of hearing loss Post-linguistic • Post-linguistic adults • Adults & Children Pre-& Post- Linguistic • Adults & Children Pre- & Post-Linguistic • Adults & Children
• Pre- & Post-linguistic children Pre- & Post-Linguistic
Degree of hearing loss Profound Profound • Severe-Profound Adults • Severe-Profound Patients 2 yrs + • Nucleus Hybrid: Normal-to-moderate in low frequencies
• Profound Children • Profound Children <2 years • Severe-Profound loss in mid to high frequencies
• Adults: Bilateral moderate to profound hearing loss in the low frequencies and profound (≥90 dB HL) loss in mid-to-high frequencies
Speech scores 0% 0% 40% or less • Sentence score 50% or less in ear to be implanted, 60% or less in the best aided condition • CNC word score >10%, but less than 60% in ear to be implanted;
• <80% CNC words in contralateral ear
* Based upon candidacy criteria for the Nucleus Cochlear Implant System, which has the broadest CI candidacy of the three cochlear implant devices approved for use in the US by the FDA. The first data row indicates which age demographic had a change in candidacy in that year.
Based upon candidacy criteria for the Nucleus Cochlear Implant System, which has the broadest CI candidacy of the three cochlear implant devices approved for use in the US by the FDA. The first data row indicates which age demographic had a change in candidacy in that year.×
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