Audiologic Contributions to Pediatric Cochlear Implants Twenty-eight years have passed since the first American child received a cochlear implant in 1980. The implant, the single-electrode system engineered at the House Ear Institute, also was the first cochlear implant to undergo U.S. Food and Drug Administration (FDA) clinical trials in adults. The first child to receive an ... Features
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Features  |   March 01, 2008
Audiologic Contributions to Pediatric Cochlear Implants
Author Notes
  • Laurie S. Eisenberg, is an audiologist at the House Ear Institute (HEI), where she heads the section on Pediatric Hearing Loss and Auditory Perception. Prior to her doctoral studies, she spent 10 years at HEI on projects related to first-generation cochlear implants and the ABI. She has been on the faculty of the UCLA School of Medicine and rejoined HEI as a scientist in the Children’s Auditory Research and Evaluation (CARE) Center. Contact her at leisenberg@hei.org.
    Laurie S. Eisenberg, is an audiologist at the House Ear Institute (HEI), where she heads the section on Pediatric Hearing Loss and Auditory Perception. Prior to her doctoral studies, she spent 10 years at HEI on projects related to first-generation cochlear implants and the ABI. She has been on the faculty of the UCLA School of Medicine and rejoined HEI as a scientist in the Children’s Auditory Research and Evaluation (CARE) Center. Contact her at leisenberg@hei.org.×
  • Karen C Johnson, is a pediatric audiologist with 25 years of experience in the assessment and habilitation of infants with hearing loss. She has directed the audiology programs at Texas Children’s Hospital in Houston, Children’s Memorial Medical Center in Chicago, and Kosair Children’s Hospital at the University of Louisville. In 2002, Johnson joined the research staff of the HEI’s CARE Center. Contact her at kjohnson@hei.org.
    Karen C Johnson, is a pediatric audiologist with 25 years of experience in the assessment and habilitation of infants with hearing loss. She has directed the audiology programs at Texas Children’s Hospital in Houston, Children’s Memorial Medical Center in Chicago, and Kosair Children’s Hospital at the University of Louisville. In 2002, Johnson joined the research staff of the HEI’s CARE Center. Contact her at kjohnson@hei.org.×
Article Information
Hearing Aids, Cochlear Implants & Assistive Technology / Features
Features   |   March 01, 2008
Audiologic Contributions to Pediatric Cochlear Implants
The ASHA Leader, March 2008, Vol. 13, 10-13. doi:10.1044/leader.FTR1.13042008.10
The ASHA Leader, March 2008, Vol. 13, 10-13. doi:10.1044/leader.FTR1.13042008.10
Twenty-eight years have passed since the first American child received a cochlear implant in 1980. The implant, the single-electrode system engineered at the House Ear Institute, also was the first cochlear implant to undergo U.S. Food and Drug Administration (FDA) clinical trials in adults. The first child to receive an implant in the United States in 1980 was a 10-year-old boy who was congenitally deaf and communicated exclusively through sign language. The following year, the first preschool-age child received an implant—a 3-year-old girl who had been deaf for six months due to meningitis and whose parents hoped that she would remain an oral communicator (for the first publications, see Eisenberg & House, 1982; Eisenberg, Berliner, Thielemeir, Kirk, & Tiber, 1983). The implantation of children was fraught with controversy and formidable adversaries. This tumultuous reaction was not surprising, however, because a similar reaction had occurred earlier with the implantation of adults.
U.S. investigations into cochlear implants for deaf adults were initiated in the 1960s, primarily in California, despite strong disapproval by the scientific community. The early pioneers were otologists—William F. House (House Ear Institute), F. Blair Simmons (Stanford University), and Robin Michelson (University of California, San Francisco). The controversy stemmed from basic scientists’ belief that initial experiments should be carried out on animals. In contrast, clinical investigators were convinced that early trials should be conducted with adults who were deaf, and who up until that time could not be helped by medical intervention. Scientists applied a yardstick of normal hearing in defining successful cochlear implant outcomes, but clinical practitioners held the view that enhanced audition could only be gauged from a perspective of no usable hearing. It is noteworthy that the clinical perspective has changed over the years as performance with a cochlear implant has improved. Current studies with children are, in fact, now using control groups of children with normal hearing (cf., Childhood Development after Cochlear Implantation [CDaCI] national study; Fink Wang, Visaya, Niparko, Quittner, Eisenberg, Tobey, & the CDaCI Investigative Team, 2007).
The Early Years of Cochlear Implantation
FDA began regulating medical devices in 1980. The regulations required that medical devices undergo clinical trials to obtain marketing approval. These trials were expanded to include centers around the United States. Commercial manufacturers began to market cochlear implants and ultimately became the sponsors of large-scale, multicenter investigations. FDA clinical trials of multichannel devices followed soon after those of single-electrode systems, with pediatric trials following adult trials. At the same time, research studies were being initiated at the University of Iowa (directed by Bruce Gantz), Central Institute for the Deaf (CID, directed by Jean Moog and Ann Geers), and Indiana University School of Medicine (directed by Richard Miyamoto and Mary Joe Osberger) through funding by the National Institutes of Health to determine efficacy of the cochlear implant in adult and pediatric populations and to compare the different cochlear implant devices independently of the manufacturers’ claims.
During the first pediatric clinical trial (with a single-electrode device), the average age at time of implant was approximately 8 years, with the majority of children communicating through sign language (Berliner, Eisenberg, & House, 1985). From what is known today, cochlear implantation at a later age (i.e., after 4 years of age), combined with long-term auditory deprivation and little or no auditory-based language skills, does not generally result in spoken language development.
The subsequent trial with the first multichannel implant (Nucleus 22, instigated in 1986) avoided some of the shortcomings of the single-electrode investigation and required that implant teams initially select children with the highest potential for success. These criteria included postlingual deafness or prelingual deafness with short duration of deafness combined with a family commitment to have the child participate in oral communication educational programs (based on recommendations by Northern, Black, Brimacombe, Cohen, Eisenberg, Kuprenas, Martinez, & Mischke, 1986). These criteria were soon relaxed, and today children with severe to profound hearing loss who meet general medical and audiological criteria are considered appropriate candidates for the cochlear implant.
The Audiologist’s Role
Throughout the recent history of this technology, the audiological work-up has been fundamental to the clinical management of children with cochlear implants. Audiologists have maintained a highly visible presence throughout the evolution of cochlear implants. As a result of this presence, the relationship between the otologist and audiologist has changed from that of physician and technician to a more professional collaborative partnership. The otologist performs the surgery and manages the medical aspects, whereas the audiologist helps determine candidacy, maps the device, and carries out post-implant follow-up assessments. In addition, audiologists have played a critical role in multicenter longitudinal investigations, contributing substantially to the research literature. Audiologists also have been involved in designing evaluation protocols and developing speech perception assessment tools.
Determination of candidacy and demonstration of successful outcomes with cochlear implants depend to a large extent on speech perception data. Assessment of speech perception in the pediatric implant population is essential because these data, in combination with other domains of communication (speech production, receptive language, and expressive language) are essential for establishing habilitation guidelines. In children, the speech perception test battery must take into consideration the child’s age (chronological, developmental, and language), communication modes, and auditory processing skills. For this reason, assessment test batteries often include measures that vary from closed-set to open-set response formats, from live voice to recorded presentation, and from auditory-visual to auditory-only administration. With each successive generation of implant technology, user performance has been shown to improve steadily, necessitating further development of clinically relevant speech perception measures to determine candidacy and monitor performance.
Development of Tools for Speech-Perception
Because early cochlear implant trials were conducted exclusively on individuals with profound hearing loss, most cochlear implant users were unable to be assessed with open-set speech recognition tests, particularly during the early years of clinical trials when the first-generation devices were fairly crude and existing speech perception measures yielded scores near the floor of standard performance. As an interesting historical note, the first adult patients at the House Ear Institute being considered for implantation were fitted with high-powered body hearing aids and subjected to six months of aural rehabilitation. Training materials were developed for this purpose, as were several closed-set measurement tools (a rhyme test and an environmental sounds test). A number of those early patients performed so well with hearing aids as to render implant surgery unnecessary. Those individuals showing no progress with hearing aids were then referred for cochlear implant surgery.
The early 1980s saw the development of new assessment batteries to establish cochlear implant candidacy and to track performance over time. The first batteries for adults were developed by researchers from the University of California, San Francisco (Owens, Kessler, Raggio, & Schubert, 1985; Owens, Kessler, Raggio, & Schubert, 1982) and the University of Iowa (Tyler, Preece, & Tye-Murray, 1983).
A decade later early test batteries for pediatric assessment were developed by researchers from the Central Institute for the Deaf (CID) and Indiana University School of Medicine. The CID test battery (described in Geers, 1994, and Kirk, 2000) was composed of auditory-only and auditory-visual measures. In addition, this battery was hierarchical, beginning with detection and progressing to auditory-only, open-set word recognition. Children were required to achieve a criterion score on one test before progressing to the next. One early test from this battery, the Early Speech Perception (ESP) Test (Moog & Geers, 1990), has continued to enjoy widespread clinical use because it can be administered to young children (2 years and older). The ESP test was derived from the original Monosyllable Trochee Spondee (MTS) test developed by Erber and Alencewicz (1976). The ESP was particularly useful as an early test for young children because it differentiated between children who were “pattern perceivers” versus “spectral perceivers.” A “pattern perceiver” could identify the correct stress pattern of words but could not identify the word. A “spectral perceiver” could identify the words (i.e., perceive the frequency components required to recognize the linguistic unit). With first-generation multichannel implants, a child who at most was a “pattern perceiver” was considered to be a candidate for a cochlear implant. Children who were “spectral perceivers” were not considered to be implant candidates.
The investigative team at Indiana University School of Medicine assembled two speech perception test batteries—one for preschool-age children and the other for school-age children (see Kirk, Diefendorf, Robbins, & Pisoni, 1997; Kirk, 2000). Depending on the age of the child, all tests within the specified battery were attempted and no assumptions were made concerning the progression of auditory skill development. The Lexical Neighborhood Test (LNT) and Multisyllabic Neighborhood Test (MLNT) are two of the more recent additions to this battery (Kirk, Pisoni, & Osberger, 1995). These two tests represent an important advancement in the field of pediatric speech perception because they tap into higher-level cognitive/linguistic processes that are involved in the word-recognition process. The implant manufacturers have typically incorporated the MLNT and LNT into the more recent clinical trial protocols.
Evolving from the CID and Indiana University School of Medicine pediatric batteries is the speech perception battery developed for the recent CDaCI multicenter study (Eisenberg, Johnson, Martinez, Cokely, Tobey, Quittner & the CDaCI Investigative Team, 2006). Combining the attributes of the two earlier batteries, the CDaCI speech recognition battery adopted a hierarchical approach similar to that used by CID, but allocated specific measures to preschool and school-age protocols as described by Indiana University School of Medicine. For each measure, a criterion score must be achieved before progressing to the next level of difficulty. Testing is discontinued when a ceiling score is achieved on two consecutive administrations of a particular speech perception measure. The advantage of the hierarchical approach is that the audiologist may focus on tests that are neither too easy nor too difficult for a given test interval. The disadvantage of this approach, at least in a large-scale investigation, is that data points are missing over time for specific test measures. To deal with this challenge statistically, a speech recognition cumulative index has been developed whereby the measures are combined and outcomes tracked longitudinally to target different stages of auditory development in the CDaCI sample (Wang, Eisenberg, Johnson, Fink, Tobey, Quittner & the CDaCI Investigative Team, 2008).
Infants aged 12 months and even younger are being implanted around the world. One of the new challenges confronting pediatric audiologists is to be able to track speech perception in infants and toddlers with hearing loss. New endeavors in clinical test development have been initiated in recent years (e.g., Dawson, Nott, Clark, & Cowan, 1998; Eisenberg, Martinez, & Boothroyd, 2007; Daemers, De Beukelaer, De Saegher, De Ceulaer, & Govaerts, 2006) that incorporate visual reinforcement and conditioned play activities. It is hoped that clinicians will soon have widespread access to these new assessment tools.
New Frontiers
The first auditory brainstem implant (ABI) was placed on the cochlear nucleus in 1979 in an adult patient with neurofibromatosis type 2 (Edgerton, House, & Hitselberger, 1982). Today the ABI has become a routine surgical procedure for this specific group of adults. In December 2005, the first American child received an ABI at age 3. However, the actual surgery was performed in Verona, Italy, because the FDA had not yet approved this device for children. The otologist who performed the surgery, Vittorio Colletti, pioneered the procedure for non-NF2 adults and children who either are not candidates for a cochlear implant (e.g., auditory nerve agenesis) or are not successful cochlear implant users (Colletti, Carner, Miorelli, Guida, Colletti, & Fiorino, 2005). The research team at House Ear Institute and the clinical team at Children’s Hear Center in Birmingham, Ala., had an opportunity to evaluate this child in 2006 (Eisenberg, Johnson, Martinez, DesJardin, Stika, Dzubak, Mahalak, & Rector, 2008). Auditory assessment was challenging in this case because the child’s early auditory performance was shown to be at a lower level than what is typically seen with cochlear implant recipients and was reminiscent of the early single-electrode days. Impressively, this child is now showing slow but steady progress in developing auditory skills with the ABI. Discussions are underway to establish a pediatric ABI clinical trial in the United States under FDA guidelines, which may be initiated in the next several years.
It is notable that researchers in Europe have begun investigating an auditory midbrain implant in adults by placing an electrode array on the inferior colliculus in hopes that that this device might provide better performance than the ABI (Colletti, Shannon, Carner, Sacchetto, Turazzi, Masotto et al., 2007; Lim, Lenarz, Joseph, Battmer, Samii, Samii et al., 2007). If outcomes from this procedure are proven to be successful in adults—and perhaps even more successful than the ABI—this technology might someday be applied to a select group of children. This type of investigation would certainly present new challenges to audiologists in terms of candidacy, mapping, and follow-up, as has been the case with the introduction of each new generation of implant technology throughout the history of auditory implants.
A Continuing Evolution
At each step in the evolution of cochlear implants, the past has been revisited before progressing forward. Evolution has been cyclical, with heavy reliance on past experience and forward movement to new endeavors and new technologies. The audiologist’s role has been at the forefront of this process and remains essential to patient management. Quantification of outcomes, development of new speech perception tests, and ongoing clinical investigation typically fall under the purview of the audiologist and inevitably will continue to do so in the future.
Acknowledgments

Support comes from the National Institute on Deafness and Other Communication Disorders of the National Institutes of Health: R01DC006238 (L.S. Eisenberg, Principal Investigator), R01DC000064 (R.T. Miyamoto, Principal Investigator), R01DC004433 (Y.S. Sininger, Principal Investigator), R01DC004797 (J.K. Niparko, Principal Investigator), and R01DC008875 (K.I. Kirk, Principal Investigator).

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FROM THIS ISSUE
March 2008
Volume 13, Issue 4