Question
How Do MED-EL's Expanded Pediatric Cochlear Implant Indications Change Candidacy Criteria and Clinical Practice?
Answer
Background and Rationale for Expanding Indications
Pediatric cochlear implant indications changed very little over the decades, with incremental steps that were few and far between. Even after the significant expansion of research and professional standards from 2000 to 2020, clinicians widely agreed that FDA changes had not gone far enough. MED-EL's newly approved expanded indications represent a major shift in candidacy criteria - encompassing changes to age, hearing thresholds, and speech recognition standards across the full range of pediatric patients, from infants to older children. The primary goal of this expansion is to align FDA indications with current clinical practice and evidence, ultimately improving cochlear implant referral rates, insurance coverage, and CI uptake. As presented at the 2024 National Early Hearing Detection and Intervention conference, only 50% of eligible children in the United States receive a cochlear implant, compared to approximately 90% in other developed countries. These new indications are intended to close that gap.
New Candidacy Criteria by Age Group
The expanded indications introduce distinct criteria across three key pediatric age groups. For children aged 7 to 11 months, bilateral cochlear implantation is indicated for profound sensorineural hearing loss defined by a three-frequency pure tone average (PTA3) of 90 dB HL or worse at 500, 1000, and 2000 Hz, with a lack of progress or plateau in auditory skill development. Research supports access to hearing before nine months of age as a critical developmental milestone; studies using tests of functional listening skills, language development, and speech production have demonstrated that children implanted before nine months outperform those implanted at nine months or older. For children aged 1 to 5 years, bilateral indications include a PTA3 of 55 dB HL or worse and thresholds of 70 dB HL or worse at 2000 to 8000 Hz. Children without speech recognition should show a lack of auditory progress, while those with measurable speech recognition should score 40% or less on a developmentally appropriate word recognition test such as the ESP, MLNT, LNT, PBK, or CNC word lists. For children aged 6 years and older, MED-EL's criteria now align with adult expanded indications: a low-frequency PTA greater than 40 dB HL at 250, 500, and 1000 Hz; thresholds of 65 dB HL or worse at 3000 to 8000 Hz; and monosyllabic word recognition scores of 50% or less in the ear to be implanted, with scores of 60% or less in the contralateral ear for unilateral candidacy.
CI360 Referral Criteria and FDA Clinical Trial Outcomes
To help clinicians identify children who warrant a cochlear implant evaluation amid these expanded criteria, a working group of approximately 30 professionals developed the CI Path Initiative and its associated CI360 referral guidelines. These recommendations use a threshold of 60 across three measures: a four-frequency pure tone average of 60 dB HL or worse, an aided Speech Intelligibility Index (SII) less than 0.60, and an aided word recognition score of 60% or less. Meeting these criteria does not confirm cochlear implant candidacy; rather, it indicates that the child should be referred for a comprehensive CI evaluation. Research further underscores the urgency of timely referral: children need an aided SII of 0.65 or better for optimal language development, and waiting three or more years between meeting candidacy and receiving implantation has been associated with poorer outcomes. MED-EL's multicenter FDA clinical trial, which enrolled 247 children across eight U.S. cochlear implant centers, demonstrated high rates of clinical success. Over 86% of children met strict predefined performance goals by 12 months post-activation - including 91% of children implanted before 9 months of age and 93% of those with a preoperative PTA better than 90 dB HL. Importantly, children implanted before 12 months did not demonstrate higher rates of device-related complications than older children.
Clinical Considerations: Barriers, Family Counseling, and Multidisciplinary Care
Audiologists participating in the MED-EL clinical trial identified several recurring challenges in clinical practice. For very young infants, earlier access to newborn hearing screening programs enables comprehensive diagnostic testing - including ABR and other objective measures - from the earliest days of life, supporting confident clinical decision-making and multidisciplinary family support well before surgical candidacy is formally established. For school-age children with progressive or sudden hearing loss, a common barrier is the perception that a child is performing adequately. Many of these children rely heavily on visual cues, supports at school, and compensatory strategies that mask underlying auditory fatigue and language delays. Clinicians emphasized that the clinical goal is not to accept adequate performance, but to ensure children meet their full communicative and academic potential. Family hesitation remains one of the most significant obstacles to timely implantation, particularly when influenced by cultural beliefs, religious perspectives on surgical intervention, social media, or reassurance from well-meaning community members. Panelists underscored the importance of guiding families with clear, evidence-based information rather than pressure - building trust so that families feel equipped to make informed decisions and remain engaged in the process even when they are not immediately ready to proceed.
Implications for Referral and Interprofessional Collaboration
Clinical panelists consistently emphasized that improving cochlear implant access for children requires proactive, interprofessional outreach. Referring providers - including pediatricians, general ENT physicians, early interventionists, and community audiologists - do not need to be experts in candidacy criteria. Rather, they need to understand one core principle: if a child does not have sufficient access to sound through hearing aids to meet their full potential, a cochlear implant evaluation is warranted. Erring on the side of earlier referral yields more information for the entire medical team and ensures that children who are not yet candidates remain in the pipeline for monitoring. Panelists also noted that pediatricians and early interventionists may hold outdated assumptions - for example, that reliable audiological testing cannot be performed before age two - which can result in unnecessary delays. Reinforcing audiology's role in the care of any child presenting with speech or language delays, and establishing strong communication channels between CI centers and referring providers around individual patient outcomes, are essential steps toward increasing CI uptake and ensuring that more children have access to the technology and the hearing outcomes they deserve.
This Ask the Expert is an edited excerpt from the course, Foster, B., Gross, A., Gonzalez, V., Park, L., & Sanchez, C. (2024). Oh Baby! New Expanded Indications for Children with MED-EL Cochlear Implants: A MED-EL Signature Series Webinar. AudiologyOnline. https://www.audiologyonline.com/audiology-ceus/course/oh-baby-new-expanded-indications-41914
