New Cochlear Implant Candidacy Criteria for Children: FDA Age Expansion and CI 3-60 Referral Guidelines Explained

19 Aug New Cochlear Implant Candidacy Criteria for Children: FDA Age Expansion and CI 3-60 Referral Guidelines Explained

MedicalResearch.com: How does a cochlear implant work?

Dr. Scharf: Cochlear implants are indicated for individuals with moderate-to-profound sensorineural hearing loss (SNHL) who receive limited benefit from hearing aids. Traditional hearing aids amplify sound and rely on a well-functioning inner ear to detect and effectively transmit the signal farther along the auditory pathway. For individuals with moderate to severe hearing loss, distortion of the signal makes it difficult to understand speech.

A cochlear implant is an effective hearing technology for individuals with moderate to severe hearing loss. The cochlear implant system includes an internal and an external component. The external component, called the audio processor, detects the sound, converts the sound from an acoustic signal to an electric signal, and transmits the signal to the internal component. The internal component includes an electrode array that is surgically placed into the inner ear. The stimulation from the cochlear implant bypasses the damaged or non-functioning inner ear and stimulates the auditory nerve directly. According to the National Institute on Deafness and Other Communication Disorders, with listening experience, cochlear implant recipients can experience significant improvements in their speech understanding.

MedicalResearch.com: What are the indications for implantation and how have they changed?

Dr. Scharf: In 2000, the approved minimum age for cochlear implantation was 12 months for children with bilateral profound SNHL. The approved minimum age was lowered to 9 months in 2020 and then to 7 months old in 2025. Early access to sound is vital for children to develop listening and spoken language. Importantly, cochlear implant surgery in children as young as 7 months is not associated with increases in surgical complications compared to older children, meaning this is a safe and effective option for this patient population.

Another recent change in the approved criteria for pediatric cochlear implantation includes the level of hearing loss for the ear to be implanted. Originally, the criterion was profound SNHL. In 2025, the criterion was expanded to include children with moderate hearing loss in the low frequencies and severe to profound hearing loss in the high frequencies. Approved criteria also include children with better hearing in the other ear, specifically those with asymmetric hearing loss (AHL) and single sided deafness (SSD). The current indications for the MED-EL Corporation device include:

• > 7 months old < 12 months with profound bilateral SNHL
• > 1 to < 6 years with moderately-severe to profound bilateral SNHL and a score < 40% on a developmentally appropriate test of word recognition
• > 6 to < 18 years with moderate to profound SNHL and score < 50% correct on a word recognition test in the ear to be implanted and <60% in the non-implanted ear on recorded monosyllabic word recognition
• > 5 years with SSD or AHL and a score < 5% on a developmentally appropriate monosyllabic word list in the ear to be implanted

MedicalResearch.com: Would you explain the 1-2-3 guidelines?

Dr. Scharf: In 2019, the Joint Committee on Infant Hearing (JCIH) reaffirmed the 1-3-6 guidelines that recommend that all infants receive a newborn hearing screening by 1 month of age, a diagnostic audiologic evaluation by 3 months of age, and initiation of appropriate intervention services by 6 months of age. The goal is to identify infants with hearing loss as soon as possible so they can begin intervention during the critical period of development. It is well established that children with hearing loss achieve better communication and language outcomes when hearing loss is identified and addressed early.

For programs that are able to meet the 1-3-6 guidelines, the JCIH recommends striving to accelerate this timeline to 1-2-3. This calls for a diagnostic evaluation by 2 months of age and initiation of appropriate intervention by 3 months of age. For families pursuing listening and spoken language, this allows for timely access to speech sounds through appropriately fit hearing technology and other supportive services. These guidelines are particularly important for infants with profound SNHL who receive little to no meaningful auditory access from hearing aids. The first year of life is a critical period of neural plasticity, and prolonged auditory deprivation can negatively affect auditory and spoken language development. The recent reduction in the FDA approved minimum age for cochlear implantation to 7 months helps bring device labeling closer to the timeline recommended by the JCIH.

MedicalResearch.com: Is there anything else you want to add?

Dr. Scharf: Recently, the Cochlear Implant Patient Access to Hearing (CI-PATH) published new guidelines for when to refer a child for a cochlear implant candidacy evaluation, which can easily be remembered as CI 3-60. The three individual criteria for referral are:

• 4-frequency Pure Tone Average ≥ 60 dB HL, or
• Aided Speech Intelligibility Index (SII) ≤ .6, or
• Aided word recognition score ≤ 60%

Children who meet any of the above criteria in at least one ear should be referred for a cochlear implant candidacy evaluation to best determine if their listening needs are being met with traditional hearing aids, or if a cochlear implant would be a more appropriate intervention. Overall, the expanded indications and referral guidelines were an important advancement for pediatric hearing healthcare. They help bring regulatory labeling more in line with the growing body of clinical evidence supporting earlier implantation and for broader degrees and configurations of hearing loss. This expansion gives more children the opportunity to receive meaningful auditory stimulation during the most important stages of speech, language, and cognitive development.

Disclosures: None disclosed.

Citations:
Scharf S, Richter ME, Park LR, Dillon MT. New Cochlear Implant Candidacy Criteria for Children. The Hearing Journal. 2026;79(8):4–7. https://doi.org/10.1097/01.HJ.0001248792.86348.f4

Joint Committee on Infant Hearing. Year 2019 Position Statement: Principles and Guidelines for Early Hearing Detection and Intervention Programs. Journal of Early Hearing Detection and Intervention. Accessed August 17, 2026.

Holder JT, Warner-Czyz AD, Park LR. Pediatric CI 3-60 Guideline: When to Refer Children for a Cochlear Implant Candidacy Evaluation. Ear & Hearing. 2026;47(5):1187–1196. https://doi.org/10.1097/AUD.0000000000001812

For a broader overview of how cochlear implant sound processor technology is expanding accessibility for children and adults with hearing loss, see this MedicalResearch.com overview of how cochlear implant technology is advancing for children.

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Last Updated on August 19, 2026 by Marie Benz MD FAAD