Pediatric hearing loss is far more common than many recognize, standing as one of the most frequent congenital conditions diagnosed in the United States. Data from the Centers for Disease Control and Prevention (CDC) shows that approximately 1 to 2 out of every 1,000 infants who undergo a newborn hearing screening have a detectable level of hearing loss. Thanks to universal newborn hearing screenings, which were implemented at the federal level in 1999, over 98 percent of U.S. newborns undergo a hearing screening. For most children with hearing loss, they can benefit from traditional hearing aids. For children with more severe degrees of hearing loss, a hearing aid is insufficient to support language development. For these children, a cochlear implant is a more appropriate intervention.
Historically, the Joint Committee on Infant Hearing (JCIH) has recommended following 1-3-6 guidelines to promote the best outcomes for children with hearing loss: screening by 1 month, diagnosis by 3 months, and initiation of appropriate intervention by 6 months. For decades, despite the known importance of early access to sound for children with hearing loss, the minimum age for a child to receive a cochlear implant per the Food and Drug Administration (FDA) was 12 months. This meant that children spent most of the critical time period for language development without meaningful access to sound. Some children were able to receive a cochlear implant at younger ages than the approved FDA criteria through “off-label” use. Data from these children demonstrated that earlier access to a cochlear implant results in better speech and language outcomes compared to children who received a cochlear implant at an older age. Fortunately, the candidacy criteria for pediatric cochlear implantation have recently expanded, supporting earlier access for children who may benefit from this technology.
Key regulatory updates
- Lowering the age limit: The minimum age for implantation has dropped from 12 months to 7 months for MED-EL Corporation devices. Children implanted as young as 7 months do not have higher rates of intraoperative complications, postoperative complications, or revision surgeries than older children. Additionally, children who have their cochlear implants activated before 9 months achieve auditory and receptive language skills that mirror their typically hearing peers. Those who had their device activated even a few months older (for example, at 11 or 12 months) demonstrated language delays and did not fully catch up to their typically hearing peers.
- Broadening audiometric criteria: Candidacy now extends to children 1 year and older with moderately severe to profound sensorineural hearing loss (SNHL) and children 6 years and older with moderate to profound SNHL for MED-EL Corporation devices. This change acknowledges that many children with seemingly “better” audiometric thresholds were not having their needs met with traditional hearing aids. These children often do better with a cochlear implant, which is able to provide better access to mid- and high-frequency sounds that are critical for speech understanding.
- Including single-sided deafness (SSD): Children 5 years and older with SSD can now receive a cochlear implant. This device has been demonstrated to improve sound source localization, reduce listening effort, and provide better hearing in noisy environments.
With so many changes to candidacy and device labeling, it can be challenging for providers to know when to refer a child for a cochlear implant candidacy evaluation. Recently, the Cochlear Implant Patient Access to Hearing (CI-PATH) published new referral guidelines that are consistent with the latest candidacy criteria. The three individual criteria for referral are:
- Four-frequency pure-tone average ≥ 60 dB HL, or
- Aided Speech Intelligibility Index (SII) ≤ 0.6, or
- Aided word recognition score ≤ 60 percent
Children who meet any of the above criteria in at least one ear should be referred for a cochlear implant candidacy evaluation. This will allow for a more thorough evaluation to determine if their listening needs are being met with traditional hearing aids, or if a cochlear implant would be a more appropriate intervention.
Samantha P. Scharf is an audiologist.
