A multicenter study published in The Laryngoscope finds strong efficacy outcomes for cochlear implantation in children as young as 7 months and in those with residual hearing, lending clinical weight to calls for updated FDA candidacy criteria.
A new multicenter study is adding to the body of evidence that current FDA pediatric cochlear implant (CI) candidacy criteria may be leaving eligible children behind — particularly those implanted at younger ages and those with residual hearing. The findings, published in The Laryngoscope, support broadening indications beyond the thresholds that have largely remained unchanged for three decades.
Under current FDA criteria, children under 2 years of age must have a bilateral profound sensorineural hearing loss (SNHL) to qualify for cochlear implantation, while children 2 years and older must present with a bilateral severe-to-profound SNHL. FDA-approved candidacy has changed little over the past three decades.
The study, led by Young et al (2026), used a non-randomized, single-subject, repeated-measures design with both prospective and retrospective patient cohorts. There were 28 prospective children and 209 retrospective patients included, all of whom received Med-El cochlear implants before the age of 6 years. Efficacy was assessed using speech perception tests administered before and after implantation, with hearing aids used as the comparison baseline.
Strong Efficacy Outcomes Across Both Cohorts
The results were notable for both groups. Among prospective patients, 80.6% met the study’s efficacy goals, while 88% of retrospective subjects with 12-month efficacy data also met those goals.
Based on these outcomes, the authors conclude that it is appropriate to expand pediatric CI indications to include two groups not currently covered under FDA criteria: children aged 7–11 months with profound SNHL, and children aged 12–71 months with residual hearing.
Mounting Evidence for Earlier Implantation
The study adds clinical data to a growing literature demonstrating the developmental advantages of earlier intervention. Prior research has shown significantly better language development and speech perception for children implanted before vs. after 12 months of age. The authors cite work by Young & Iler Kirk (2024) and Chweya et al (2021), among others, in framing the urgency of revisiting candidacy standards.
The push to expand cochlear implant access has been a recurring theme in the audiology and otolaryngology communities, with clinicians and researchers pointing to a disconnect between evolving clinical evidence and regulatory standards that have not kept pace.
Implications for Audiology Practice
For audiologists involved in CI evaluation and counseling, the study underscores the importance of identifying candidates early and remaining informed about the evolving evidence base. As the field continues to build a case for updated FDA criteria, clinicians may face increasing questions from families of young children — particularly those under 12 months — about implantation timelines and eligibility.
The study was published in The Laryngoscope and was summarized by the American Academy of Audiology. The full citation is: Young NM, Thomas D, Hoff SR, et al. Multicenter study results on expanded indications in Med-Elpediatric cochlear implant population. The Laryngoscope. 2026. https://doi.org/10.1002/lary.70840
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‘Residual hearing’ is an extremely vague term. What is the definition used for this article?