Related Experiment Video
Updated: Feb 10, 2026

Systematic Hearing Performance Evaluation Process for Adolescents with Cochlear Implantation at Early Ages
Published on: March 24, 2023
Cochlear implantation in infants below 12 months of age
Richard T Miyamoto1, Bethany Colson1, Shirley Henning1
1Department of Otolaryngology-Head and Neck Surgery, DeVault Otologic Research Laboratory, Indiana University School of Medicine, Indianapolis, IN, USA.
Insights
Cochlear implantation is safe and effective for infants under 12 months. This early intervention supports age-appropriate language development, offering a vital solution for pediatric hearing loss.
Area of Science:
- Pediatric Otolaryngology
- Developmental Pediatrics
- Auditory Neuroscience
Background:
- Newborn hearing screening identifies deafness early, making cochlear implantation a critical intervention when hearing aids fail.
- Early cochlear implantation is crucial as age at implantation significantly impacts language outcomes.
- Current FDA guidelines previously excluded infants under 12 months, necessitating further safety and efficacy research.
Purpose of the Study:
- To evaluate the safety and efficacy of cochlear implantation in infants younger than 12 months.
- To gather long-term language development data for this pediatric cohort.
- To assess the feasibility of using a minimally invasive surgical technique in very young children.
Main Methods:
- A prospective clinical trial involving infants under 12 months who failed hearing aid trials.
- Use of a preferential listening paradigm to assess speech sound-object association learning.
- Long-term language assessments, including the Peabody Picture Vocabulary Test (PPVT).
Main Results:
- No surgical or anesthetic complications were reported in the study cohort.
- Infants demonstrated listening skill development comparable to normal-hearing peers.
- Long-term data indicated that many infants achieved age-appropriate language skills.
Conclusions:
- Cochlear implantation in infants under 12 months is a safe and effective procedure.
- Early implantation supports the development of age-appropriate language skills, as evidenced by PPVT results.
- This study supports expanding cochlear implantation candidacy to younger infants.
Objectives:
To provide safety and efficacy data on infants implanted below 12 months of age.
Methods:
With the wide application of newborn hearing screening programs, infants with deafness are being identified at birth. When a hearing aid trial fails, cochlear implantation is the only option to restore hearing. Mounting evidence suggests that age at implantation is a strong predictor of language outcomes. Using the minimally invasive surgical technique we have employed for nearly two decades, a limited clinical trial was initiated in the year 2000 because this age limitation fell outside of FDA guidelines. The infants were initially assessed using the preferential listening paradigm to confirm that they could learn associations between speech sounds and objects. Sufficient time was allowed to pass to administer more traditional language measures.
Results:
No surgical or anesthetic complications occurred in this group of infants. The pattern of listening skill development mirrored that seen in normal hearing infants. Long-term language assessments using the Peabody Picture Vocabulary Test (PPVT) and other measures have demonstrated that many of infants achieved age appropriate language skills.
Conclusion:
Cochlear implantation in children less than 12 months of age is safe and efficacious as demonstrated by long-term PPVT language data.
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