2027 Early Hearing Detection & Intervention Conference
March 22-24, 2027 • Bellevue, WA
3/17/2026 | 1:45 PM - 2:15 PM | New candidacy criteria for cochlear implants in children: Study results and FDA approval | City Terrace 9
New candidacy criteria for cochlear implants in children: Study results and FDA approval
Early Hearing Detection and Intervention (EHDI) guidelines recommend timely and appropriate intervention as early as possible, but what if hearing aids are not enough? Candidacy criteria for cochlear implants in children changed very little over the last 25 years, creating barriers to insurance coverage and cochlear implant access. In November 2025, the United States Food and Drug Administration (FDA) approved major changes to candidacy criteria for MED-EL cochlear implants in children. MED-EL conducted an FDA study to show the safety and efficacy of new criteria for children with the MED-EL Cochlear Implant System. The study included 247 children in two groups and showed clinical success in 81% of children in the first group and 88% of children in the second group. Children with clinical success improved on auditory skill development and speech recognition. The rate of serious complications was low in both groups, and children under 12 months old did not have more complications than children 12 months and older. This FDA approval includes children as young as 7 months old and children aged 12 months and older with less hearing loss. This presentation will discuss the FDA study, new candidacy criteria, and the importance of this approval for children of all ages.
- Participants will be able to identify the minimum age approved by the FDA for MED-EL cochlear implants.
- Participants will be able to define how new cochlear implant candidacy criteria align with EHDI initiatives for children with permanent hearing loss.
- Participants will be able to discuss expected outcomes from earlier cochlear implantation.
Presentation:
View Presentation File
Handouts:
Handout is not Available
Transcripts:
CART transcripts are NOT YET available, but will be posted shortly after the conference
Presenters/Authors
Aimee Gross
(Primary Presenter), MED-EL Corporation, aimee.gross@medel.com;
Aimee Gross is the Senior Manager of Regulated Research at MED-EL Corporation. She manages FDA studies for approval of MED-EL hearing implants in the United States (US). Aimee has been with MED-EL for 24 years and works at their US office in the Research Triangle Park of North Carolina. She holds a Master of Science (MS) in Audiology, Certificate of Clinical Competence in Audiology (CCC-A), and the Medical Writer Certified (MWC) credential. Aimee is a pediatric audiologist at heart and previously worked with the pediatric cochlear implant team at the University of North Carolina. She has a passion for children with hearing loss and hearing implants. Her goal is to make life a little easier for every child and family on their hearing journey.
ASHA DISCLOSURE:
Financial -
• Receives Salary for Employment from MED-EL Corporation.
Nonfinancial -
No relevant nonfinancial relationship exists.
AAA DISCLOSURE:
Financial -
Financial relationship with MED-EL Corporation.
Nature: Salary for full-time employment with MED-EL .
Nonfinancial -
No relevant nonfinancial relationship exists.