Toddler thrives after receiving newly FDA-approved cochlear implant system

Six months after becoming the first patient in the United States to receive a newly FDA-approved cochlear implant system, 18-month-old Nene Gudavadze is responding to sound, dancing to music, and saying her first words.

Nene, who lives in Brooklyn with her parents, underwent surgery at NYU Langone Health in August after being diagnosed with severe bilateral sensorineural hearing loss. She had failed multiple newborn hearing screenings, something her parents initially hoped was temporary.

"No one in our large extended family had ever experienced hearing loss, so it came as a big shock," said Nene's mother, Natia Kikutadze. "It was an emotional and uncertain time for us, but we also had hope."

After evaluation at NYU Langone's Cochlear Implant Center, the family learned that Nene was a candidate for the new technology from Cochlear Limited, which is cleared for children as young as 9 months. Early implantation is associated with improved speech and language outcomes, and research indicates that many children who receive cochlear implants before the age of 1 year develop vocabulary and communication skills within the typical range by school age.

The Nucleus Nexa System that Nene received is the first cochlear implant designed with upgradable firmware, similar to the way smartphones receive updates. Instead of requiring patients to switch to a new external processor to benefit from advances and innovation in sound processing, many improvements can be delivered through firmware updates to their implant, reducing the need for hardware changes as children grow. The update-ready design is intended to give young patients more consistent access to evolving technology throughout their lives. It is also approved for use in adults who qualify for cochlear implants.

 

"For patients like Nene, the earlier we can give them access to sound, the better their chances of developing speech on time and engaging with the world around them," said William H. Shapiro, AuD, co-director of the Cochlear Implant Center. "Our role is not just fitting the device, but also guiding families through every stage of the process."

NYU Langone's Cochlear Implant Center, one of the earliest programs of its kind in the country, provides coordinated care that spans evaluation, surgery, audiologic programming, and ongoing speech-language support. The center sees several hundred patients each year and participates in research that helps refine implant candidacy and early intervention strategies.

In the months since activation, Nene has begun to respond to everyday sounds and is developing early speech patterns. "She's saying things like 'mama,' 'babu,' and she tries to sing in her own way," her mother said. "Whenever she hears music, she immediately starts dancing. We are very happy with her progress."

Her parents remain focused on helping Nene continue to grow, hear, and communicate.

"This surgery was a new beginning for her," her mother said. "We're doing everything we can to help her connect with the world."

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