Babies as young as 7 months now have access to ‘transformative’ cochlear implants

<i>Courtesy Carrie Beth Summers via CNN Newsource</i><br/>"The first time he heard

By CNN Newsource

Published December 5, 2025 5:19 AM

By Jacqueline Howard, CNN

(CNN) — Ben Summers lights up with a smile the moment he talks about the “Batman” theme song or the afternoons he spends playing the piano at his grandmother’s house.

Just a few years ago, Ben could not hear music, laughter or any sounds at all. But today, the 6-year-old revels in the melodies from his favorite action hero movies, thanks to a cochlear implant he received at just 9 months old. He proudly calls the device his “ears.”

Now, babies who are even younger may have the same chance to hear sounds for the first time with the use of cochlear implants.

Medical technology company MED-EL announced Thursday that the US Food and Drug Administration has approved expanding the use of its Synchrony cochlear implants to children as young as 7 months who have bilateral profound sensorineural hearing loss. The implants were previously indicated for 9 months and older.

“We can do this procedure safely in infants that are 7 months of age,” said Dr. Nancy Young, founder and medical director of the cochlear implant program at Ann & Robert H. Lurie Children’s Hospital of Chicago, who led MED-EL’s clinical trial.

The approval means that for the first time, even younger infants with hearing loss may be able to benefit from these cochlear implants, just like Ben did.

Ben was diagnosed with sensorineural hearing loss in both ears at birth. This type of permanent hearing loss occurs due to damage to the inner ear, which for Ben was a result of congenital cytomegalovirus or CMV, an infection that developed in the womb.

“It is one of the rare viruses that can cross the placenta,” said Ben’s mother, Beth Summers.

They made the discovery when she was 20 weeks pregnant, she said, during an ultrasound anatomy scan.

CMV is a common virus that usually doesn’t have symptoms in adults, but when it is passed from mother to baby in pregnancy, it can sometimes cause developmental problems, including hearing loss. CMV is estimated to affect about 1 in every 200 births in the United States and is the most common cause of non-hereditary hearing loss.

After Ben was born, his parents saw early signs of hearing loss right away.

“We would bang pots and pans behind his little head, and he couldn’t hear,” Summers said, adding that hearing aids didn’t help.

Ben was born in December, before Christmas, and at the time, Summers’ biggest wish was for her son to have hearing by his second Christmas, right after he turned 1.

“I was like, ‘you know what, if he could hear Christmas music … that would be a miracle,’ ” she said.

When Ben was 9 months old, her wish came true.

Ben was enrolled in MED-EL’s clinical trial to be fitted with a cochlear implant device, enabling him to hear sound for the first time.

“It was interesting, because the first time he heard, he was a little scared. He was kind of like, ‘What is happening?’ But I just remember being so excited,” Summers said.

The device was implanted in the fall. By winter, Ben could hear Christmas carols.

“When I saw him respond the first time to my voice, to my husband’s voice, it was just like, this is a whole new world for us and for our baby,” Summers said. “I would do it again 100 times. This has opened so many doors for our son and for our family.”

‘A transformative technology’

Access to cochlear implants can make a “huge difference” for infants with hearing loss, Young said. Children who are born without significant hearing in either ear are not as likely to develop spoken language skills.

“If they do develop spoken language, it likely will not be clear nor age-appropriate. And 90% of children born with significant hearing loss in both ears have hearing parents, and they want to communicate with their child, like they communicate with everyone else in their family. But there’s more to having hearing than just speech and language,” Young added.

“It’s important for safety. It connects us with others. It connects us with our environment. It’s constantly giving us really important feedback,” she said. “That’s the whole idea behind early intervention is to change the outcome, and a cochlear implant is one way to do that.”

Cochlear implants are small electronic hearing devices that work by electrically stimulating the auditory nerve in people with severe to profound hearing loss.

“The cochlear implant is really a transformative technology. It’s the first technology to ever return a human sense,” Young said.

Cochlear implant research began in the 1950s, and the first was placed into a patient in the early 1960s. By the mid-1980s, the FDA approved cochlear implants in the United States. It’s now estimated that more than 1 million cochlear implants have been implanted around the world. In the United States, more than 118,000 devices have been implanted in adults and at least 65,000 in children.

The cochlear implant device is the same, in size and scope, for both children and adults, Young said, and it is surgically implanted in the patient’s head.

The cochlear implant system consists of an external speech processor, worn behind the ear, and an internal implant with components surgically placed under the skin and into the inner ear. The external processor picks up sound, which is changed to electrical impulses that are sent to the internal implant to stimulate the auditory nerve, enabling the user to hear. The surgery is typically performed as an outpatient procedure.

“It’s an ear surgery,” Young said. “And it’s also a system. The child or adult needs to wear the speech processor – which has a microphone, electronics and a rechargeable battery – to hear.”

After they’re implanted, the devices aren’t activated right away, Summers said of Ben’s experience. “They let the internal part have some healing time. And then you go back to the audiologist, and that’s when they turn them on, or activate them, and the baby can hear for the first time.”

There is a “learning curve” during which the brain makes sense of the electric signals generated by the implant, Young said, ultimately helping the wearer to hear sound.

The total cost, including the device and surgery, can be more than tens of thousands of dollars without insurance. But the technology has advanced rapidly in recent years, now even allowing for streaming through a Bluetooth connection.

Young said some patients may have skin irritation or infection around the site of the implant, but overall, the benefits far outweigh the risks.

“It’s incredibly moving when a child hears for the first time,” Young said.

‘The earlier … the better’

Doctors have long known that there are benefits to placing a cochlear implant in young patients as early as possible, said Dr. Justin Golub, a hearing loss specialist and associate professor of otolaryngology-head and neck surgery at Columbia University Vagelos College of Physicians and Surgeons.

He described the new FDA approval as “very exciting.”

“We have long known that the earlier a cochlear implant is placed, the better the ultimate hearing outcome. The brain is very flexible at birth but within a short period of time stops being able to learn certain things well, particularly language. By performing a cochlear implant down to 7 months old, we are harnessing the flexibility of the brain to learn how to hear with a bionic ear,” Golub, who was not involved in the MED-EL research, said in an email.

“Cochlear implant surgery is very proven and generally very safe. The main consideration is making sure all the needed testing is performed already to ensure that hearing really is poor enough to justify a cochlear implant,” he said. “The main benefit is improved lifelong hearing by giving the brain access to sound when it is maximally flexible.”

In general, once most healthy infants reach about 6 months of age, cochlear implant surgery is considered safe for them, said Dr. Keiko Hirose, a professor of otolaryngology at WashU Medicine who sees pediatric patients at St. Louis Children’s Hospital.

“Pediatric surgical specialists, along with pediatric anesthesiologists have long debated the pros and cons of waiting versus early surgery for many conditions. In the case of cochlear implantation for deaf infants and children, earlier activation of hearing can make all the difference,” Hirose, who was not involved in MED-EL’s research, wrote in an email.

“I am excited about approval for cochlear implants in children age 7 months and older,” she said. “We have known for a long time that early exposure to hearing provides better outcomes for speech and language development.”