MED-EL announced Thursday that the US Food and Drug Administration has approved its Synchrony cochlear implants for children as young as 7 months who have bilateral profound sensorineural hearing loss, expanding the previous age limit of 9 months, reports BritPanorama.
This development aims to provide even younger infants with opportunities to hear for the first time, an experience already enjoyed by children like 6-year-old Ben Summers. Ben underwent cochlear implant surgery at just 9 months old, allowing him to revel in sounds after years of silence due to congenital cytomegalovirus.
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, stated, “We can do this procedure safely in infants that are 7 months of age.”
The latest approval signifies the potential for early intervention in treating hearing loss, which can facilitate better developmental outcomes for children. “If they do develop spoken language, it likely will not be clear nor age-appropriate,” Dr. Young explained, emphasizing the critical window for effective communication development.
Ben’s journey began with a diagnosis of sensorineural hearing loss at birth, caused by CMV, a virus that can cross the placenta. His mother, Beth Summers, recalls discovering his condition during a routine ultrasound. CMV affects about 1 in every 200 births and is a leading non-hereditary cause of hearing loss in infants.
Following his birth, early signs of hearing impairment were evident. “We would bang pots and pans behind his little head, and he couldn’t hear,” said Summers, noting that conventional hearing aids were ineffective. Her wish for Ben to hear by his second Christmas was realized when he received the cochlear implant.
Once implanted, the devices require a healing period, after which audiologists activate them, providing the child with sound for the first time. Young explained that a learning curve follows this activation, helping the brain adapt to the electrical signals. The total cost for the procedure can exceed tens of thousands of dollars without insurance, but many parents consider it a worthwhile investment.
‘A transformative technology’
Dr. Young termed cochlear implants a “transformative technology” as they facilitate access to sound from an early age, setting the stage for improved language skills. She underscored the importance of hearing for safety and environmental awareness.
The FDA’s approval reflects a broader recognition of the benefits of cochlear implants for young children. Dr. Justin Golub, an associate professor at Columbia University, called the decision “very exciting,” noting that earlier implantation leads to superior outcomes. “The brain is very flexible at birth but within a short period stops being able to learn certain things well, particularly language,” he stated.
Experts agree on the importance of comprehensive testing to justify the necessity of cochlear implants. Despite some associated risks, the benefits often outweigh them significantly.
‘The earlier … the better’
Medical evidence solidifies the advantages of placing cochlear implants at an early age. Dr. Keiko Hirose, a pediatric specialist, remarked on the exciting prospect that early exposure to sound results in better speech and language development outcomes.
The push for younger candidates to receive cochlear implants signifies a continuing evolution in pediatric hearing loss treatment and remarkable strides in medical technology. With advancements in technology, families now have greater hope and options for their children’s auditory health.
