FDA Approves Cochlear Implants for Infants as Young as 7 Months

A groundbreaking decision by the US Food and Drug Administration (FDA) now allows for the use of cochlear implants in infants as young as 7 months who suffer from bilateral profound sensorineural hearing loss. This announcement, made by medical technology firm MED-EL on December 7, 2023, marks a significant shift, as the previous age limit was set at 9 months.

The approval opens new avenues for young children to experience sound for the first time. Dr. Nancy Young, founder and medical director of the cochlear implant program at Ann & Robert H. Lurie Children’s Hospital in Chicago, emphasized the procedure’s safety for infants as young as 7 months. “We can do this procedure safely in infants that are 7 months of age,” she stated, highlighting the potential benefits for children with hearing loss.

For families like that of Ben Summers, this change is life-altering. Ben, now 6 years old, received his cochlear implant at 9 months old, allowing him to enjoy music and laughter—a stark contrast to his early days when he could not hear. Diagnosed with sensorineural hearing loss due to congenital cytomegalovirus (CMV), Ben’s journey illustrates the profound impact of this technology. His mother, Beth Summers, recalls the moments of despair as they realized Ben could not hear sounds around him. “We would bang pots and pans behind his little head, and he couldn’t hear,” she recalled.

The approval of cochlear implants for younger infants aims to address critical developmental needs. Children born with significant hearing loss are less likely to develop age-appropriate spoken language skills. Dr. Young noted that 90% of these children have hearing parents who wish to communicate with them as they do with others. “It’s important for safety. It connects us with others. It connects us with our environment,” she explained, underscoring the importance of early intervention.

Transformative Technology for Early Hearing Loss

Cochlear implants are small electronic devices that stimulate the auditory nerve, enabling individuals with severe to profound hearing loss to perceive sound. The technology has evolved since its inception in the 1960s, with over 1 million cochlear implants implanted worldwide, including more than 118,000 in adults and 65,000 in children in the United States alone.

The process involves an outpatient surgery where an internal implant is placed in the inner ear, complemented by an external speech processor worn behind the ear. This processor captures sound and converts it into electrical impulses that stimulate the auditory nerve. After implantation, there is a necessary healing period before the device is activated, allowing the recipient to experience sound for the first time.

The cost of cochlear implants, including the device and surgical procedure, can exceed tens of thousands of dollars without insurance. However, advancements have led to features such as Bluetooth streaming, enhancing their functionality for users.

Importance of Early Intervention

The new FDA approval for cochlear implants in infants as young as 7 months is seen as a crucial step in improving hearing outcomes. Dr. Justin Golub, a hearing loss specialist at Columbia University, described the decision as “very exciting.” He explained that the earlier a cochlear implant is placed, the better the hearing outcome, as infants’ brains are particularly adaptable during early development.

Similarly, Dr. Keiko Hirose, a professor of otolaryngology at WashU Medicine, emphasized the benefits of early exposure to sound for speech and language development. “I am excited about approval for cochlear implants in children age 7 months and older,” she stated, reinforcing the consensus among specialists regarding the advantages of early intervention.

As the medical community embraces this groundbreaking change, families are hopeful that cochlear implants will provide their children with the opportunity to connect with the world through sound, fostering their development and social interactions from an early age.