Summary: Cochlear Limited gained FDA approval to lower the age requirement for their Cochlear Osia System from 12 to 5 years old, extending its availability to children with conductive hearing loss, mixed hearing loss, and single-sided sensorineural deafness. 


  1. The Osia System utilizes digital piezoelectric stimulation to transmit sound vibrations directly to the inner ear, providing high power and clarity, particularly in high-frequency sounds crucial for communication.
  2. The Osia System offers improved high-frequency hearing, as evidenced by testimonials from recipients and healthcare professionals, facilitating better communication and social interaction.
  3. The news from Cochlear aligns with its mission to support people of all ages.

Cochlear Limited, a provider of implantable hearing solutions, obtained U.S. Food and Drug Administration (FDA) clearance to lower the age of the Cochlear Osia System from 12 years old to 5 years old for children with conductive hearing loss, mixed hearing loss and single-sided sensorineural deafness (SSD).

The Cochlear Implant Osia System

The Osia System is a new category of bone conduction hearing solutions that uses digital piezoelectric stimulation to bypass damaged areas of the natural hearing system to send sound vibrations directly to the inner ear (cochlea). It is the first and only active bone conduction system that allows patients to undergo MRI scans at both 1.5 T and 3.0 T without the need for surgery.(1)

Children Can Adopt the Osia System

Now children as young as 5 will be able to have full access to the Osia System’s unique technology that is optimized to deliver high power and clarity, especially in high-frequency sounds, which are important for hearing what others are saying.

“I love my Osia System. It’s given me the confidence to succeed in school. I can hear everything my teacher and my friends say,” says Adrian R., an 8-year-old Osia System recipient.

Adrian was diagnosed with hearing loss at age 4 and started with the Baha Sound Processor with a Baha Softband before transitioning to the Osia System at age 6.

“It has been amazing to see the transformation in Adrian. She has been doing so well in school and is able to keep up with her friends both in school and out. She is even learning the piano now and I never thought I would be able to say that. It has truly been life changing,” Dea R., parent to 8-year-old Adrian said.

Improved High-Frequency Hearing for Children

The Osia System has been shown to provide clinically significant improvements in high frequency hearing for children.(2,3,4)

“I choose the Osia System for my pediatric patients because it really made the difference in terms of the sound clarity. It is absolutely incredible,” says Daniela Carvalho, MD, MMM, Pediatric Otolaryngologist at Rady Children’s Hospital.

“All of my patients with the Osia System have come back to my office saying it’s the first time they’ve heard the birds chirping or other high-frequency sounds.”

Cochlear’s product portfolio is inspired by meaningful innovation and a core belief that technology is only as useful as the benefit it provides.

“The Osia System is transformative technology, and we’re pleased that it’s now accessible for children as young as 5. This aligns with our commitment to empower people across all stages of life to stay connected and thrive,” Lisa Aubert, President, Cochlear North America said.

Feautred image: Adrian with her Osia System. Photo: Cochlear


  1. Ellsperman SE, Nairn EM, Stucken EZ. Review of Bone Conduction Hearing Devices. Audiol Res. 2021;11(2):207-219.
  2. ClinicalTrials.Gov ID NCT 0500931
  3. You, P., A. Choi, J. Drob, S. M. Hunsaker, Y. C. Liu, and R. Silva. 2022. ‘Early Outcomes of a New Active Transcutaneous Bone Conduction Implant in Pediatric Patients’, Otol Neurotol, 43: 212-18.
  4. Florentine, M. M., J. Virbalas, and D. K. Chan. 2022. ‘Early surgical and audiologic outcomes of active, transcutaneous, osseointegrated bone-conduction hearing device (Osia 2 system) placement’, International Journal of Pediatric Otorhinolaryngology, 156.