Cochlear Ltd Introduces New Osia OSI300 Bone Conduction Implant System that Enables MRIs at 3.0 Tesla (T)

Cochlear Limited, a global leader in implantable hearing solutions with US headquarters in Lone Tree, Colo, has launched its next-generation Cochlear™ Osia^® System, the Osia OSI300 Implant. This new bone-conduction implant enables patients to undergo MRI at 3.0 Tesla (T) without the need for surgery. It is designed to improve hearing outcomes for people with conductive hearing loss, mixed hearing loss, and single-sided sensorineural deafness (SSD).

The new OSI300's unique Piezo Power™ and next-generation 3.0 T magnet technologies are said to result in 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

"An improvement in the ability of patients to undergo high-resolution MRI scans with our technology was the number one request we heard from customers,” said Cochlear CEO and President Dig Howitt in a press statement. “With the new system, patients with an active bone conduction system can conveniently undergo MRI at 1.5 T and at 3.0 T with no impact to their hearing—MRI should be accessible to everyone."

The Osia OSI300 Implant System will be available in clinics across the United States this fall and is currently being reviewed by Health Canada. Availability in other countries is subject to regulatory approvals.

The New Osia System with OSI300 Implant

Launched in January 2020, Cochlear’s Osia 2 system provided a unique solution in implantable bone conduction hearing devices and represented the world’s first active osseointegrated steady-state implant, meaning the active implant is located entirely under the skin. Cochlear described this as a new category of bone conduction hearing solutions using digital piezoelectric stimulation to bypass damaged areas of the natural hearing system to send sound vibrations directly to the inner ear (cochlea).

The latest OSI300 System is said to offer the same proven benefits as Osia 2: excellent hearing outcomes,² ease of use, discreetness, and reliability.³ With the introduction of the OSI300 Implant, the system combines the unique properties of the Osia System's Piezo Power™ transducer—which does not contain magnetic material—and the next generation in implant magnet technology.

MRIs are becoming commonplace in medicine, with almost 40 million MRI scans being performed in the United States in 2019. MRIs use strong magnetic fields and radio waves that can damage medical implants containing magnets, like those found in some hearing implants. In certain cases, this can necessitate surgical removal of the implant magnet before the MRI, then replacing it afterward. The latest MRI scanners, Tesla 3T, are twice as powerful as the previous generation 1.5T scanners.

According to Cochlear, the OSI300 Implant is specifically designed to support access to MRI with no performance degradation after MRI exposure,⁴ as there is nothing to be demagnetized as in an electromagnetic transducer. Unlike an axial magnet—which is found in most bone conduction implants today and is unsuitable for a patient undergoing an MRI examination at 3.0 T—the OSI300 uses a diametric magnet that sits within a casing and rotates to align with the magnetic field of the MRI machine.

"Not only does the new design allow for MRI scans at 3.0 T without surgery or the need for a headwrap or splint kit; we have also designed the magnet cassette to be simple to remove if needed,” said Ryan Lopez, head of Portfolio Strategy & Professional Marketing at Cochlear. “The easy removal of the implant magnet reduces image artifact, an important consideration for maximum visibility of areas around the implant. Both features mean less MRI preparation time and less time without sound, which is beneficial to both recipients and professionals.”

For details, visit the Cochlear Osia System website.