MRI guidelines for professionals

Cochlear™ Nucleus® Implants

Designed for access to MRI scans

Cochlear™ Nucleus® Implants have been designed with MRI access in mind for two decades. Access to MRI scans vary based on the generation of the device with our legacy products having more conditions to follow for scans. Details are outlined in our MRI Guidelines.

Cochlear Nucleus Profile™ Plus, the latest implant offering, provides access to MRI scans at 1.5 T and 3.0 T with implant magnet in place. The Profile, CI24RE, CI24R, and CI24M implants are approved for MRI scans at 1.5T with the implant magnet in place with the use of a Cochlear Nucleus MRI Kit, or 3.0T with the implant magnet surgically removed unless otherwise contraindicated. MRI access is available for the majority of Nucleus implant recipients, but the specific conditions and access differ based on implant type.

Each cochlear implant generation has specific guidelines that need to be followed. The approved scan types for implants are as follows:

Implant Type	MRI Status at 1.5 T*	MRI Status at 3.0 T*
Profile Plus (CI632, CI624, CI622, CI612)	Implant magnet in place	Implant magnet in place
Profile (CI532, CI522, CI512, ABI541)	Implant magnet in place with the use of the Nucleus MRI Kit	Implant magnet should be surgically removed
Freedom® (CI422, CI24REH, CI24RE(CA), CI24RE(ST), ABI24M)	Implant magnet in place with the use of the Nucleus MRI Kit	Implant magnet should be surgically removed
CI24R, CI24M	Implant magnet in place with the use of the Nucleus MRI Kit	Implant magnet should be surgically removed
CI11+11+2M	Implant magnet in place with the use of the Nucleus MRI Kit	Contraindicated for MRI
CI22M with removable implant magnet	Implant magnet in place with the use of the Nucleus MRI Kit	Contraindicated for MRI
CI22M without removable implant magnet	Contraindicated for MRI	Contraindicated for MRI

To provide a safe and effective experience for recipients undergoing MRI, the Nucleus MRI Kit is indicated to be applied by ENT Physicians.

*For full conditions, please refer to the Cochlear Nucleus Implants MRI Guidelines:

• MRI Components Order Form
• Nucleus MRI Guidelines (US)
• Nucleus MRI Guidelines (Canada)
• Nucleus MRI Kit User Guide
• Nucleus MRI Safety Checklist

For further assistance on scanning patients with cochlear implants, call our MRI Information Line at:
1-866-210-9217.

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MRI Guidelines for Cochlear™ Osia® System

The Cochlear™ Osia® System was designed with the same technology that has allowed for access to MRI for over two decades in Cochlear Nucleus Implant recipients. This key design feature allows for removal of the magnet.

The Osia System is MRI Conditional at 1.5T with the implant magnet in place and the use of the Cochlear MRI Kit for Osia, or with the implant magnet surgically removed, and at 3.0T with the implant magnet surgically removed.

Implant Type	MRI Status at 1.5 T**	MRI Status at 3.0 T**
Osia OSI200 Implant	Implant magnet in place with use of Cochlear MRI Kit for Osia	Implant magnet must be surgically removed
Osia OSI100 Implant	Implant magnet in place with use of the Cochlear MRI Kit for Osia	Implant magnet must be surgically removed

To provide a safe and effective experience for recipients undergoing MRI, the Cochlear MRI Kit is indicated to be applied by ENT Physicians.

**For additional details, please refer to the Cochlear Osia MRI Guidelines:

• MRI Components Order Form
• Osia MRI Guidelines
• Osia MRI Kit User Guide
• Osia MRI Safety Checklist for Professionals

For further assistance on scanning patients with Osia System, call our MRI Information Line at:
1-866-210-9217.

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MRI Guidelines for Cochlear™ Baha® System

Baha® Connect System

For the Baha Connect System, as long as the sound processor is removed, you can have an MRI scan without any additional risk. There could be a resulting shadow in the image.

Baha® Attract System

The Baha Attract System includes a magnet implanted under the skin, and is MRI conditional for scans at 1.5T. There may be a significant shadow effect for scans of the head. For access to higher strength scans or to reduce the shadow effect, the magnet can be temporarily removed in a straightforward procedure. Baha sound processors should be removed prior to any MRI scan.

Implant Type	MRI Status at 1.5 T***	MRI Status at 3.0 T***
Baha Connect	May undergo MRI with implant in place	May undergo MRI with implant in place
Baha Attract	May undergo MRI with BI300 implant and BIM400 (internal magnet) in place	May undergo MRI with BI300 implant in place and BIM400 (internal magnet) must be surgically removed

***For specific radiology instructions, please refer to the Cochlear Baha System Radiographer’s Instructions for MRI:

• Baha Connect System Radiographer’s Instructions for MRI
• Baha Attract System Radiographer’s Instructions for MRI

For further assistance on scanning patients with Baha system, call our MRI Information Line at:
1-866-210-9217.

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MRI Guidelines for Cochlear™ Vistafix® System

The Cochlear prior generation Vistafix System and Vistafix 3 System are implant systems for facial prosthetics. The systems include osseointegrated titanium implants and titanium abutments that protrude through the skin. A Vistafix prosthesis is worn on the head.

Cochlear Vistafix implants offer patients a high level of MRI compatibility. These guidelines are intended for radiologists performing MRI scans on a patient with a Cochlear Vistafix System. Please read this information carefully. For more information, contact Cochlear.

Vistafix Prosthesis

As long as the Vistafix prosthesis, bar construction, any fixation magnets, magnabutments or magnacaps are removed for the MRI procedure, a patient fitted with a Vistafix System may be exposed to an MRI examination. When undergoing an MRI, the following conditions apply.

MRI Safety information

The prosthesis, the bar construction, any fixation magnets, magnabutments or magnacaps attached to the implants must be removed before entering a room where an MRI scanner is located.

Non-clinical testing has demonstrated that Vistafix implants, cover screws, and abutments are MR Conditional at 1.5 and 3.0 Tesla. They can be scanned safely under the following conditions. Scanning under other conditions may result in severe patient injury or device malfunction.

• Static magnetic field of 1.5 Tesla and 3 Tesla only
• Maximum spatial gradient field of 3000 Gauss/cm (30 T/m)
• Maximum MR System reported whole body averaged specific absorption rate (SAR) of 2 W/kg or maximum head averaged SAR of 3.2 W/kg (Normal Operating Mode)

Under the scan conditions defined above, the implant, cover screw, abutment, and healing cap are expected to produce a maximum temperature rise of 1.1 °C after 15 minutes of continuous scanning.

In non-clinical testing with the implant and abutment in place, the image artifact caused by the device extends approximately 1.8 cm from the implant and abutment when imaged with a gradient echo pulse sequence and a 3.0 Tesla MRI system. The artifact is reduced to 1.2 cm from the implant when the abutment is removed.

NOTE: MR System manufacturers may claim that scanning patients with implanted devices is generally contraindicated. This is a general precautionary claim due to the fact that MR System manufacturers are unable to ensure safety for all types of implantable devices. Cochlear has performed specific testing for the above implants and established the necessary SAR safety limits as outlined. Recently available MR Systems are able to monitor SAR levels. The MR System manufacturer should be able to provide advice on how to maintain SAR levels with their system.

For further assistance on scanning patients with Vistafix Systems, call our MRI Information Line at:
1-866-210-9217.