MRI guidelines for professionals

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MRI guidelines for the following products

On this page you will find MRI information about the Cochlear™ Nucleus® System, Cochlear™ Osia® System, Cochlear™ Baha® System and the Cochlear™ Vistafix® System.

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

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:

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


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.

Access to MRI scans vary based on the generation of the implant, additional conditions follow for scans. Complete details are outlined in our MRI Guidelines. The approved scan types for implants are as follows:

Implant Type

MRI Status at 1.5 T**

MRI Status at 3.0 T**

Osia OSI300 Implant

Implant magnet in place

Implant magnet in place

Osia OSI200 Implant

Implant magnet in place with use of the Cochlear Osia MRI Kit±

Implant magnet must be surgically removed

Osia OSI100 Implant

Implant magnet in place with use of the Cochlear Osia MRI Kit±

Implant magnet must be surgically removed

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

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

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


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 will be a resulting shadow in the image.

Baha® Attract System

The Baha Attract System includes a magnet implanted under the skin, and is MR 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:

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


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.

Disclaimer

This material is intended for health professionals. If you are a consumer, please seek advice from your health professional about treatments for hearing loss. Outcomes may vary, and your health professional will advise you about the factors which could affect your outcome. Always read the instructions for use. Not all products are available in all countries. Please contact your local Cochlear representative for product information.

For a full list of Cochlear’s trademarks, please visit our Terms of Use page.