Information for the patient

Dear Patient,


Your doctor has chosen a medical device producted by Audio Technologies to be used during your planned treatment. Your doctor will discuss the planned treatment plan, the mode of action and future risks and possible therapy options with you in detail in a private interview prior to the surgery. The purpose of this FAQs is to assist you for the interview and inform you about the characteristics of the medical device used.

This information should not replace the private discussion with your doctor.

Magnetic Resonance Imaging (MRI)

Compatibility with the exam

All of Audio Technologies middle ear implants are MRI compatible till at least 3 Teslas.

 

Information for the patient:

MRI exam can pose risks for patients who carry metallic prosthesis in their body. The risk can be caused by the magnetic field interactions or excessive MRI-related heating.

The middle ear implants manufactured by Audio Technologies are all MR compatible till 3 Tesla and allow patients to undergo the MRI exam.

The declaration, that can be downloaded below, doesn't list all the manufactured items. In fact, for each model, only the worst case - calculated considering weight and mass - have been tested. All the other smaller and lighter prosthesis, which are magnetically less relevant, are consequently considered compatible.

The ear prosthesis without any metallic part are all MR safe.

Download RMI safety declaration

mr-compatibility-declaration---eng.pdf

IFU - Instruction for Use and SSCP - Summary of Safety and Clinical Performance

IFU

The IFU (Instructions for use) are an integral part of the device and constitute the means through which the Manufacturer addresses the user to illustrate the composition and functioning of the device itself and to indicate safety warnings together with any integration features.

SSCP

The Summary of Safety and Clinical Performance (SSCP) is intended to provide the public with access to an up-to-date summary of key safety and clinical performance aspects of the device. The information presented within the SSCP is intended for both patients and users. The SSCP is not intended to provide general advice on the treatment of a medical condition. Please contact your healthcare professional if you have any questions about your medical condition or use of the device.

Click below for more details: