Important Safety Information

Important Safety Information
Cochlear Implant Systems

The MED-EL Cochlear Implant Systems are intended to evoke auditory sensations via electrical stimulation of the auditory pathways for severely to profoundly hearing impaired individuals who obtain little or no benefit from acoustic amplification in the best aided condition.

Cochlear implantation is a prescription treatment, if you believe you are a potential candidate, contact your physician or hearing healthcare center for a pre-operative assessment according to the local professional standards. Certain medical conditions, including auditory nerve damage, inner ear malformations, middle ear infection, cranial malformation and allergies to the implant materials may constitute some contraindication(s).

To obtain the optimal benefit from the implant, the prospective implant users and their families shall be highly motivated and have realistic expectations about the expected benefit of the implant and shall understand the importance of returning to the implant center for regular audio processor programming, assessment sessions and training.

Risks associated with cochlear implantation include, but are not limited to: complications from general anesthesia, post-operative surgical complications (dizziness, increased vertigo, delay of healing of the scar, impairment of the sense of taste, infection including rare instances of meningitis, potential for swallowing difficulties, numbness, increased tinnitus, stimulation of the facial nerve, temporary pain and uncomfortable sounds during stimulation), potential loss of residual hearing, need for additional surgery in case of damage to the implant. After implantation, some limitations regarding magnetic resonance imaging will apply.
 

Medical Procedures
for MED-EL Implant Systems

This manual provides important instructions and safety information for MED-EL Implant System users who have to undergo a medical procedure (e.g. MRI).

As an implant user, you might have questions about undergoing further medical procedures. Your medical team may also want more information about any special considerations for implant users. This guidance provides information that will help prevent damage to your implant and injury to yourself. Please share this information with your healthcare provider.

Not all products in this document are currently approved or available in all countries. Please contact your local MED-EL representative for information on current product availability in your country.

In this document the general term “MED-EL Implant System” is used for all implant types. The specific implant name is identified in the header of the applicable section.

Download Manual (pdf)
English

MRI Checklist
for professionals

The “MRI Checklist for professionals” contains excerpts of product labeling relevant for MRI examinations. It may be helpful when planning and performing an MRI as it lists tasks to be completed in chronological order.

Download Checklist (pdf)
English

© 2017 MED-EL