Important Safety Information
Cochlear Implant Systems
MED-EL Cochlear Implant Systems are intended to evoke auditory sensations via electrical stimulation of the auditory pathways for individuals with severe-to-profound sensorineural hearing loss who obtain little or no benefit from acoustic amplification (traditional hearing aids) in the best aided condition. The cochlear implant system consists of an implant, which is surgically placed under the skin behind the ear, and an audio processor which is typically worn on the ear.
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 an absent or non-functioning auditory nerve pathway, inner ear malformations, middle ear infection, cranial malformation and allergies to the implant or audio processor materials constitute contraindications.
Expected performance with cochlear implants cannot be accurately predicted. To obtain the optimal benefit from the implant, the prospective implant users and their families must be highly motivated and have realistic expectations about the expected benefit of the implant and must understand the importance of returning to the implant center for regular audio processor programming, assessment sessions and training. The adjustment to a cochlear implant and adequate fitting of the device are gradual processes that occur over time.
Please talk with your physician about any particular risks related to implant use, surgery, and/or general anesthesia that might apply to your specific situation.
Risks Related to Surgery:
Cochlear implant surgery is comparable to middle ear surgery with additional access to the inner ear. The normal risks of surgery and general anaesthesia are applicable. Primary surgical risks include the following: infection, inflammation, swelling, necrosis, haematoma, leakage of cerebrospinal fluid (CSF), damage to the facial nerve, pain, scarring of the wound, skin irritation, swallowing difficulties and complications related to general anesthesia. Additionally, meningitis can be a rare postoperative complication, but has the potential to be serious. The risk of meningitis may be reduced, for example by vaccination, antibiotic cover, and surgical technique.
Possible post-operative side-effects include the following: loss of residual hearing, dizziness, increased vertigo, delay of healing of the scar, impairment of the sense of taste, potential for swallowing difficulties, numbness, increased tinnitus, stimulation of the facial nerve, temporary pain and uncomfortable sounds during stimulation. There is also a possibility of post-operative device failure or a decrease in device performance.
Some post-operative complications may require revision surgery.
Cochlear implant users are able to enjoy nearly any activity, but some restrictions or cautions will apply, including but not limited to the following:
- The implant package and the electrodes are located directly under the skin. In order to avoid damage to the implant you/your child should not unnecessarily move and extensively scratch the skin above the implant site and should also avoid mechanical pressure on the site. When brushing or styling the hair at the site of implantation, you should be careful not to harm the skin (at the site of the implant there may be a slight bulge).
- A blow to the head may damage the implant and result in its failure. Implant recipients are strongly encouraged to use head protection whenever possible during sports and activities in which head trauma is a risk (e.g. bicycling, motorcycling, skiing) and should never participate in sports in which head trauma is part of the activity (e.g. boxing).
- Consult with your physician before snorkeling or scuba diving.
- Children shall be instructed not to swallow or put any components of their Cochlear Implant System into their mouths and not to play with any components. For young children, it is mandatory to use the safety lock to prevent them from disassembling the audio processor.
- If you plan to enter an environment that could potentially adversely affect the operation of your Cochlear Implant System (e.g. an area that is protected by a warning notice preventing entry by patients fitted with a pacemaker) it is advisable to first contact your clinic or MED-EL.
- Care should be taken with the external components of the cochlear implant system. They should not be dropped or subjected to dangerous areas (machines or high voltage) which could result in damage to the components.
- Infections in the implanted ear must be treated promptly by a physician who will prescribe antibiotics as necessary.
- In rare cases, audio processors may interfere with reception when using certain TV sets (sets with an indoor antenna).
- Mobile phones and other portable and mobile RF communications equipment may interfere (perceived as a buzzing sound) with the external parts of the MED-EL Cochlear Implant System if they are used within a distance of less than 9.84 feet.
- The audio processor should never be connected directly to any equipment connected to an electrical outlet of any kind, including a power strip. Galvanic isolation systems, such as an infrared system or FM system, should always be used if you want to connect to a device that plugs into an electrical outlet. Battery operated devices can be directly connected to the audio processor. Special cables may be needed (e.g. for connection to FM systems). For further information please contact MED-EL.
- Electronic devices are influenced by electrostatic discharge (ESD). Although the MED-EL Cochlear Implant System has several internal safety features designed to reduce ESD, there is a small risk that the external or internal equipment can be damaged if the static discharge flows through the external equipment.
- MED-EL cochlear implants are MR conditional devices. Individuals implanted with a MED-EL cochlear implant may be safely scanned with MRI only under very specific conditions. Scanning under different conditions may result in severe patient injury or device malfunction. The external components of the MED-EL cochlear implant system are MR unsafe and must be removed prior to scanning.
For implant specific Magnetic Resonance Imaging (MRI) safety information, please see the Medical Procedures Manual links below.
For SYNCHRONY, testing has demonstrated that migration or magnet displacement will not occur when scanned under the conditions listed in the Medical Procedures Manual. For field strengths of 1.5T and 3.0T, a supportive head bandage is optional, but not required.
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 proce- dures. Your medical team may also want more information about any special consid- erations 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.
English - United States
Spanish - United States
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.
English - United States
Spanish - United States