Important Safety Information
Bone Conduction System - BONEBRIDGE
The Bone Conduction Implant (BCI) is the implantable part of the BONEBRIDGE and can only be used together with compatible MED-EL external components. The device is an osseointegrated bone conduction implant system, intended to provide a level of useful sound perception for individuals 12 years of age or older with conductive and mixed hearing loss, as well as those suffering from single-sided deafness. The BCI is surgically implanted into the mastoid bone.
Bone conduction 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 chronic or non-revisable vestibular or balance disorders, abnormally progressive hearing loss, an absent or non-functioning auditory nerve pathway, central auditory disorders, conditions that would prevent good speech recognition potential, skin or scalp conditions which may preclude attachment of the audio processor and skull size or abnormality that would preclude appropriate placement of the BONEBRIDGE implant constitute contraindications.
Expected performance with bone conduction 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 bone conduction 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.
Possible adverse effects:
The BCI 601 is a long term implantable medical device. Before operating, surgeons shall explain to the patient all the relevant generic complications of otologic surgery and general anesthesia. Other complications that may occur include: post-surgery displacement of the implant; post-surgical translocation of the BC-FMT due to trauma or inferior surgical positioning and extrusion of the implant.
Potential risks include, but are not limited to, local skin numbness or pain, infection, transient tinnitus, vertigo or headache, dural erosion/compression, CSF leak, bleeding/hematoma from injury to sigmoid sinus, subdural hematoma, infection, and facial nerve injury.
Interference with other equipment:
- Electrosurgery: Electrosurgical instruments (e.g. monopolar electrocautery) can produce radio frequency voltages that might result in direct coupling between the instrument and the implant. Monopolar electrosurgical instruments must not be used within the vicinity of the implant. The induced currents could cause damage to the implant or the patient’s hearing.
- Therapeutic ultrasound, transcranial magnetic stimulation, electroconvulsive therapy: May never be applied directly over the implant because these procedures may damage the implant or the patient´s hearing.
- Surgical diathermy: Diathermy must never be applied over the implant because the high currents induced into the implant could cause damage to the implant or the patient’s hearing.
- Ionizing radiation therapy: Radiation therapy does not harm the implant. It is recommended not to wear an audio processor during irradiation.
- X-ray, CT, cobalt treatment, PET scan, diagnostic ultrasound: No restriction within clinically useful exposures. It is recommended not to wear an audio processor during these procedures.
- Cardioversion: The energy induced during cardioversion could cause damage to the implant. Defibrillation should not be applied on or near the device.
- Theft and metal detection systems: Commercial theft detection systems and metal detectors produce strong electromagnetic fields. Patients with an implant should be advised that passing through security metal detectors may generate harmless audible sensations and may activate the detector alarm. For this reason, it is advised that patients carry their User Identification Card at all times.
- Magnetic resonance imaging (MRI) safety information:
The external components of the MED-EL implant system (audio processor and accessories) are MR Unsafe and need to be removed prior to scanning. The implant components of the MED-EL implant system are MR Conditional.
- Static magnetic field of 1.5 T
- Maximum spatial field gradient of 3000 Gauss/cm (30 T/m) or less
- Maximum MR system reported, whole body averaged specific absorption rate (SAR) of < 4 W/kg (First Level Operating Mode) during body imaging, or Maximum MR system reported, whole head averaged specific absorption rate (SAR) of < 3.2 W/kg (Normal and First Level Operating Mode) during head imaging
- The external components of the Bonebridge system are MR Unsafe and must be removed prior to scanning.
Under the scan conditions defined above, the BCI 601 is expected to produce a maximum temperature rise of less than 4 °C (7.2 °F) after 15 minutes of continuous scanning.
In non-clinical testing, the image artifact caused by the device extends approximately 15 cm (6 in) from the geometrical center of the BCI 601 when imaged with a gradient echo pulse sequence in a 1.5 T MRI system.
The BCI 601 has not been tested for safety in combination with other devices.
The audio processor shall not be worn during an MRI examination; however, it is still possible that audible interference can occur. Adequate counseling of the patient is advised prior to performing the MRI. The likelihood and intensity of auditory sensations can be reduced by selecting sequences with a lower SAR and slower gradient slew rates.
The above instructions should also be followed if areas of the body other than the head are to be examined (e.g. knee). When lower extremities are to be examined, it is recommended that the patient’s legs are positioned in the scanner first.
Scanning under different conditions may result in severe patient injury or device malfunction.
- The audio processor contains small parts that may be hazardous if swallowed. Children should be instructed not to swallow or put any components of the BONEBRIDGE system into their mouths and not to play with any components.
- 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 (i.e., bicycling, motorcycling, skiing) and should never participate in sports in which head trauma is part of the activity (i.e., boxing).
Electromagnetic fields produced by other electrical equipment such as cell phones, metal detectors, microwaves, RFID systems and commercial theft detection systems (also known as electronic article surveillance [EAS]) may interfere with your device. In the event that you perceive unexpected noise or interference in the presence of such electrical equipment, remove the external portion of your device and if the noise or interference persists, move away from the source of electromagnetic field. Please note some of these RF emitters (e.g. RFID) might be concealed and not visible. If you experience repeated interference or have further concerns, contact your hearing healthcare professional.
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