Important Safety Information

Middle Ear Implant Systems

The VIBRANT SOUNDBRIDGE consists of an external audio processor and an implanted stimulator, called the VORP. The audio processor converts sound to a signal that is transmitted to the VORP through the skin. The VORP contains an internal receiver, which relays the signal from the audio processor to the Floating Mass Transducer (FMT) through the conductor link. The FMT converts the signal into vibrations, which move the bones of the middle ear (ossicles), similar to natural hearing. The Vibrant Soundbridge is indicated for use in adults who have moderate to severe sensorineural hearing impairment and cannot achieve success or adequate benefit from traditional therapy such as hearing aids.
Middle ear 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 conductive hearing loss, an absent or non-functioning auditory nerve pathway , central auditory disorders, active middle ear infections, tympanic membrane perforations associated with recurrent middle ear infections, and skin or scalp conditions which may preclude attachment of the audio processor constitute contraindications.
Expected performance with middle ear 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 middle ear 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:


Patients implanted with a Vibrant Soundbridge are  exposed to the normal risk of surgery and general anesthesia. Major ear surgery may result in numbness, swelling, or discomfort around the ear, the possibility of facial paresis, disturbance of balance or taste, or neck pain. If these occur, they are usually transient and resolve within a few weeks of surgery.

 

Post-operative Side-Effects:


Possible post-operative side-effects include: decrease in residual hearing, delay in healing of the scar, and skin irritation. The is also a possibility of post-operative device failure or a decrease in device performance.
Some post-operative complications may require revision surgery.

 

Interference with Other Equipment:
 

  • Magnetic Resonance Imaging (MRI): Patients implanted with a Vibrant Soundbridge should not enter an MRI suite or come into close proximity to other sources of strong magnetic fields.
  • Electrosurgery: Electrosurgical instruments are capable of producing radio frequency voltages that can directly couple the instrument tip and the implant. Monopolar electrosurgical instruments must not be used within the vicinity of the implant because the induced currents could cause damage to the implant or the patient’s hearing.
  • 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.
  • Electroconvulsive Therapy: Electroconvulsive therapy must never be used on a patient with a Soundbridge because it may damage the implant or the patient’s hearing.
  • The effects of cobalt treatment, PET scans, transcranial diagnostic ultrasound, and linear acceleration techniques on the implant are unknown.

 

Every-Day Use:


Middle ear implant users are able to enjoy nearly any activity, but some restrictions or cautions will apply, including but not limited to:

  • The audio processor contains small parts that may be hazardous if swallowed.
  • 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).
  • Care should be taken with the external components of the Vibrant Soundbridge System.
  • Cellular telephones and strong magnetic sources, such as high voltage power lines or transformers, may interfere with the operation of the audio processor. As a result, you may experience interference or distorted sound when in close proximity to a mobile phone or strong magnetic source. If this occurs, you should move away from the source.

 

The products, applications and performance characteristics are subject to approval by the national competent authorities; some features may be currently unavailable or not offered for sale by MED-EL in your region. Please contact your local MED-EL representative for further information.

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