MED-EL Corporation officials announce that the U.S. Food and Drug Administration approval of the new FLEX24 and FLEX28 electrode arrays. The exciting new surgical option will be coming to the U.S. market soon for use with the MAESTRO Cochlear Implant System.
The FLEX electrode design incorporates FLEX-Tip technology and MED-EL’s exclusive wave-shaped wires. The electrode arrays feature paired electrode contacts for the seven basal channels and single electrode contacts for the five apical channels. This design creates an electrode that is narrower, tapered and more flexible on the apical end to better match the shape of most cochleae. Offered in two lengths, 28mm or 24mm, the new electrode arrays offer surgeons additional options for atraumatic insertion, which provides the best possibility for preserving the delicate structures in the cochlea.
All of MED-EL’s electrode arrays feature ultra-flexible wave-shaped wires, designed to significantly reduce rigidity in comparison to a straight-wire design. This design provides a better chance to preserve the integrity of neural tissue targeted for electrical stimulation. When considering that future hearing treatments may depend on preserving the anatomy, preservation of neural tissue becomes an important goal of electrode design and development. While MED-EL has always provided a number of options to best meet the unique needs of every candidate, the new FLEX electrode arrays are specifically engineered for atraumaticity during both insertion and extraction, if that is required. In addition to the new FLEX options, MED-EL will continue to offer the Standard, Medium and Compressed electrode arrays.
“With today’s rapidly-changing technology, it’s much more likely that patients will have more than one electrode insertion over their lifetime. A child implanted today will hopefully still be benefitting from cochlear implants or other innovative hearing implant technologies and treatments 80 years from now. So, patients and surgeons want to consider electrodes that are as gentle to insert and extract as possible,” states Richard Collette, president and CEO, MED-EL Corporation USA.
“An atraumatic electrode is also very important when thinking about accessing developments on the horizon. Technologies being researched today, including stem cell treatments, genetic treatments, optical stimulation, and drug delivery, will likely benefit from intact cell structures. We want to do all we can to help preserve that future potential for our patients, while still providing an opportunity to take advantage of all that our current cochlear implants have to offer,” he continued.
In addition to helping to preserve the delicate neural structures for future innovations, many individuals with severe to profound hearing loss may still be able to hear some very loud sounds; this is referred to as residual hearing. Preserved residual hearing after implantation indicates that the electrode was atraumatic and that the surgical technique was excellent. FLEX electrodes are demonstrated to preserve residual hearing in a variety of peer-reviewed publications, thus supporting the goal of ensuring a hearing future for implant recipients.