Advanced Bionics wins FDA nod for HiFocus Slimj cochlear implant electrode

Advanced Bionics said late last week it won FDA approval for its HiFocus SlimJ electrode designed for use with the company’s HiRes Ultra cochlear implant. The Valencia, Calif.-based company touts the new electrode as featuring a thin, straight design for easier insertion during procedures and a slim profile to protect the delicate structures of the cochlea during insertion. “The HiFocus SlimJ electrode addresses the surgeon need for an alternate type of electrode whilst still offering full spectrum coverage and maintaining the performance potential of the individual. And surgeons have commented that it is easy to handle and to insert,” Advanced Bionics medical marketing & product management director Mark Downing said in a prepared statement. Advanced Bionics said the addition of the new electrode along with its HiFocus Mid-Scala electrode provides surgeons with personalized choices during procedures to accomodate individual patient anatomy and surgical preferences. “I am very pleased with the successful implantations in Europe following the TÜV approval. This marks an important milestone not only for Advanced Bionics but for all future CI candidates,” Sonova cochlear implants group VP Hansjuerg Emch said in a press release. Last November, a federal appeals court overturned a win for Cochlear Ltd. (ASX:COH) in its patent spat with Advanced Bionics over hearing implant technology, sending the case back to district court for reconsideration ...
Source: Mass Device - Category: Medical Devices Authors: Tags: Food & Drug Administration (FDA) Otolaryngology Ear, Nose & Throat Regulatory/Compliance Advanced Bionics LLC Source Type: news