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- The FDA has broadened the indications for MED-EL cochlear implants, allowing more adults with moderate-to-profound sensorineural hearing loss to qualify for the device. - MED-EL received FDA approval for hearing preservation claims, highlighting the FLEX electrode design's ability to maintain functional residual hearing post-implantation. - The expanded criteria utilize a single-word test (CNC) for speech recognition, representing a more challenging measure and the widest candidacy indication in the industry. - MED-EL's technology, including Anatomy-Based Fitting (ABF), aims to provide a richer, fuller hearing experience and natural sound quality, enhancing patient outcomes.
- The FDA has approved expanded indications for the MED-EL Cochlear Implant System, allowing more adults with bilateral moderate-to-profound sensorineural hearing loss to qualify. - MED-EL is the first cochlear implant manufacturer to receive FDA approval for marketing claims related to the preservation of functional residual hearing after implantation. - The FLEX electrode design by MED-EL has been proven to reduce cochlear trauma, which is critical for preserving residual hearing in cochlear implant recipients. - Anatomy-Based Fitting (ABF) has been added to MED-EL implants, allowing audiologists to align the pitch of sounds to the placement of each individual’s electrode array.
- MED-EL's cochlear implant system secures FDA approval for expanded use in adults with moderate-to-profound sensorineural hearing loss, setting a new industry standard. - The approval includes the first-ever FDA endorsement for marketing claims related to the preservation of functional residual hearing after cochlear implantation. - MED-EL's FLEX electrode design is proven to minimize cochlear trauma, aiding in the preservation of residual hearing, as demonstrated in clinical research and registry data. - Anatomy-Based Fitting (ABF) enhances the implant's sound coding, providing a richer, more natural hearing experience, especially for music appreciation.
