Technischer Überwachungsverein (TÜV), a European Notified Body, has granted CE Mark approval for Advanced Bionics' HiRes 90K Advantage cochlear implant.
The implant is designed to be used in patients with unilateral (asymmetric) hearing loss, also known as single-sided deafness (SSD).
Approval was granted for the HiRes 90K Advantage cochlear implant with the HiFocus1J, HiFocus Helix and HiFocus Mid-Scala electrodes.
Reviews from three recent studies showed that SSD patients with cochlear implants have improved sound localisation abilities and better perception of speech in noise, two areas of considerable difficulty for people with unilateral hearing.
The trials also showed that SSD patients who did not benefit from other implantable options received significant benefit from cochlear implants.
The company also provides speech understanding solutions, including ClearVoice speech enhancement technology and UltraZoom, in the Naída CI family of sound processors.
Advanced Bionics president Hansjuerg Emch said: "We are pleased that patients with single-sided deafness can now benefit from our cochlear implant technology."
The new AB electrode array, HiFocus Mid-Scala electrode, was designed for optimal placement in the cochlea with low insertion force to protect its delicate structures and promote the latest soft surgery approaches to suit surgeon preferences.
As a result, the HiFocus Mid-Scala provides recipients the opportunity to hear the most pitches possible for enjoying music and improved speech understanding.
Advanced Bionics offers the HiResolution Bionic Ear System, with five times more sound resolution than its competitors, designed to help recipients hear in noisy settings and enjoy the full dimensions of music and tonal languages.
Image: HiRes 90K Advantage cochlear implant from Advanced Bionics. Photo: courtesy of Business Wire.