Oticon Medical obtains FDA clearance to market Ponto Plus bone anchored sound processors
Published on December 18, 2013 at 8:17 AM
Oticon Medical has obtained 510(k) clearance from the U.S. Food and Drug Administration to market Ponto Plus, the company's newest family of bone anchored sound processors. New Ponto Plus is available in regular and power versions and is designed for use with Oticon Medical's proprietary OptiFit™/OptiGrip™ implant design concepts that have also been cleared by the FDA for use in tissue-preserving surgery.
Built on the Inium platform, the latest chip technology from OM's sister company Oticon, Ponto Plus features a new powerful transducer, efficient and innovative Inium feedback shield and newest Bluetooth 2.4 GHz wireless technology, all designed to deliver better sound quality, less feedback and fewer artificial sounds.
Available in regular (down to a hearing loss of 45 dB) and power (down to a hearing loss of 55 dB) versions, Ponto Plus is the most powerful ear-level bone anchored sound processor family. The optimized design of the transducer enables Ponto Plus solutions to reproduce louder sounds so that users can enjoy more everyday sounds without sounds becoming distorted.
Used in combination with Oticon Medical's newly FDA cleared OptiFit™ and OptiGrip™ implant design concepts, Ponto Plus supports exciting new tissue-preserving surgical possibilities for clinicians to increase long term prospects and well-being for new and experienced users of hearing implant technology.
Innovative wireless capabilities make it possible to connect Ponto Plus directly to smart phones, loop systems in public venues and other modern communication devices to allow conversation, music and other sounds to transmit from the Ponto Streamer directly to the sound processor. The Ponto Streamer can also act as a remote control, creating an easy way for users to change programs or adjust volume, and built-in jacks allow simple connections to FM systems, music players and computers.
Ponto Plus has been robustly designed to meet the challenges of active lives and everyday activities, and is IP57 certified. The durable, reliable design reduces wind noise and limits water, dust and debris from getting inside the processor. The housing is nano-coated to repel water. In addition to IP57 certification, Ponto Plus is now FDA cleared, CE marked and meets EU safety requirements.