Oticon Medical, a manufacturer of bone anchored hearing systems, has obtained 510(k) approval the US Food and Drug Administration (FDA) to market its Ponto Plus bone anchored sound processors in regular version (down to a hearing loss of 45dB) and power version (down to a hearing loss of 55dB).
Designed for use in combination with Oticon Medical’s proprietary OptiFit/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.
OptiFit/OptiGrip implant design concepts have also obtained FDA approval for use in tissue-preserving surgery.
According to Oticon Medical, Ponto Plus system is the most powerful ear-level bone anchored sound processor family.
The system is built on the Inium platform, the latest chip technology from Oticon Medical’s sister company Oticon.
Ponto Plus comprises a new transducer, Inium feedback shield and newest Bluetooth 2.4 GHz wireless technology, all designed to deliver better sound quality, less feedback and fewer artificial sounds.
Oticon Medical has optimized the design of the new transducer to enable Ponto Plus solutions reproduce louder sounds so that users can enjoy more everyday sounds without sounds becoming distorted.
The wireless technology enables the device to connect 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 function 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.
The IP57 certified device reduces wind noise and limits water, dust and debris from getting inside the processor. The nano-coated housing repels water.
Ponto Plus has also obtained CE Mark approval and meets EU safety requirements.
Image: Oticon Medical receives FDA 510(K) approval for Ponto Plus. Photo: Courtesy of Business Wire/Oticon Medical.