Sweden-based Oticon Medical has received 510(k) approval from the US Food and Drug Administration (FDA) for its new Ponto Plus bone anchored sound processors.
Ponto Plus has been designed for use with Oticon Medical‘s proprietary OptiFit/OptiGrip implant design concepts and is available in regular version (down to a hearing loss of 45dB) and power version (down to a hearing loss of 55dB).
The OptiFit/OptiGrip implant design concepts have also received FDA approval for use in tissue-preserving surgery.
Built on the Inium platform, the latest chip technology from Oticon Medical’s sister company Oticon, the Ponto Plus features a new transducer, Bluetooth 2.4GHz wireless technology and Inium feedback shield.
With these features, the device delivers improved sound quality, reduced feedback and fewer artificial sounds, the company claims.
According to Oticon Medical, Ponto Plus system is the most powerful ear-level bone anchored sound processor family. The system supports new tissue-preserving surgical possibilities for clinicians to increase long-term prospects and well-being for new and experienced users of hearing implant technology.
Oticon Medical has optimised the design of the new transducer to enable Ponto Plus solutions reproduce louder sounds.
Wireless technology enables the device to connect directly to smartphones, 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 programmes or adjust volume, and built-in jacks allow simple connections to FM systems, music players and computers.
Oticon Medical president Jes Olsen said: "Our ability to rapidly advance bone anchored hearing solutions with new technologies, such as the powerful Inium platform, demonstrates our ongoing commitment to identify new competencies and methods that will empower physicians to achieve the best possible results for patients.
"By delivering more benefits to patients through superior sound quality, power solutions, connectivity options, tissue-preserving surgery and other breakthroughs, we aim to significantly expand the market for bone anchored solutions."
Ponto Plus had already obtained IP57 certification and CE Mark approval. With its reliable design, the device reduces wind noise and limits water, dust and debris from getting inside the processor. The nano-coated housing repels water.
Image: Oticon Medical gets FDA approval for Ponto Plus bone anchored sound processors. Photo: courtesy of Business Wire/Oticon Medical.