Oticon Medical Receives 510(k) Clearance from FDA to Market New Ponto 4 Processor

May 13, 2019

SOMERSET, NEW JERSEY — Oticon Medical announced today that it has obtained 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market the new Ponto 4 bone anchored sound processor. According to the company, the new Ponto 4 will officially launch in the US in early summer 2019.

“With Ponto 4, Oticon Medical enters a new era by bringing the largest improvements for bone anchored users in many years. The introduction of Ponto 4 and the Velox S™ platform signals a paradigm shift in bone anchored hearing. Many users around the world have already had their lives changed by the groundbreaking technology in Oticon Opn™ and Oticon Opn S™ hearing aids. Now, we combine Oticon Medical’s know-how in bone conduction hearing with the newest state-of-the-art technology from one of the world’s leading hearing healthcare groups.”

–Jes Olsen, President of Oticon Medical


Quickly Managing Multiple Sound Sources


Built on the unique Velox S™ platform, Ponto 4 delivers fast and precise sound processing for an open soundscape and noise-optimized listening experience. The OpenSound Navigator™ analyzes the sound environment more than 100 times per second to balance the sound sources and attenuate noise even between words. Users can then “enjoy an open and balanced sound experience”.

“With Ponto 4, we are moving away from using directionality as we know it. The OpenSound Navigator handles multiple speech and noise sources in a new, fast and efficient way. It balances the environment and targets noise to a much higher degree that we have been able to before. We feel proud and confident that this will make a huge difference in the ability of bone anchored users to follow conversations and keep up with the dynamics of life,” says Olsen.


Smaller Size and Wireless Connectivity


The Ponto 4 is currently the smallest bone anchored device on the market, at 27% smaller in size compared with the Ponto 3. 

The Ponto 4 will also bring world-first advancements in wireless capabilities to the bone anchored field. Through a unique Oticon cloud solution, the web-based service IFTTT (If This Then That) and the Oticon ON App are used to unlock a world of potential for connected device communication. Users can program connections between their sound processor to a range of devices and services, for example “smart” doorbells, smoke detectors and baby alarms.

“The Internet of Things brings endless opportunities for Ponto 4 users. What we see now is just the starting point of a future of connected hearing care. The launch of Ponto 4 means bone anchored users can be part of this journey.”  

–Jes Olsen, President of Oticon Medical

For readers interested in more information about the new Ponto 4 sound processor, visit the Oticon Medical website here


Source: Oticon Medical

Leave a Reply