|[December 18, 2013]
Oticon Medical Receives FDA Clearance to Market New Ponto Plus Bone Anchored Sound Processors in Regular and Power Versions
SOMERSET, N.J. --(Business Wire)--
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 sound
so that users can enjoy more everyday sounds without sounds becoming
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
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.
For more information on bone anchored hearing solutions, Oticon Medical
and the new Ponto Plus family, visit www.oticonmedical.com.
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