Sounds good news for people who have been waiting for this. Now, Sonitus Medical Inc., a privately held medical device company that produces the world’s first non-surgical and removable hearing prosthetic to transmit sound via the teeth, now received its much-awaited CE Mark Certification for its baby – SoundBite Hearing System. Sonitus Medical now holds its EC Certificate, which means Full Quality Assurance System Approval. The company prides itself doe having such because this is the first European regulatory certification the company and the product has ever received.
According to the CEO of Sonitus Medical, receiving such mark for the SoundBite Hearing System is an important milestone toward the global commercialization of the company’s non-surgical bone-conduction hearing device. The company also attained FDA clearance earlier this year, which, along with the CE Marking, signifies that Sonitus Medical’s design and manufacturing processes for the SoundBite Hearing System comply with particular manufacturing and design standards under the European directive concerning medical devices. With this certification, Sonitus Medical is able to commercialize the SoundBite Hearing System in Europe.
Meanwhile, SoundBite hearing system takes pride in being the world’s first and only non-surgical and removable hearing solution that’s designed to imperceptibly transmit sound via the teeth to help people who are deaf in one ear get back their spatial hearing ability and be able to join again in conversations. This hearing aid employs bone conduction principle to deliver clear, high quality sound to the inner ear. It’s nearly invisible when worn and it comes with easy to insert and remove ITM (in-the-mouth) hearing device. If you think you have a special need for this product, check out availability of Soundbite hearing system and other digital hearing aids at Amazon.
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