MED-EL USA Launches SAMBA 2 Audio Processor for BONEBRIDGE System
DURHAM, NORTH CAROLINA – MED-EL USA, a leader in implantable hearing solutions, today announced the launch of the SAMBA 2, a next-generation audio processor for the BONEBRIDGE Bone Conduction System, which includes the recently launched BCI 602. BCI 602 is an active transcutaneous bone conduction implant that leaves skin intact. The BONEBRIDGE System is indicated for…
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Oticon Medical Launches Ponto 4 Bone Anchored Sound Processor in US Market
SOMERSET, NEW JERSEY — Oticon Medical has launched the Ponto 4, a small and high-performing sound processor that it says marks a significant breakthrough in bone anchored hearing care in the US. According to the company’s press release, the new processor represents “a powerful combination of Oticon Medical’s expertise in bone conduction hearing with the…
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Oticon Medical Receives 510(k) Clearance from FDA to Market New Ponto 4 Processor
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…
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Oticon Medical Introduces the Ponto Trial Companion App
SOMERSET, NEW JERSEY — Oticon Medical has introduced the new Ponto Trial Companion App, which the company says is a “simple-to-use app that provides an easy way for patients to evaluate whether bone anchored hearing and the Ponto Sound System are the right decision for them”. Aimed at improving patient engagement in the trial process…
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MED-EL Bone Conduction Implant System Granted FDA De Novo Clearance
MED-EL USA announced this week that the U.S. Food and Drug Administration (FDA) has granted de novo clearance for the BONEBRIDGE bone conduction hearing implant system for individuals 12 years and older who have been diagnosed with conductive hearing loss, mixed hearing loss, or single-sided deafness. Unlike many bone anchored hearing aids, which include an…
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MED-EL Obtains FDA Clearance for ADHEAR, Non-Surgical Bone Conduction Device
Hearing implant maker, MED-EL, announced today that it had received clearance from the US Food and Drug Administration (FDA) for its latest non-surgical bone conduction hearing technology: ADHEAR. According to the company, ADHEAR is an option for people with conductive hearing loss, or single-sided deafness (SSD), that are either not candidates for, or who would…
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