Healthcare Industry News:  Oticon Medical 

Devices FDA

 News Release - June 27, 2011

Oticon Medical Secures FDA Clearance for Ponto Pro Power, World’s Most Powerful Fully Digital, Programmable Bone Anchored Power Processor

SOMERSET, N.J.--(Healthcare Sales & Marketing Network)-- Oticon Medical, an international medical device company within the William Demant Group, today announced that the U.S. Food and Drug Administration (FDA) has granted the company 510(k) clearance to market Ponto Pro Power, the world’s most powerful fully digital and programmable bone anchored power processor. Ponto Pro Power will benefit adults and children with severe hearing loss due to malfunctioning of the ear canal or middle ear (conductive or mixed hearing loss) and single sided deafness who require an increased level of audibility.

The new sound processor is built on Oticon’s advanced RISE sound processing platform and offers innovative features that aim to deliver the two benefits most requested by power users -- enhanced speech intelligibility and reduced feedback.1 The sleek, ergonomically designed Ponto Pro Power is the newest addition to Oticon Medical’s expanding portfolio of bone anchored hearing solutions designed to give physicians and hearing care professionals more choice in a healthcare arena with growing patient demand.

“For the first time, Ponto Pro Power brings the advanced innovative features that have revolutionized the field of air conduction hearing devices to people with severe hearing loss who cannot benefit from traditional hearing solutions,” said Jes Olsen, Oticon Medical General Manager. “With the introduction of Ponto Pro Power, we re-affirm our commitment to delivering more patient-centered innovation and to increasing freedom of choice in bone anchored hearing systems.”

Oticon Medical’s Ponto bone anchored implant system includes a fully upgraded product range that includes many of the up-to-date advanced features available in new Ponto Pro Power. Bone anchored implant systems are comprised of an external sound processor, such as the new Ponto Pro Power, held in place by an external abutment attached to a titanium screw that is surgically implanted behind the ear. The bone carries vibrations that bypass the external and middle ear and travel directly to the inner ear. A relatively new advance in hearing healthcare, bone anchored implant systems were first approved by the FDA for conductive and mixed hearing loss in 1996 and for single-sided deafness in 2002.

Oticon Medical works closely with leading otolaryngologists, neuro otologists, audiologists and clinics throughout the world that specialize in surgical procedures and fitting of bone anchored implant systems. “At Oticon Medical, our focus is patient-centered,” explained Olsen. “We will continue to develop the innovative hearing solutions, service and support that will enable our professional partners to optimize successful outcomes for their patients with conductive and mixed hearing loss and one-sided deafness.”

1 Bosman AJ et al. “Evaluation of a New Powerful Bone-Anchored Hearing System.” Poster presented at the Third International Symposium on Bone Conduction Hearing-Craniofacial Osseointegration, Sarasota, Florida, 2011.

Source: Oticon Medical

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