Oticon Medical Receives FDA Clearance To Market Innovative Bone Anchored Hearing System
Oticon Medical, a global medical device company within the William Demant Group, announced that it has obtained 501(k) clearance from the U.S. Food & Drug Administration (FDA) to market the innovative Ponto bone anchored hearing system.
The Ponto System features an easy-to-operate computer fitting platform to enable a more precise match between patient and sound processor. The Ponto and Ponto Pro sound processor models are fully digital, based on the proprietary Oticon RISE™ platform, the world's most advanced sound technology. The ground breaking system is Oticon Medical's first entry into the high growth bone anchored hearing market, giving new choice to the people with hearing loss who cannot benefit from traditional hearing instruments.
Oticon Medical plans to launch the Ponto System globally later this year.
Superior Technology and Unprecedented Choice
"The Ponto System will move bone anchored hearing solutions to the next level," says Jes Olsen, General Manager of Oticon Medical. "Ponto offers physicians and hearing care professionals unprecedented choice in an arena with growing patient demand. The new system combines exceptional sound quality, improved aesthetics, user friendliness and reliability. In an industry in which only a few companies have the technical skill to act, Oticon Medical brings a freedom to choose that will benefit new and existing patients."
Bone anchored hearing solutions benefit people with hearing losses that cannot be treated with traditional hearing aids, including hearing loss due to malfunctioning of the ear canal or middle ear (conductive or mixed hearing loss) and single sided deafness. The FDA has cleared Ponto and Ponto Pro for use by "patients with conductive or mixed hearing losses, who can still benefit from amplification of the sound. The pure tone average (PTA) bone conduction (BC) threshold for the indicated ear should be better than 45 dB HL (measured at 0.5, 1, 2, and 3 kHz)."
Since bone anchored implant systems require patients to undergo a surgical procedure, Oticon Medical will work closely with leading otolaryngologists, neuro otologists and clinics throughout the world specializing in these types of surgical procedures.
Until now, the market for bone anchored hearing solutions has consisted of a few key markets including the USA, Scandinavia, the United Kingdom and the Netherlands where reimbursements are available for these treatment options. Oticon Medical's entry into the market is expected to continue to expand penetration of the existing markets and build new markets to increase patient access to the new technology.
Oticon Medical will emphasize sound processors, implants, fitting software, patient accessories and special tools for surgeons that deliver outstanding flexibility, safety and patient outcomes. "Our focus is patient-centered," explains Olsen. "We aim to provide the advanced technology solutions and the quality service, support and training hearing care providers require to optimize successful outcomes for patients with conductive and mixed hearing loss and single sided deafness."
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