Jes Olsen, general manager of Oticon Medical

Askim, Sweden—Oticon Medical, a global medical device company within the William Demant Group, has obtained 510(k) clearance from the FDA to market the Ponto bone anchored hearing system, according to a statement released by the company.

The Ponto System features a user-friendly computer fitting platform to enable a more precise match between patient and sound processor, says the statement. The Ponto and Ponto Pro sound processor models are fully digital, based on the proprietary Oticon RISE™ platform. The 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.

“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, such as hearing loss due to malfunctioning of the ear canal or middle ear (conductive or mixed hearing loss) and single-sided deafness, says the statement. 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, says the statement. 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 United States, Scandinavia, the UK, 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, says the statement.

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,” says 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."

[Source: Oticon Medical AB]