Oticon Medical’s Ponto Hearing System Receives FDA Clearance

Jes Olsen

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, says the company.

The Ponto System features a user-friendly, computer-fitting platform to enable a more precise match between patient and sound processor, according to the company. 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, and plans are under way to launch the 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. The company says it will emphasize sound processors, implants, fitting software, patient accessories, and special tools for surgeons that deliver outstanding flexibility, safety, and patient outcomes. “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.”

Bone-anchored hearing solutions help 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. 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 dBHL (measured at 0.5, 1, 2, and 3 kHz).”

Since bone-anchored implant systems require patients to undergo a surgical procedure, the company says it will work closely with leading otolaryngologists, neuro-otologists, and clinics worldwide specializing in these types of procedures.

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, says the company. 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.

Starkey UK Awards Research Grant to Manchester University

Starkey Laboratories Inc, Eden Prairie, Minn, has awarded a £200,000 research grant over 3 years to the Audiology and Deafness Research Group at Manchester University through Starkey UK, says the company. The research will explore the benefits of bilateral amplification, or fitting hearing instruments in both ears.

More than 80% of people in the United States are fit bilaterally, but the number is much lower in the UK and Europe. Practicing audiologists in greater Manchester will help test the patient benefit of the research, which will look at how bilateral fitting can aid concentration and help people focus on specific sounds.

In 2008, Deafness Research UK designated the group as a Centre of Excellence for research that leads to benefit for people with hearing impairment, says the company.