SOMERSET, NJ–The U.S. Food and Drug Administration (FDA) has granted Oticon Medical 510(k) clearance to market a bone-anchored power processor called Ponto Pro Power. In announcing the FDA approval on June 27, Oticon Medical said that the new device 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 those with single-sided deafness who require an increased level of audibility. Oticon Medical is part of the Danish-based William Demant Group.
The new sound processor is built on Oticon’s RISE sound processing platform and offers features designed to deliver the two benefits most requested by power hearing aid users: enhanced speech intelligibility and reduced feedback.
Jes Olsen, Oticon Medical’s general manager, said, “Ponto Pro Power brings the advanced innovative features [used in] air-conduction hearing devices to people with severe hearing loss who cannot benefit from traditional hearing solutions.”
