Cochlear Ltd. (ASX:COH) said landed 510(k) clearance from the FDA for its Baha 4 attract system, a bone conduction hearing system.
The Baha uses a system of magnets to conduct sound. A sound processor attached to an external magnet transmits sounds to a magnet implanted under the skin, which then conducts sound to a titanium implant.
The FDA win makes Centennial, Colo.-based Cochlear Limited "the only company to now offer patients a choice of either a magnetic or a direct bone conduction hearing solution," according to a press release.
“The Baha 4 attract system sets new standards in simplicity, comfort and hearing performance for magnetic bone conduction implant systems," Americas president Chris Smith said in prepared remarks. "We are pleased to be bringing this new hearing option to patients who want to enjoy the benefits of the Baha System without a skin penetrating abutment."
The hearing-device maker notched another win just weeks ago when the FDA’s Ear, Nose & Throat Devices advisory committee approved its Nucleus Hybrid L24 implantable hearing system. The Nucleus system combines acoustic amplification of low frequencies and electrical stimulation for high frequencies in a single device.
