FDA approves cochlear implant designed for individuals with ossified cochlea

Otorhinolaryngology

Date: 8/4/2002

2002 AUG 4 - (NewsRx.com & NewsRx.net) -- Cochlear Americas announced that the U.S. Food and Drug Administration (FDA) approved the Nucleus 24 Double Array cochlear implant for use in patients with ossification (bone growth) in their cochlea (inner ear). This bone growth may block the space inside the cochlea preventing the use of conventional cochlear implants, which consist of a single array of electrodes. The Nucleus 24 Double Array allows patients with significantly ossified cochlea to gain the benefits of cochlear implantation by offering two shorter electrode arrays. Unlike a single electrode array, these shorter electrodes arrays are surgically implanted into two different positions in the cochlea bypassing ossification that may be obstructing the passage way. "The Nucleus 24 Double Array is an innovative solution offering patients with ossified cochlea the option to benefit from cochlear implants," said Jim Miller, president, Cochlear Americas. "We are delighted that the collaborative efforts of Cochlear Americas and Professor Lenarz resulted in a product that provides an alternative to patients who, due to this disorder, could not normally benefit from a cochlear implant." Additional features of the Nucleus 24 Double Array: * Two electrode arrays, providing 22 channels of stimulation. * Compact arrays, each consisting of 11 electrodes, designed to provide the most sound information over the shortest distance. * Thin and tapered electrode arrays for easy insertion. * Supports SPEAK, CIS and ACE speech coding strategies to help maximize hearing performance. * Compatible with the ESPrit 3G and Sprint speech processors. A cochlear implant bypasses damaged hair cells and directly stimulates the hearing nerve fibers in the cochlea (inner ear). A small, directional microphone located in the headset at the ear picks up sounds. Sound is carried through a cord to the speech processor, which is a powerful miniaturized computer that filters, analyzes and digitizes sounds into coded signals and sends them to the transmitting coil. The transmitting coil sends them as FM radio signals to the cochlear implant located under the skin. Appropriate electrical energy is delivered to the array of electrodes, which has been inserted into the cochlea, stimulating the auditory nerve fibers. Sound is sent to the auditory system to the brain for interpretation. This article was prepared by Medical Devices & Surgical Technology Week editors from staff and other reports.