Opinion ID: 627205
Heading Depth: 3
Heading Rank: 2

Heading: Cochlear Implants

Text: As Appellants explain, a cochlear implant is a type of hearing aid for an individual whose hearing loss is too severe for the use of a traditional acoustical hearing aid. The device consists of both an external component and a surgically implanted internal component. The external componenta microphone, a speech processor, and a transmitter systemdetects and processes sound and then transmits the sound to the internal component in the form of radio waves. The internal componenta receiver connected to an electrode arrayreceives the radio waves and stimulates the corresponding electrodes so that the brain can process the audio signals. A cochlear implant periodically must be mapped to function properly. Mapping is the process by which an audiologist optimizes the amount of stimulation that the electrodes provide to the auditory nerve. According to Appellants, an audiologist maps an implant by measuring the user's response to electrical stimulation by connecting the device's speech processor to a computer with specialized software. Based on the user's response to the stimuli, the audiologist calibrates the speech processor so that the electrodes stimulate the auditory nerve in a way that the user can process. Periodic mapping is essential, because, without it, the cochlear implant may transmit auditory information to the brain that does not accurately reflect the sounds around the user. Mapping must be performed by an audiology specialist who possesses a specific set of skills. See Letter from Am. Acad. of Audiology to Troy R. Justesen, U.S. Dep't of Educ. (Aug. 12, 2005) (Academy Letter), J.A. 43. Moreover, the audiologist must have familiarity with the speech coding, processing and programming parameters of all . . . manufacturers of cochlear implants. Id., J.A. 44. Thus, the American Academy of Audiology requires that, even to sit for the examination for Board Certification in Audiology with Speciality in Cochlear Implants, an audiologist must have two years experience as an audiologist, 450 hours of direct contact with individuals with cochlear implants, and 50 hours of case management of individuals with [cochlear implants]. Id., J.A. 43. Marilyn Neault, the Director of Habilitative Audiology at the Children's Hospital in Boston, has explained why mapping must be performed by a specialist: Programming (mapping) of a cochlear implant processor alters the electrical stimulation that the implant provides to the surrounding tissue inside the inner ear. Too much stimulation can cause pain or facial twitching. Programming that is poorly done can result in a lower outcome in terms of the child's ability to hear. Failure of the programming audiologist to notice changes in the child's electrical stimulation requirements that signal partial extrusion or malfunction of the internal device can result in poor outcome. Failure of the audiologist to notice that the headpiece magnet is too tight can result in skin breakdown over the magnet which can require hospitalization and surgery. Lack of communication access between the programming audiologist and the implant surgeon can delay action regarding internal device problems. Letter from Marilyn W. Neault to Troy R. Justesen 1 (Sept. 6, 2005) (Neault Letter), J.A. 48.