AAMI News September 2015
Spotlight on Standards: Cochlear Implants Committee Nears Completion of Standard
A voluntary standard that addresses the safety, performance, labeling, and reliability of cochlear implants is on track for a vote and approval this fall, following years of detailed and intense discussions among manufacturers, clinicians, academic experts, and members of the U.S. Food and Drug Administration (FDA).
Julie Verhoff, the user co-chair of the AAMI Cochlear Implants Committee, described one of the key benefits of the pending standard this way: “Safety for people who use the device.” Verhoff is director of audiology at the River School and the Chattering Children organization, both in Washington, DC.
The formal title of the standard, which has been in development since March 2011, is AAMI CI86, Cochlear implant systems: Requirements for safety, functional verification, labeling, and reliability reporting.
Cochlear implant systems consist of an implantable device that electrically stimulates surviving nerve fibers within the inner ear to produce perceptions of sound in patients with significant sensorineural hearing loss. The implanted device is controlled by an external sound processing device that encodes acoustic sound signals into patterns of electrical stimulation.
Patients who receive cochlear implants often have severe-to-profound hearing loss and cannot benefit from the use of a traditional hearing aid. While not everyone with this type of hearing loss is a candidate for a cochlear implant, those who do receive such implants often experience an improvement in their functional hearing and enjoy a better quality of life.
The standard covers a variety of issues related to cochlear implants, including the specification of basic safety and performance criteria. It is intended to assist manufacturers in functionally verifying and labeling their devices. It also covers how to gather information from the field regarding signs and symptoms of suspected failure for both medical and non-medical reasons. The standard sets uniform requirements for failure analysis and reporting of device system reliability to the FDA, the professional healthcare community, and the public. In addition, the standard includes general guidelines for characterizing a cochlear implant system—a move intended to streamline the regulatory review process.
The standard also calls for the reporting of information regarding the design, operation, testing, and reliability of the implantable and non-implantable components of the cochlear implant system. Access to this information will allow patients (or their parents) to compare the performance characteristics and feature sets of different products in order to choose the cochlear implant system that will best fit their needs.
The committee met at AAMI on July 27–29 to discuss the comments received during the second ballot and public review period, and to resolve areas of disagreement in the standard.
Vasant Dasika, a biomedical engineer with the FDA and the agency representative on the committee, described the standards work as “interesting and challenging,” saying it was important for committee members to thoroughly consider the various issues to reach consensus. “It’s very important to look at that level of detail to create a quality standard that the cochlear implant manufacturers and FDA can concur with.”
A third ballot is scheduled to conclude at the end of September, and the expectation is the standard will be approved and published this fall.
Committee members will give two presentations to highlight areas of particular interest in the standard at CI 2015, a symposium organized by the American Cochlear Implant Alliance and set for next month in Washington, DC. Additionally, Dasika gave a presentation on the standard at the Conference on Implantable Auditory Prostheses this past July in Lake Tahoe, CA.
If you have any questions about the committee or the standard, please contact Colleen Elliott at firstname.lastname@example.org. Once finalized, the standard will be available in the AAMI Store.