scope:

This standard specifies requirements, test procedures, methods and labeling for active implantable medical devices intended to treat hearing impairment by means of electrical stimulation of the cochlea. Such devices are referred to as cochlear implants or cochlear prostheses. This standard is also applicable to non-implantable parts and accessories of the devices, including fitting and diagnostic components.

A cochlear implant system can be a single device, a combination of devices, or a combination of a device or devices and one or more accessories. Not all of these parts are required to be either partially or totally implantable, but some requirements for non-implantable parts and accessories must be specified if they could affect the safety or performance of the implantable part.

Devices that treat hearing impairment exclusively by means other than direct electrical stimulation are not covered by this standard (e.g., hearing aids, bone conduction devices, middle ear prostheses). For devices that treat hearing impairment using combined electrical and acoustic stimulation, only the components relevant to electrical stimulation are covered by this standard. The acoustic stimulation is covered by other relevant standards. For devices that deliver medicinal substances and are consequently combination products for regulatory purposes, this standard covers only the components relevant to electrical stimulation.

The tests specified in this standard serve two purposes:

a) To demonstrate compliance with specific requirements in the standard (type tests) and

b) To demonstrate functional performance of the system and/or subsystem components at specified reliability levels within known confidence limits (reliability tests)

The sample sizes and selection methods vary across the tests, depending on the purpose of the test, the degree of patient risk associated with failure of the component being tested, and the desired degree of confidence for the test.

The electrical, mechanical, and thermal characteristics of the implantable part shall be determined either by the appropriate method detailed in this particular standard or by another method demonstrated to have accuracy equal to, or better than, the method specified. In the case of dispute, the method detailed in this particular standard shall apply.

This standard requires the reporting of information regarding the design, operation, testing, and reliability of the implantable and non-implantable components of the cochlear implant system, including accessories required for or which extend the operation of the system. All such information shall be considered confidential to the manufacturer unless the standard states specifically that the information is for broader distribution and the standard provides detailed requirements for that broader distribution.

Throughout this standard, descriptive or explanatory information is included with the text describing requirements and tests. The information contained in notes should be considered in the implementation of tests and/or in the interpretation of results.

This standard does not address all of the appropriate aspects of wireless technology incorporated into cochlear implant systems. The standard does include some tests for specific aspects of wireless functionality of the system and its components.

This standard does not address the clinical/audiological performance data that a manufacturer might include as part of a regulatory submission to support the safety and effectiveness of a device.