BIHIMA statement concerning the use of hearing instruments and implanted medical devices
Some hearing instrument users will also have medical implants fitted (e.g. cardiac pacemakers or cardiac internal defibrillators). The following statement outlines the position of BIHIMA members in relation to using the hearing technology they manufacture in conjunction with implanted medical devices.
BIHIMA members strongly advise users of hearing instruments to always follow the instructions and guidance set out in the user manual included with their hearing instrument. Furthermore, when using implanted medical devices (such as cardiac pacemakers or cardiac internal defibrillators) at the same time as a hearing instrument manufactured by any BIHIMA members, we strongly advise that you follow the instructions and guidance supplied by the manufacturer of the implanted medical device.
Users of implanted medical devices should always immediately stop using electronic devices, including hearing instruments, if any interference to the implant is experienced. The user should immediately contact the manufacturer of the implant.
To ensure that hearing instruments from BIHIMA members can operate safely and efficiently without interference in the vicinity of other electronic devices, they have been manufactured according to international standards for electromagnetic compatibility (EMC).
Hearing instruments manufactured by BIHIMA members are designed to comply with the international standard for EMC and electrical safety IEC 60601—1—2.
Implanted medical devices are required to comply with the standards described in ANSI/AAMI/ISO 14117 on securing electromagnetic compatibility with other electronic devices including hearing instruments. As a consequence, implanted medical devices which comply with ANSI/AAMI/ISO 14117 standards should continue to operate within the requirements of basic safety and essential performance when used with hearing instruments manufactured by BIHIMA members.