Enquiry about the classification by US customs officials of hearing loop equipment as 'medical devices', requiring FDA approval

Our response was that the equipment had been incorrectly described by the shippers and that exports to the USA should be careful about the wording used and to avoid the SIV designation ‘assistive medical devices’. One suggestion from a member experienced with US importing is to use the description ‘communications equipment’. We also now have a copy of a letter from the FDA confirming that hearing assistive listening systems are not medical devices and do not require a 510(k) premarket notification.