So Xo Posted January 28, 2018 Report Share Posted January 28, 2018 Why doesn´t Bonebridge get aproval by FDA in USA? It has been aproved for northern europe now for over 2 and half year. Does anyone now? Quote Link to comment Share on other sites More sharing options...
HearPeers Heroes Ivana Marinac Posted February 4, 2018 HearPeers Heroes Report Share Posted February 4, 2018 I do not know whether it was even asked the approval from the FDA. Every audiologist who has been asked made a complimentary praise for the BB technical characteristics, yet the U.S. has not been conquered yet. Quote Link to comment Share on other sites More sharing options...
HearPeers Heroes Kara of Canada Posted February 6, 2018 HearPeers Heroes Report Share Posted February 6, 2018 I believe it is available in Canada. The first one in North America was five years ago. Quote Link to comment Share on other sites More sharing options...
HearPeers Heroes Ivana Marinac Posted February 13, 2018 HearPeers Heroes Report Share Posted February 13, 2018 Yes, it is available in Canada definitely. There is a link where it can be checked what is going on with Bonebridge on the FDA list. Quote Link to comment Share on other sites More sharing options...
HearPeers Heroes Mary Beth Posted February 13, 2018 HearPeers Heroes Report Share Posted February 13, 2018 Will you share the link @Ivana Marinac? Quote Link to comment Share on other sites More sharing options...
HearPeers Heroes Ivana Marinac Posted February 14, 2018 HearPeers Heroes Report Share Posted February 14, 2018 Unfortunately, I do not remember. I have never saved it because it is not important to me. But some people provided it in the FB unofficial Med-EL group as well as in that group where people share more technical details. I have reminded that link when users in the U.S. still had not activated 2nd microphone. Quote Link to comment Share on other sites More sharing options...
HearPeers Heroes Mary Beth Posted February 14, 2018 HearPeers Heroes Report Share Posted February 14, 2018 The FDA links I follow only post info after FDA approval. Quote Link to comment Share on other sites More sharing options...
HearPeers Heroes Ivana Marinac Posted February 14, 2018 HearPeers Heroes Report Share Posted February 14, 2018 Not sure, because I have never actually looked the described link - all I know, that it was written that when a proposal was raised, or similar. Quote Link to comment Share on other sites More sharing options...
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