Below is the latest from Neuromod we received today - so it's just about waiting some more now. A more detailed update should come sometime in the future...
We are working diligently to make the product available to patients as soon as we can. As you know we are still in the process of completing TENT-A2 12 month follow up and are finalising the publication of TENT-A1 results. In addition we are working hard to ensure that all of the necessary steps are completed to support qualified clinicians in fitting and overseeing treatment with the Neuromod device. And as outlined in the Q&A with Ross, we are working hard to engage with regulatory authorities in the United States and elsewhere to apply for marketing clearance.
We continue to work hard to make the product available as early as possible in 2019, however, early 2019 should not be interpreted to mean January. We are confident that the treatment will be available soon and are working with leading experts in the field to make this possible. We will provide a more detailed update at the appropriate time. We have asked interested parties to sign up for information about product availability in their region at https://www.neuromoddevices.com/signup
We understand and are encouraged by the strong interest in the treatment, and are doing all we can to address that interest. We are a regulated medical device company seeking to bring evidence-based treatments for tinnitus to the market, and the process of making the product available in the appropriate setting cannot be rushed unfortunately.
Thank you for keeping us informed and aware of your members’ requests.
