Replies to post #23960 on Innerscope Hearing Technologies Inc (INND)

[Sheddoggie]

Matt had mentioned FDA clearance by mid-late 4th quarter in a tweet. Where did you find this new information?

[jeffshir]

Hard to guess FDA timelines for approvals. FDA works at their own pace

[Magnum7419]

November 01, 2018 08:00 ET | Source: InnerScope Hearing Technologies, Inc.
InnerScope and Erchonia have entered into Joint Development & Exclusive Distribution Agreements and intend to obtain a 510k FDA-Clearance via clinical trial to study the effect on using Erchonia's Low-Level Laser Therapy Technology for the relief of tinnitus symptoms

https://www.globenewswire.com/news-release/2018/11/01/1641109/0/en/InnerScope-Hearing-Technologies-Inc-Erchonia-Corporation-to-Conduct-FDA-Clinical-Trial-for-the-Treatment-of-Tinnitus.html

[Magnum7419]

"A 510(K) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device (21 CFR §807.92(a)(3)) that is not subject to premarket approval"

https://www.accessdata.fda.gov/scrIpts/cdrh/cfdocs/cfpmn/pmn.cfm