InnerScope and Erchonia expect to be the first to receive a 510k FDA-Clearance for their Hearing Products that are not considered tinnitus "maskers" and/or tinnitus management devices, but offers a treatment protocol for relief of tinnitus symptoms. Both companies anticipate receiving the FDA-Clearance by the end of the third quarter of 2019.
InnerScope plans to introduce (depending upon when the 510k FDA-Clearance happens) and commercially market and distribute the tinnitus hearing products to the audiological global market as early as December 2019