More than 30 million Americans are exposed to hazardous sound levels on a regular basis. Of the 28 million Americans who have significant hearing loss, about one-third can be attributed, in part, to noise exposure. Availability of an effective treatment that prevents hearing loss in at-risk human populations would improve the quality of life for millions, and decrease healthcare costs for individuals, businesses, and government agencies. OtoMedicine Inc. has identified a proprietary combination of dietary supplements called Auraquell"""""""", which is highly effective in preventing permanent noise-induced hearing loss (NIHL) and sensory cell death in a guinea pig model. To efficiently evaluate the efficacy of Auraquell"""""""" in humans, clinical trials should evaluate prevention of temporary noise-induced hearing loss in human subjects. To justify this clinical paradigm, the Phase I research proposes to demonstrate the therapeutic efficacy of Auraquell"""""""" in a guinea pig model of temporary noise-induced hearing loss. These results will support the three Specific Aims of the Phase II program: (1) determine the plasma concentrations of the active components of Auraquell"""""""" in guinea pigs that are effective in attenuating temporary noise-induced hearing loss, (2) establish an oral dosing paradigm in humans that achieves similar plasma concentrations as those in (1), and (3) evaluate the efficacy of the human oral Auraquell"""""""" dose in a clinical study designed to measure temporary threshold shift (TTS temporary hearing loss) from exposure to moderate-level music presented via an iPOD personal music player and insert earphones. In Phase III, we will petition the FDA (as specified in 21CFR 101.70) for a health claim and market Auraquell"""""""" as a safe and efficacious preventative treatment for NIHL. ? ? ?
| Le Prell, Colleen G; Dolan, David F; Bennett, David C et al. (2011) Nutrient plasma levels achieved during treatment that reduces noise-induced hearing loss. Transl Res 158:54-70 |
