Approximately 28 million Americans have some degree of hearing loss. Age-related hearing loss (ARHL) is the most common form of hearing loss, followed by noise-induced hearing loss (NIHL) from exposure to hazardous levels of occupational noise. Availability of an effective treatment that prevents hearing loss in at-risk human populations would improve quality of life for millions, and decrease healthcare costs for individuals, businesses, and government agencies. We have identified a proprietary dietary supplement, Auraquell, which is highly effective in preventing NIHL and sensory cell death in a guinea pig model.
The Specific Aim of our Phase I proposal is to demonstrate therapeutic efficacy of Auraquell active agents in mice exposed to loud noise. Mice will be treated with daily injections, or via additions to their diet. We will use the data from the proposed Phase I studies, along with previously generated data, to petition the FDA to allow specific medical product label claims as described in 21 CFR 101.70 for a nutritional supplement. Data from this project will also support a Phase II proposal to assess the efficacy of Auraquell in prevention of ARHL in mice. Our Phase II research program will define the dependency of NIHL on age, at the time of noise exposure, and will demonstrate efficacy of treatment with age. In Phase III, we will submit health related claims to the FDA for review and approval, and will commercialize the product. ? ? ?
| Le Prell, Colleen G; Gagnon, Patricia M; Bennett, David C et al. (2011) Nutrient-enhanced diet reduces noise-induced damage to the inner ear and hearing loss. Transl Res 158:38-53 |
