Prevention of temporary hearing loss with AuraQuell

Award Information
Agency:
Department of Health and Human Services
Branch
n/a
Amount:
$1,117,573.00
Award Year:
2009
Program:
SBIR
Phase:
Phase II
Contract:
2R44DC009106-02
Award Id:
89036
Agency Tracking Number:
DC009106
Solicitation Year:
n/a
Solicitation Topic Code:
n/a
Solicitation Number:
n/a
Small Business Information
330 E. Liberty St., Lower Level, Ann Arbor, MI, 48104
Hubzone Owned:
N
Minority Owned:
N
Woman Owned:
N
Duns:
620122817
Principal Investigator:
PETERBOXER
(734) 904-0931
PABOXER@OTOMEDICINE.COM
Business Contact:
PETERBOXER
() -
dcbennett@otomedicine.com
Research Institute:
n/a
Abstract
DESCRIPTION (provided by applicant): 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. Avai lability 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. Research conducted during the Phase I SBIR demonstrated tha t AuraQuell was also effective at reducing temporary hearing loss in the guinea pig. This is highly relevant, because for practical and ethical reasons clinical testing of the efficacy of AuraQuell in humans will initially be conducted in subjects expose d to loud noise producing temporary NIHL. This Phase II SBIR will first establish a paradigm to reliably produce a temporary threshold shift (TTS) in subjects exposed to loud, but safe video-game shooting noise. The goal is to produce approximately a 10-15 decibel temporary hearing loss, which is sufficient to power a clinical trial. Once established, a double-blind, placebo-controlled clinical trial will be conducted in 120 subjects to establish the efficacy of AuraQuell to prevent TTS (temporary hearing loss). Gunfire noise was chosen because it is relevant to significant markets including the military and hunters. Data generated by this SBIR is critical to the successful commercialization of AuraQuell . In Phase III, OtoMedicine will petition the FDA's C enter for Food Safety and Applied Nutrition (as specified in 21CFR 101.70) for a health claim and market AuraQuell as a safe and efficacious preventative treatment for NIHL. PUBLIC HEALTH RELEVANCE: Approximately 28 million Americans have some degr ee of hearing loss; approximately one-third of which is the result of exposure to loud noise. This proposal will test a safe product that could be an effective treatment that reduces noise-induced hearing loss in at-risk human populations. This would impro ve the quality of life for millions, and decrease healthcare costs for individuals, businesses, and the military.

* information listed above is at the time of submission.

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