The National Institute on Deafness and Other Communication Disorders lists hearing loss as the third most prevalent chronic condition in the older population. About 28 million people in the United States have some degree of reduced hearing sensitivity, including one million children. Moreover, ear infections affect a sizeable proportion of children. Otitis media, or middle ear infection, is a common reason that children visit a health care provider. Four out of every 1000 individuals will develop otitis externa (swimmer's ear) in any given year. While ear pathology may not be directly responsible for an increased mortality rate in subjects, it causes morbidity in a significant proportion of the general population. Furthermore, the cost associated with ear pathology is staggering. The societal cost of hearing loss (for rehabilitation, lost productivity, etc) is estimated at almost 3% of the gross national product.

Some statistics related to ear pathology relevant to the US include:

Condition	Incidence / Prevalence	Cost
Otitis Media	- Almost all children will have had at least one ear infection by 5 years of age. - Thirty million prescriptions are written for treatment of Otitis Media each year.	$ 5 billion/year
Otitis Externa	Four out of each 1,000 people, annually
Hearing loss	28 million people (one million children)	3% Gross national product

There are very few current clinical trials listed in the field of Otolaryngology related to Otitis and Hearing loss. Of the two ongoing trials for the management of Otitis Media, the first is for the evaluation of a Hemophilus influenza vaccine. Currently, infants receive hemophilus influenza type b vaccine as three separate doses with a booster dose at 15 months. Since the introduction of this vaccine, cases of haemophilus influenza meningitis have occurred in less than two in 100,000 children, and there has been a reduction in the incidence of otitis media. However, most cases of bacterial otitis media are primarily due to three pathogens: Streptococcus pneumoniae, nontypeable Haemophilus influenzae (NTHi), and Moraxella catarrhalis. Antex Biologics is conducting phase I/II trials for a non-typeable Hemophilus influenza vaccine.

The second trial is a phase II trial evaluating the use of Gatifloxacin (Tequin/Bristol-Myers Squibb) in children with Otitis Media. Gatifloxacin is an advanced-generation broad-spectrum 8-methoxy fluoroquinolone with a long half-life already approved for adults with susceptible infections. Phase II trial results suggest that Tequin is safe and effective in the treatment of recurrent or difficult-to-treat acute otitis media in children.