Otic Disorders

The field of otology is a subspecialty within otolaryngology that focuses on diseases and disorders of the ear. We estimate that more than 50 million people in the United States are affected by otic disorders, with approximately 20 million patients seeking treatment each year for the most common conditions, including ear infections, balance disorders, tinnitus and hearing loss. This page provides a brief overview of these common conditions and links to access additional information.

Otitis Media

Otitis media is defined as an infection or inflammation of the middle ear. It is typically the result of a viral, bacterial or respiratory infection that spreads into the middle ear. This condition is extremely common during childhood. By age three, over 75 percent of children will have suffered from otitis media and more than half of these children will experience recurrent ear infections. It is estimated that the medical costs and associated lost wages due to otitis media amount to $5 billion a year in the United States alone. Since infections occur prior to a child being old enough to be able to verbally communicate, physical signs may include:

  • tugging at the ears
  • excessive fussiness and crying
  • trouble sleeping
  • fever
  • fluid draining from the ears
  • trouble hearing or responding to quiet sounds

Oral antibiotics are routinely prescribed for the treatment of otitis media. Patients with persistent or recurrent disease are often treated using a surgical procedure to insert tubes through the tympanic membrane which allows for ventilation of the middle ear cavity and the localized delivery of topical antibiotics to the middle ear. The typical regimen of antibiotic ear drops requires multiple drops two times per day for up to 10 days.

More information regarding otitis media may be found at: http://www.aafp.org/afp/2013/1001/p435.html .

Acute Otitis Externa

Acute otitis externa (AOE), also known as swimmer’s ear, is a common condition involving infection and inflammation of the ear canal typically caused by bacterial infection. According to medical claims data, there are nearly 4 million episodes of AOE each year in the United States. Symptoms usually appear within a few days of swimming and include:

  • itchiness inside the ear
  • redness and swelling of the ear
  • pain when the infected ear is tugged or when pressure is placed on the ear
  • pus draining from the infected ear

Antibiotic ear drops are considered the standard of care treatment for acute otitis externa with the typical regimen requiring several administrations to the affected ear each day for up to 10 days.

More information about acute otitis externa may be found at: http://www.aafp.org/afp/2012/1201/p1055.html

Balance Disorders including Ménière’s disease

According to the National Institute on Deafness and Other Communication Disorders (NIDCD), more than four out of 10 Americans will experience dizziness or vertigo sometime in their lives that is significant enough to see a physician. There are many causes and types of balance disorders including benign positional vertigo, labyrinthitis, vestibular neuritis, and Ménière’s disease.

Ménière’s disease is a chronic condition impacting more than 600,000 people in the United States that is characterized by acute vertigo attacks, tinnitus, fluctuating hearing loss, and a feeling of fullness in the ear. The underlying cause of Ménière’s disease is not well understood and there is no known cure. There are no FDA-approved drug treatments, however patients are often treated with a low-salt diet and diuretics followed by steroid treatment (oral steroids and/or repeat intratympanic injections of steroid solution) for patients who have persistent or severe symptoms. Patients who are unresponsive to the use of steroids may resort to surgical or chemical ablation, which can cause irreversible hearing loss.

Additional information on balance disorders can be found at: http://www.nidcd.nih.gov/health/balance/pages/balance_disorders.aspx

Tinnitus

Tinnitus is the medical term for hearing noise when there is no outside source of the sound. It is often described as a ringing in the ear but can also sound like roaring, clicking, hissing or buzzing. The American Tinnitus Association reports that approximately 16 million patients in the United States have tinnitus symptoms severe enough to seek medical attention, and about two million patients cannot function on a normal day-to-day basis. Furthermore, the United States Department of Defense reports that tinnitus accounts for the most prevalent service-connected disability among veterans and that the costs of service-related tinnitus are estimated to exceed $2 billion. While the most common cause of tinnitus is exposure to loud noise, a number of other factors can be involved including heart or blood vessel problems, hormonal changes in women, ear and sinus infections, certain medications and thyroid problems. People with severe tinnitus may have trouble hearing, working and sleeping. At this time, there is no cure for tinnitus and there are no FDA-approved drug treatments for this debilitating condition.

Additional information on tinnitus can be found at: http://www.nidcd.nih.gov/health/hearing/pages/tinnitus.aspx

Cisplatin-Induced Hearing Loss

Cisplatin and other platinum-based chemotherapeutic agents are routinely used in treating numerous tumor types with approximately 500,000 patients including 2,000 children treated each year in the United States. While use of platinum agents has contributed to improved patient survival, ototoxicity and associated permanent hearing loss is well documented in the clinical literature. In particular, hearing loss has been reported in up to 90% of children and young adults treated with platinum-based agents1. This adversely affects speech and language development and has been associated with academic and social difficulties which can have a significant impact on patients and their families. At this time, there is no FDA-approved drug treatment to protect against platinum-based ototoxicity.

1Source: Landier et al., Journal of Clinical Oncology, 2014.

Sensorineural Hearing Loss

Hearing loss is the most common sensory disorder with about 15% of American adults reporting some trouble hearing according to the National Institute on Deafness and Other Communication Disorders (NIDCD). Sensorineural hearing loss is caused by damage to the inner ear hearing organ called the cochlea or its connection to the brain. While many patients realize a gradual decline in hearing with aging (also known as presbycusis), other patients experience an acute onset hearing loss resulting from exposure to excessive noise, head trauma, or treatment with certain drugs including platinum based chemotherapy agents. In some cases, an emergency otologic condition known as sudden sensorineural hearing loss occurs for no apparent reason. There are no FDA-approved drug treatments for sensorineural hearing loss, however oral and repeat intratympanic injections of steroid solution have shown some clinical benefits for patients with sudden hearing loss.

Additional information on sensorineural hearing loss can be found at: http://www.nidcd.nih.gov/health/hearing/Pages/Default.aspx

Opportunity for Developing New Treatment Options

Given the compliance challenges of multi-dose, multi-day ear drop regimens for treating the ear, and anatomical barriers associated with achieving high and sustained drug levels in the inner ear via oral administration or an intratympanic injection of solution, Otonomy believes that there is a large unmet medical need for improved otic drug delivery. We are committed to researching and developing new treatments for physicians and patients.