Awkward and Non-Operative Otoscopes
The simple evaluation of the eardrum during a physical exam is performed millions of times each day as part of routine exams as well as when a patient is symptomatic.
Current otoscopes require the use of stiff and uncomfortable speculum that hurt the ear canal. The current otoscopes also require the examiner to bend over in awkward positions to view the eardrum through this speculum. As such, along with the need to improve instrumentation of the eardrum is the need to improve its inspection.
Need for AOM Treatment Procedure for Tympanocentesis
There has been an increase in the prevalence of recurrent otitis media among children in the United States, particularly in infants. Otitis media is often controlled by antibiotics. However, otitis media has a high rate of recurrence, and if unresolved by antibiotics (otitis media with effusion), it may be treated surgically. There are approximately 2.4 million cases of this each year in the US1. A retrospective analysis of a fee-for-service Medicaid program claims database led to a national estimate of $4.1 billion in direct medical costs incurred by otitis media in children younger than 14 years old2.
If drug therapy fails, controlled perforation of the eardrum (tympanocentesis) is sometimes accompanied by placement of a tiny section of tubing, known as a pressure equalization (PE) tubes (tympanostomy) to relieve the infection and allow the inner ear to drain. These procedures are often done under general anesthesia, to prevent the patient from moving during the delicate maneuvers required.
In addition, the indication for tympanocentesis may well be to prevent the need for pain medication AND antibiotics. Indeed, antibiotics may not even offer much of a clinical benefit. Meta-analyses and systematic reviews of the literature have found a spontaneous resolution rate of 81% compared with a 93% resolution rate with antibiotic therapy, for an overall benefit of shortening the course of AOM by one day in 1 of 8 children treated3.
Eustachian Tube Dysfunction
There is an increasingly identified problem of eustachian tube dysfunction (ETD) that can lead to both AOM as well as pain and chronic disability. EDT has an incidence of 2% in the general population translating to 6-7 million sufferers in the US alone. Simple actions such as swallowing, yawning, chewing or forced exhalation against a closed mouth and nose can help to equalize pressure in the middle ear and resolve symptoms. But, some symptoms can linger, in which case treatment may be desirable. Medications such as decongestants, leukotriene antagonists, and steroids have a variable effect, but long-term consequences of their use are problematic.
Eustachian tube dysfunction and inner ear problems with effusion (non-infected fluid in the middle ear space) affects 70% of children by the age of 7. Children are particularly at risk of Eustachian tube problems because their tubes are narrower than those of an adult. Eustachian tubes in children are more horizontally oriented and more prone to inflammation when a child has a cold.
A blocked eustachian tube causes air pressure in the middle ear to change the pressure on the outside of the eardrum. This can damage the ear and cause pain for the child4.
Recent advancements have brought to the market dilation therapies that involve identifying, accessing and dilating the tube with a balloon. Despite this, the processes to do so have been complicated where visualization and access to the appropriate site have been difficult. Further, the process is uncomfortable and not readily amenable to a quick office-based procedure. Balloon dilatation (dilatation) of the Eustachian tube, is a procedure that attempts to dilate the Eustachian tube. It consists of introducing a balloon catheter into the Eustachian tube through the nose, under transnasal endoscopic vision. The balloon is filled with saline. Pressure is maintained for approximately 2 minutes, following which the balloon is emptied and removed. The procedure has been performed experimentally under local and general anesthesia. The remaining issues are that this is a promising procedure but one that should be made amenable to the office practitioner and one that should not be overly uncomfortable.
Better methods, including stabilized micro-instrumentation, are needed so that these procedures do not require general anesthesia and may be moved to an ambulatory medical environment.
2 Ref (Bondy J, Berman S, Glazner J, Lezotte D. Direct expenditures related to otitis media diagnoses: extrapolations from a pediatric Medicaid cohort. Pediatrics. 2000;105:E72.)
Takata GS, Chan LS, Shekelle P, et al. Evidence assessment of management of acute otitis media: I. The role of antibiotics in treatment of uncomplicated acute otitis media. Pediatrics. 2001;108(2): 239–247.[PubMed]