Jack M. Kartush, MD

July 3, 1997

(A) Tympanic Membrane perforation	(B) Patcher in place

Most tympanic membrane (TM) perforations require surgical repair. For some patients, however, the risks, costs and inconvenience of an operation are significant concerns. This is particularly true for those with a perforation in an only-hearing ear and for those too ill or too elderly for surgery.

As an alternative to tympanoplasty, closure is sometimes attempted in the office by "patching" the hole with a small piece of paper or plastic. Unfortunately, office techniques are rarely successful except for tiny perforations. In addition, because there are no adhesives available for human use, patients must repeatedly return to the office in order to have the patch replaced.

A Tympanic Membrane (TM) Patcher has been designed to allow stability while avoiding the need for adhesives. The Patcher is a cross between a tympanostomy tube and a nasal septal perforation button. Three sizes are available (3, 5, 7mm) from which the final patch can be trimmed to fit if needed. Thin, malleable silicone allows enough flexibility to fold the deep flange into the perforation while allowing enough rigidity for the lateral flange to remain in place.

When the Patcher is implanted in patients with an intact ossicular chain, hearing routinely improves. Small perforations may heal just as when a tympanostomy tube extrudes. Large perforations are not expected to heal but, as with nasal septal buttons, the functional problems are circumvented while the Patcher is in place.

The ear is cleaned under the operating microscope. Following a baseline audiogram, the perforation edges are prepared in a routine fashion and an antibiotic powder instilled. A Patcher is selected and trimmed to fit if needed. It is then inserted using an alligator forceps by placing the medial flange through the perforation.

• Avoidance of the risks and costs associated with surgery including persistence or widening of the perforation, infection, taste disturbance, hearing loss, tinnitus, vertigo and facial weakness.
• Avoidance of the risks and costs associated with general anesthesia.
• Little or no pain compared to surgery
• Immediate results including hearing gain (with normal ossicular chains) and protection of the middle ear.
• Easily removed if desired
• No incisions, adhesives or sutures

Although the functional consequences of the perforation will typically be corrected, most perforations will remain. As in patients with tubes, infections may occur requiring removal of the Patcher and treatment with antibiotics.

Clean, dry tympanic membrane perforations in patients: 1) with a perforation in an only-hearing , 2) too elderly or too ill for formal tympanoplasty surgery, 3) children in whom surgery needs to be delayed to await maturation of eustachian tube dysfunction, and 4) patients who do refuse surgery.

• Active infection
• Known cholesteatoma
• Patient unable or unwilling to return for regular followup.

• Most patients obtain immediate improvement of hearing and protection of their middle ear by a simple outpatient procedure without need for formal surgery or a general anesthetic.
• Most patches will remain stable with only occasional re-positioning required on followup.
• Patients may rarely develop an infection; while this may be due to reaction to the Patcher (as is sometimes seen with tympanostomy tubes), it may also indicate that the patient has an underlying eustachian tube dysfunction or cholesteatoma, thus providing the physician with clinical information that may be important even if a formal tympanoplasty is to be considered in the future.