Tympanic membrane Patcher: a new device to close tympanic membrane perforations in an office setting.

OBJECTIVE

To assess a new device intended to cover tympanic membrane (TM) perforations in an office setting.

STUDY DESIGN

Not all patients with TM perforations require or choose tympanoplasty surgery. Alternatives to surgery (e.g., paper and plastic onlay) have limitations that prompted a need for an alternative method. A new, simple device, designed to be inserted into the perforation, is made out of a very soft silicone in the shape of a sealed tympanostomy tube. The TM Patcher is self-stabilizing without adhesives.

SETTING

An outpatient office.

PATIENTS

Twenty-nine patients with 30 consecutive dry TM perforations, who volunteered to participate in the study. Patients with known cholesteatomas or persistent drainage were excluded.

INTERVENTIONS

In the office, patients had the Patcher inserted into their dry TM perforation. No anesthetics were needed.

MAIN OUTCOME MEASURES

Hearing was tested before and after patching by conventional audiometry. The ears were assessed for Patcher position, perforation status, and infection.

RESULTS

Patients with normal ossicular chains had immediate improvement of hearing. No patient experienced hearing loss. Twenty-six of 30 patients (87%) were free of infection. Two patients (7%) with persistent drainage were taken to surgery and were found to have mastoid disease (cholesteatoma or granulation tissue). Three patients (10%) had rare otorrhea after patching and were treated by drops or temporary removal of the Patcher. Two of these three ears subsequently became dry and then healed. Small perforations often healed or became smaller (46% of 3-mm perforations) despite failure of tympanoplasty or conventional office patching with a flat piece of paper or plastic. Perforations >5 mm did not heal; however, these patients simply continued wearing their Patcher and benefited by protection of their middle ear, typically with improved hearing and resolution of tinnitus. Occasional spontaneous lateralization was allowed to occur in the small perforations, which often later healed. In larger perforations, the Patcher was simply repositioned.

CONCLUSIONS

The Patcher is a safe and effective alternative for office patching of dry perforations when surgery is contraindicated or is refused by the patient. New materials should increase healing rates when applied to a Phase II Patcher.