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 tympa noplasty surgery, Alternatives to surgery (e.g., paper and plastic onlay) h ave limitations that prompted a need For an alternative method. A new, simp le device, designed to be inserted into the perforation, is made out of a v ery soft silicone in the shape of a scaled tympanostomy tube. The TM Patche r is self-stabilizing without adhesives. Setting: An outpatient office. Patients: Twenty-nine patients with 30 conse cutive dry TM perforations, who volunteered to participate in the study. Pa tients with known cholesteatomas or persistent drainage were excluded. Interventions: In the office, patients had the Patcher inserted into their dry TM pel fc,ration. No anesthetics were needed. Main Outcome Measures: Hearing was tested before and after patching by conv entional audiometry. The ears were assessed for Patcher position, perforati on status, and infection. Results: Patients with normal ossicular chains had immediate improvement of hearing. No patient experienced hearing loss. Twenty-six of 30 patients (8 7%) 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 oft en healed or became smaller (46% of 3-mm perforations) despite failure of t ympanoplasty or conventional office patching with a flat piece of paper or plastic. Perforations >5 mm did not heal, however, these patients simply co ntinued wearing their Patcher and benefited by protection of their middle e ar, 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 re positioned. Conclusions: The Patcher is a safe and effective alternative for office pat ching 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.