Release: Embargoed until September 24, 2000Contact: Kenneth Satterfield202-371-4517 (9/23-27)703-519-1563[email protected]

REMOVAL OF A COCHLEAR IMPLANT DEVICE IS NOT NECESSARY TO TREAT POSTOPERATIVE INFECTION

Washington, DC -- Postoperative infection is a threat to the successful operation of a cochlear implant. Many believe that to eradicate the infection, removal of the device is necessary. Now a team of otolaryngologist--head and neck surgeons have completed a study which demonstrates that limited surgery, with medical intervention, can clear the infection without removing the cochlear implant.

The authors of the study, "Postoperative Cochlear Implant Infection: A Conservative Management Strategy," are Kenneth Yu, MD, Joseph Hegarty, MD, Anil L. Lalwani, MD, and Jan Larky, all from the University of California -- San Francisco. Their findings will be presented on September 25, 2000, at the Annual Meeting/Oto Expo of the American Academy of Otolaryngology -- Head and Neck Surgery Foundation being held September 24-27, 2000, at the Washington, DC Convention Center.

Methodology: The researchers conducted a retrospective review of 108 adult and pediatric patients who underwent cochlear implantation at the University of California -- San Francisco between 1991 and 2000 and 290 patients who had received the same procedure at the University of Iowa between 1997 and 2000. The review focused on postoperative complications, specifically infections. The clinical presentation, intervention, laboratory results, and outcome were analyzed in each case.

Results: There were five patients at one institution who developed postoperative complications; two of the five developed major wound infections. Two patients from the second institution developed major wound infections. Summaries of the postoperative complications (wound infections) follow:

Case 1: A 58 year-old male with a history chronic otitis media developed profound hearing loss in the left ear and severe loss in his left ear. Hearing loss was progressive; he received a cochlear implant in his left ear in 1994. The cochlear implant offered excellent benefits, but five years later he complained of otaglia (ear ache) in the left ear. A physical examination revealed pus in the external auditory canal and over the cochlear implant; a CT scan found a mastoid abscess extending to the implant consistent with a cholesteatoma. The abscess was drained and the cholesteatoma exteriorized, while preserving the integrity of the implant. Intravenous vancomycin was maintained for six weeks. As of January, 2000, the patient was clear of pain and infection.

Case 2: Complete deafness was the consequence of a closed head injury sustained in March, 1999, to a 44 year-old male. After a recovery from a coma, a CT scan revealed bilateral temporal bone fractures. A cochlear implant was placed in his left ear. Upon suture removal erythema, edema, and purulence were noted. He was taken to the operating room; an incision and drainage were performed, and 30 cc of pus was found around the implant. The device was not disturbed. Six weeks of intravenous ceftriaxone were administered, and the implant was not removed. The implant now functions well without complications.

Case 3: A 17 year-old female with a history of chronic otitis media, dilated vestibular aqueduct syndrome, and a bilateral stepwise sensorineural hearing loss underwent a left mastoid obliteration and cochlear implantation. She derived excellent benefits from the device. However, a medical history included allergy and childhood infections. Despite an extensive range of treatment with antibiotics and surgery, there was little clinical improvement. Further tests found the patient was anergic (lack of ability to express sensitivity to an allergic property). Intravenous immunoglobulin along with antibiotics were then administered providing immediate improvement. Her implant functions well, but the electrodes remained exposed and required explantation (transfer of living tissue to an artificial medium for culture).

Case 4: A cochlear implantation to a left ear was performed for a 51 year-old woman following deafness resulting from consecutive episodes of sensorineural hearing loss. Her medical history included multiple episodes of pneumonia as a child and adult. Six months after implantation, a one to two ml abscess was drained from a site adjacent to the implant. Two more abscesses developed over a one year period with a regimen of antibiotics provided. The patient was found to be anergic, but the infection has now settled.

Conclusions: The cases demonstrated that surgical intervention using limited incision and drainage followed by antibiotics was effective in treating postoperative cochlear implantation infections, without the need for removing the device. Implant function remained unaffected.

The researchers believe cochlear implant infections can be controlled using limited surgical and prolonged medical management. This course should be advocated prior to consideration of device removal.

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