Clobetasol's Influence on the Management and Cost of Skin Overgrowth Associated with the Bone-Anchored Hearing Aid.

BACKGROUND: Management of the skin/abutment interface in patients with bone-anchored hearing aids (BAHAs) can occasionally be a challenge. Even with the most compliant patients and the most intensive home/office treatment regimens, painful triamcinolone injections and revision surgery can become necessary. Such treatments can be associated with an inordinate cost burden. To our knowledge this research provides the first objective comparison of cost and patient outcomes after the introduction of topical 0.05% clobetasol cream for the care of the skin/abutment interface in patients with BAHAs. METHODS: Thirty-three patients were managed with the traditional algorithm (local wound care, triamcinolone injection, and revision surgery). Nineteen patients were managed with the contemporary algorithm in which 0.05% topical clobetasol cream was added to the traditional treatment regimen. RESULTS: Common postoperative skin reactions were comparable in the traditional vs contemporary treatment groups: granulation tissue (53.8% vs 56.3%), soft-tissue overgrowth (30.8% vs 18.8%), and both granulation tissue and soft-tissue overgrowth (15.4% vs 25.0%). The addition of clobetasol cream was associated with a marked decrease in the invasive treatment endpoints in the contemporary vs traditional treatment groups: triamcinolone injections (0.0% vs 12.1%) and surgical revision (0.0% vs 9.1%). The difference in cost for managing soft-tissue overgrowth at the abutment site was substantial, with the traditional treatment group averaging $2,773.25 per patient and the contemporary treatment group averaging $47.94 per patient (P<0.021) according to 2013 estimates and values. CONCLUSION: Clobetasol use during early postoperative care of a BAHA implant dramatically decreases cost and improves treatment outcomes by reducing the need for invasive postoperative procedures to treat common postoperative skin reactions.

Nucleus N5 CI500 series implant recall: hard failure rate at a major Cochlear implantation center.

OBJECTIVES/HYPOTHESIS: To compare the cumulative failure percentage of the Cochlear Nucleus N5 CI500 series implant observed, both before and after the voluntary recall of unimplanted devices, to that of the Cochlear Nucleus Freedom CI24RE series implant. STUDY DESIGN: Retrospective review of 411 patients implanted with either the Nucleus Freedom or the Nucleus N5 device. METHODS: Cochlear implantation was performed in standard fashion. A database was created by combining information obtained from operative case logs, an integrated clinical electronic medical records system, and an external database of devices maintained by Cochlear Corporation. RESULTS: Of the 289 implants of the Nucleus Freedom CI24RE series device at this institution, the cumulative failure percentage was 0%. There were 122 implants of the Nucleus N5 CI500 series device, yielding a 9.8% cumulative failure percent; 82 were manufactured before the voluntary recall and 40 were produced afterward. The 82 implants manufactured before the recall had two associated failures, while the 40 produced afterward had 10 failures. CONCLUSIONS: It is possible that the cumulative failure percentage (CFP) of the Cochlear Nucleus N5 CI500 series implant is not fully defined. While the CFP of the Nucleus Freedom CI24RE series implant at this institution was 0%, it was 9.8% for the Nucleus N5. The CFP of Nucleus N5 devices manufactured before the voluntary recall was 2.4%, while the CFP afterward was 25.0%-nearly 6-fold higher than the company-published value of 4.2% for all Nucleus N5 implants registered globally.

Device fixation in cochlear implantation: is bone anchoring necessary?

OBJECTIVES/HYPOTHESIS: To compare complication rates between patients whose cochlear implants were secured by a bony tie-down technique versus those secured by a periosteal tie-down technique. STUDY DESIGN: A retrospective review of 302 consecutive patients undergoing cochlear implantation (327 implants), including both adults and children, at a single institution by a single surgeon. METHODS: Cochlear implantation was performed in the standard fashion with bony securement of the device in the first subset of patients. The surgical technique was then modified to exclude the bony tie-down step in favor of a periosteally placed suture tie-down in the next subset of patients. The patient's medical records were then reviewed to determine complications, which were then compared between groups using chi(2) testing. RESULTS: The overall complication rate for the periosteally secured cochlear implant subset was 9.5%, with no significant difference noted when compared to the 12.2% overall complication rate seen with the bone-secured implants. Minor complication rates were 9.5% versus 8.1%, respectively, with major complications occurring in 0% versus 4.1% of periosteally secured versus bone-secured devices. There were no statistical differences between groups for major, minor, or any specific complications. There were no cases of device migration. CONCLUSIONS: Cochlear implant devices may be secured in place with periosteally anchored sutures in lieu of bone-anchored sutures without any significant increases in perioperative complications.