A Prospective Multicenter Study on the Performance of a Bone-Anchored Hearing Implant Using Minimally Invasive Ponto Surgery

一项关于采用微创桥体手术植入骨锚式助听器性能的前瞻性多中心研究

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Abstract

INTRODUCTION: The minimally invasive Ponto surgery (MIPS) was launched in 2015 as a straightforward, fast single-stage surgical solution designed to minimize postoperative complications and deliver improved cosmetic outcomes for placement of percutaneous bone-anchored hearing systems (BAHS). OBJECTIVE: To investigate the proportion of Ponto implant/abutment complexes providing a reliable sound processor anchorage 3 months after MIPS. SUBJECT POPULATION: Sixty-four adult patients undergoing BAHS treatment using the MIPS. STUDY METHODS: A 12-month prospective, multinational, multicenter single-arm investigation. All patients underwent implant placement using MIPS with endpoints at 7 days, 21 days, 3, 6, and 12 months. Implant stability, skin reactions, pain and numbness, sound processor usage, and patient-reported quality of life measures were assessed. RESULTS: No severe intraoperative complications were reported, and average procedure duration was 10.5±9.1 minutes. 96.6% of Ponto implant/abutment complexes provided a reliable sound processor anchorage 3 months after MIPS. Two spontaneous implant losses were registered before the 3-month endpoint at 40 days and 57 days post-MIPS. At 3 months after MIPS, 98.2% of implant sites were judged to be completely healed, 96.5% of patients had no adverse skin reactions, 89.5% reported no pain, and 98.2% reported no numbness. Patient-reported outcomes indicated quality of life improvements for the majority of patients. CONCLUSIONS: The MIPS procedure continues to be a safe and efficient surgical technique for BAHS. Low intraoperative and postoperative complication rates paired with low rates of adverse skin reactions, pain, and numbness can be expected from the procedure.

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