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A Prospective Multicenter Study on the Performance of a Bone-Anchored Hearing Implant Using Minimally Invasive Ponto
Daniel H Coelho1, Sam J Daniel2, Xabier Altuna3
1Department of Otolaryngology-Head and Neck Surgery, Virginia Commonwealth University, Richmond, Virginia.
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.
