Evaluation of Clinical Performance of Ponto Implantation Using a Minimally Invasive Surgical Technique-A Prospective Multicenter Study.

Autor:	Teunissen EM; Department of Otorhinolaryngology-Head and Neck Surgery, Donders Center for Neuroscience, Radboud University Medical Center, Radboud University, Nijmegen., Aukema TW, Banga R; Department of Otorhinolaryngology, Queen Elizabeth Hospital Birmingham, Birmingham, United Kingdom., Eeg-Olofsson M, Hol MKS, Hougaard DD; Department of Otolaryngology, Head & Neck Surgery & Audiology, Aalborg University Hospital, Aalborg, Denmark., Tysome JR; Department of Otorhinolaryngology, Addenbrooke's Hospital, Cambridge, United Kingdom., Johansson ML, Svensson S; Oticon Medical, Askim., Powell HRF; Department of Otorhinolaryngology, St Thomas' Hearing Implant Centre, Guy's and St Thomas' NHS Foundation Trust, London, United Kingdom.
Jazyk:	angličtina
Zdroj:	Otology & neurotology : official publication of the American Otological Society, American Neurotology Society [and] European Academy of Otology and Neurotology [Otol Neurotol] 2024 Oct 01; Vol. 45 (9), pp. 1037-1044. Date of Electronic Publication: 2024 Aug 26.
DOI:	10.1097/MAO.0000000000004315
Abstrakt:	Objective: To investigate the clinical outcomes of bone-anchored hearing implant surgery using the MONO procedure. Study Design: Multicenter, multinational, single-arm, prospective trial with a 12-month follow-up. Setting: Seven European university hospitals from the United Kingdom, Sweden, Denmark, and The Netherlands. Patients: Fifty-one adult patients requiring surgical intervention for bone conduction hearing. Intervention: Bone-anchored hearing implant surgery using the MONO procedure. Main Outcome Measures: The primary endpoint assessed implant usability 3 months after surgery. Implant status, soft tissue reactions, pain and numbness, postoperative events, and sound processor usage were assessed at all follow-up visits. Hearing-related quality of life was evaluated using the Glasgow Benefit Inventory (GBI). Results: At 3 months, 94.2% of the implant/abutment complexes provided reliable anchorage for sound processor usage. No severe intraoperative complications occurred. Sixty-nine percent of surgeries were performed under local anesthesia, with surgery lasting 10 minutes on average. Four implants were lost due to trauma (n = 2), spontaneous loss of osseointegration (n = 1), or incomplete insertion (n = 1). Adverse soft tissue reactions occurred in 2.6% of visits, with a maximum Holgers grade of 3 (n = 1) and grade 2 (n = 5) across patients. Hearing-related quality of life at 3 months improved in 96% of patients. Conclusion: The MONO procedure provides a safe and efficient surgical technique for inserting bone-anchored hearing implants with few and minor intra- and postoperative complications. Competing Interests: Conflict of Interest: Outside the submitted work, the authors report financial support to the authors' institution (Radboudumc) for conducting clinical studies from Oticon Medical AB (Askim, Sweden) and from Cochlear Bone Anchored Solutions AB (Mölnlycke, Sweden). The authors declare that they have no other conflict of interest. (Copyright © 2024 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of Otology & Neurotology, Inc.)
Databáze:	MEDLINE
Externí odkaz:	Zobrazit plný text záznamu