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Evaluation of Clinical Performance of Ponto Implantation Using a Minimally Invasive Surgical Technique-A Prospective
Emma M Teunissen1, Tjerk W Aukema, Rupan Banga2
1Department of Otorhinolaryngology-Head and Neck Surgery, Donders Center for Neuroscience, Radboud University Medical Center, Radboud University, Nijmegen.
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.
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