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

Abstract

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.

Trial registration: ClinicalTrials.gov NCT04606823.