Very Early Loading of a Bone-Anchored Hearing System Is Safe.

ABSTRACT

OBJECTIVE: To investigate the feasibility of early sound processor loading with two separate bone-anchored hearing aid implants 1 to 2 weeks after implantation. Secondary endpoints included registration of any postoperative complications, skin reactions, and any adverse events. STUDY DESIGN: Prospective, nonrandomized, noncontrolled, multicenter clinical trial. SETTING: Tertiary referral center. PATIENTS Sixty adult patients, eligible for bone-anchored hearing aid surgery, were enrolled. INTERVENTION Implantation of the bone-anchored hearing aid implants were done using minimally invasive surgery with tissue preservation. MAIN OUTCOME MEASURE: Implant stability quotient (ISQ) values were recorded using resonance frequency analysis. Follow-ups were scheduled 5 to 12 days, 4 to 8 weeks, 6 months, and 12 months postoperatively. Differences between the lowest ISQ values (ISQ low) over time were analyzed by paired-samples t test with a significance level of 0.05. Skin and soft tissue reactions were assessed according to Holger's classification. RESULTS: Loading time of the Ponto Wide implant was 11.6 ± 1.4 days (SD) in average (median, 12 d; range, 7-19 d). Loading of the Ponto BHX implant was done 9.7 ± 3.5 days (SD) postoperatively (median, 9 d; range, 5-19 d). The implant stability increased significantly during the 12-month study period with both implants. One Ponto BHX implant was lost. Skin and soft tissue reactions were few in both groups. Across all planned follow-up visits, no skin and soft tissue reactions were observed in 86% (Ponto BHX implant) and 85% (Ponto Wide implant). CONCLUSION: Very early loading of sound processors after percutaneous bone-anchored hearing system surgery is safe already 1 to 2 weeks postoperatively.