Predisposing factors for adverse skin reactions with percutaneous bone anchored hearing devices implanted with skin reduction techniques.

Abstract

We present an analysis of adverse events after implantation of bone anchored hearing device in our patient population with focus on individual risk factors for peri-implant skin reactions. The investigation involved a chart review of adult Baha patients (n=179) with 203 Bahas implanted with skin reduction techniques between 1993 and 2009, a questionnaire (n=97) and a free clinical examination (n=47). Skin reactions were graded by severity from 0 (no skin reaction) to 4 (implant loss resulting from infection) according to Holgers. We analyzed the skin reaction rate (SRR) defined as the number of skin reactions per year and the worst Holgers grade (WHG), which indicates the grade of the worst skin reactionper implant. We defined 20 parameters including the demographic characteristics, surgery details, subjective benefits, handling and individual factors. The most frequent adverse events (85%) were skin reactions. The average SRR was 0.426 per Baha year. Six parameters showed an association with the SRR or the WHG. The clinically most relevant factors are an elevated Body Mass Index (BMI, p=0.02) and darker skin type (p=0.03). The SRR increased with the distance between the tragus and the implant (p=0.02). Regarding the identified risk factors, the SRR might be reduced by selecting a location for the implant near the pinna and by specific counseling regarding post-operative care for patients with darker skin type or an elevated Body Mass Index (BMI). Few of the factors analyzed were found to influence the SRR and WHG. Since most adverse skin reactions could be treated easily with local therapy, our results suggest that in adult patients, individual risk factors for skin reactions are not a contraindication for Baha implantation. Thus, patients can be selected purely on audiological criteria.