Clinical evaluation and resonance frequency analysis of laser-ablated titanium bone-anchored hearing implant system in children with Down Syndrome

Objectives: To evaluate complication rates and resonance frequency analysis (RFA) of the stability of a new laser ablated titanium Bone Anchored hearing Implant system in children with Down syndrome. Methods: A prospective, single-subject, repeat measure, cohort study in which each participant served as their own control. Consecutive paediatric patients 4yrs-15 years old, with a primary diagnosis of Down syndrome (trisomy 21) were implanted between January 2015-January 2020 with BHX Oticon wide implants. Evaluation of soft tissue reactions, fixture failure rates and post implantation Implant stability Quotient (ISQ) at both fixtures and abutment levels were studied over a 12-month period. Data was analysed for statistical significance through mixed effect modelling with significance set at p = 0.01. Results: 31 consecutive paediatric patients with a diagnosis of Down syndrome were implanted with 43 Ponto BHX OticonTM implant system. Twelve children had bilateral implants and nineteen were unilateral. Over the 12 month follow up 2 fixtures (4.6%) were lost, and adverse skin reactions (Holgers >2) were recorded in 3.2% of all clinical reviews. Implant level stability quotient showed no statically significant change between first and second stage 71.1-71.7. Abutment level ISQ increased from 46.2 to 56.7 p = 0.0001 at the 12-month review point as compared to that recorded at loading. Conclusion: Implant survival and adverse skin reactions were found to be in keeping with those in published literature and much improved compared to previous implant systems placed at this centre. Although abutment level ISQ showed an increase over the review period no correlation between this and implant loss can be concluded.

Automated summary

This study evaluated the complication rates and stability of a new laser ablated titanium Bone Anchored hearing Implant system in children with Down syndrome. Results showed that implant survival and adverse skin reactions were consistent with published literature, and improvement was observed in abutment level ISQ over the review period.