Clinical Evaluation of a Novel Laser-Ablated Titanium Implant System for Bone Anchored Hearing Systems in a Pediatric Population and the Relationship of Resonance Frequency Analysis With Implant Survival.

OBJECTIVE: To evaluate the clinical outcomes of pediatric patients implanted a novel 4.5 mm wide laser ablated titanium bone anchored implant system and to evaluate the implant stability over the first 12-month period. STUDY DESIGN: A prospective, single-subject, repeated measure, cohort study. Participants served as their own controls. SETTING: Community and tertiary referral hospital pediatric assessment center. PATIENTS: A total of 115 consecutive pediatric patients aged 4 to 15 years were implanted with 176 laser ablated titanium bone anchored implants from January 2016 to January 2019. MAIN OUTCOME MEASURE: Clinical outcomes, implant failure rates, and post implantation implant stability quotient (ISQ) scores were studied over the first 12-month period. Data were analyzed for statistical significance through mixed effect modeling, with the significance level p = 0.01. RESULTS: A median 12-month survival of 96.6% was observed. Six implants (3.5%) were lost in total, one of these (0.6%) was lost due to trauma. Adverse skin reactions (Holgers grade 2-4) were observed in 4.4% of all postoperative visits, occurring in 22 individuals (19.1%). Neither the ISQ high (ISQH) nor ISQ low (ISQL) values increased significantly between the stage 1 and 2 surgeries. In contrast, the ISQ results, irrespective of abutment size, demonstrated an increasing trend from 49.1 to 57 over the 12 months review period. A statistically significant change was only demonstrated from the 3 months follow up onwards. CONCLUSION: The use of 4.5 mm wide laser-ablated titanium bone anchored hearing implants resulted in superior survival rates and excellent clinical outcomes compared with previous implant systems.