A Multinational Cost-Consequence Analysis of a Bone Conduction Hearing Implant System—A Randomized Trial of a Conventional vs. a Less Invasive Treatment With New Abutment Technology

Abstract

Background: It is hypothesized that, for patients with hearing loss, surgically placing an implant/abutment combination whilst leaving the subcutaneous tissues intact will improve cosmetic and clinical results, increase quality of life (QoL) for the patient, and reduce medical costs. Here, incremental costs and consequences associated with soft tissue preservation surgery with a hydroxyapatite (HA)-coated abutment (test) were compared with the conventional approach, soft tissue reduction surgery with an all-titanium abutment (control).Methods: A cost-consequence analysis was performed based on data gathered over a period of 3 years in an open randomized (1:1) controlled trial (RCT) running in four European countries (The Netherlands, Spain, France, and Sweden). Subjects with conductive or mixed hearing loss or single-sided sensorineural deafness were included. Results: During the first year, in the Netherlands (NL), France (FR), and Spain (ES) a net cost saving was achieved in favor of the test intervention because of a lower cost associated with surgery time and adverse event treatments [NL e86 (CI −50.33; 219.20), FR e134 (CI −3.63; 261.30), ES e178 (CI 34.12; 97.48)]. In Sweden (SE), the HA-coated abutment was more expensive than the conventional abutment, which neutralized the cost savings and led to a negative cost (SE e-29 CI −160.27; 97.48) of the new treatment modality. After 3 years, the mean cost saving reduced to e17 (CI −191.80; 213.30) in the Netherlands, in Spain to e84.50 (CI −117.90; 289.50), and in France to van Hoof et al. CCA of Less Invasive Treatment e80 (CI −99.40; 248.50). The mean additional cost in Sweden increased to e-116 (CI −326.90; 68.10). The consequences in terms of the subjective audiological benefit and Health-related quality of life (HRQoL) were comparable between treatments. A trend was identified for favorable results in the test group for some consequences and statistical significance is achieved for the cosmetic outcome as assessed by the clinician.Conclusions: From this multinational cost-consequence analysis it can be discerned that health care systems can achieve a cost saving during the first year that regresses after 3 years, by implementing soft tissue preservation surgery with a HA-coated abutment in comparison to the conventional treatment. The cosmetic results are better. (sponsored by Cochlear Bone Anchored Solutions AB; Clinical and health economic evaluation with a new Baha ® abutment design combined with a minimally invasive surgical technique, ClinicalTrials.gov NCT01796236).

Bioinstructive Micro-Nanotextured Zirconia Ceramic Interfaces for Guiding and Stimulating an Osteogenic Response In Vitro

“…The increased life span, resistance to fracture, mechanical strength, and good compatibility with human tissues of metal-based implants make Ti and its alloys the main candidates for dental and orthopedic implantology [ 4 , 5 , 6 , 7 , 8 ]. Coatings, mainly based on ceramics or hydroxylapatite (HA), aim at improving osteoconduction and have been used for clinical trial as an upgrade to the standard of care [ 9 ].…”

Association of Bone Conduction Devices for Single-Sided Sensorineural Deafness With Quality of Life

“…After the screening of titles and abstracts, 84 articles were retrieved, and full manuscript review was performed. After applying inclusion and exclusion criteria, the final 11 studies were selected to be included in the meta-analysis . Ten studies were prospective, nonrandomized, preintervention and postintervention studies.…”

“…Ten studies were prospective, nonrandomized, preintervention and postintervention studies. One study was a randomized clinical trial that included a treatment arm with patients undergoing QOL assessment before and after insertion of BCDs.…”

Toward Optimal Care for Children With Congenital Unilateral Aural Atresia

“…Hopefully the development of new hearing implants for conductive hearing loss (28-30, 58, 59) results in an increased compliance compared to percutaneous BCDs. These new devices might provide an alternative for the current suboptimal generation of BCDs although both the functionality and the increased costs for this system need to be considered (60). Implantation of the new active transcutaneous devices is more invasive compared to the conventional percutaneous BCDs.…”