A cost-utility analysis of the transcutaneous Osia System® compared to the percutaneous bone-conduction hearing implant Baha® Connect for hearing loss in Spain

Objective: To evaluate the cost-effectiveness of the transcutaneous bone-conduction hearing implant Osia® System compared to the percutaneous bone-conduction hearing implant Baha® Connect System in a pooled population of adults eligible for bone-conduction hearing implants, from the perspective of the Spanish National Health System. Methods: A lifetime Markov model with 6-month cycles was simulated based on a previously published Swedish study, incorporating three primary health states: "with implant," "without implant," and "dead." Clinical inputs included probabilities of adverse events (e.g., complications, device failure), health utilities in Quality-Adjusted Life Years (QALYs), and direct healthcare costs. Costs and QALYs were discounted at a 3% annual rate. Deterministic and probabilistic sensitivity analysis were conducted to assess the uncertainty of the model parameters. Results: In the base-case analysis, the Osia® System incurred a total cost of €24,555 per patient and yielded 15.94144 QALYs, while the Baha® Connect System accounted for €20,968 and generated 15.17033 QALYs. The incremental cost-effectiveness ratio (ICER) of the Osia® System was €4,651/QALY gained, compared to the Baha® Connect System. The model was most sensitive to utility values for each device. At a willingness-to-pay threshold of €30,000/QALY, the probabilistic sensitivity analysis showed that the Osia® System had a 62% probability of being cost-effective. Conclusion: From the Spanish healthcare system perspective, the Osia® System is a cost-effective alternative to the Baha® Connect System for the overall adult patient population with hearing loss in Spain eligible for a bone-conduction hearing implant. These results support its inclusion in national coverage and reimbursement policies to improve clinical and patient-reported outcomes and to promote sustainable healthcare delivery. However, these findings should be interpreted cautiously due to the reliance on non-Spanish clinical inputs and the absence of subgroup-specific analyses.