Clinical performance, safety, and patient-reported outcomes of an active osseointegrated bone-conduction hearing implant system at 24-month follow-up

Abstract

Purpose To investigate 2-year post-operative hearing performance, safety, and patient-reported outcomes of hearing-impaired adults treated with the Osia® 2 System, an active osseointegrated bone-conduction hearing implant that uses piezoelectric technology. Methods A prospective, multicenter, open-label, single-arm, within-subject clinical study conducted at three tertiary referral clinical centers located in Melbourne, Sydney and Hong Kong. Twenty adult recipients of the Osia 2 System were enrolled and followed up between 12 and 24 months post-implantation: 17 with mixed or conductive hearing loss and 3 with single-sided sensorineural deafness. Safety data, audiological thresholds, speech recognition thresholds in noise, and patient-reported outcomes were collected and evaluated. In addition, pre-and 6-month post-implantation data were collected retrospectively for this recipient cohort enrolled into the earlier study (ClinicalTrials.gov NCT04041700). Results Between 6- and 24-month follow-up, there was no statistically significant change in free-field hearing thresholds or speech reception thresholds in noise (p = > 0.05), indicating that aided improvements were maintained up to 24 months of follow-up. Furthermore, improvements in health-related quality of life and daily hearing ability, as well as clinical and subjective measures of hearing benefit remained stable over the 24-month period. No serious adverse events were reported during extended follow-up. Conclusions These study results provide further evidence to support the longer term clinical safety, hearing performance, and patient-related benefits of the Osia 2 System in patients with either a conductive hearing loss, mixed hearing loss, or single-sided sensorineural deafness. Trial Registration ClinicalTrials.gov Identifier: NCT04754477. First posted: February 15, 2021.

Piezoelectric Bone Conduction Hearing Implant: A Case Series of Audiological, Surgical and Patient-Reported Outcomes

“…In light of our findings, it is discerned that the Osia system is emerging as a secure substitute to percutaneous BCHI, a corroboration consistent with antecedent investigations [ 1 , 9 , 17 , 18 , 19 , 20 ]. Despite the apparent infrequency of severe complications, it is crucial to emphasize the need for extended periods of observation and an enlarged study cohort to augment the statistical robustness of our findings.…”

“…The mean pure tone threshold improved by 27 dB from unaided to aided, which is in the same range as previous studies. In the study of 20 recipients of the Osia 2 by Cowan et al [ 17 ], the PTA 4 improved by 26.7 dB when comparing pre-implantation to 12 months post-implantation. In the study by Briggs et al [ 18 ] of 27 Osia recipients, the PTA 4 improvement was 28.4 dB from unaided to 6 months aided.…”

“…The primary limitation of this study is the relatively short follow-up duration (average follow-up, 10.8 months) for patients implanted with this novel hearing device. However, insights from Cowan et al’s investigation [ 17 ], which reported adverse events up to 24 months after surgery, indicated that the majority of such events manifested within the initial three months. This suggests that our study captures a significant portion of the post-operative adverse events timeline.…”