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.

Keywords: Active transcutaneous bone conduction implant; Conductive and mixed hearing loss; Semi-implantable hearing device; Single-sided deafness; Speech recognition in noise; Speech recognition in quiet.

Fig. 1

Cumulative number of related adverse events between implantation and 24-month follow-up (N = 20). AEs adverse events

Fig. 2

Box plot of the distribution of PTA4 hearing thresholds for subjects with MHL/CHL (N = 17) (a) and SSD (N = 3) (b) between the unaided situation and 24-month follow-up. Open circles represent outliers and lines within boxes represent the median values of each follow-up. The change between the unaided situation and all follow-ups is statistically significant for the cohort (p values < 0.05)

Fig. 3

Box plot of the distribution of speech recognition thresholds for subjects with MHL/CHL (N = 17) (a) and SSD (N = 3) (b) between the unaided situation and 24-month follow-up. Open circles represent outliers and lines within boxes represent the median values of each follow-up. The change between the unaided situation and all follow-ups is statistically significant for the cohort (p values < 0.05)