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European Archives of Oto-Rhino-Laryngology
Published in: European Archives of Oto-Rhino-Laryngology 2/2024

Open Access 08-08-2023 | Hearing Implant | Otology

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

Authors: Robert Cowan, Aaran T. Lewis, Carina Hallberg, Michael C. F. Tong, Catherine S. Birman, Iris H.-Y. Ng, Robert Briggs

Published in: European Archives of Oto-Rhino-Laryngology | Issue 2/2024

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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.
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Metadata
Title
Clinical performance, safety, and patient-reported outcomes of an active osseointegrated bone-conduction hearing implant system at 24-month follow-up
Authors
Robert Cowan
Aaran T. Lewis
Carina Hallberg
Michael C. F. Tong
Catherine S. Birman
Iris H.-Y. Ng
Robert Briggs
Publication date
08-08-2023
Publisher
Springer Berlin Heidelberg
Published in
European Archives of Oto-Rhino-Laryngology / Issue 2/2024
Print ISSN: 0937-4477
Electronic ISSN: 1434-4726
DOI
https://doi.org/10.1007/s00405-023-08133-3

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