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

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

doi:10.1007/s00405-023-08133-3

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

Eur Arch Otorhinolaryngol. 2024 Feb;281(2):683-691. doi: 10.1007/s00405-023-08133-3. Epub 2023 Aug 8.

Authors

Robert Cowan¹, Aaran T Lewis², Carina Hallberg², Michael C F Tong³, Catherine S Birman^{4

5

6}, Iris H-Y Ng³, Robert Briggs⁷

Affiliations

¹ Department of Otolaryngology, The University of Melbourne, Melbourne, Australia.
² Cochlear Limited, Sydney, Australia.
³ Department of Otorhinolaryngology, Head and Neck Surgery and Institute of Human Communicative Research, The Chinese University of Hong Kong, Hong Kong SAR, People's Republic of China.
⁴ Nextsense, Sydney, Australia.
⁵ Faculty of Medicine and Health, Sydney University, Sydney, Australia.
⁶ Faculty of Medicine and Health Sciences, Macquarie University, Sydney, Australia.
⁷ Department of Otolaryngology, The University of Melbourne, Melbourne, Australia. rjbriggs@melbourne-ear.com.

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.

Publication types

Multicenter Study

MeSH terms

Adult
Bone Conduction
Deafness*
Follow-Up Studies
Hearing
Hearing Aids*
Hearing Loss*
Hearing Loss, Conductive / surgery
Hearing Loss, Mixed Conductive-Sensorineural* / surgery
Hearing Loss, Sensorineural*
Humans
Patient Reported Outcome Measures
Prospective Studies
Quality of Life
Retrospective Studies
Speech Perception*

Associated data

ClinicalTrials.gov/NCT04041700
ClinicalTrials.gov/NCT04754477