Clinical performance, safety, and patient-reported outcomes of an active osseointegrated steady-state implant system

Robert Briggs*, Catherine S. Birman, Nicholas Baulderstone, Aaran T. Lewis, Iris H. Y. Ng, Anna Östblom, Alex Rousset, Sylvia Tari, Michael C. F. Tong, Robert Cowan

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

7 Citations (Scopus)
72 Downloads (Pure)

Abstract

Objective: To investigate the clinical performance, safety, and patient-reported outcomes of an active osseointegrated steady-state implant system that uses piezoelectric technology. Study Design: A prospective, multicenter, open-label, single-arm, within-subject clinical investigation. Setting: Three tertiary referral clinical centers located in Melbourne, Sydney, and Hong Kong. Patients: Twenty-nine adult subjects, 24 with mixed hearing loss or conductive hearing loss and 5 with single-sided sensorineural deafness. Intervention: Implantation with the Cochlear Osia 2 System. Main Outcome Measures: Audiological threshold evaluation and speech recognition in quiet and in noise. Patient satisfaction and safety. Results: At 6-month follow-up after surgery, a mean improvement in pure-tone average of 26.0 dB hearing level and a mean improvement of 8.8 dB signal-to-noise ratio in speech reception threshold in noise was achieved with the investigational device as compared with the unaided situation. Usability of the investigational device was rated 71.4/100 mm for sound processor retention and 81.4/100 mm for overall comfort using a visual analog scale. Conclusion: These outcomes confirm the clinical safety, performance, and benefit of an innovative active transcutaneous bone conduction implant using a piezoelectric transducer design in subjects with conductive hearing loss, mixed hearing loss, or single-sided sensorineural deafness.

Original languageEnglish
Pages (from-to)827-834
Number of pages8
JournalOtology and Neurotology
Volume43
Issue number7
DOIs
Publication statusPublished - 1 Aug 2022
Externally publishedYes

Bibliographical note

Copyright the Author(s) 2022. Version archived for private and non-commercial use with the permission of the author/s and according to publisher conditions. For further rights please contact the publisher.

Keywords

  • Active transcutaneous bone conduction implant
  • Conductive and mixed hearing loss
  • Piezoelectric
  • Safety
  • Semi-implantable hearing device
  • Single-sided deafness
  • Speech recognition in noise
  • Speech recognition in quiet

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