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, 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

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.

Trial registration: ClinicalTrials.gov NCT04041700.

Copyright © 2022 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of Otology & Neurotology, Inc.

Figures

FIG. 1
FIG. 1
Mean baseline audiograms for subjects with mixed or conductive hearing loss (n = 23; A) or single-sided sensorineural deafness (n = 4; B). Error bars represent the standard deviation of the mean.
FIG. 2
FIG. 2
Free-field thresholds measured preoperatively and with the investigational device 6 months after surgery in patients with MHL or CHL (n = 23; A) and patients with SSD (n = 4; B), where error bars represent the standard deviation of the mean. Word recognition scores in quiet (n = 27; mean and 95% CIs; C) and SRTs in noise (n = 27; mean and 95% CIs; D), both measured preoperatively unaided and with the investigational device at 6 months. CHL indicates conductive hearing loss; CI, confidence interval; MHL, mixed hearing loss; SRTs, speech reception thresholds.

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Source: PubMed

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