Clinical Performance, Safety, and Patient-Reported Outcomes of an Active Osseointegrated Steady-State Implant System

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.

Systematic Review and Meta‐Analysis of a New Active Transcutaneous Bone Conduction Implant

“…Four studies explicitly addressed higher frequency gain. 5,8,9,23 investigational system, comparatively statistically significant (p = <0.05) mean improvements for Osia in aided thresholds of 3.4, 4.6, 7.3, and 13.9 dB were recorded at 1.5, 2, 4, and 6 kHz, respectively. 8 Goycoolea et al demonstrated average and high frequencies gain for Osia was statistically higher compared with presurgical results of BAHA 5 Power with Softband.…”

“…There were six cohort studies, 5,8,9,23,25,26 four case-series, 3,7,27,28 two case-control studies, 12,29 two administrative database studies, 12,30 and one case series abstract 31 included into the systematic review. One study included results for two cohorts and were treated as two separate cohorts: as a database study for complications, and case-control for clinical outcome data.…”

“…Audiological outcomes were reported in 12 studies (n = 195 patients, 212 implants). 5,[7][8][9]12,23,[25][26][27][28][29]31 FG was calculated by study authors in 10 studies, utilizing a variety of assessment methods (Supplement 2). 5,[7][8][9]12,23,25,26,28,29 All studies reporting PTA FG utilized 0.5-4 kHz frequencies.…”

“…9,23 SRT in quiet was reported in 11 studies (n = 158 patients) utilizing an assortment of tests and noise levels. Seven studies used percentages of correct words, 8,9,12,23,28,29,31 and four studies used SRT threshold. 5,7,25,26 8,9 SRT in noise was reported in seven studies (n = 103 patients), wherein SNR for 50% intelligible speech was used in six studies.…”

“…were collected in nine studies (n = 148). 5,8,9,12,23,25,28,29,31 Common measures were Abbreviated Profile of Hearing Aid Benefit (APHAB) (n = 123, six studies), 8,9,23,28,29,31 Speech, Spatial and Qualities of Hearing Scale-12 (SSQ12) (n = 111, four studies), 5,8,9,23 Health Utilities Index (HUI) (n = 102, three studies), 8,9,23 and Glasgow Benefit Inventory (GBI) (n = 29, three studies). 5,25,29 Some, but not all, studies, demonstrated improvement in quality of life using different PROM.…”