Multicenter Clinical Investigation of a New Active Osseointegrated Steady-State Implant System
AuthorMylanus, EAM; Hua, H; Wigren, S; Arndt, S; Skarzynski, PH; Telian, SA; Briggs, RJS
Source TitleOtology and Neurotology: an international forum
PublisherLIPPINCOTT WILLIAMS & WILKINS
University of Melbourne Author/sBriggs, Robert
Document TypeJournal Article
CitationsMylanus, E. A. M., Hua, H., Wigren, S., Arndt, S., Skarzynski, P. H., Telian, S. A. & Briggs, R. J. S. (2020). Multicenter Clinical Investigation of a New Active Osseointegrated Steady-State Implant System. OTOLOGY & NEUROTOLOGY, 41 (9), pp.1249-1257. https://doi.org/10.1097/MAO.0000000000002794.
Access StatusOpen Access
OBJECTIVE: A new active transcutaneous bone conduction hearing implant system that uses piezoelectric technology has been developed: an active osseointegrated steady-state implant system (OSI). This was the first clinical investigation undertaken to demonstrate clinical performance, safety, and benefit of the new implant system. STUDY DESIGN AND SETTING: A multicenter prospective within-subject clinical investigation was conducted. PATIENTS: Fifty-one adult subjects with mixed and conductive hearing loss (MHL/CHL, n = 37) and single-sided sensorineural deafness (SSD, n = 14) were included. MAIN OUTCOME MEASURE: Audiological evaluations included audiometric thresholds, speech recognition in noise, and quiet. Hearing and health-related patient-reported outcomes (PROs; health utilities index [HUI], abbreviated profile of hearing aid benefit [APHAB], and speech, spatial of qualities of hearing scale [SSQ]), daily use, surgical and safety parameters were collected. RESULTS: Intra- and postoperative complications were few. One implant was removed before activation due to post-surgical infection. Compared with the preoperative softband tests, a significant improvement in speech recognition-in-noise was observed in the MHL/CHL group (-7.3 dB, p ≤ 0.0001) and the SSD group (-8.1 dB, p = 0.0008). In quiet, word recognition improved in the MHL/CHL group, most markedly at lower intensity input of 50 dB SPL (26.7%, p ≤ 0.0001). The results of all PROs showed a significant improvement with the new device compared with preoperative softband in the MHL/CHL group. In the SSD group significant improvements were observed in the APHAB and SSQ questionnaires. DISCUSSION: The results confirmed the clinical safety, performance, and benefit of this new treatment modality for subjects with CHL, MHL, and SSD.
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