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Objective: The aim of the Cochlear-Implanted Recipient Observational Study (Cochlear IROS) is to collect information on performance outcomes and surgical details in a systematic, consistent observation of routine clinical practice. Here, we report the surgical details collected for the Cochlear MicroDrive™ Actuator implanted as part of Cochlear's middle ear implant systems by 9 European Tertiary Referral Centers. Materials and Methods: The observational data was collected in an online database. 33 subjects (21 female and 12 male) implanted with either the Carina system (n=20) or the MET system (n=13) were included in this study. The average age of the subjects was 51 years. 16 subjects were implanted on the right ear and 17 on the left ear. Results: The average surgery time was 2:17 (range 1:20 -- 5:45) for the Carina system while it was 1:47(1:10 -- 3:30) for the MET system. In all but one patient the MicroDrive actuator was coupled to the incus. For one patient it was coupled to the stapes head with a CliP prosthesis. The intra- operative test system was used and passed in all subjects. 23 surgeons rated the surgical difficulty as easy or very easy, 9 as medium and 1 as difficult. Conclusions: The surgical time to implant the Carina system is acceptable. Combined with the fact that 70% of the surgeons rated the surgical difficulty as easy or very easy, this confirms that the surgical procedure is straightforward for incus coupling. Additionally, the surgical procedure is new for many of the surgeons so that a reduction in surgical time can be expected once they gain more experience with the system and its surgical procedure. The surgical time goes down to 80 minutes for experienced surgeons. [ABSTRACT FROM AUTHOR]

Objective: Patient-reported outcomes and quality of life data are important for supporting efficacy claims and reimbursement for health technology solutions. To evaluate self-perceived benefits after hearing treatment with the Cochlear™ Carina, participation in an observational study (i.e. post-market follow-up, Cochlear-IROS) was undertaken. Preliminary longitudinal data will be summarized for 14 recipients. Materials and Methods: Self-assessment of quality of life via the Health-Utilities-Index Mk3 (HUI3) and daily hearing function via the Speech Spatial Qualities (SSQ) scales was performed at preimplant and at 1 year in the postimplant representing the daily listening condition at each interval. Routinely measured air- and bone-conduction hearing threshold levels were also collected. Demographic, audiological and preliminary self-assessment data are reported. Results: The majority of recipients presented with a sensorineural hearing loss, with hearing loss ranging from moderate to severe in the implanted ear. Longitudinal outcomes are available for n=14 recipients to date. At one year, a clinically important trend for improvement is observed for HUI3 multi-attribute scores (median 0.12, scale 0 -1.0) and for SSQ49 subcategory scores (~2.0 scale points, scale 0-10.0). Bone-conduction thresholds at one year post-implant are clinically similar to pre-operative levels. Conclusions: These preliminary data suggest that Carina patients accrue a clinically significant improvement in health-related quality of life compared to their preimplant listening condition where increases in HUI3 scores were generally >0.03. Improvements in all three subcategories are also observed for the group. Sound quality was also improved using the Carina. The bone conduction thresholds were stable after 1 year of implant use. [ABSTRACT FROM AUTHOR]

Objective: The aim of this work is to describe the first outcomes for the active middle ear implant fully implantable Cochlear™ Carina® System. Study Design: retrospective observational nonrandomized group study. Methods: from December 2014 to June 2017, 15 patients underwent Carina implantation. All the implants were from the last generation developed by Cochlear® company. Preoperative and postoperative air conduction and bone conduction thresholds were evaluated. Speech perception in silence and in noise, and localization sounds abilities, were also analyzed. Results: 16 Carina implants were performed. Post-operatively, the mean pure tone audiometry threshold, in the operated ear, was 50,45 dB (± 12,64 SD) in BC and 64,92 dB (± 15,36 SD). The difference between post-operative and pre-operative mean pure tone audiometry threshold in the operated ear was not significant (p > 0,05). The mean post-operative threshold in free field with the Carina™ device switched on was 46,77 dB, 45,75 dB, 43,57 dB and 45,38 dB, at 1 months, 3 months, 6 months and 1 year, respectively. In speech discrimination in silence, the mean post-operative SRT in free field with the Carina™ device switched on and contralateral masking, was 51,7 dB, 48,18 dB, 45 dB and 45dB, at 1 months, 3 months, 6 months and 1 year, respectively. Speech discrimination in noise and localization improve significantly with Carina. Conclusion: In spite of the small number of patients our results confirm that fully implantable middle ear implant is a viable treatment for patients with moderate to severe sensorineural hearing loss. [ABSTRACT FROM AUTHOR]