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Objectives: First, to assess for the performance of the Carina placed on the round window at various European centers; second, to study the follow-up after 2 years and discuss limitations and technical issues; and finally, to further develop our understanding of the principles of acoustic transfer through the round window. Materials and Methods: Eleven patients were included in this retrospective study (7 women and 4 men) from 7 European tertiary referral hospitals (4 centers in France, 2 in Belgium, 1 in Spain). The mean age was 50.8 years (35-71 yr). All patients have multiple previous surgeries (93 surgical procedures) for otosclerosis (3 patients) or chronic otitis media (8 patients), and in all cases, the stapes was not accessible due to obliteration by sclerotic tissue. Preoperative and postoperative air conduction, bone conduction, as well as aided and unaided thresholds and speech scores were measured. Results: No significant differences were observed between pre-operative and postoperative air-conduction and bone-conduction pure-tone averages. The average free field functional gain obtained with the implant ranged from 22 to 42 dB at each individual frequency, with a mean of 29 T 5 dB across all audiometric frequencies. Word recognition scores demonstrated significant differences between unaided and implant-aided conditions. Complications included 2 cases of postoperative infection (including 1 anacusis) that required explantation, and 1 case reduced initial benefit, followed by a nonfunctioning device. In 10 patients, postoperative hearing was unchanged. The 8 other patients are using their implant daily. Conclusion: These results show that this option is valid for patients with a fixed footplate and unsuccessful previous surgeries or patients who cannot benefit from a stapedotomy for anatomic reasons. In some cases, access to the round window membrane could represent a limitation. However, these promising initial results establish the need for further works with regard to 3 issues: 1) clinical data studies are needed, including a greater number of patients to confirm these preliminary results; 2) a long-term follow-up must be performed to detect any possible cochlear adverse effects, in particular, on the basilar membrane; 3) the effect of fascia interposition and tip size has to be evaluated in experimental studies.

Background The efficacy of systemic antibiotics on the treatment of ventilator-associated infectious maxillary sinusitis (VAIMS) is debated. The objective of this study was to determine the etiologic diagnosis of VAIMS in patients receiving antibiotics. Methods Patients mechanically ventilated for more than or equal to 72 h, who had persistent fever while on antibiotics for more than or equal to 48 h, underwent computed tomography scan followed by transnasal puncture of involved maxillary sinuses. VAIMS was defined as follows: fever greater than or equal to 38 degrees C, radiographic signs (air fluid level or opacification of maxillary sinuses on computed tomography scan), and a quantitative culture of sinus aspirate yielding more than or equal to 103 colony-forming units/ml. Results Twenty-four patients had radiographic signs of sinusitis. The mean +/- SD prior durations of mechanical ventilation and antibiotic exposure were 9.5 +/- 4.7 days and 6 +/- 4 days, respectively. Six unilateral and nine bilateral VAIMS were diagnosed in 15 patients. The median number of etiologic organisms per patient was two (range, one to four). The bacteriologic cultures yielded gram-positive bacteria (n = 21), gram-negative bacteria (n = 22), and yeasts (n = 5). Forty percent of causative agents were susceptible to the antibiotics prescribed. Seven patients with VAIMS developed 10 concomitant infections: ventilator-associated pneumonia (n = 5), urinary tract infection (n = 3), catheter infections (n = 2). In all cases of ventilator-associated pneumonia, the implicated agents were the causative agents of VAIMS. Conclusion In VAIMS patients on antibiotics, quantitative cultures of sinus aspirates may contribute to establish the diagnosis. The frequent recovery of microorganisms susceptible to the antimicrobial treatment administered suggests that therapy of VAIMS with systemic antibiotics may not be sufficient.