To demonstrate the non-inferiority of perioperative comfort in patients undergoing otosclerosis surgery under local anesthesia versus general anesthesia and to compare audiometric results, quality of life and complications. A prospective non-interventional study was performed. Patients undergoing otosclerosis surgery between January 2019 and March 2021 at the University Hospital of Rennes were included consecutively. Perioperative comfort of LA versus GA (at ward admission, surgery, recovery and 48 h following surgery) was measured on a visual analogue scale at 10 days postoperatively and quality of life by the Glasgow Benefit Inventory at 3 months. Complications and audiometric results were also assessed. To demonstrate the non-inferiority of LA versus GA with a margin of 1.5 points on the comfort VAS, a power of 80
Importance Cochlear implants are an effective technique for enhancing speech perception abilities in quiet environments for people with severe to profound deafness. Nevertheless, complex sound signals perception, such as music perception, remains challenging for cochlear implant users. Objective To assess the benefit of a tonotopic map on music perception in new cochlear implant users. Design, Setting, and Participants A prospective, randomized, double-blind, 2-period crossover study including 26 new cochlear implant users was performed over a 6-month period (June 2021 to November 2021). An anatomical tonotopic map was created using postoperative flat-panel computed tomography and a reconstruction software based on Greenwood function. New cochlear implant users older than 18 years with bilateral severe to profound sensorineural hearing loss or complete hearing loss for less than 5 years were selected in the University Hospital Centre of Rennes in France. The trial was conducted from June to November 2021 (inclusion) and to February 2022 (end of the assessment procedure at 12 weeks postactivation), and the analysis itself was completed in December 2022. Intervention Each participant was randomized to receive a conventional map followed by a tonotopic map or vice versa. Main Outcomes and Measures Participants performed pitch-scaling tasks (multidimensional qualitative assessment, melodic contour identification, melodic recognition test) after 6 weeks of each setting. Results Thirteen participants were randomized to each sequence. Two of the 26 participants recruited (1 in each sequence) had to be excluded due to the COVID-19 pandemic. The multidimensional qualitative assessment (Gabrielsson test), melodic contour identification, and melodic recognition scores were significantly higher with the tonotopic setting than the conventional one (mean effect [ME], 7.8; 95% CI, 5.0-10.5; ME, 12.1%; 95% CI, 5.7%-18.4%; ME, 14.4%, 95% CI, 8.5%-20.2%; and ME, 2.1, 95% CI, 1.7-2.5, respectively). Among the different dimensions evaluated by the Gabrielsson test, the mean scores for clarity, spaciousness, fullness, nearness, and total impression were significantly higher with tonotopic fitting. Ninety-two percent of the participants kept the tonotopy-based map after the study period. Conclusions In this randomized clinical trial of patients with new cochlear implants, a tonotopic-based fitting was associated with better results in perception of complex sound signals such as music listening experience.
Importance:Cochlear implants are an effective technique for enhancing speech perception abilities in quiet environments for people with severe to profound deafness. Nevertheless, complex sound signals perception, such as music perception, remains challenging for cochlear implant users. Objective:To assess the benefit of a tonotopic map on music perception in new cochlear implant users. Design, Setting, and Participants:A prospective, randomized, double-blind, 2-period crossover study including 26 new cochlear implant users was performed over a 6-month period (June 2021 to November 2021). An anatomical tonotopic map was created using postoperative flat-panel computed tomography and a reconstruction software based on Greenwood function. New cochlear implant users older than 18 years with bilateral severe to profound sensorineural hearing loss or complete hearing loss for less than 5 years were selected in the University Hospital Centre of Rennes in France. The trial was conducted from June to November 2021 (inclusion) and to February 2022 (end of the assessment procedure at 12 weeks postactivation), and the analysis itself was completed in December 2022. Intervention:Each participant was randomized to receive a conventional map followed by a tonotopic map or vice versa. Main Outcomes and Measures:Participants performed pitch-scaling tasks (multidimensional qualitative assessment, melodic contour identification, melodic recognition test) after 6 weeks of each setting. Results:Thirteen participants were randomized to each sequence. Two of the 26 participants recruited (1 in each sequence) had to be excluded due to the COVID-19 pandemic. The multidimensional qualitative assessment (Gabrielsson test), melodic contour identification, and melodic recognition scores were significantly higher with the tonotopic setting than the conventional one (mean effect [ME], 7.8; 95% CI, 5.0-10.5; ME, 12.1%; 95% CI, 5.7%-18.4%; ME, 14.4%, 95% CI, 8.5%-20.2%; and ME, 2.1, 95% CI, 1.7-2.5, respectively). Among the different dimensions evaluated by the Gabrielsson test, the mean scores for clarity, spaciousness, fullness, nearness, and total impression were significantly higher with tonotopic fitting. Ninety-two percent of the participants kept the tonotopy-based map after the study period. Conclusions:In this randomized clinical trial of patients with new cochlear implants, a tonotopic-based fitting was associated with better results in perception of complex sound signals such as music listening experience. Trial Registration:ClinicalTrials.gov Identifier: NCT04922619.
OBJECTIVES:While cochlear implants (CIs) have provided benefits for speech recognition in quiet for subjects with severe-to-profound hearing loss, speech recognition in noise remains challenging. A body of evidence suggests that reducing frequency-to-place mismatch may positively affect speech perception. Thus, a fitting method based on a tonotopic map may improve speech perception results in quiet and noise. The aim of our study was to assess the impact of a tonotopic map on speech perception in noise and quiet in new CI users. DESIGN:A prospective, randomized, double-blind, two-period cross-over study in 26 new CI users was performed over a 6-month period. New CI users older than 18 years with bilateral severe-to-profound sensorineural hearing loss or complete hearing loss for less than 5 years were selected in the University Hospital Centre of Rennes in France. An anatomical tonotopic map was created using postoperative flat-panel computed tomography and a reconstruction software based on the Greenwood function. Each participant was randomized to receive a conventional map followed by a tonotopic map or vice versa. Each setting was maintained for 6 weeks, at the end of which participants performed speech perception tasks. The primary outcome measure was speech recognition in noise. Participants were allocated to sequences by block randomization of size two with a ratio 1:1 (CONSORT Guidelines). Participants and those assessing the outcomes were blinded to the intervention. RESULTS:Thirteen participants were randomized to each sequence. Two of the 26 participants recruited (one in each sequence) had to be excluded due to the COVID-19 pandemic. Twenty-four participants were analyzed. Speech recognition in noise was significantly better with the tonotopic fitting at all signal-to-noise ratio (SNR) levels tested [SNR = +9 dB, p = 0.002, mean effect (ME) = 12.1%, 95% confidence interval (95% CI) = 4.9 to 19.2, standardized effect size (SES) = 0.71; SNR = +6 dB, p < 0.001, ME = 16.3%, 95% CI = 9.8 to 22.7, SES = 1.07; SNR = +3 dB, p < 0.001 ME = 13.8%, 95% CI = 6.9 to 20.6, SES = 0.84; SNR = 0 dB, p = 0.003, ME = 10.8%, 95% CI = 4.1 to 17.6, SES = 0.68]. Neither period nor interaction effects were observed for any signal level. Speech recognition in quiet ( p = 0.66) and tonal audiometry ( p = 0.203) did not significantly differ between the two settings. 92% of the participants kept the tonotopy-based map after the study period. No correlation was found between speech-in-noise perception and age, duration of hearing deprivation, angular insertion depth, or position or width of the frequency filters allocated to the electrodes. CONCLUSION:For new CI users, tonotopic fitting appears to be more efficient than the default frequency fitting because it allows for better speech recognition in noise without compromising understanding in quiet.
This study was designed to identify risk factors for post-operative complications in micro-anastomosed osteomyocutaneous free flaps (MOFF) and analyzed their consequences in long term. A retrospective review of 100 MOFF realized between May 2007 and October 2019 was performed. Demographic data, perioperative management and postoperative complications were enrolled and analyzed in a multivariate model. Patients were followed for ≥ 6 months. Major surgical complication rate was 20