Single-Case Experimental Designs and N-of-1 Trials-An Alternative to Randomized Clinical Trials for Clinical Research in Otorhinolaryngology.

This Viewpoint explores the use of single-case experimental designs in otolaryngology research.

Early management of presbycusis: recommendations from the French Society of Otorhinolaryngology and Head and Neck Surgery, the French Society of Audiology, and the French Society of Geriatrics and Gerontology.

INTRODUCTION: Presbycusis is the physiological decrease in hearing due to advancing age and begins well before the sixth decade. These recommendations recall the principles of early diagnosis of presbycusis and the means of optimal rehabilitation as soon as the first symptoms appear. MATERIAL AND METHODS: The recommendations are based on a systematic analysis of the literature carried out by a multidisciplinary group of ENT physicians, audiologists, geriatricians and hearing specialists from all over France. They are classified as grade A, B, C or professional agreement according to a decreasing level of scientific evidence. RESULTS: The diagnosis of presbycusis is more difficult at the beginning of its evolution but a certain number of tools are available for its early diagnosis and its face-to-face or remote management. CONCLUSION: In the case of a clinical profile suggestive of presbycusis in a young subject, especially if there are several family cases, it is recommended to propose a genetic investigation. Free-field speech audiometry in noise is recommended to measure intelligibility in a realistic environment. Questionnaires in addition to audiometric tests would allow the best assessment of the patient's disability. Hearing rehabilitation with a hearing aid or cochlear implant may slow or prevent cognitive decline. Combined auditory and cognitive rehabilitation should be offered regardless of the time since the hearing was fitting. It is recommended to integrate programs accessible via smartphones, tablets or the Internet, that include different training domains to complement face-to-face sessions.

Evolution in the management of vestibular schwannoma: a single-center 15-year experience.

PURPOSE: To highlight the changes in the management of vestibular schwannoma (VS) since 2004 with a focus on small- to middle-size VS. METHODS: Retrospective analysis of the decisions made in skull base tumor board between 2004 and 2021. RESULTS: 1819 decisions were analyzed (average age 59.25, 54% females). Overall, 850 (47%) cases were allocated to a Wait and Scan (WS) approach, 416 (23%) received radiotherapy and 553 (30%) were treated surgically (MS). All stages considered WS increased from 39% before 2010 to 50% after 2010. Similarly, Stereotactic Radio Therapy (SRT) increased from 5 to 18%. MS decreased from 46 to 25%. It was more commonly proposed to younger patients and larger tumors, p < 0.001. For Koos stages 1, 2, and 3 there was a statistically significant increase in SRT, and a decrease in MS, p < 0.001. WS also increased for stages 1 and 2. However, such a trend was not observed for stage 3. MS remained the primary treatment modality for stage 4 tumors throughout the study period, p = 0.057. The significance of advanced age as a factor favoring SRT decreased over time. The opposite is true for serviceable hearing. There was also a decrease in the percentage of the justification "young age" in the MS category. CONCLUSION: The is a continuing trend towards non-surgical treatment. Small- to medium-sized VS witnessed an increase in both WS and SRT. There is only an increase in SRT for moderately large VS. Physicians are less and less considering young age as a factor favoring MS over SRT. There is a tendency towards favoring SRT when hearing is serviceable.

[Early management of presbycusis: recommendations from the French Society of Otorhinolaryngology and Head and Neck Surgery, the French Society of Audiology, and the French Society of Geriatrics and Gerontology]. / Recommandations de la Société française d'otorhinolaryngologie et de chirurgie de la face et du cou, la Société française d'audiologie et la Société française de gériatrie et gérontologie pour la prise en charge précoce de la presbyacousie.

INTRODUCTION: Presbycusis is the physiological decrease in hearing due to advancing age and begins well before the sixth decade. These recommendations recall the principles of early diagnosis of presbycusis and the means of optimal rehabilitation as soon as the first symptoms appear. MATERIAL AND METHODS: The recommendations are based on a systematic analysis of the literature carried out by a multidisciplinary group of doctors and audioprosthetists from all over France. They are graded A, B, C or expert opinion according to decreasing level of scientific evidence. RESULTS: The diagnosis of presbycusis is more difficult at the beginning of its evolution but a certain number of tools are available for its early diagnosis and its management in face-to-face or even distance learning. CONCLUSION: In case of a clinical profile suggestive of presbycusis in a young subject, especially if there are several family cases, it is recommended to propose a genetic investigation. It is recommended to perform free-field speech audiometry in noise to measure intelligibility in an environment as close as possible to reality. Questionnaires can be used in addition to audiometry to best assess the patient's disability. It is recommended that hearing rehabilitation with a hearing aid or cochlear implant may slow or prevent cognitive decline. Combined auditory and cognitive rehabilitation should be offered regardless of the time elapsed since the fitting. It is recommended to integrate programs accessible via smartphones, tablets or the Internet, integrating different training domains in addition to face-to-face sessions.

Stapedotomy Versus Hearing Aids in the Management of Conductive Hearing Loss Caused by Otosclerosis: A Prospective Comparative Study.

OBJECTIVE: To compare the outcomes of patients with unilateral otosclerosis treated consecutively by a hearing aid then stapedotomy. STUDY DESIGN: Monocentric, nonrandomized, prospective, longitudinal, cohort study. SETTING: Tertiary university hospital. PATIENTS: Adult patients with a unilateral conductive hearing loss of at least 30 dB caused by otosclerosis. INTERVENTIONS: Consecutive treatment by an external hearing aid followed by stapedotomy. MAIN OUTCOME MEASURES: Differences between hearing aids and stapedotomy in quality of life, pure-tone audiometry, binaural hearing, tinnitus severity, and patient satisfaction. RESULTS: Twenty-two patients were included, of which 20 (91%) underwent stapedotomy. Stapedotomy demonstrated increased quality of life according to Glasgow Health Status Inventory scores versus hearing aids (+10.4 ± 9.4 [p = 0.0001]). Stapedotomy versus hearing aids showed improved pure-tone averages (-11.1 ± 11.0 dB [p = 0.002]) and air-bone gaps (-11.8 ± 10.7 dB [p = 0.0006]). Stapedotomy was superior to hearing aids for speech-in-noise recognition in the reverse dichotic condition (-8.4 ± 26.9 dB [p = 0.004]) and showed improved sound localization accuracy in root mean square error (-14.5 ± 24.5 degrees [p = 0.02]). Stapedotomy, but not hearing aids, showed improved patient self-evaluated tinnitus after baseline adjustment according to the Tinnitus Handicap Inventory (-8.0 ± 13.4 [p = 0.02]) and visual analog scale for tinnitus intensity (-28.7 ± 34.1 [p = 0.006]). Overall, patients were more satisfied with surgery versus hearing aids. CONCLUSIONS: Stapedotomy remains more effective compared with hearing aids with greater improvements in quality of life, patient satisfaction, hearing outcomes, and self-evaluated tinnitus.

Surgical treatments of superior semicircular canal dehiscence: A single-centre experience in 63 cases.

OBJECTIVE: Different procedures have been described to treat superior canal dehiscence. The present study aims to describe the results obtained with middle fossa approach, transmastoid approach, and round window reinforcement in a large series of patients. METHODS AND DESIGN: In this single-center retrospective study, we report the results of the procedures performed between 2006 and 2019 using the three main surgical approaches, middle fossa approach (MFA), transmastoid approach (TMA), and round window reinforcement (RWR). The outcome on cardinal cochlear and vestibular symptoms, audiometric results, and changes in cervical vestibular evoked myogenic potentials (cVEMPs) were analyzed. The patients were also interviewed 12 months to 13 years post-treatment to establish their overall satisfaction following surgery. RESULTS: Sixty-three patients were divided into three groups: 42 MFA; 12 RWR; 9 TMA. Postsurgical control rates exceeded 80% for the majority of symptoms in the MFA and TMA groups, and ranged from 11.1% to 83.3% for the RWR group. Over 90% of MFA or TMA patients and 60% of the RWR cohort were satisfied overall with their treatment. Hearing thresholds were intact following surgery in the MFA and TMA groups. There was one case of profound postoperative deafness in the RWR group. CONCLUSION: MFA and TMA are both safe and effective techniques in the treatment of disabling SSCD. Since MFA is the more invasive technique, we suggest that TMA should be proposed as first-line treatment, temporal bone anatomy permitting. RWR outcomes are more variable in term of symptomatic control, and this option could be offered to patients at risk under general anesthesia. LEVEL OF EVIDENCE: Level 4 evidence.

Treatment choice in single-sided deafness and asymmetric hearing loss. A prospective, multicentre cohort study on 155 patients.

OBJECTIVES: To describe the treatment choice in a cohort of subjects with single-sided deafness (SSD) and asymmetric hearing loss (AHL). To assess the reliability of the treatment trials. DESIGN: In this national, multicentre, prospective study, the choice of subjects was made after two consecutive trials of Contralateral Routing Of the Signal (CROS) hearing aids and a Bone Conduction Device (BCD) on a headband. Subjects could proceed with one of these two options, opt for cochlear implantation or decline all treatments. SETTING: Seven tertiary university hospitals. PARTICIPANTS: One hundred fifty-five subjects with SSD or AHL fulfilling the candidacy criteria for cochlear implantation, with or without associated tinnitus. MAIN OUTCOME MEASURES: After the two trials, the number of subjects choosing each option was described. Repeated assessments of both generic and auditory-specific quality of life were conducted, as well as hearing assessments (speech recognition in noise and horizontal localization). RESULTS: CROS was chosen by 75 subjects, followed by cochlear implantation (n = 51), BCD (n = 18) and abstention (n = 11). Patients who opted for cochlear implantation had a poorer quality of life (P = .03). The improvement of quality of life indices after each trial was significantly associated with the final treatment choice (P = .008 for generic indices, P = .002 for auditory-specific indices). The follow-up showed that this improvement had been overestimated in the CROS group, with a long-term retention rate of 52.5%. CONCLUSIONS: More than one third of SSD/AHL subjects are unsatisfied after CROS and BCD trials. Repeated quality of life assessments help counselling the patient for his/her treatment choice.

Objective, audiological and quality of life measures with the CI532 slim modiolar electrode.

OBJECTIVES: To report on electrode array measurements for the Nucleus® CI532 Slim Modiolar Electrode device including: ECAP thresholds, electrode impedances, and psychophysical comfort levels, as well as speech perception results pre- and post-operatively and standardized evaluations of quality of life. METHODS: Forty-four subjects were implanted with the CI532. Electrically evoked compound action potential (ECAP) thresholds and impedances were measured using automatic Neural Response Telemetry intra-operatively, at activation and at six months post implant. Pre- and post-operative measures of words in quiet and sentences in noise were made in multiple languages. Quality of life was assessed using The Speech Spatial Qualities questionnaire (SSQ) and Glasgow Benefit Inventory (GBI). RESULTS: Intra-operative ECAP thresholds were recorded successfully from 90% of electrodes tested. ECAP thresholds varied across the array and a post-hoc Dunn's test showed that median thresholds for electrodes E1-E13 were significantly greater than those for E17-E22 (all P < 0.001). Impedances increased significantly between surgery and activation. Speech recognition scores for words in quiet and sentences in noise showed a significant improvement for the group at six months, when using the cochlear implant, compared with pre-operative performance (P < 0.001). There was a significant increase compared to pre-operative ratings for all sections of the SSQ at six months post activation (P < 0.001). The GBI gave scores significantly above zero for the 'general' subscale and total score. CONCLUSION: Objective ECAP and impedance measures for this new electrode array were as expected and similar to results reported for other array types. Speech perception and quality of life improved significantly following implantation. (Registered as NCT02392403 on ClinicalTrials.gov PRS).

Clinical investigation of the Nucleus Slim Modiolar Electrode.

AIMS: The Nucleus CI532 cochlear implant incorporates a new precurved electrode array, i.e., the Slim Modiolar electrode (SME), which is designed to bring electrode contacts close to the medial wall of the cochlea while avoiding trauma due to scalar dislocation or contact with the lateral wall during insertion. The primary aim of this prospective study was to determine the final position of the electrode array in clinical cases as evaluated using flat-panel volume computed tomography. METHODS: Forty-five adult candidates for unilateral cochlear implantation were recruited from 8 centers. Eleven surgeons attended a temporal bone workshop and received further training with a transparent plastic cochlear model just prior to the first surgery. Feedback on the surgical approach and use of the SME was collected via a questionnaire for each case. Computed tomography of the temporal bone was performed postoperatively using flat-panel digital volume tomography or cone beam systems. The primary measure was the final scalar position of the SME (completely in scala tympani or not). Secondly, medial-lateral position and insertion depth were evaluated. RESULTS: Forty-four subjects received a CI532. The SME was located completely in scala tympani for all subjects. Pure round window (44% of the cases), extended round window (22%), and inferior and/or anterior cochleostomy (34%) approaches were successful across surgeons and cases. The SME was generally positioned close to the modiolus. Overinsertion of the array past the first marker tended to push the basal contacts towards the lateral wall and served only to increase the insertion depth of the first electrode contact without increasing the insertion depth of the most apical electrode. Complications were limited to tip fold-overs encountered in 2 subjects; both were attributed to surgical error, with both reimplanted successfully. CONCLUSIONS: The new Nucleus CI532 cochlear implant with SME achieved the design goal of producing little or no trauma as indicated by consistent scala tympani placement. Surgeons should be carefully trained to use the new deployment method such that tip fold-overs and over insertion may be avoided.

Speech-in-noise perception in unilateral hearing loss: Relation to pure-tone thresholds and brainstem plasticity.

We investigated speech recognition in noise in subjects with mild to profound levels of unilateral hearing loss. Thirty-five adults were evaluated using an adaptive signal-to-noise ratio (SNR50) sentence recognition threshold test in three spatial configurations. The results revealed a significant correlation between pure-tone average audiometric thresholds in the poorer ear and SNR thresholds in the two conditions where speech and noise were spatially separated: dichotic - with speech presented to the poorer ear and reverse dichotic - with speech presented to the better ear. This first result suggested that standard pure-tone air-conduction thresholds can be a reliable predictor of speech recognition in noise for binaural conditions. However, a subgroup of 14 subjects was found to have poorer-than-expected speech recognition scores, especially in the reverse dichotic listening condition. In this subgroup 9 subjects had been diagnosed with vestibular schwannoma at stage III or IV likely affecting the lower brainstem function. These subjects showed SNR thresholds in the reverse dichotic condition on average 4dB poorer (higher) than for the other 21 normally-performing subjects. For the 7 of 9 subjects whose vestibular schwannoma was removed, the deficit was no longer apparent on average 5 months following the surgical procedure. These results suggest that following unilateral hearing loss the capacity to use monaural spectral information is supported by the lower brainstem.

Effect of corticosteroids on facial function after cerebellopontine angle tumor removal: a double-blind study versus placebo.

The aim of this study was to assess the effect of corticosteroids administered intra- and postoperatively on the occurrence of facial palsy after a cerebellopontine angle (CPA) tumor resection, and to investigate pre- and intraoperative prognostic factors. A multicenter, prospective, randomized, double-blind and versus-placebo study was conducted between 2006 and 2010. Three hundred and ten patients operated on for a CPA tumor (96% vestibular schwannomas, 4% miscellaneous) were included by five participating centers. The population was stratified into patients with small (≤15 mm CPA on axial MRI views) and large tumors. In each group, patients were randomized to receive corticosteroid (1 mg/kg/day i.v. methylprednisolone intraoperatively and at postoperative days 1-5) or placebo. Steroids did not affect the facial function at postoperative days 1, 8 and 30 in patients with small or large tumors as evaluated by House and Brackmann grading.

Improvement of cognitive function after cochlear implantation in elderly patients.

IMPORTANCE: The association between hearing impairment and cognitive decline has been established; however, the effect of cochlear implantation on cognition in profoundly deaf elderly patients is not known. OBJECTIVE: To analyze the relationship between cognitive function and hearing restoration with a cochlear implant in elderly patients. DESIGN, SETTING, AND PARTICIPANTS: Prospective longitudinal study performed in 10 tertiary referral centers between September 1, 2006, and June 30, 2009. The participants included 94 patients aged 65 to 85 years with profound, postlingual hearing loss who were evaluated before, 6 months after, and 12 months after cochlear implantation. INTERVENTIONS: Cochlear implantation and aural rehabilitation program. MAIN OUTCOMES AND MEASURES: Speech perception was measured using disyllabic word recognition tests in quiet and in noise settings. Cognitive function was assessed using a battery of 6 tests evaluating attention, memory, orientation, executive function, mental flexibility, and fluency (Mini-Mental State Examination, 5-word test, clock-drawing test, verbal fluency test, d2 test of attention, and Trail Making test parts A and B). Quality of life and depression were evaluated using the Nijmegen Cochlear Implant Questionnaire and the Geriatric Depression Scale-4. RESULTS: Cochlear implantation led to improvements in speech perception in quiet and in noise (at 6 months: in quiet, 42% score increase [95% CI, 35%-49%; P < .001]; in noise, at signal to noise ratio [SNR] +15 dB, 44% [95% CI, 36%-52%, P < .001], at SNR +10 dB, 37% [95% CI 30%-44%; P < .001], and at SNR +5 dB, 27% [95% CI, 20%-33%; P < .001]), quality of life, and Geriatric Depression Scale-4 scores (76% of patients gave responses indicating no depression at 12 months after implantation vs 59% before implantation; P = .02). Before cochlear implantation, 44% of the patients (40 of 91) had abnormal scores on 2 or 3 of 6 cognition tests. One year after implant, 81% of the subgroup (30 of 37) showed improved global cognitive function (no or 1 abnormal test score). Improved mean scores in all cognitive domains were observed as early as 6 months after cochlear implantation. Cognitive performance remained stable in the remaining 19% of the participants (7 of 37). Among patients with the best cognitive performance before implantation (ie, no or 1 abnormal cognitive test score), 24% (12 of 50) displayed a slight decline in cognitive performance. Multivariate analysis to examine the association between cognitive abilities before implantation and the variability in cochlear implant outcomes demonstrated a significant effect only between long-term memory and speech perception in noise at 12 months (SNR +15 dB, P = .01; SNR +10 dB, P < .001; and SNR +5 dB, P = .02). CONCLUSIONS AND RELEVANCE: Rehabilitation of hearing communication through cochlear implantation in elderly patients results in improvements in speech perception and cognitive abilities and positively influences their social activity and quality of life. Further research is needed to assess the long-term effect of cochlear implantation on cognitive decline.

Decisive criteria between stapedotomy and cochlear implantation in patients with far advanced otosclerosis.

OBJECTIVES: To describe the hearing outcomes in patients with far-advanced otosclerosis and to identify the best initial approach based on preoperative word recognition scores (WRS), pure tone averages (PTA), and radiological classification. STUDY DESIGN: Retrospective case review. SETTING: Academic neurotology tertiary referral center. PATIENTS: All patients (n = 58) with preoperative air conduction PTA less than 85 dB (HL), disyllabic WRS less than or equal to 50% at 60 dB (HL) with well-fitted hearing aids, and evidence of otosclerosis on CT scan, treated in our department over the past 20 years. INTERVENTIONS: Stapedotomy, cochlear implantation, or both. MAIN OUTCOME MEASURES: Postoperative WRS after a minimum of 12 months' follow-up, percentage of patients with WRS greater than 50%. Reliability of air and bone conduction PTAs and WRS in predicting failure of stapedotomy. RESULTS: Fifty-eight patients were divided into three groups: group I, primary stapedotomy (n = 32); group II, primary cochlear implantation (n = 9); and group III, secondary cochlear implantation (with a previous history of stapedotomy) (n = 25). The mean postoperative WRS were 50.6% (± 34), 75% (± 17), and 72% (± 20), respectively. Sixty percent of patients in the stapedotomy group had a postoperative WRS greater than 50% requiring no further treatment, compared to 85% for cochlear implant recipients. No specific predictive factors for stapedotomy outcome could be identified. Surgical difficulties during cochlear implantation were significantly higher in patients with advanced radiological stage. CONCLUSION: Although cochlear implantation gives better overall results, stapedotomy with hearing aids can still be very effective in the management of patients with far-advanced otosclerosis. It should therefore be proposed as a first-line treatment.

Reliability of cone beam computed tomography in scalar localization of the electrode array: a radio histological study.

Postoperative imaging plays a growing role in clinical studies concerning prognostic factors in cochlear implantation. Indeed, intracochlear position of the cochlear implant has recently been identified as a contributor in functional outcomes and radiological tools must be accurate enough to determine the final placement of the electrode array. The aim of our study was to validate cone beam computed tomography as a reliable technique for scalar localization of the electrode array. We performed therefore a temporal bone study on ten specimens that were implanted with a perimodiolar implant prototype. Cone beam reconstructions were performed and images were analyzed by two physicians both experienced in cochlear implant imaging, who determined the scalar localization of the implant. Temporal bones then underwent histological control to document this scalar localization and hypothetical intracochlear lesions. In four cases, a dislocation from scala tympani to scala vestibuli was suspected on cone beam reconstructions of the ascending part of the basal turn. In three of these four specimens, dislocation in pars ascendens was confirmed histologically. In the remaining temporal bone, histological analysis revealed an elevation with rupture of the basilar membrane. Histological assessment revealed spiral ligament tearing in another bone. We conclude that cone beam is a reliable tool to assess scalar localization of the selectrode array and may be used in future clinical studies.

Benefits from upgrade to the CP810 sound processor for Nucleus 24 cochlear implant recipients.

The objective of this study was to measure performance benefits obtained by upgrading recipients of the Cochlear Nucleus CI24 cochlear implant to the new CP810 sound processor. Speech recognition in quiet and in spatially separated noise was measured in established users of the Cochlear ESPrit 3G (n = 22) and Freedom (n = 13) sound processors, using the "Everyday" listening program. Subjects were then upgraded to the CP810 processor and were re-assessed after a 3-month period, using both the "Everyday" program and the new "Noise" program, which incorporates several pre-processing features including a new directional microphone algorithm ("Zoom"). Subjective perceptions were also recorded using the abbreviated profile of hearing aid benefit (APHAB) questionnaire. Mean scores for monosyllables in quiet, presented at 50 and 60 dB SPL, increased by 11% (p < 0.0001) and 8% (p < 0.001), respectively, after upgrade, for all subjects combined. Significant increases were also recorded for both processor groups. In noise, the mean scores were 60.0 and 67.4% for the original and CP810 Everyday programs, respectively (difference not significant). With the CP810 Noise programs the mean score increased to 82.5% (p < 0.01), with significant increases in both processor groups. There was evidence of slightly greater upgrade benefit in users of the ESPrit 3G processor and in relatively poor performers. The APHAB questionnaire also indicated significant reduction in perceived difficulty in the background noise and reverberation sub-scales after upgrade. The findings of the study appear to support the expectation of increased benefit from the new CP810 sound processor.

Very far-advanced otosclerosis: stapedotomy or cochlear implantation.

CONCLUSION: Every patient with severe or profound hearing loss must have a temporal bone high-resolution computed tomography (CT) scan. Stapedotomy is a simple, safe and low-cost procedure compared with cochlear implantation and can provide very good results. This can justify our decision to propose stapedotomy at the initial treatment in patients with very far-advanced otosclerosis. In cases of hearing failure after stapes surgery, cochlear implantation is an option. OBJECTIVE: This study aimed to find the best first intention treatment of very far-advanced otosclerosis. MATERIALS AND METHODS: This was a retrospective study and included 14 patients with non-measurable preoperative bone and air conduction thresholds and otosclerosis on temporal bone high-resolution CT scan. Stapes surgery followed by a well fitted hearing aid was the initial treatment in 11 patients and cochlear implantation in 7 patients, including 4 patients who had poor results after stapedotomy. Objective and subjective audiometric results were studied and compared between stapedotomy and cochlear implantation groups. RESULTS: Objective and subjective results were statistically better in the cochlear implant group than in the stapedotomy group. However, four patients in the stapedotomy group had comparable results to the patients with cochlear implants.