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Objective: To investigate the effect of day-case stapes surgery on hearing results, quality of life, patient satisfaction, and complications rates, compared with inpatient stapes surgery. Study Design: A single-center, nonblinded, randomized controlled trial in a tertiary referral center. Methods: One hundred twelve adult patients planned for primary or revision stapes surgery were randomly assigned to either the day-case or inpatient treatment group. The effect on hearing outcomes (primarily), hearing benefits, quality of life, patient satisfaction, postoperative complications, and causes of crossover or readmission (secondarily) were assessed using auditory evaluations, questionnaires, and patients' charts over a follow-up period of 1 year. Results: Audiometric measurements and postoperative success rates were not different between the inpatient and day-case group. There were no statistically significant differences between both groups regarding the overall quality of life (QoL) (HUI3), disease-specific QoL (GHSI), change in postoperative health status (GBI), and postoperative complications rate. We found a high patient satisfaction toward the day-case approach. Six patients allocated to the inpatient group requested same-day discharge. Of the day-case patients, there was a crossover rate to inpatient care of 38% (20 patients), mainly due to postoperative nausea and vomiting (25%), vertigo (20%), or dizziness (40%). Conclusion: We found no significant differences in outcomes of audiometric measurements, QoL, patient satisfaction and postoperative complications following day-case, and inpatient stapes surgery. Therefore, stapes surgery in a day-case setting seems to be a feasible approach in terms of postoperative outcome, safety, and desirability when taking patient selection and surgical planning into account. Besides this, the familiarity with a day-case approach of both patient and the surgical team, will increase the acceptance and feasibility of day-case stapes surgery.

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OBJECTIVES: To evaluate pure-tone audiometric results in otosclerosis patients undergoing revision stapes surgery following previous middle ear interventions. METHODS: A retrospective cohort study was performed in a tertiary referral center. Consecutive otosclerosis patients who underwent revision stapes surgeries, following previous middle ear interventions, for persistent conductive hearing loss, recurrent conductive hearing loss, or vertigo and had available postoperative pure-tone audiometry were included. Mean pre- and postoperative air conduction, bone conduction, and air-bone gap averaged over 0.5, 1, 2, and 3 kHz were obtained. Audiometric outcomes were obtained at 7 weeks postoperatively. RESULTS: In total, 63 consecutive otosclerosis patients who underwent 66 revision stapes surgeries were included. Air-bone gap improved significantly with a mean gain of 19 dB (95% CI, 15-22). Air conduction improved significantly with a mean gain of 18 dB (95% CI, 14-23). Bone conduction did not change significantly, with a mean deterioration of 0 dB (95% CI, -2 to 1). Air-bone gap closure to 10 dB or less was achieved in 38% of cases and to 20 dB or less in 80% of cases. Indication for surgery, previous type of procedure, primary cause of failure, and current surgical technique were not significantly associated with air-bone gap closure to 10 dB or less. Indication for surgery and primary cause of failure were associated with one another. CONCLUSIONS: Compared to the available literature, a slightly larger gain in air conduction and air-bone gap was achieved in our study. Air-bone gap closure to 10 dB or less was achieved less often in our study.

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OBJECTIVES/HYPOTHESIS: To investigate hearing capabilities and self-reported benefits of simultaneous bilateral cochlear implantation (BiCI) compared with unilateral cochlear implantation (UCI) after a 2-year follow-up and to evaluate the learning effect of cochlear implantees over time. STUDY DESIGN: Multicenter randomized controlled trial. METHODS: Thirty-eight postlingually deafened adults were included in this study and randomly allocated to either UCI or simultaneous BiCI. Our primary outcome was speech intelligibility in noise, with speech and noise coming from straight ahead (Utrecht-Sentence Test with Adaptive Randomized Roving levels). Secondary outcomes were speech intelligibility in noise with spatially separated sources, speech intelligibility in silence (Dutch phoneme test), localization capabilities and self-reported benefits assessed with different quality of hearing and quality of life (QoL) questionnaires. This article describes the results after 2 years of follow-up. RESULTS: We found comparable results for the UCI and simultaneous BiCI group, when speech and noise were both presented from straight ahead. Patients in the BiCI group performed significantly better than patients in the UCI group, when speech and noise came from different directions (P = .01). Furthermore, their localization capabilities were significantly better. These results were consistent with patients' self-reported hearing capabilities, but not with the questionnaires regarding QoL. We found no significant differences on any of the subjective and objective reported outcomes between the 1-year and 2-year follow-up. CONCLUSIONS: This study demonstrates important benefits of simultaneous BiCI compared with UCI that remain stable over time. Bilaterally implanted patients benefit significantly in difficult everyday listening situations such as when speech and noise come from different directions. Furthermore, bilaterally implanted patients are able to localize sounds, which is impossible for unilaterally implanted patients. LEVEL OF EVIDENCE: 1b Laryngoscope, 127:1161-1168, 2017.

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BACKGROUND: Otosclerosis is characterized by bony deposits in the otic capsule, resulting in stapes fixation and progressive hearing loss. It can be treated effectively by surgically removing (part of) the stapes and replacing it with a prosthesis. Increasingly, stapes surgery is performed as a day-case procedure. The major drive towards day-case surgery has been out of economic considerations. However, it is also increasingly an explicit patient request and leads to shorter waiting times for surgery, a reduced risk of infection and most likely positively influences the patient's quality of life as a result of rapid discharge and rehabilitation. Even though stapes surgery seems well suited to a day-case approach, given the low complication rates and early recovery, evidence is scarce and of low quality. METHODS AND DESIGN: A single-center unblinded randomized controlled trial was designed to (primarily) investigate the effect of hearing outcomes of day-case stapes surgery compared to inpatient stapes surgery and (secondarily) investigate the effect of both methods on quality of life, tinnitus, vertigo and cost-effectiveness. One hundred and twelve adult otosclerosis patients who are eligible for stapes surgery will be randomly assigned to either the day-case or inpatient treatment group. The primary and secondary outcome measures will be assessed using pure-tone audiometry (at approximately 2 months and 1 year follow-up), questionnaires (at 3 months and 1 year follow-up) and costs diaries (weekly the first month after which once a month until 1 year follow-up). DISCUSSION/CONCLUSION: This trial allows for a comparison between day-case and inpatient stapes surgery to investigate the hypothesis that day-case stapes surgery is associated with a higher quality of life and higher cost-effectiveness, while maintaining equal hearing results, compared to inpatient stapes surgery. TRIAL REGISTRATION: Netherlands Trial Register (www.trialregister.nl): NTR4133, registration date 21(st) August 2013.

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IMPORTANCE: The cost of bilateral cochlear implantation (BCI) is usually not reimbursed by insurance companies because of a lack of well-designed studies reporting the benefits of a second cochlear implant. OBJECTIVE: To determine the benefits of simultaneous BCI compared with unilateral cochlear implantation (UCI) in adults with postlingual deafness. DESIGN, SETTING, AND PARTICIPANTS: A multicenter randomized clinical trial was performed. The study took place in 5 Dutch tertiary referral centers: the University Medical Centers of Utrecht, Maastricht, Groningen, Leiden, and Nijmegen. Forty patients eligible for cochlear implantation met the study criteria and were included from January 12, 2010, through November 2, 2012. The main inclusion criteria were postlingual onset of hearing loss, age of 18 to 70 years, duration of hearing loss of less than 20 years, and a marginal hearing aid benefit. Two participants withdrew from the study before implantation. Nineteen participants were randomized to undergo UCI and 19 to undergo BCI. INTERVENTIONS: The BCI group received 2 cochlear implants during 1 surgery. The UCI group received 1 cochlear implant. MAIN OUTCOMES AND MEASURES: The primary outcome was the Utrecht Sentence Test with Adaptive Randomized Roving levels (speech in noise, both presented from straight ahead). Secondary outcomes were consonant-vowel-consonant words in silence, speech-intelligibility test with spatially separated sources (speech in noise from different directions), sound localization, and quality of hearing questionnaires. Before any data were collected, the hypothesis was that the BCI group would perform better on the objective and subjective tests that concerned speech intelligibility in noise and spatial hearing. RESULTS: Thirty-eight patients were included in the study. Fifteen patients in the BCI group used hearing aids before implantation compared with 19 in the UCI group. Otherwise, there were no significant differences between the groups' baseline characteristics. At 1-year follow-up, there were no significant differences between groups on the Utrecht Sentence Test with Adaptive Randomized Roving levels (9.1 dB, UCI group; 8.2 dB, BCI group; P = .39) or the consonant-vowel-consonant test (median percentage correct score 85.0% in the UCI group and 86.8% in the BCI group; P = .21). The BCI group performed significantly better than the UCI group when noise came from different directions (median speech reception threshold in noise, 14.4 dB, BCI group; 5.6 dB, BCI group; P <.001). The BCI group was better able to localize sounds (median correct score of 50.0% at 60°, UCI group; 96.7%, BCI group; P <.001). These results were consistent with the patients' self-reported hearing capabilities. CONCLUSIONS AND RELEVANCE: This randomized clinical trial demonstrates a significant benefit of simultaneous BCI above UCI in daily listening situations for adults with postlingual deafness. TRIAL REGISTRATION: trialregister.nl Identifier: NTR1722.

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OBJECTIVES/HYPOTHESIS: To determine the effect of cochlear implantation on tinnitus perception in patients with severe bilateral postlingual sensorineural hearing loss and to demonstrate possible differences between unilateral and bilateral cochlear implantation. STUDY DESIGN: Prospective study. METHODS: Thirty-eight adult patients were included in this prospective study, as part of a multicenter randomized controlled trial investigating the benefits of bilateral cochlear implantation versus unilateral cochlear implantation. Pre- and postoperative tinnitus perception scores were evaluated, before and 1 year after implantation on three tinnitus questionnaires; the Tinnitus Handicap Inventory (THI), the Tinnitus Questionnaire (TQ), and a visual analogue scale for tinnitus burden. RESULTS: Before implantation, the tinnitus prevalence was 42.1% (16 of 38) in the whole study group. One year after implantation, the tinnitus questionnaire scores had decreased in 71.4% according to the TQ and 80.0% according to the THI. Tinnitus was induced after cochlear implantation in six patients, five in the bilateral and one in the unilateral group. CONCLUSIONS: Our study shows that cochlear implantation is effective in the reduction of tinnitus in patients with bilateral sensorineural hearing loss who suffered from preoperative tinnitus. Conversely, tinnitus may also increase or even be induced by the cochlear implantation itself. Cochlear implant candidates should be well informed about these possible consequences before undergoing surgery. LEVEL OF EVIDENCE: 2b.

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OBJECTIVE: To assess hearing results and complications following primary stapedotomy in otosclerosis patients, comparing different laser types. DATA SOURCES: Pubmed, Embase, The Cochrane Library, CINAHL, and Scopus. STUDY SELECTION: A systematic bibliographic search was conducted to identify all original articles, comparing hearing outcome between different lasers used for fenestration in stapedotomy. DATA EXTRACTION: Directness of evidence and risk of bias of the selected articles were assessed. Studies with low or moderate directness of evidence, or high risk of bias, were not further analyzed. DATA SYNTHESIS: The absolute risks, risk differences, and 95% confidence intervals were extracted only for the studies with high directness of evidence and moderate to low risk of bias. CONCLUSION: A total of 383 unique articles were retrieved. Four studies provided direct evidence, whereas all studies carried moderate to high risk of bias. After exclusion of the studies that did not provide direct evidence and/or carried high risk of bias, 2 studies were considered eligible for data extraction. This best available evidence shows a slightly better air-bone gap closure for CO2 laser compared to potassium titanyl phosphate laser, but the clinical relevance is unclear. The risk difference of 28.1% [95% confidence interval, 22.8, 33.4] between CO2 and erbium yttrium aluminium garnet favors CO2 laser. Unfortunately, this current best available evidence is insufficient to draw any definitive conclusions on which laser to use for fenestration in stapedotomy.

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OBJECTIVES/HYPOTHESIS: To assess hearing results and complications following primary stapedotomy in otosclerosis patients comparing the use of laser and conventional techniques for fenestration. STUDY DESIGN: Systematic literature review. METHODS: A systematic bibliographic search was conducted in PubMed, Embase, the Cochrane Library, Cumulative Index to Nursing and Allied Health Literature, and Scopus. Studies reporting original data on the effect of laser fenestration, compared to conventional techniques, on closure of air-bone gap in patients undergoing primary stapedotomy were included. Directness of evidence and risk of bias of the selected articles were assessed. Studies with low directness of evidence, high risk of bias, or both were not further analyzed. The absolute risks, risk differences, and 95% confidence intervals were extracted only for studies with moderate to high directness of evidence and moderate to low risk of bias. RESULTS: In total, 383 unique studies were retrieved. Eight of these (including 999 procedures) provided high or moderate directness of evidence and carried a moderate risk of bias, and were considered eligible for data extraction. The included studies show no consistent difference in postoperative air-bone gap closure or immediate postoperative vertigo. CONCLUSIONS: Both footplate fractures and sensorineural hearing loss appear to occur more frequently in the conventional group than in the laser group. Therefore, we prefer laser above conventional methods for footplate fenestration in primary stapedotomy. LEVEL OF EVIDENCE: NA.

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OBJECTIVE: To evaluate the effectiveness of primary stapes surgery with and without a vein graft in patients with otosclerosis and to determine the differences in the postoperative gain in air-bone gap (ABG) and air-conduction (AC). STUDY DESIGN: A nonrandomized multicenter clinical evaluation. SETTING: Two tertiary referral centers in The Netherlands and France. PATIENTS: Otosclerosis patients that underwent primary stapedotomy surgery. INTERVENTION: Primary stapedotomy surgery without a vein graft (n = 939, first center) compared with primary stapedotomy surgery with a vein graft (n = 3691, second center). MAIN OUTCOME MEASURES: Preoperative and postoperative audiometric results were compared. An analysis of variance was performed to evaluate differences in postoperative ABG and AC gains between surgeries with and without a vein graft, adjusted for potential confounders. RESULTS: The postoperative ABG was 10 dB or lesser in 72.1% of the patients without a vein graft and in 93.2% of patients with a vein graft. After adjustments for differences at baseline, the mean gain in ABG was 18.6 dB (95% CI, 18.1-19.1) in the group without vein graft, compared with 24.2 dB (95% CI, 23.9-24.6) in the group with vein graft (mean difference, 5.6 dB; 95% CI, 5.0-6.2). The mean gain in AC was 19.5 dB (95% CI, 18.7-20.3) in the group without vein graft, compared with 24.3 dB (95% CI, 23.7-24.7) in the group with vein graft (mean difference, 4.8 dB; 95% CI, 3.8-5.7). CONCLUSION: Patients with otosclerosis undergoing primary stapes surgery may benefit more from a vein graft interposition. LEVEL OF EVIDENCE: 2B.

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OBJECTIVES/HYPOTHESIS: An increasing number of patients with low-frequency residual hearing are fitted with a cochlear implant. The challenge is to optimize cochlear implant device properties and develop atraumatic surgical techniques to preserve residual hearing. In view of the ongoing debate about the optimal procedure for opening the cochlea during cochlear implantation, we reviewed the evidence on the round window and the cochleostomy insertion techniques and compared their effects on postoperative residual hearing. DESIGN: Systematic review. METHODS: Electronic databases were systematically searched for relevant studies published up to January 2012. All studies reporting on residual hearing and hearing preservation surgery were included. RESULTS: Sixteen studies, with a total of 170 patients, were included. There were no studies directly comparing both surgical insertion techniques. The methodologic quality of the studies was poor and might be subjected to a high risk of bias. Because there were no studies directly comparing the 2 techniques and controlling for possible influencing factors, differences between studies might also be influenced by intersurgeon variance in many facets regarding cochlear implantation surgery. The available data show a postoperative low-frequency hearing loss ranging from 10 to 30 dB at 125, 250, and 500 Hz, regardless of surgical technique. The number of patients with a postoperative complete hearing preservation ranged from 0% to 40% for the cochleostomy group and from 13% to 59% in the round window group. CONCLUSION: The available data do not show that there is a benefit of one surgical approach over the other regarding the preservation of residual hearing. To provide solid evidence, a double-blind randomized trial is needed, which compares the clinical outcomes, notably the degree of hearing preservation, of both surgical approaches.

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OBJECTIVE: Vestibular symptoms are seen variably in patients with otosclerosis, both in patients with the disease and in patients after treatment with stapes surgery. The goal of this study was to objectify any changes of the bone-conducted (BC) ocular vestibular evoked myogenic potentials (oVEMPs) in patients with otosclerosis before and after stapes surgery. STUDY DESIGN: Twenty-six healthy subjects and 27 patients with otosclerosis were tested in a tertiary care center, and 11 of the patients were tested preoperatively and postoperatively. The ears of patients were divided in 4 groups: normal ears, otosclerotic ears, ears after primary stapes surgery, and ears after revision surgery. The stimulus used in oVEMP testing was a BC stimulus delivered by a mini-shaker at stimulus frequencies of 250 and 500 Hz. oVEMP characteristics were the n1 and p1 latencies, n1 - p1 amplitude, and threshold. RESULTS: No significant differences were seen in all oVEMP characteristics between the 4 groups of ears without surgery nor in the ears that were tested preoperatively and postoperatively. CONCLUSION: No or undetectably little damage to the utricle is caused by both otosclerotic disease and stapes surgery. There is no additive value of screening with BC oVEMPs perioperatively in otosclerotic patients.

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OBJECTIVES: To evaluate the audiometric results of primary stapes surgery in patients with otosclerosis and to determine predictors of a postoperative air-bone gap (ABG) of 10 dB or less and a postoperative gain in air conduction (AC) exceeding 20 dB. DESIGN: Retrospective cohort study. SETTING: Tertiary referral center in Utrecht, the Netherlands. PATIENTS: Nine hundred thirty-nine patients with otosclerosis who underwent primary stapes surgery between January 1, 1982, and March 1, 2009. INTERVENTION: Primary stapes surgery. MAIN OUTCOME MEASURES: Preoperative and postoperative audiometric results were compared. Logistic regression analyses were performed to evaluate which factors (ie, sex, age at surgery, bilateral otosclerosis, and preoperative 4-frequency [0.5, 1, 2, and 4 kHz] ABG, AC, or bone conduction) independently contributed to the prediction of a postoperative ABG of 10 dB or less and a postoperative gain in AC exceeding 20 dB. RESULTS: A total of 72.1% of patients had a postoperative ABG of 10 dB or less, and 93.8% of patients had a postoperative ABG of 20 dB or less. Age at surgery and preoperative ABG and AC were independent prognostic determinants. A patient older than 40 years with a preoperative ABG of 30 dB or less has a 77.6% chance of achieving a postoperative ABG of 10 dB or less. A patient with a preoperative AC exceeding 50 dB and a preoperative ABG exceeding 30 dB has an 86.2% chance of achieving a postoperative gain in AC exceeding 20 dB. CONCLUSIONS: Following primary stapes surgery, a postoperative ABG of 10 dB or less and a postoperative gain in AC exceeding 20 dB may be predicted with accuracies of 62.1% and 80.1%, respectively. Clinicians can use this information to inform patients more explicitly about expected postoperative audiometric results.

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OBJECTIVES/HYPOTHESIS: The preservation of residual hearing has become a high priority in cochlear implant surgery. This study was designed to substantiate whether conservation of residual hearing can be preserved after cochlear implantation using the suprameatal approach. STUDY DESIGN: Retrospective chart review. METHODS: Retrospective chart review was performed in 109 severely to profoundly hearing impaired cochlear recipients who had some measurable hearing preoperatively. Subsequently, the pre- and postoperative pure-tone thresholds were analyzed by three different analyses to observe the degree of hearing preservation. RESULTS: Single-subject results showed a complete conservation of residual hearing (change in pure-tone average [ΔPTA] ≤ 10 dB) in 27 of 109 patients (24.7%). Partial conservation of residual hearing (ΔPTA > 10 dB) was observed in 77 patients (70.6%), but these percentages have been affected severely by ceiling effects. Furthermore, group-subject results demonstrated that the median postoperative PTA was 11.7 dB worse than the preoperative PTA. For individual frequencies, the median deteriorations were 15, 20, 10, and 5 dB at 250, 500, 1,000, and 2,000 Hz, respectively. Stratification for the absence of postoperative hearing thresholds showed a conservation of measurable postoperative hearing levels in 17.4% of all study patients. CONCLUSIONS: The results of this study demonstrate that complete preservation of residual hearing is possible in a limited number of patients using the suprameatal approach technique for cochlear implantation. For a reliable analysis of the audiometric effects of cochlear implant surgery, it is important to take into account the ceiling effects, therefore using different calculation methods to estimate the accurate deterioration of hearing thresholds.

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OBJECTIVE: To report on surgical complications arising postoperatively in 104 patients undergoing cochlear implantation surgery using the suprameatal approach (SMA). Second, to examine the advantages and disadvantages of the SMA technique compared with the classic mastoidectomy using the posterior tympanotomy approach. STUDY DESIGN: Retrospective study assessing surgical complications in deaf adults and children undergoing cochlear implantation. SETTING: Tertiary referral center for cochlear implantation (Academic Medical Centre). PATIENTS: The mean age at the time of surgery was 39.6 years (1.0-82.3 yr), and the mean duration of deafness was 26.3 years (0.3-66.0 yr). The main cause was a congenital hearing loss (30.8%) and a progressive sensorineural hearing loss e.c.i. (25.0%), followed by meningitis (12.5%) and otosclerosis (6.7%). The mean duration of follow-up after surgery was 25.7 months (range, 3.0-59.0 mo). RESULTS: The overall major complication rate was 3.7% (4 of 107). All complications developed postoperatively. The major complications consisted of extrusion of the implant due to wound infection (n = 2), a wrong route for the electrode (n = 1), and device failure (n = 1). The minor complication rate was 23.4% (25 of 107). The mean time taken for cochlear implantation was 111.7 minutes (range, 60.0-261.1 min). CONCLUSION: This study confirms the SMA is a safe, simple, and quick technique that is feasible for cochlear implantation in most cases. Although the stretching of the electrode array when it enters the scala tympani and a low-lying dura could present a potential restriction for the SMA technique, our results do not support this hypothesis.

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OBJECTIVES/HYPOTHESIS: Our study was designed to compare two surgical approaches that are currently employed in cochlear implantation. METHODS: There were 315 patients who were divided into two groups according to the surgical technique used for implantation. The suprameatal approach (SMA) was followed for 104 patients (107 implantations) in Amsterdam, whereas the mastoidectomy with posterior tympanotomy approach (MPTA) was adhered to for 211 (214 implantations) in Maastricht. The outcome variables of interest were duration of surgery and peri- or postoperative complications. RESULTS: In the SMA group the incidence of major and minor complications was 3.7% (4/107) and 23.4% (25/107), respectively, whereas it was 6.5% (14/214) and 22.4% (48/214), respectively, in the MPTA group. A chi-square statistic of 1.096 (P = .295) and 0.021 (P = .884) for minor and major complications, respectively, indicated no statistically significant differences between the two techniques. Mean duration of surgery was significantly shorter (P < .0005) in the SMA (111.7 minutes) than in the MPTA (132.2 minutes) group. CONCLUSIONS: The suprameatal approach is clearly a good alternative to the classical surgery technique for cochlear implantation.

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The history of vascularization of the human cochlea began with the first anatomical description of the cochlea in the 16th century. Three different periods are recognizable in the development of knowledge concerning this subject: the macroscopic period, with the description of the structure of the cochlea from the 16th to the 19th century; the microscopic period, with the description of the part of the organ of Corti in the 19th century; and the injection period, with the description of the fine vascularization of the cochlea in the 20th century. Various techniques were used during these three periods, which will be presented here, using only original references. This historical study reveals the ingenuity of the researchers in using different aspects of technological progress to enhance their performance in research.

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