Otology & Neurotology

Density of Macrophages Immunostained With Anti-Iba1 Antibody in the Vestibular Endorgans After Cochlear Implantation in the Human Hypothesis: Cochlear implantation may result in an increase in the density of macrophages in vestibular endorgans in the human. Background: Vestibular symptoms are a common complication of cochlear implantation. In a previous study, we demonstrated histological evidence of a foreign-body response caused by silicon and platinum in the human cochlea following cochlear implantation. The objective of the current study was to seek evidence of a possible immune response in vestibular endorgans after cochlear implantation. Methods: The density of macrophages immunostained with anti-Iba1 antibody in the vestibular endorgans (lateral and posterior semicircular canals, utricle and saccule) in 10 human subjects who had undergone unilateral cochlear implantation was studied by light microscopy. The densities of macrophages in the neuroepithelium, subepithelial stroma, and among dendritic processes in the mid-stromal zone in four vestibular endorgans in the implanted and the opposite unimplanted ears were compared. The distributions of macrophage morphology (amoeboid, transitional and ramified) were also compared. Results: The densities of macrophages in implanted ears in four vestibular endorgans were significantly greater than that in opposite unimplanted ears except in the subepithelial zone of the utricle and posterior semicircular canal. In contrast to the neuroepithelium, the subepithelial distribution of amoeboid macrophages in implanted ears was significantly less than in unimplanted ears. Conclusion: An increase in the density of macrophages in four vestibular endorgans after implantation was demonstrated. The transition among phenotype of macrophages suggested possible migration of amoeboid macrophages from the subepithelial stroma into the neuroepithelium. Address correspondence and reprint requests to Joseph B. Nadol Jr, M.D., Department of Otolaryngology, Massachusetts Eye and Ear Infirmary, 243 Charles Street, Boston, MA 02114; E-mail: joseph_nadol@meei.harvard.edu This work was supported by grants #U24-DC013983 and R01-DC000152-34 from the National Institute of Deafness and Other Communication Disorders (NIDCD). The authors disclose no conflicts of interest. Copyright © 2019 by Otology & Neurotology, Inc. Image copyright © 2010 Wolters Kluwer Health/Anatomical Chart Company

Vestibular Schwannoma Tumor Size Is Associated With Acute Vestibular Symptoms After Gamma Knife Therapy Objective: To assess how pretreatment vestibular schwannoma (VS) tumor characteristics are associated with vestibular symptoms after gamma knife (GK) surgery. Study Design: Retrospective chart review of patients undergoing GK treatment for VS at our institution from 2005 to 2018. Setting: Academic tertiary referral center. Patients: Patients receiving primary GK surgery for vestibular schwannomas with at least 6 months of follow up. Patients with neurofibromatosis 2 or previous surgery were excluded. Main Outcome Measures: The presence of posttreatment vestibular symptoms within 6 months after GK. Clinical records were assessed for pretreatment tumor, patient, and treatment characteristics that impacted posttreatment symptoms. Results: All patients received radiation doses between 12 and 13 Gy. Of 115 patients, the average age was 60. Thirty-seven (32%) patients developed vestibular symptoms within 6 months post-GK, and 18 patients were referred for vestibular rehabilitation. Ten of 13 patients undergoing vestibular rehabilitation reported improvement. Overall, 112 patients had tumor measurements. Pretreatment tumors were significantly smaller for patients with acute vestibular symptoms (mean 1.43 cm versus 1.71 cm, p = 0.007). On multivariate analysis, smaller tumor size (p = 0.009, odds ratio [OR] = 0.29, 95% confidence interval [CI] [0.12–0.73]) was significantly associated with vestibular symptoms within 6 months of GK. Patients with tumors less than 1.6 cm were more likely to receive referrals for vestibular rehabilitation within 6 months posttreatment (25% versus 9.4%, p = 0.026, OR = 3.22, 95% CI [1.00, 11.32]). Conclusions: Smaller vestibular schwannomas were significantly associated with higher rates of post-GK vestibular symptoms. Pretreatment tumor size may be used to counsel patients on the likelihood of post-GK vestibular symptoms and vestibular rehabilitation. Address correspondence and reprint requests to Michael J. Ruckenstein, M.D., M.Sc., Department of Otorhinolaryngology, 3400 Civic Center Blvd, South Pavilion 3rd Floor, Philadelphia, PA 19104; E-mail: michael.ruckenstein@uphs.upenn.edu This work was not funded. Disclosures: J.A.B. is the owner of MobileOptx, LLC and was a consultant for TympBio. M.A.B. received honoraria from Varian. There are no conflicts of interest. Copyright © 2019 by Otology & Neurotology, Inc. Image copyright © 2010 Wolters Kluwer Health/Anatomical Chart Company

Hearing and Quality of Life Over Time in Vestibular Schwannoma Patients: Observation Compared to Stereotactic Radiosurgery Objective: To examine quality of life changes for patients with vestibular schwannoma (VS) undergoing observation or stereotactic radiosurgery (SRS). Study Design: Retrospective review. Setting: Academic medical center. Patients: Patients with VS who underwent observation or SRS and had at least two audiograms and Penn Acoustic Neuroma Quality of Life (PANQOL) surveys, a quality of life survey for patients with VS. Interventions: SRS or observation. Main Outcome Measures: Pure-tone average (PTA), speech discrimination score (SDS), PANQOL score; controlling for tumor size, baseline hearing, and other factors. Results: One hundred twenty-three patients met inclusion criteria: 89 underwent observation and 34 SRS. There was no significant difference in the rate of decline measured by PTA (PTA worsened at a rate of 0.25 dB/yr more in the observation group compared with the SRS group, p = 0.77) and SDS (SDS worsened at a rate of 2.1%/yr more in the SRS group compared with the observation group, p = 0.82). Kaplan–Meier analysis demonstrated the SRS group had a higher probability to progress to class D hearing over observation (hazard ratio 7.1, p = 0.005). The rate of change of the SRS PANQOL scores was significantly improved in the total (p = 0.005) and hearing (p = 0.04) domain score compared with observation. However, both groups regress to a similar PANQOL total and hearing domain score over time. Conclusion: PANQOL scores were higher at baseline in the observation group than in the SRS group. However, over time, PANQOL scores in the observation group decreased while PANQOL scores in the SRS group increased, resulting in PANQOL scores that were equivalent by the end of follow-up. Address correspondence and reprint requests to Lauren E. Miller, M.D., M.B.A., Massachusetts Eye and Ear Infirmary, Harvard Medical School, 243 Charles Street, Boston, MA 02114; E-mail: Lauren_miller@meei.harvard.edu The Institutional Review Board at the Hospital of the University of Pennsylvania approved this study (Protocol 814830). The authors disclose no conflicts of interest. Copyright © 2019 by Otology & Neurotology, Inc. Image copyright © 2010 Wolters Kluwer Health/Anatomical Chart Company

Incidence and Risk of Various Disorders of the External Ear in Patients With Hearing Aids Treated in ENT Practices in Germany Objective: The aim of the study was to investigate the relationship between the presence of a hearing aid (HA) and the occurrence of various disorders of the external ear, using data from ear, nose, and throat (ENT) practices in Germany from a nationwide, representative practice database. Methods: In the period between 2012 and 2016, the incidences of disorders of the external ear (ICD-10 groups H60 and H61) in patients with HA prescriptions were compared retrospectively with a control group without HA prescriptions (1:1 matching). Results: A total of 20,127 patients with HA prescriptions were compared with 20,127 controls. The highest 12-month incidences (HA vs. controls) were determined for "Impacted cerumen" (H61.2) (16.5% vs. 4.2%), "Unspecified otitis externa" (H60.9) (2.6% vs. 1.2%) and "Acute noninfective otitis externa" (H60.5) (2.3% vs. 0.7%). The most significant risk increases for HA wearers were found for "Abscess of external ear" (H60.0, OR 10.03), "Other otitis externa" (H60.8, OR 6.00), and "Impacted cerumen" (H61.2, OR 4.55). A smaller risk increase was found for "Cholesteatoma of external ear" (H60.4, OR 2.26), among others. Conclusion: In HA wearers, the risk of developing almost all of the diagnoses reviewed is significantly increased, especially for external auditory canal (EAC) furuncle, chronic otitis externa, and impacted cerumen. This study provides the first epidemiological evidence for HA as a risk factor for the rare EAC cholesteatoma. Address correspondence and reprint requests to Karel Kostev, Ph.D., D.M.Sc., Epidemiology IQVIA, Unterschweinstiege 2-14, 60549 Frankfurt am Main, Germany; E-mail: kkostev@de.imshealth.com Compliance with ethical guidelines: Under certain conditions, German law permits the use of anonymized electronic medical data for research purposes. According to this legislation, this type of observational study without identifiable patient data does not require consent or an ethics committee vote. The authors did not have access to identifiable patient data at any time during the study. There are no conflicts of interest. Copyright © 2019 by Otology & Neurotology, Inc. Image copyright © 2010 Wolters Kluwer Health/Anatomical Chart Company

The Influence of Metabolic Syndrome on the Prognosis of Idiopathic Sudden Sensorineural Hearing Loss Objectives: We aimed to verify the hypothesis that metabolic syndrome (MetS) and its components affect the prognosis of idiopathic sudden sensorineural hearing loss (ISNNHL). Study Design: A retrospective cohort study. Setting: Tertiary otology referral center. Patients: We divided patients who were diagnosed with ISSNHL between January 2015 and January 2018 into a MetS group and a Non-MetS group according to the diagnostic criteria of MetS. Interventions: We diagnosed ISSNHL patients by using pure-tone audiometry and treated them with oral steroids, blood flow promoting agents, and hyperbaric oxygen therapy. Main Outcome Measures: We used multivariate logistic analysis to identify prognostic factors of ISSNHL. Results: The MetS group comprised 94 patients, and the Non-MetS group comprised 162 subjects. Despite the rate of hypertension, diabetes mellitus, hyperlipidemia, and BMI, no significant difference was observed between the two groups (p > 0.05). The rates of complete recovery and partial recovery of the MetS group were significantly lower than those of the Non-MetS group (p < 0.05). According to the multivariate analysis, MetS was significantly correlated with a poor prognosis (OR = 2.912, p = 0.008), and the OR increased with an increase in the number of MetS components. Late onset of treatment, high initial hearing threshold, and presence of diabetes mellitus and hyperlipidemia were associated with a poor prognosis (p < 0.05). Conclusions: The presence of MetS may negatively affect the recovery of Chinese patients with ISSNHL, and the prognosis was poorer with an increase in the number of MetS components. Early onset of treatment, low initial hearing threshold and absence of diabetes mellitus, and hyperlipidemia are associated with favorable hearing recovery. Address correspondence and reprint requests to Hong Sun, M.D., Ph.D., Department of Otolaryngology Head and Neck Surgery, Xiangya Hospital of Central South University, Xiangya Road 87, Changsha 410008, Hunan, China; E-mail: shjhaj@126.com Data collection: Q.J. and S.X. Data analysis and draft writing: Y.Z. Technical and material support: X.W. and Y.F. Study design and supervision: H.S. Research was funded by the National Key Basic Research Program of China (No. 2014CB943003), Natural Science Foundation of Hunan Province (No. 2018JJ3842), and the Fundamental Research Funds for the Central Universities of Central South University (No. 2017zzts236). The authors disclose no conflicts of interest. Copyright © 2019 by Otology & Neurotology, Inc. Image copyright © 2010 Wolters Kluwer Health/Anatomical Chart Company

Speech Perception Growth Patterns in Prelingual Deaf Children With Bilateral Sequential Cochlear Implantation Objective: To evaluate speech perception following the first (CI-1) and second (CI-2) cochlear implantation (CI) in children with sequential bilateral CI. Study Design: Retrospective. Patients: Seventy children with follow-up for 60 months post CI-1 and 36 months post CI-2. Main Outcome Measures: Word recognition score (WRS) was the main outcome. WRSs were compared by age at CI operation (group A ≤ 3.5 yr, B 3.6–8.6, for CI-1; group I ≤ 3.5 yr, II 3.6–7.0, III 7.1–13, IV > 13, for CI-2). Results: For CI-1, the WRS of group A exceeded 80% at 24 months post procedure, earlier than group B (54 mo). Group A also had a shorter period of CI-1 use up to the WRS plateau than group B. CI-2 showed an initial burst of WRS growth much earlier than CI-1. This initial burst was most robust within 3 months in group II, but modest in group IV. The periods of CI-2 use (11–17 mo) up to the WRS plateau were much shorter than CI-1 (40–64 mo). Group I did not show the best WRS at 1 month post CI but later exceeded the other groups. Conclusion: Children received an immediate benefit by a burst of WRS growth from CI-2 earlier than CI-1, even within 3 months, suggesting that CI-1 gets the auditory cortex ready to foster speech processing from CI-2. The CI-2 performance depends on age at CI-2 implantation and on CI-1 performance. Our current findings will be relevant for clinicians who are counselling parents on CI-2 surgery. Address correspondence and reprint requests to Hong Ju Park, M.D., Ph.D., Department of Otorhinolaryngology-Head and Neck Surgery, Asan Medical Center, University of Ulsan College of Medicine, 88 Olympic-ro 43-gil, Songpa-gu, Seoul 05505, Republic of Korea; E-mail: dzness@hotmail.com The authors disclose no conflicts of interest. Copyright © 2019 by Otology & Neurotology, Inc. Image copyright © 2010 Wolters Kluwer Health/Anatomical Chart Company

Long-term outcomes of bone conduction hearing implants in patients with bilateral microtia-atresia Objectives: To evaluate the long-term outcomes of three different types of bone conduction hearing implants (BCHI)—BAHA, Ponto, and Bonebridge—in Mandarin-speaking patients with bilateral microtia-atresia. Methods: This cohort study enrolled 59 patients affected by bilateral microtia-atresia, with an upper bone conduction threshold limit of 30 dB HL at frequencies of 0.5 to 4 kHz. All subjects underwent unilateral BCHI surgery, including 26 (18 males, 8 females, of mean age 8.7 ± 1.9 yr) implanted with BAHA devices; 10 (7 males, 3 females, of mean age 11.7 ± 2.8 yr) implanted with Ponto devices; and 23 (14 males, 9 females, of mean age 9.0 ± 1.8 yr) implanted with Bonebridge devices. The main outcome measures included long-term audiological benefits, patient satisfaction, and complications. Each subject acted as his or her own control. Results: Two years after BCHI surgery, the mean hearing thresholds in the BAHA, Ponto, and Bonebridge groups had improved to 22.6 ± 1.6 dB HL, 21.6 ± 1.2 dB HL, and 22.5 ± 1.5 dB HL, respectively. The mean percentages of subjects in these three groups recognizing speech at 65 dB SPL under quiet conditions were 97.7 ± 4.2%, 96.3 ± 1.1%, and 94.4 ± 9.4%, respectively, whereas the mean percentages recognizing speech under noise conditions (signal:noise ratio +5) were 87.0 ± 1.8%, 89.3 ± 9.3%, and 85.3 ± 4.7%, respectively. Questionnaires revealed patients' benefits and satisfaction with this surgery. Three (11.5%) of 26 patients in the BAHA group and 1 (10%) of 10 in the Ponto group experienced skin irritation, but all recovered after local treatment. Five (19.2%) patients in the BAHA group and two (20%) in the Ponto experienced abutment extrusion about 6 months postoperatively, with all achieving good results after revision surgery to replace the abutment. One (3.8%) patient in the BAHA group experienced local chronic inflammation and underwent surgery to replace the BAHA with a Bonebridge implant. One (4.3%) patient in the Bonebridge group developed a local infection 3 months postoperatively and underwent implant removal. Conclusions: All three BCHIs were well tolerated after long-term follow-up, and all improved audiometric thresholds and the intelligibility of speech in the presence of both quiet and noise. These implants should be considered valid and safe options for the functional rehabilitation of patients with bilateral microtia-atresia. Address correspondence and reprint requests to Xiaowei Chen, M.D., Department of Otolaryngology, Peking Union Medical College Hospital, #1 shuaifuyuan, Beijing 100730, China; E-mail: chenxw_pumch@163.com This work was supported by grant to X.C. from the General Programs of National Natural Science Foundation of China (81271053) and The National Key Research and Development Program of China (2016YFC0901501). The authors have received no payment in the preparation of this manuscript. The authors alone are responsible for the content and writing of this article. X.C. acted as head surgeon for the BCHIs performed in this study and collected data. X.F. analyzed data, composed the manuscript, and participated in some of the operations as an assistant. T.Y., X.N., Y.W., and Y.F. participated in some of the operations as assistants, and collected and analyzed data. All authors read and approved the final manuscript. The authors disclose no conflicts of interest. Supplemental digital content is available for this article. Direct URL citations appear in the printed text and are provided in the HTML and PDF versions of this article on the journal's Website (http://journals.lww.com/otology-neurotology). This is an open access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND), where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal. http://creativecommons.org/licenses/by-nc-nd/4.0 Copyright © 2019 by Otology & Neurotology, Inc. Image copyright © 2010 Wolters Kluwer Health/Anatomical Chart Company

Anatomical Correlates and Surgical Considerations for Localized Therapeutic Hypothermia Application in Cochlear Implantation Surgery Hypothesis: Application of localized, mild therapeutic hypothermia during cochlear implantation (CI) surgery is feasible for residual hearing preservation. Background: CI surgery often results in a loss of residual hearing. In preclinical studies, local application of controlled, mild therapeutic hypothermia has shown promising results as a hearing preservation strategy. This study investigated a suitable surgical approach to deliver local hypothermia in patients utilizing anatomical and radiologic measurements and experimental measurements from cadaveric human temporal bones. Methods: Ten human cadaveric temporal bones were scanned with micro-computed tomography and anatomical features and measurements predicting round window (RW) visibility were characterized. For each bone, the standard facial recess and myringotomy approaches for delivery of hypothermia were developed. The St. Thomas Hospital (STH) classification was used to record degree of RW visibility with and without placement of custom hypothermia probe. Therapeutic hypothermia was delivered through both approaches and temperatures recorded at the RW, RW niche, over the lateral semicircular canal and the supero-lateral mastoid edge. Results: The average facial recess area was 13.87 ± 5.52 mm2. The introduction of the cooling probe through either approach did not impede visualization of the RW or cochleostomy as determined by STH grading. The average temperatures at RW using the FR approach reduced by 4.57 ± 1.68 °C for RW, while using the myringotomy approach reduced by 4.11 ± 0.98 °C for RW. Conclusion: Local application of therapeutic hypothermia is clinically feasible both through the facial recess and myringotomy approaches without limiting optimal surgical visualization. Address correspondence and reprint requests to Suhrud M. Rajguru, Ph.D., University of Miami Ear Institute, 1095 NW 14 Terrance, Lois Pope Life Center, Room 4-25, Miami, Florida 33134; E-mail: s.rajguru@miami.edu E.P. and A.V.E. have equal contribution. This work was supported by a Research Grant from Cochlear, R01 DC01379801A1 and a pilot award from National Center For Advancing Translational Sciences of the National Institutes of Health under Award Number UL1TR002736, Miami Clinical and Translational Science Institute. S.M.R. and C.K. are named inventors on intellectual property related to the design of hypothermia system and probe discussed here. The authors declare no competing financial interests related to the findings presented. This is an open access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND), where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal. http://creativecommons.org/licenses/by-nc-nd/4.0 Copyright © 2019 by Otology & Neurotology, Inc. Image copyright © 2010 Wolters Kluwer Health/Anatomical Chart Company

Evaluation of the Effect of Diclofenac Sodium and 5-Fluourasil in a 3D Cholesteatoma Cell Culture Model Introduction: Middle ear cholesteatoma is a benign disease with invasive and destructive clinical behaviors. It increases the rate of both chronic otitis media complications and revision surgeries. The most effective treatment of middle ear cholesteatoma is surgical excision, and there is no medical treatment for this disease. Exploring new medical treatment options may help to create treatment alternatives instead of surgery. Materials and Methods: Required cholesteatoma tissues for cell culture were excised from 4 different participants who underwent surgery in our clinic and agreed to give tissue for the study. Cholesteatoma-derived keratinocytes and fibroblasts were cocultured in temperature-sensitive culture dishes to make a three-dimensional (3D) cholesteatoma model. Then, the effects of 1% and 2% diclofenac sodium on viability and cell proliferation rates were examined using WST-1 and annexin-V tests. Results: Cell viability and proliferation rates were found to be lower and apoptosis rates were higher in the diclofenac sodium group versus the negative and positive control groups. Conclusion: In this present study, we described a new 3D cholesteatoma cell culture model developed using cell sheet technology and demonstrated the efficacy of diclofenac sodium on cholesteatoma for the first time in the literature. It may be used in patients with chronic otitis media with cholesteatoma, but further studies investigating ototoxic and neurotoxic effects of this molecule are needed. Address correspondence and reprint requests to Ahmet Kara, Sakarya University Training and Research Hospital, 54000 Korucuk, Sakarya, Turkey. E-mail: doktor.kbb@hotmail.com Funding: This study has been funded by Turkey Scientific and Technological Research Center (project number: 216S961) (TUBITAK). Date of presentation at scientific meeting: AAO-HNSF Annual Meeting & OTO Experience, 7–10.10.2018. The research protocol was approved by the Kocaeli University Animal Ethics Committee (KU GOKAEK 2013). The authors report no conflicts of interest Copyright © 2019 by Otology & Neurotology, Inc. Image copyright © 2010 Wolters Kluwer Health/Anatomical Chart Company

Hearing Preservation With the Use of Flex20 and Flex24 Electrodes in Patients With Partial Deafness Objective: To evaluate the impact of electrode length on hearing preservation (HP) in Partial Deafness Treatment–Electrical Complement (PDT-EC) subjects. Study Design: Retrospective case review. Setting: Tertiary referral center. Patients: Twenty-three PDT-EC patients (with preoperative air-conduction thresholds ≤30 dB up to 500 Hz) were divided into two groups: Flex20 electrode (Med-EL GmbH, Innsbruck, Austria) (12 patients) and Flex24 electrode (Med-EL GmbH, Innsbruck, Austria) (11 patients). Interventions: All participants were subjected to minimally invasive cochlear implantation using the round window approach. Main Outcome Measure(s): Pure tone audiometry (125–8000 Hz) was performed preoperatively and at 1, 6, 12, and 24 months postoperatively. HP was established using the HEARRING group formula. Speech understanding was assessed preoperatively and at 12 and 24 months postoperatively. Results: Analysis of HP for every individual indicates that more than half the patients with Flex20 and Flex24 had complete HP at 6 months follow-up. None of the patients from either group had complete loss of hearing. At activation, average air-conduction thresholds for low frequencies (125–500 Hz) were slightly better for the short electrode (M = 29.03) than for the long (M = 39.10) but the difference was not statistically significant (p = 0.067). The effect of electrode (Flex20 versus Flex24) was not significant in terms of pure tone audiometry and speech recognition at long-term follow-up. Conclusions: In the early postoperative period, complete HP was possible in a majority of patients from both groups, but slightly better HP outcomes were achieved by Flex20. In the long term, the length of the electrodes does not affect the degree of HP or speech understanding. Address correspondence and reprint requests to Piotr H. Skarzynski, Ph.D., M.D., M.S., Mokra 17 Street, 05-830 Kajetany, Poland; E-mail: p.skarzynski@ifps.org.pl No other benefits were received. The authors disclose no conflicts of interest. Supplemental digital content is available in the text. Supplemental digital content is available for this article. Direct URL citations appear in the printed text and are provided in the HTML and PDF versions of this article on the journal's Website (http://journals.lww.com/otology-neurotology). This is an open access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND), where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal. http://creativecommons.org/licenses/by-nc-nd/4.0 Copyright © 2019 by Otology & Neurotology, Inc. Image copyright © 2010 Wolters Kluwer Health/Anatomical Chart Company

Alexandros Sfakianakis
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alsfakia@gmail.com