Otology & Neurotology

Preclinical Validation of a Novel Device Designed to Reduce Biofilms on Percutaneous Osseointegrated Abutments Aim: To assess the efficacy of a prototype cleaning device in removing biofilm from skin-penetrating abutments. Background: Adverse skin reactions around percutaneous osseointegrated implants have been linked to poor hygiene and infection. A cleaning device made from open-cell polyfoam has been developed to facilitate manual cleaning of abutments by the patient. Methods: Serratia biofilm was grown on clean and sterile conical bone-anchored hearing system abutments including both pre-2007 (straight sided) and post-2007 (conical-sided) designs. Eighteen were photographed and then subjected to cleaning using a toothbrush or the cleaning device soaked in water or a proprietary mouthwash. Biofilm on a further group of 10 conical abutments was recorded using a scanning electron microscope before and after cleaning with the test device soaked in water. Quantitative analysis of the efficiency of the cleaning was made using image analysis. Results: Removal of biofilm using a dry or wet toothbrush was not as effective as cleaning with the device. In 10 cases subjected to image analysis, approximately 90% of the biofilm was removed from the top third of the abutments, 85% from the middle third, and 48% from the basal third. Conclusion: The cleaning device is effective in removing most biofilm from the test abutments and represents a significant improvement in comparison with traditional methods such as a toothbrush. Address correspondence and reprint requests to Rachel Sammons, Ph.D., School of Dentistry, University of Birmingham, 5, Mill Pool Way, Birmingham B5 7EG, UK; E-mail: r.l.sammons@bham.ac.uk This study was funded by Sapere Systems Ltd. UK. The authors disclose no conflicts of interest. Copyright © 2019 by Otology & Neurotology, Inc. Image copyright © 2010 Wolters Kluwer Health/Anatomical Chart Company

Histopathology of Inner Ear Malformations: Potential Pitfalls for Cochlear Implantation Hypothesis: The presence of bony inner ear malformations may associate with a number of anatomical abnormalities affecting the middle ear structures. Those malformations may create pitfalls and complications for cochlear implantation. Background: Inner ear malformations associate with varying degrees of hearing loss, and frequently require cochlear implantation for hearing rehabilitation. Therefore, the abnormalities affecting the middle- and inner-ear structures may increase the risk of surgical complications. Methods: We examined 38 human temporal bones from donors with bony inner ear malformations. Using light microscopy, we analyzed the presence of abnormalities in the structures of the middle- and inner-ear. Results: Our collection comprises of 38 specimens with inner-ear malformations (cochlear aplasia, n = 3; cochlear hypoplasia, n = 30; incomplete partition, n = 3; isolated vestibular malformation, n = 2). The anatomy of the middle ear was abnormal in most temporal bones with cochlear aplasia, cochlear hypoplasia, and incomplete partition type I (40%–100%). Some of those abnormalities (hypoplastic or obliterated mastoid, 55.2%; aplastic or obliterated round window, 71.0%; aberrant course of the facial nerve, 36.8%) may hinder the access to the round window using the conventional facial recess approach for cochlear implantation. The cochlear nerve and associated bony structures (internal auditory canal and bony canal for cochlear nerve) were normal in 71.0% of all temporal bones with inner ear malformations. Conclusion: Each different type of malformation may create specific surgical challenges to surgeons. Comprehensive preoperative imaging is fundamental toward the surgical success of cochlear implants in patients with malformations. Alternatives to circumvent those middle- and inner-ear abnormalities and potential complications are further discussed. Address correspondence and reprint requests to Rafael da Costa Monsanto, M.D., Ph.D., Department of Otolaryngology, Head and Neck Surgery – University of Minnesota, Lions Research Building, Room 210 – 2001 6th St. SE, Minneapolis, MN 55455, U.S.A. E-mail: rafaelmonsanto@hotmail.com The content is solely the responsibility of the authors and does not necessarily represent the official views of the funding agencies. R.d.C.M. received a scholarship from the "Coordenação de Aperfeiçoamento de Pessoal de Nível Superior – Brasil (CAPES)" (Finance Code 001). The research reported in this publication was supported by the National Institute of Neurological Disorders and Stroke of the NIH (UG3NS107688), the International Hearing Foundation, the 5 M Lions International, the Starkey Foundation, and the "Coordenação de Aperfeiçoamento de Pessoal de Nível Superior – Brasil. (CAPES). The authors disclose no conflicts of interest. Copyright © 2019 by Otology & Neurotology, Inc. Image copyright © 2010 Wolters Kluwer Health/Anatomical Chart Company

Osteonecrosis of the External Auditory Canal Associated With Oral Sorafenib Therapy: Sorafenib and Temporal Bone Osteonecrosis Objective: To present the first case of osteonecrosis of the external auditory canal associated with sorafenib treatment. Patient: 58-year-old patient with right-sided otorrhea and otalgia was treated for otitis externa for 1 month without improvement. Otoscopic examination revealed a large defect in the inferior wall of the tympanic bone filled with skin debris and bony fragments. Previous medical history included treatment with sorafenib for metastatic renal cell cancer; he had never been exposed to radiotherapy. Computed tomography of the temporal bone showed a large right external auditory canal bony erosion with involvement of the tympanic bone and bony sequestra extending to the mastoid cells and temporomandibular joint. Histologic examination revealed necrotic bone and inflammatory changes with no signs of malignancy. A diagnosis of osteonecrosis of external auditory canal was made. Intervention: Right subtotal petrosectomy with obliteration of surgical cavity with abdominal fat was performed. Results: Final histological report revealed avascular necrosis of the bone with perivascular lymphocitic infiltration of the soft tissues. Diagnosis of medication-related external auditory canal osteonecrosis was confirmed. Conclusion: Medication-related osteonecrosis of the temporal bone is not a well-known entity among otolaryngologists and could therefore be misclassified as another diagnosis. In patients with othorrea and earache following sorafenib treatment, temporal bone osteonecrosis should be suspected. Address correspondence and reprint requests to Dr. Federica Canzano, M.D., University Hospital of Parma, Parma, Italy; E-mail: Federica.canzano@gmail.com The authors disclose no conflicts of interest. Copyright © 2019 by Otology & Neurotology, Inc. Image copyright © 2010 Wolters Kluwer Health/Anatomical Chart Company

Effect of Vestibular Exercises Associated With Repositioning Maneuvers in Patients With Benign Paroxysmal Positional Vertigo: A Randomized Controlled Clinical Trial In addition to positional vertigo, it is quite common for patients with benign paroxysmal positional vertigo (BPPV) to present complaints associated with balance problems and a feeling of dizziness even after repositioning maneuvers. Objective: It was to evaluate the additional effects of vestibular rehabilitation exercises as a therapeutic resource in the treatment of BPPV, to improve symptoms and reduce recurrence. Study Design: This was an experimental, prospective, randomized, controlled study. Setting: Instituto Brasiliense de Otorrinolaringologia (IBORL) from August 2016 to September 2017. Patients: Thirty-two individuals, both men and women, over 18 years of age with BPPV. Intervention: They were randomly assigned to two groups: the control group (n = 15) performing only the maneuver technique as treatment and the experimental group (n = 17) performing the maneuvers and vestibular rehabilitation exercises. Patients underwent treatment and responded to the dizziness handicap inventory (DHI) and visual analog scale (VAS) questionnaires for comparison between groups. Participants were followed up for 6 months to observe recurrence of symptoms. Main Outcome Measures: To investigate the additional effects of vestibular exercises in the treatment of BPPV. Results: The experimental group had a lower level of dizziness in the posttreatment period (p < 0.05) and a lower incidence of recurrences (p = 0.038) than the control group. Conclusions: Vestibular exercises performed after repositioning treatments for BPPV increased the overall efficacy of treatment by improving symptoms with a lower rate of recurrence. Address correspondence and reprint requests to Fayez Bahmad, Jr, M.D., Ph.D., Setor Médico Hospitalar Norte Quadra 02, Bloco C, Ed. Dr. Crispim, Sala 515 - Asa Norte, Brasília - DF, 70710-149, Brazil; E-mail: fayezbjr@gmail.com There are no conflicts of interest. Copyright © 2019 by Otology & Neurotology, Inc. Image copyright © 2010 Wolters Kluwer Health/Anatomical Chart Company

Speech Perception Outcomes in Transcutaneous Versus Percutaneous Bone Conduction Stimulation in Individuals With Single-Sided Deafness Objective(s): To investigate the differences in percutaneous versus passive transcutaneous bone-conduction stimulation in individuals with single-sided deafness. Study Design: Prospective, single-subject. Setting: Tertiary academic referral center. Patients: Adult bone-anchored implant listeners with single-sided deafness using a percutaneous implant system. Interventions: Experienced percutaneous bone anchored implant recipients were tested in the percutaneous and transcutaneous conditions using a BAHA 5 (Cochlear Corp., Cochlear Bone-Anchored Solutions, Mölnlycke, Sweden) sound processor on the patient's own abutment and on a softband. Main Outcome Measures: Phoneme recognition was assessed using Consonant-Nucleus-Consonant (CNC) words for soft (47 dB SPL) and average (62 dB SPL) speech inputs. Speech perception in noise performance was also assessed for soft (47 dB SPL) and average (62 dB SPL) speech inputs using sentences presented in multi-talker babble. Aided free-field thresholds were obtained in both conditions using warble tone stimuli. Results: Compared with percutaneous bone-conduction stimulation, transcutaneous stimulation demonstrated reduced effective gain for high frequency stimulation. Transcutaneous stimulation required higher signal to noise ratios to achieve comparable performance to the percutaneous condition. Phoneme recognition was poorer in transcutaneous versus percutaneous stimulation with the most significant impact observed for soft speech inputs. Conclusion: A significant performance gap in speech recognition is observed between percutaneous and transcutaneous bone-conduction stimulation in individuals with single-sided deafness at the same signal to noise ratios. Compared with percutaneous bone-conduction stimulation, transcutaneous stimulation demonstrated reduced effective gain, decreased phoneme recognition, word recognition, and performance in noise, with the most significant impact observed for soft speech inputs. Address correspondence and reprint requests to Hillary A. Snapp, Au.D., Ph.D., 1120 NW 14th Street, 5th Floor, Miami, FL 33136; E-mail: hsnapp@med.miami.edu This research was presented in part at the 6th International Congress on Bone Conduction Hearing and Related Technologies, May 2017, Nijmegen, The Netherlands. The authors disclose no conflicts of interest. Copyright © 2019 by Otology & Neurotology, Inc. Image copyright © 2010 Wolters Kluwer Health/Anatomical Chart Company

Outcomes of Primary Pediatric Stapedotomy Objective: To review a single institution experience with pediatric stapedotomy for juvenile otosclerosis (JO), congenital stapes footplate fixation (CSFF), or tympanosclerosis. Study Design: Retrospective chart review. Setting: Tertiary referral center. Patients: Pediatric patients undergoing surgery for stapes fixation from 2001 to 2017. Main Outcome Measures: Hearing result based on preoperative, first postoperative, and final postoperative pure-tone average air-bone gap (PTA-ABG). Age, sex, diagnosis, procedure performed, prosthesis, and ossicular anomalies were considered. Results: A total of 59 children (4–16 years of age) underwent surgery for stapes fixation (67 ears), with an average postoperative audiogram out to 2.88 years. Final postoperative ABG for tympanosclerosis (30.4 dB ± 10.9 dB) showed some improvement but the outcome was significantly worse than in CSFF (21.0 dB ± 11.4 dB) (p = 0.020) and JO (22.8 dB ± 14.9 dB). Conclusion: Our data suggest, that in our clinic, surgery for stapes fixation is safe to perform in children. While we achieved desirable results for JO and CSFF, patients with tympanosclerosis showed a statistically worse hearing outcome. Tympanosclerosis deserves special consideration and may be better served with a malleovestibulopexy, total ossicular replacement prosthesis (TORP), or amplification in lieu of traditional stapes surgery. Address correspondence and reprint requests to Joshua Cody Page, M.D., Department of Otolaryngology–Head and Neck Surgery, University of Arkansas for Medical Sciences, 4301 W. Markham #543, Little Rock, AR 72205; E-mail: jcpage@uams.edu Funding is not received for this work. The authors disclose no conflicts of interest. Copyright © 2019 by Otology & Neurotology, Inc. Image copyright © 2010 Wolters Kluwer Health/Anatomical Chart Company

Management of Traumatic Injury and Osseointegration Failure in Children With Percutaneous Bone Conduction Implants Objective: This study examines the incidence and management of traumatic loss or osseointegration failure of percutaneous bone conduction implants in children. Study Design: Case series. Setting: Pediatric tertiary care institution. Patients: Children who underwent percutaneous osseointegrated implant placement from 1996 to 2016. Interventions: Clinical evaluation and revision surgery after implant loss. Main Outcome Measures: This study compares the characteristics of children who experienced traumatic loss of implant to those who did not to calculate odds ratios (ORs) describing the risk of injury and investigate device utilization after implant failure. Results: One hundred forty-seven children received percutaneous bone conduction devices; 129 were followed for at least 1 year. Trauma occurred in 19 of 129 cases (15%). Among children with traumatic injury, mean age at initial surgery was 5 years (SD = ±3.3), and 42% had a developmental delay. Among children without traumatic injury, mean age at initial surgery was 6.5 years (SD = ±4.4), and 28% had a developmental delay. Multivariate logistic regression found no significant differences in age, sex, or developmental delay associated with implant loss. In five of 19 traumatic cases (26%), the implant remained in situ due to either skull fracture or abutment loss. In the remaining 14 of 19 cases (74%), there was osseointegration failure with extrusion of the implant. Seventeen children underwent revision surgery utilizing previously placed "sleeper," or backup, osseointegrated implant, and 14 (82%) of these continued to use their device. Two patients with extruded implants did not undergo revision surgery. Conclusion: Traumatic injury or osseointegration failure leads to loss of percutaneous bone conduction implants in approximately 15% of children. Revision surgery is often successful. Address correspondence and reprint requests to Patricia L. Purcell, M.D., M.P.H., Department of Otolaryngology, Head & Neck Surgery, 555 University Avenue, 6th floor Burton Wing, Toronto, ON M5G1X8, Canada; E-mail: patricia.purcell@sickkids.ca Financial Disclosures: S.L.C., B.C.P., and K.A.G. hold sponsored research agreements with Cochlear Americas. B.C.P. and K.A.G. receive speaking fees from Cochlear Americas. S.L.C. receives speaking fees for Interacoustics. S.L.C. earns royalties from the book, Balance Disorders in the Pediatric Population. S.L.C. and B.C.P. are Patent Holders for Patents #: 7041-0: Systems and Methods for Balance Stabilization. Copyright © 2019 by Otology & Neurotology, Inc. Image copyright © 2010 Wolters Kluwer Health/Anatomical Chart Company

Physical and Emotional Burden of the Epley Maneuver in the Elderly Objective: To analyze and compare experiences of anxiety and discomfort caused by the Epley maneuver and the willingness for a potential retreatment between younger (≤70 yr) and older (>70 yr) patients. Study Design: Prospective, observational cohort study. Setting: Tertiary referral center. Methods: Dutch adults, diagnosed with posterior canal benign paroxysmal positional vertigo, were included. Patients with dementia or subjected to an Epley maneuver ≤4 months before the hospital visit were excluded. Patients were asked about their experiences with the Epley maneuver directly after the maneuver, after 2 weeks and after 2 months. Differences in experiences between the age groups were tested with the Fisher's exact test and subgroup analyses were performed using multivariable logistic regression. Results: Out of 179 included patients, 115 (64%) were aged ≤70 and 134 (75%) were female. In both groups, 25% reported anxiety directly after the Epley maneuver. Two weeks later, 19 and 27%, respectively (p = 0.26) reported anxiety. In the young group, 30% expressed discomfort directly after treatment compared with 45% in the elderly (OR 1.98, 95% CI 1.05–3.75, p = 0.04). Two weeks later, this was 36 and 38%, respectively (p = 0.87). This decreased to 24 and 33%, respectively (p = 0.37), after 2 months. There was no significant difference in willingness for potential retreatment between both groups after 2 weeks (93 and 95%, respectively, p = 0.75) nor after 2 months (97 and 92%, respectively, p = 0.13). Conclusion: The Epley maneuver results in little anxiety and discomfort both in young and in elderly patients. Most patients show willingness for potential retreatment in case symptoms recur. Address correspondence and reprint requests to Britta D.P.J. Maas, M.D., Apeldoorn Dizziness Centre, Gelre Hospital, Albert Schweitzerlaan 31, 7334 DZ, Apeldoorn, the Netherlands; E-mail: b.maas@gelre.nl This work was supported solely from institutional and/or departmental sources from the Apeldoorn Dizziness Centre, Gelre Hospital, Apeldoorn. The authors disclose no conflicts of interest. Copyright © 2019 by Otology & Neurotology, Inc. Image copyright © 2010 Wolters Kluwer Health/Anatomical Chart Company

Meta-analysis of Delayed Facial Palsy Following Middle Ear Surgery Objective: Delayed facial palsy has been reported following various types of otologic surgery. However, the exact characteristics of this disease have not been fully elucidated because of its low incidence. This study analyzed case series studies on delayed facial palsy to increase the sample size and outline credible disease characteristics. Data Sources: PubMed, Embase, and Cochrane Library databases were searched on October 10, 2018. Study Selection: Delayed facial palsy case series covered in English in which the intervention was typical tympanoplasty, mastoidectomy, stapedectomy, or cochlear implantation including a statement of sample size. Data Extraction: Evaluated according to the Joanna Briggs Institute Critical Appraisal Checklist for Case Series. Data Synthesis: Fourteen case series studies were included. Incidence rate, onset time, prognosis were evaluated with meta-analysis. Etiology and treatment were discussed with systematic review. Conclusions: The overall incidence rate of delayed facial palsy after middle ear surgery was 0.65%; however, it differed depending on the type of surgery. The mean onset time of facial palsy was 8.47 ± 3.98 days after surgery, and 95.3% of the patients completely recovered. The disease seems to have multiple etiologies. Facial palsy occurring 2 to 20 days after surgery is suggested to be considered delayed facial palsy. Address correspondence and reprint requests to Jinsei Jung, M.D., Ph.D., Department of Otorhinolaryngology, Yonsei University College of Medicine, 50 Yonsei-ro, Seodaemun-gu, Seoul 120-752, Republic of Korea; E-mail: jsjung@yuhs.ac 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 (www.jcraniofacialsurgery.com). Copyright © 2019 by Otology & Neurotology, Inc. Image copyright © 2010 Wolters Kluwer Health/Anatomical Chart Company

A Transcutaneous Active Middle Ear Implant (AMEI) in Children and Adolescents: Long-term, Multicenter Results Objective: Evaluation of the long-term safety and performance of an active middle ear implant (AMEI) in the treatment of hearing loss in children and adolescents with a primary focus on improvement in speech discrimination. Study Design: Prospective, multicentric, single-subject repeated-measures design in which each subject serves as his or her own control. Subjects: Thirty-one pediatric subjects aged 5 to 17 years. Intervention: Implantation of an active middle ear implant. Methods: Improvement in word recognition scores, speech reception thresholds (SRT) in quiet and noise, in addition to air conduction, bone conduction, and sound field thresholds were evaluated in two age groups. Results: Residual hearing did not change over time and speech intelligibility significantly improved and remained stable after 36 months. Children aged 5 to 9 improved in WRS from 21.92 to 95.38% and in SRT in quiet and in noise respectively from 62.45 dB SPL (sound pressure level) and +1.14 dB SNR to 42.07 dB SPL and −4.45 dB SNR. Adolescents aged 10 to 17 improved in WRS from 12.78 to 84.71% and in SRT in quiet and in noise respectively from 63.96 dB SPL and +3.32 dB SNR to 35.31 dB SPL and −4.55 dB SNR. Conclusions: The AMEI, under investigation, is a safe treatment for children and adolescents, and significantly improved audiological performance that remains stable on the long-term scale (up to 36 mo postimplantation). In general, all adult-related issues and questions regarding safety and performance can also be applied to the pediatric population, as no apparent specific issues developed. Address correspondence and reprint requests to John-Martin Hempel, Priv.-Doz. Dr. med., Clinic and Policlinic for ENT Treatment, Ludwig-Maximilians-University (LMU) Clinic Grosshadern, Marchioninistr. 15, 81377 München, Germany; E-mail: John-Martin.Hempel@med.uni-muenchen.de MED-EL, Innsbruck, Austria, initiated, organized, and monitored this study and gave support for statistical analysis and manuscript preparation. There was no external financial funding for this project (National Institutes of Health [NIH], Wellcome Trust, Howard Hughes Medical Institute [HHMI], or others). None of the authors has any financial interest (consultancies, stock ownership, or other equity interests, patent licensing arrangements, or payments for conducting or publicizing a study) in the used and mentioned products or companies. The authors disclose no conflicts of interest. Copyright © 2019 by Otology & Neurotology, Inc. Image copyright © 2010 Wolters Kluwer Health/Anatomical Chart Company

Alexandros Sfakianakis
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