Auditory brainstem implants: an analysis of adverse events in the MAUDE database.

OBJECTIVE: Auditory Brainstem Implants (ABI) are used to restore hearing in patients lacking appropriate cochlear anatomy and/or cochlear nerve. The objective of this study was to examine the Manufacture and User Facility Device Experience (MAUDE) database to analyze adverse events. STUDY DESIGN: This is a study of a multi-institutional database maintained by the US FDA. SETTING: A database analysis was performed via collaboration of multiple clinicians at tertiary referral centers. METHODS: The MAUDE database was queried for Medical Device Reports (MDRs) relating to ABIs. MDRs were identified using the advanced search term "Implant, Auditory Brainstem" and reviewing all reports with the basic search term "Brainstem Implant". All collected reports were individually reviewed. RESULTS: A total of 265 individual patient reports were reviewed, of which 55 reports met inclusion criteria. Reports regarding audiologic outcome included failure to provide hearing benefit (n = 27), implant failure/device malfunction (n = 10), and device non-use (n = 6). Postoperative complications included local skin infection (n = 3), CSF leak (n = 3), elevated ICP (n = 1), surgical site dehiscence (n = 1), swelling (n = 1), seroma formation requiring drainage (n = 1), and meningitis (n = 2). Two patients had dislodged magnets during 1.5 Tesla MRI acquisition. There were 35 instances of full explantation of the device and 1 partial removal; 13 patients had a new device implanted following explantation. CONCLUSIONS: Poor hearing results, device failure, and non-use were commonly reported causes for explanation in this analysis. This information can aid physicians in counseling patients and family members and managing device expectations.

Diagnosis and management of facial nerve palsy secondary to granulomatosis with polyangiitis - A systematic review.

OBJECTIVE: Granulomatosis with polyangiitis is associated with otolaryngologic complaints in 70-95 % of cases, with the most common being serous otitis media. In rare cases, patients may experience facial nerve palsy in conjunction with otologic or nasal symptoms; and, often, initially present to an otolaryngologist. It is important for healthcare professionals to be able to recognize the nuisances of facial nerve palsy as a potential presentation of granulomatosis with polyangiitis. STUDY DESIGN: Systematic review. METHODS: Following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) Protocol, PubMed and MED-LINE Databases were queried for articles published from January 2007 to December 2022 describing facial nerve palsy in the context of Granulomatosis with polyangiitis, formerly known as Wegener's Granulomatosis. The keywords included "facial nerve palsy", "facial palsy", "granulomatosis with polyangiitis", "Wegener's granulomatosis", "ANCA positive" in the title/abstract. All full-text articles available in English were screened, including single case presentations. Abstracts, commentaries, and publications deemed outside the scope of our study aims were excluded from review. After removal of duplicate articles, a total of 85 articles were screened. After applying inclusion and exclusion criteria, 14 articles were included in the review. RESULTS: There were a total of 28 reports of facial nerve palsy in the literature in patients who were eventually diagnosed with granulomatosis with polyangiitis. The patients' ages ranged from 14 to 68 years old. None of the patients had been previously diagnosed with GPA, and a majority of them presented initially with other otologic symptoms. Hearing loss was reported in 24 patients (86 %), otalgia was present in 11 patients (39 %), and otorrhea was present in 6 patients (21 %). Bilateral facial paralysis was reported in 10 patients in the literature (36 %). In total, 16 patients underwent surgery for facial paralysis: 6 tympanomastoidectomies, 4 mastoidectomies, 2 explorative tympanotomies. Surgery was generally considered ineffective in resolving facial weakness. All patients ended up receiving some combination of steroids and immunosuppressant, most commonly prednisolone and cyclophosphamide or rituximab, which was eventually transitioned to azathioprine for maintenance. Unlike auditory thresholds, which remained decreased in two patients, all patients recovered facial function following appropriate medical treatment of their vasculitis. CONCLUSIONS: Facial nerve paralysis in patients with granulomatosis with polyangiitis is a rare but treatable phenomenon. In patients with intractable otitis media, unresolving facial palsy, or a combination of otologic issues, it is important to consider GPA as a possible source. The prognosis for facial function appears to be excellent in patients who undergo appropriate treatment for vasculitis, but further studies are needed for confirmation.

Eustachian Tube Balloon Dilation: A Comprehensive Analysis of Adverse Events.

BACKGROUND: Eustachian tube balloon dilation (ETBD) has been Food and Drug Administration (FDA) approved for refractory Eustachian tube dysfunction since 2016. While ETBD is generally seen as safe, the complication profile has not been well defined. OBJECTIVE: The objective of this study was to utilize the FDA manufacturer and user facility device experience (MAUDE) database to better assess adverse events (AE) related to ETBD. METHODS: This is a study of a multiinstitutional database maintained by the U.S. FDA. A database analysis was performed via the collaboration of multiple clinicians at tertiary referral centers. The FDA MAUDE database was queried for all medical device reports (MDR) related to ETBD devices from January 2012 to November 2022. Eighty-eight unique MDR were identified, 16 of which met inclusion criteria. RESULTS: Three MDRs were classified as device-related (18.8%); none resulted in an AE. Thirteen MDRs (81.3%) were patient-related; all were classified as AEs. The most common AE was postoperative subcutaneous emphysema (n = 6, 46.2%). Of the patients with subcutaneous emphysema, there was a wide range of severity. The most severe AE (n = 1, 6.3%) was postoperative stroke secondary to carotid artery dissection. CONCLUSION: Though ETBD is generally seen as a safe procedure, there have been several concerning AEs reported to date. Increased awareness of ETBD complications can serve as a primer for improved patient education and counseling during the informed consent process and aid surgeons in clinical decision-making. Future studies with standardized reporting protocols are warranted to create a central registry for ETBD.

Otologic use of porcine small intestinal submucosal graft (biodesign): A MAUDE database review.

OBJECTIVE: To review and summarize reported adverse events related to the use of porcine small intestine submucosal grafts (Biodesign™) in otologic procedures. STUDY DESIGN: Retrospective cross-sectional analysis. SETTING: Food and Drug Administration's Manufacturer and User Facility Device Experience (MAUDE) database. MATERIAL AND METHODS: The MAUDE database was queried for all medical device reports (MDR) related to otologic use of Biodesign™ (Cook Medical, Bloomington, IN) from January 2016 to November 2022. Adverse events (AEs) were identified by reviewing all reports with the basic search term "Biodesign" and "Biodesign, Otologic". Reports were individually reviewed and categorized with special attention to AEs. RESULTS: A total of 500 reports were reviewed. Since FDA approval of Biodesign™ in 2016, there have been 5 adverse events reported for use of Biodesign™ during otologic surgery (tympanoplasty, n = 3; stapes surgery, n = 2). All reported events described patient injury, and all cases required at least one revision surgery. Four cases described significant foreign body inflammatory reactions. Complications included hearing loss (n = 3), severe otalgia (n = 2), persistent perforation (n = 2), vertigo (n = 2), and facial paralysis (n = 1). CONCLUSION: The use of porcine small intestinal submucosal graft has been thought to be a safe and effective option for otologic surgery, with the advantage of availability without graft harvest in minimally invasive endoscopic surgery. However, foreign body or granulomatous reactions have been documented and should be considered prior to its use in otologic surgery.

Is there a role for Eustachian tube balloon dilation in pediatric patients with refractory Eustachian tube dysfunction?

BACKGROUND: Eustachian tube dysfunction (ETD) is common in children. Over the past decade, eustachian tube balloon dilation (ETBD) has become a more widespread treatment for this condition. Data has been encouraging in the adult population, but data among the pediatric population has been sparser. This comprehensive review aims to assess current evidence for ETBD in pediatric patients. REVIEW: Studies relevant to ETBD in the pediatric population were identified by utilizing the PubMed MEDLINE database. While multiple retrospective studies were found, this search yielded two systematic reviews focused on the pediatric population as the highest level of evidence assessing ETBD in children. There was overlap of included studies, but each review contained a unique set of studies. These reviews found that ETBD was safe in children. BEST PRACTICE SUMMARY: Overall, ETBD appears safe and efficacious in children with refractory ETD. Future prospective trials confirming this conclusion are warranted. At this time, there appears to be a role for ETBD with or without ventilation tube placement in children with refractory ETD.

Assessing Patient Barriers to Cochlear Implantation.

OBJECTIVE: Evaluate barriers that deter adult patients from following through with cochlear implantation. STUDY DESIGN: Retrospective chart review and phone survey. SETTING: Single tertiary referral center. PATIENTS: Between January 2019 and August 2021, 113 patients, without a previous cochlear implant (CI), were determined to be candidates for cochlear implantation. Thirty-eight (33.6%) patients deferred cochlear implantation. Survey response rate was 61.1% (22/36). INTERVENTION: None. MAIN OUTCOME MEASURES: Demographic, socioeconomic, otologic history, and comorbidity factors associated with deferment of cochlear implantation. Patient survey assessment of factors that had the greatest impact, rated on a scale of 1 to 10 (10 being the most impactful), on their decision to defer a CI. RESULTS: Out of the 113 patients who met inclusion criteria, 75 (66.3%) underwent cochlear implantation and 38 (33.6%) patients deferred. Comparing implanted versus deferred groups, there was no statistical difference in age (67.1 y versus 68.5 y; p = 0.690) or male sex (53.3% versus 57.9%; p = 0.692). The deferred group had higher mean neighborhood disadvantage state decile (5.3 versus 4.3; p = 0.064) and national percentile (73.0 versus 66.2; p = 0.106) scores, although neither were statistically significant. A greater proportion of the deferred group were not living independently at time of CI evaluation (13.2 versus 2.7%; p = 0.017). Fear of losing residual hearing was rated the highest among the survey respondents (mean rating of 5.1), followed by general medical health (4.9) and cost and financial concerns (3.6). CONCLUSION: The greatest concern among the patients was the fear of losing residual hearing. Spending greater time educating patients about the success and failure rates of cochlear implantation may reduce patient hesitancy with implantation.

Head trauma and Cochlear implant displacement - A systematic review.

OBJECTIVE: Cochlear implant (CI) migration due to head trauma is a rare complication, and there is limited data summarizing this topic. This review seeks to provide a more comprehensive understanding of risk factors, clinical presentations, diagnosis, and intervention strategies for traumatic CI displacement. METHODS: The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) Protocol was followed using the PubMed and MED-LINE databases from 2000 to 2021, with manual cross-checks of reference lists of identified articles for additional relevant studies. The keywords used for database searches included "cochlear implant", "migration", "displacement", "extrusion" and "head trauma". All full-text articles available in English were screened, including single case presentations. Abstracts, commentaries, and publications deemed outside the scope of our study aims were excluded from review. RESULTS: After the removal of duplicate articles, a total of 152 articles were screened. After applying inclusion and exclusion criteria, 11 articles were included in the review. Due to heterogeneity of the available literature, a qualitative synthesis was employed to integrate results by identifying common themes among the relevant studies. CONCLUSIONS: The incidence of traumatic CI migration is extremely low and can be due to receiver-stimulator displacement, magnet displacement, or electrode extrusion. Migration occurred anywhere from 3 months to 26 years after implantation, suggesting that risk of migration from head trauma does not depend solely on time from implantation. There are several methods for repairing migrated CI, but there is limited data comparing operative techniques, specifically in the prevention of traumatic CI migration.

Impact of Surgery for Velopharyngeal Insufficiency on Eustachian Tube Function in Children: Pharyngeal Flap Versus Sphincter Pharyngoplasty.

OBJECTIVE: Velopharyngeal insufficiency (VPI) is a common speech disorder in patients with a history of cleft palate (CP) or 22q11.2 deletion syndrome. Pharyngeal flap (PF) and sphincter pharyngoplasty (SP) are 2 common surgeries to treat this disorder by decreasing unwanted nasal air emission and hypernasal resonance. Because Eustachian tube dysfunction (ETD) in patients with CP may be more frequent after surgery for VPI, we examined whether ETD was associated with either type of surgery. DESIGN: Retrospective cohort study. SETTING: Children's hospital-based tertiary referral center. PATIENTS: A total of 225 children with VPI who underwent primary PF (201) or SP (24) between 2006 and 2017. OUTCOME MEASURES: We examined differences in risk of ETD according to both surgical groups and proxies for postoperative nasal obstruction. These proxies included postoperative resonance measures and development of obstructive sleep apnea (OSA). RESULTS: Both surgical groups had similar preoperative measures, except the PF group had higher hypernasality by PSA. Postoperatively, the PF group demonstrated lower hypernasal resonance by nasometry and PSA. There were no differences between PF and SP groups with regard to ETD. Proxies for postoperative nasal obstruction also were not predictive of postoperative ETD. Degree of CP and younger age were found to be risk factors for ETD. CONCLUSION: There was no significant difference in the effects of PF and SP on ETD in this study. Neither lower hypernasality nor incidence of OSA had any impact on ETD. Degree of CP and younger age were the only significant risk factors for ETD that this study identified.

T-tubes Through Cartilage Tympanoplasty: Is It Worth the Perforation Risk?

OBJECTIVE: To review a single surgeon's experience with T-tube placement through cartilage tympanoplasty versus native tympanic membrane for long-term ventilation of the chronic ear and residual perforation rates following tube removal. STUDY DESIGN: Retrospective chart review. SETTING: Two tertiary referral centers. PATIENTS: One hundred sixteen patients (4-71 yr of age) who underwent either total island cartilage tympanoplasty or posterior palisade cartilage tympanoplasty with T-tube placement primarily or secondarily from 1998 to 2016. MAIN OUTCOME MEASURES: Long-term outcome of each T-tube was recorded with respect to retention and patency, and tympanic membrane status following either tube removal or extrusion. Audiometric data, age, sex, diagnosis, and procedure(s) performed were considered. RESULTS: There were 116 patients (122 total ears and 139 total T-tubes) included: 57 ears underwent total island cartilage tympanoplasty with tube placed through cartilage and 65 ears underwent posterior island graft with tube placed through native tympanic membrane. Sixty-eight T-tubes were placed in the total island cartilage group with three (4.4%) residual perforations following removal. Seventy-one T-tubes were placed in the posterior palisade graft group with six residual perforations (8.5%) following removal or extrusion. The mean retention rate for the T-tubes was 3.93 years for the total island tympanoplasty group and 3.58 years for the posterior palisade tympanoplasty group. The mean follow-up for total island tympanoplasty and posterior palisade tympanoplasty was 5.36 and 5.66 years, respectively. CONCLUSION: Our data suggest that T-tube placement through cartilage tympanoplasty is worthwhile providing long-term ventilation to the middle ear and portends no higher risk for residual perforation than T-tube placement through native tympanic membrane.

Outcomes Following Revision Stapes Surgery in Children: A Single-Surgeon, Single-Center 15-Year Experience.

OBJECTIVE: To review a single surgeon experience with revision pediatric stapes surgery for congenital stapes fixation (CSF) and tympanosclerosis (TS). Secondly, to determine whether hearing outcomes following revision surgery may be predicted by a thorough work-up aimed at assessing whether an extruded or malpositioned prosthesis is likely to be encountered intraoperatively. SETTING: Tertiary referral center. STUDY DESIGN: Retrospective chart review. PATIENTS: Fifteen patients having revision surgery for fixation of the stapes footplate over a 15-year period. MAIN OUTCOME MEASURES: Hearing results based on pre- and post-revision pure-tone average air-bone gap (PTA-ABG) and speech recognition threshold testing (SRT). RESULTS: Overall, the mean improvement of PTA-ABG following revision surgery was 11.9 dB (standard deviation [SD] 15.2) while SRTs improved by a mean of 12.3 (SD 19.9). Outcomes were significantly better in patients who reported a history of trauma following their initial surgery, when there was otoscopic evidence of an extruding or extruded prosthesis and/or a pre-revision CT (where performed) suggested an extruded or malpositioned prosthesis. No patients had a significant postoperative sensorineural hearing loss. CONCLUSION: Revision stapes surgery in children is a safe procedure in experienced hands which nonetheless should only be contemplated in patients in whom preoperative work-up suggests an extruded or malpositioned prosthesis is likely to be encountered intraoperatively.

Quality of life outcomes after transmastoid plugging of superior semicircular canal dehiscence.

PURPOSE: This study was performed to evaluate the effectiveness and impact on quality of life in patients undergoing plugging of superior semicircular canal dehiscence using the transmastoid approach. MATERIALS AND METHODS: Retrospective chart review with prospective outcomes assessment, using validated quantitative scoring systems, was performed on 10 patients (23-76 years) who underwent transmastoid plugging of superior semicircular canal dehiscence between February 2014 and February 2018 at a tertiary referral center. Pre-operative and post-operative autophony and vertigo were measured by The Autophony Index and the Dizziness Handicap Index. Overall quality of life following intervention was measured by the Glasgow Benefit Inventory. Subjective improvement, audiological changes, and subjective quality of life changes were also recorded. RESULTS: A significant reduction in the total Dizziness Handicap Index was seen following transmastoid repair of superior semicircular canal dehiscence (p = 0.0078). This was also evident when subgroup analysis of the Dizziness Handicap Index was performed, as physical (p = 0.0273), emotional (p = 0.0078), and functional subgroups were all significantly reduced (p = 0.0117). Autophony was also significantly reduced following intervention (p = 0.0312). Overall quality of life was seen to be improved following surgery as measured by the Glasgow Benefit Inventory (p = 0.0345). CONCLUSION: Our data suggest that transmastoid plugging of a dehiscence in the superior semicircular canal is a safe and effective means of improving autophony, dizziness and overall quality of life in these patients. We believe that these results should be taken into consideration in discussions regarding surgical approach for patients who are contemplating this procedure.

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 ±â€Š10.9 dB) showed some improvement but the outcome was significantly worse than in CSFF (21.0 dB ±â€Š11.4 dB) (p = 0.020) and JO (22.8 dB ±â€Š14.9 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.

Long-term Outcomes of Ossiculoplasty With and Without an Intact Malleus.

OBJECTIVE: To compare long-term hearing outcomes following ossiculoplasty with cartilage tympanoplasty with (M) and without (M) the malleus present. STUDY DESIGN: Retrospective chart review. SETTING: Tertiary referral center. PATIENTS: One twenty-six patients (18-88 yr of age) undergoing ossiculoplasty with tympanoplasty or tympanomastoidectomy using cartilage tympanic membrane grafts from 1998 to 2012 with at least 5 years of documented postoperative follow-up. MAIN OUTCOME MEASURES: Short-term hearing results (pure-tone average air-bone gap [PTA-ABG] measured between 60 d and 1 yr after surgery), long-term hearing results (PTA-ABG measured ≥5 yr after surgery), Ossiculoplasty Outcome Parameter Staging (OOPS) index, and complications. RESULTS: There were 46 patients in the M group and 80 in the M group. Preoperative PTA-ABG was 23.8 dB for M and 34.5 dB for M (p = 0.00001). Short-term postoperative PTA-ABG was 19.3 dB for M and 18.5 dB for M (p = 0.727). Long-term postoperative PTA-ABG was 18.2 dB for M and 19.6 dB for M (p = 0.500). The OOPS index was 4.11 and 6.41 for M and M, respectively, (p = 0.00001). Thirteen patients (10.3%) experienced complications. CONCLUSION: Our data suggest that the malleus is not statistically significant with regard to its impact on final audiometric outcome following ossiculoplasty. This has implications in our clinic, particularly in our use of the OOPS index as a prognostic tool, and will likely lead to its revision. These data may further support the coupling theory of acoustic gain and weaken the catenary lever theory.

International Otology Outcome Group and the International Consensus on the Categorization of Tympanomastoid Surgery.

The International Otology Outcome Group (IOOG) was founded in 2017 to encourage and facilitate international collaboration with regard to the surgical outcome of ear surgery. This report outlines the methodology and recommendations of the consensus-based categorization of tympanomastoid surgery produced by the IOOG. The IOOG Steering Committee used the acronym SAMEO-ATO to categorize tympanomastoid operations, representing the stage of surgery, approach, mastoid bone extirpation, external bony wall repair, obliteration of the mastoid cavity, access to the middle ear, tympanic membrane reconstruction, and ossicular reconstruction. A modified Delphi technique was used to obtain international consensus. The expert panels included the chairpersons from 21 otology societies. The approval rate of the SAMEO-ATO system from the otology societies was 95%. The SAMEO-ATO scheme was presented at the 31st Politizer Meeting for field testing. There were no objections or serious concerns raised. Some international otologists wished to see more surgical categories included to reflect the varieties of surgical techniques, but they accepted that it would make the whole system cumbersome. In addition to providing an international categorization of tympanomastoid surgery, the IOOG Steering Committee plans to introduce a common otology dataset that the international otology community could use to record their surgical outcome. The high level of international consensus on the IOOG categorization of tympanomastoid surgery supports this tool for surgeons to pool their surgical data into a large database for research and comparative audit.

Evaluation of Intraoperative Testing During Cochlear Implantation From a Time and Cost Perspective: A Single-Center Experience in the United States.

OBJECTIVE: To measure the time spent performing intraoperative testing during cochlear implantation (CI) and determine the impact on hospital charges. STUDY DESIGN: Prospective study. SETTING: Tertiary referral hospital. PATIENTS: Twenty-two children (7 mo-18 yr) who underwent a total of 22 consecutive primary and/or revision CIs by a single surgeon from December 2016 to July 2017. INTERVENTION: The time spent performing intraoperative testing, including evoked compound action potentials (ECAP) and electrical impedances (EI), was recorded for each case. The audiologist performing the testing was unaware of the time measurement and subsequent evaluations with regard to cost data. Billing information was used to determine if the testing contributed to increased operative charges to the patient. OUTCOME MEASURES: Whether intraoperative testing had an impact on operative charges to the patient. RESULTS: The average time spent in testing (ECAPs/EIs in all cases) was 6.7 minutes (range, 2-26 min). No correlation was found between testing time and preoperative computed tomography findings, the audiologist performing testing, or the electrode type used (p > 0.05). Based on billing data, including time spent in the operating room (OR), 5/22 (23%) cases incurred greater charges than if intraoperative testing had not been performed. CONCLUSION: Our data suggest that intraoperative testing increases time in the OR and can contribute to increased hospital charges for CI patients. By using testing selectively, costs incurred by patients and hospitals may be reduced. This is of interest in a healthcare environment that is increasingly focused on cost, quality, and outcomes.

Trends in Intraoperative Testing During Cochlear Implantation.

OBJECTIVE: No consensus guidelines exist regarding intraoperative testing during cochlear implantation and wide variation in practice habits exists. The objective of this observational study was to survey otologists/neurotologists to understand practice habits and overall opinion of usefulness of intraoperative testing. STUDY DESIGN: Cross-sectional survey. SETTING: A web-based survey was sent to 194 practicing Otologists/Neurotologists. MAIN OUTCOME MEASURES: Questions included practice setting and experience, habits with respect to electrodes used, intraoperative testing modalities used, overall opinion of intraoperative testing, and practice habits in various scenarios. RESULTS: Thirty-nine of 194 (20%) completed the survey. For routine patients, ECAPs and EIs were most commonly used together (38%) while 33% do not perform testing at all. Eighty-nine percent note that testing "rarely" or "never" changes management. Fifty-one percent marked the most important reason for testing is the reassurance provided to the family and/or the surgeon. CONCLUSION: Intraoperative testing habits and opinions regarding testing during cochlear implantation vary widely among otologic surgeons. The majority of surgeons use testing but many think there is minimal benefit and that surgical decision-making is rarely impacted. The importance of testing may change as electrodes continue to evolve.

Long-term Complications and Surgical Failures After Ossiculoplasty.

OBJECTIVE: To study long-term complications after ossiculoplasty. STUDY DESIGN: Case series with chart review. SETTING: Tertiary care referral center otology practice. PATIENTS: One hundred ninety-five patients (18-88 yr of age) undergoing ossiculoplasty with tympanoplasty or tympanomastoidectomy using cartilage tympanic membrane grafts, retrograde mastoidectomy with canal wall reconstruction, or mastoid obliteration techniques between July 1998 and July 2012. The studied patients all had at least 3 years of clinical follow-up. OUTCOME MEASURES: Incidence of long-term complications, including need for revision surgery, need for secondary ventilation tube placement, recurrence of conductive hearing loss (and related etiologies), recurrent cholesteatoma, and delayed graft failure (recurrent tympanic membrane perforation). RESULTS: Long-term complications were observed in 10.3% (20/195) of patients. 8.2% (16/195) required revision surgery, 10.2% (17/195) required secondary ventilation tube placement, 3.6% (7/195) experienced recurrence of conductive hearing loss, 4.1% (8/195) had delayed failure of tympanic membrane graft, and 1.5% (3/195) had recurrence of cholesteatoma. Recurrence of conductive hearing loss was caused by the displacement of prosthesis in 3 of 7 patients and extensive scar tissue formation without prosthesis displacement in 4 of 7 patients. Seventy-two percent obtained a postoperative pure-tone average - air-bone gap  < 20 dB. Forty-eight percent (93/195) obtained a hearing result worse than expected based on the ossiculoplasty outcome parameter staging index. CONCLUSION: Long-term complications are a significant consideration in all the patients undergoing ossiculoplasty. Our data suggest that tobacco smoking, Eustachian tube dysfunction, and an unexpectedly poor hearing result on the first postoperative audiogram are all important risk factors for the development of significant complications.

The Influence of Intraoperative Testing on Surgical Decision-making During Cochlear Implantation.

OBJECTIVE: To review our use of intraoperative testing during cochlear implantation (CI) and determine its impact on surgical decision-making. STUDY DESIGN: Retrospective chart review. SETTING: Tertiary referral center. PATIENTS: A total of 197 children and adults who underwent a total of 266 primary and/or revision CI by a single surgeon from 2010 to 2015. INTERVENTION: Intraoperative electrophysiologic monitoring including evoked compound action potentials and electrical impedances. MAIN OUTCOME MEASURES: Whether surgical management was changed based on intraoperative testing. RESULTS: In only 2 of 266 patients (0.8%), the back-up device was used due to findings on intraoperative testing. In three patients (1.1%), X-ray was performed intraoperatively to confirm intracochlear electrode placement, which was found to be normal in all patients. CONCLUSION: Our data suggest that with respect to CI in children and adults in straightforward cases (e.g., normal anatomy, nondifficult insertion, etc.), routine intraoperative evoked compound action potentials, impedances, and imaging rarely influence surgical decision-making in our clinic and may have limited usefulness in these patients. The implications of this are discussed and a review of the literature is presented.