Comparison of Outcomes with the Use of Different Heat-Activated Crimping Prostheses in Stapedotomy.

OBJECTIVE: To determine differences in failure rate and hearing outcomes of a completely encircling heat-activated crimping prosthesis (SMart 360°) compared to partially encircling prosthesis (SMart). STUDY DESIGN: Retrospective chart review. SETTING: Private neurotology tertiary referral center. PATIENTS: Patients who underwent stapedotomies performed by the senior authors from 2008 to 2019 using the SMart prosthesis and SMart 360° prothesis. INTERVENTIONS: Stapedotomy operations with placement of a SMart or SMart 360° prosthesis. MAIN OUTCOME MEASURES: Incidence of early failure requiring revision surgery. Differences in preoperative air-bone gap (ABG) compared to postoperative ABG at 3 months, 1 year, and 2 years after surgery. RESULTS: A total of 228 stapedotomies were performed (SMart n = 48 and SMart 360° n = 180). Mean preoperative ABG for SMart and SMart 360° were 26.15 and 29 dB, respectively. The mean difference in ABG for the SMart at 3 months, 1 year, and 2 years were 17, 18, and 11 dB, respectively. The mean difference in ABG for the SMart 360° at 3 months, 1 year, and 2 years were 20, 20, and 19 dB. ABG differences at 3 months (p = 0.10) and 1 year (p = 0.36) were not statistically different. The failure rate for the SMart prosthesis was 12.5% and for the SMart 360° 2.2% (p = 0.002). CONCLUSIONS: There were no statistically significant differences in ABG changes for SMart compared to SMart 360°. The Smart 360 corrects the problem with early failure seen with the Smart prosthesis. PROFESSIONAL PRACTICE GAP AND EDUCATIONAL NEED: Determination of most efficacious stapes prosthesis. LEARNING OBJECTIVE: Which stapes prosthesis produces better hearing results with fewer failures. DESIRED RESULT: To disseminate information necessary to choose the best stapes prosthesis for patients. LEVEL OF EVIDENCE: Level III. INDICATE IRB OR IACUC: 2022-029-agh.

Outcomes of Mastoidectomy With Antibiotic Catheter Irrigation for Patients With Draining Ventilation Tubes.

OBJECTIVES: To evaluate the effectiveness of mastoidectomy with antibiotic catheter irrigation in patients with chronic tympanostomy tube otorrhea. METHODS: A chart review of adult and pediatric patients with persistent tympanostomy tube otorrhea who had failed outpatient medical management and underwent mastoidectomy with placement of a temporary indwelling catheter for antibiotic instillation was performed. Patients were retrospectively followed for recurrent drainage after 2 months and outcomes were categorized as resolution (0-1 episodes of otorrhea or otitis media with effusion during follow-up), improvement (2-3 episodes), or continued episodic (>3 episodes). RESULTS: There were 22 patients and 23 operated ears. Median age was 46 years (interquartile range, IQR = 29-65). The median duration of otorrhea from referral was 5.5 months (IQR = 2.8-12). Following surgery, 14 ears had resolution of drainage, 6 had improvement, and 3 had episodic. The observed percentage of resolved/improved ears (87%) was significant (P = .0005, 95% CI = 67.9%-95.5%). Median follow-up time was 25 months (IQR = 12-59). Pre and postoperative pure tone averages improved (difference of medians = -3.3 dB, P = .02) with no significant difference in word recognition scores (P = .68). Methicillin-resistant Staphylococcus aureus was the most common isolated microbe while no growth was most frequently noted on intraoperative cultures. CONCLUSIONS: Mastoidectomy with antibiotic catheter irrigation may be an effective surgical strategy, and single stage alternative to intravenous antibiotics, for select patients with persistent tube otorrhea who have failed topical and oral antibiotics.

A Deep Learning Model for Automated Classification of Intraoperative Continuous EMG.

OBJECTIVE: Intraoperative neurophysiological monitoring (IONM) is the use of electrophysiological methods during certain high-risk surgeries to assess the functional integrity of nerves in real time and alert the surgeon to prevent damage. However, the efficiency of IONM in current practice is limited by latency of verbal communications, inter-rater variability, and the subjective manner in which electrophysiological signals are described. METHODS: In an attempt to address these shortcomings, we investigate automated classification of free-running electromyogram (EMG) waveforms during IONM. We propose a hybrid model with a convolutional neural network (CNN) component and a long short-term memory (LSTM) component to better capture complicated EMG patterns under conditions of both electrical noise and movement artifacts. Moreover, a preprocessing pipeline based on data normalization is used to handle classification of data from multiple subjects. To investigate model robustness, we also analyze models under different methods for processing of artifacts. RESULTS: Compared with several benchmark modeling methods, CNN-LSTM performs best in classification, achieving accuracy of 89.54% and sensitivity of 94.23% in cross-patient evaluation. CONCLUSION: The CNN-LSTM model shows promise for automated classification of continuous EMG in IONM. SIGNIFICANCE: This technique has potential to improve surgical safety by reducing cognitive load and inter-rater variability.

The Role of Mastoidectomy in Draining Ventilation Tubes.

OBJECTIVES: To discuss the indication for performing a mastoidectomy with catheter placement in patients with chronic tympanostomy tube otorrhea. METHODS: The Medical Literature Analysis and Retrieval System Online was searched via PubMed for relevant articles using serous mastoiditis, mastoidectomy, chronic otorrhea, tube otorrhea, tympanostomy tubes, and biofilm as keywords. RESULTS: Further understanding of the pathophysiology of otorrhea and the development of ototopical fluoroquinolones have made a draining tympanostomy tube more manageable. Nevertheless, chronic otorrhea refractory to an otolaryngologist's traditional treatment algorithm still occurs and may benefit from a mastoidectomy with antibiotic irrigation using a catheter in certain cases. We theorize that resolution of otorrhea results from this technique by decreasing the burden of diseased mucosa and providing a larger concentration or dose of antibiotic to the middle ear cleft through the antrum. High-resolution images of the technique and catheter placement are included in this review. CONCLUSIONS: Despite being an uncommon management strategy, the literature suggests an indication for performing a mastoidectomy in a small percentage of patients with a chronically draining tympanostomy tube.

Long-term outcomes of cartilage-buttressed T-tube tympanoplasty for prolonged middle ear ventilation.

OBJECTIVES/HYPOTHESIS: To report on the safety and efficacy of cartilage-buttressed T-tube tympanoplasty for long-term middle ear ventilation, specifically by examining duration of tube survival, as well as adverse events associated with prolonged middle ear intubation, including persistent tympanic membrane perforation. STUDY DESIGN: Retrospective case series of patients undergoing cartilage-buttressed T-tube tympanoplasty between January 2005 and December 2016 in a tertiary-care neurotology private practice. METHODS: Patients who underwent cartilage T-tube tympanoplasty with complete pre- and postoperative audiometric data and a minimum follow-up duration of 12 months were analyzed. T-tube survival and adverse events including persistent tympanic membrane perforation were recorded and compared to published data for other long-term middle ear ventilation techniques. RESULTS: The study cohort included 72 cartilage-buttressed T-tube tympanoplasties in 68 patients. Median tube survival was 34 months (range, 2-131 months). Incidence of persistent tympanic membrane perforation (n = 1) was 1.4% CONCLUSIONS: Cartilage-buttressed T-tube tympanoplasty is a safe and effective means of accomplishing long-term middle ear ventilation with a considerably lower rate of persistent tympanic membrane perforation as compared to alternative methods of prolonged middle ear ventilation. LEVEL OF EVIDENCE: 4 Laryngoscope, 129:203-208, 2019.

Enhanced hearing in heat-activated-crimping prosthesis stapedectomy.

OBJECTIVES: Compare short-term hearing outcomes with a heat-activated-crimping versus manual-crimping stapedectomy prosthesis. STUDY DESIGN: Retrospective chart review. SETTING: Tertiary care neurotology referral center. PATIENTS: 219 charts reviewed. INTERVENTION: Laser stapedectomy. MAIN OUTCOME MEASURES: Audiometric. METHODS: Retrospective study comparing postoperative hearing in manual-crimp prostheses stapedectomies versus heat-activated-crimp prostheses stapedectomies. RESULTS: Of the 219 patients reviewed, 94 met inclusion criteria for the study, with 47 receiving manual-crimp prosthesis and 47 receiving heat-activated-crimp prosthesis. Short-term poststapedectomy air-bone gaps, long-term air-bone gaps, long-term pure-tone averages, and long-term air-bone gap closures were significantly better for heat-activated-crimp versus manual-crimp prostheses. CONCLUSION: Heat-activated-crimping prostheses demonstrated enhanced stapedectomy hearing outcomes versus manual-crimping prostheses on short- and long-term follow-up. Three-dimensional reorientation of the heat-activated prosthesis may enhance the hearing outcome; however, theoretical nickel allergy considerations, effects of case selection, follow-up duration, possible eventual loosening of the heat-activated crimp, and long-term incus necrosis are considerations requiring continued longitudinal analysis.

Acoustic neuroma in a private neurotology practice: trends in demographics and practice patterns.

OBJECTIVES/HYPOTHESIS: To determine whether changes in demographics and management of patients with acoustic neuromas occurred between the years 1990 and 2005. STUDY DESIGN: Retrospective chart review. METHODS: Charts of all 614 patients with a diagnosis of acoustic neuroma, excluding neurofibromatosis-2, from 1990 through 2005 were reviewed. Age at diagnosis, tumor size, hearing, and initial therapy (observation, stereotactic radiation, or surgical excision) were obtained. Patients were grouped by time period (1990-1994, 1995-2000, 2001-2005). RESULTS: Mean age at diagnosis increased slightly from the middle period (53.4 yr) to the most recent (56.9 yr) (P < or = .025). The proportion of patients 65 years or older increased from 21% to 29% to 32%, respectively, but the change was not significant. Average tumor size decreased from 1.7 cm initially to 1.4 cm most recently (P < or = .039). There were no significant changes in hearing. Although surgical excision remains our most common treatment (58.5% in 2001-2005), it is becoming less frequent (>80% in earlier periods) (P < or = .001). Observation with serial imaging was recommended in 37.3% in 2001 to 2005 as compared with 18.3% and 11.6% in the previous two time periods (P < or = .001). These changes in initial treatment choices occurred for all age groups and primarily for small tumors. Use of radiation has increased only slightly, to 4.2% in the recent period. CONCLUSION: : Patients with acoustic neuroma are presenting with increased age and smaller tumors compared with 16 years ago. However, these changes cannot totally account for the large change in treatment trends. Technology and demographics are influential in these changes, but other difficult to measure forces, such as patient influence and patient use of the Internet, are also factors.

Endolymphatic mastoid shunt versus endolymphatic sac decompression for Ménière's disease.

OBJECTIVE: This study compares the efficacy of endolymphatic mastoid shunt (EMS) versus endolymphatic sac decompression (ESD) without sac incision for the treatment of Ménière's disease. STUDY DESIGN AND SETTING: The AAO-HNS Guidelines for the Diagnosis and Evaluation of Therapy in Ménière's disease were used to retrospectively identify suitable candidates for the study. All patients who failed medical management and underwent either endolymphatic-mastoid shunt (EMS) (n = 88) or endolymphatic sac decompression (ESD) (n = 108) were selected for review using the AAO-HNS guidelines. The study was carried out at a tertiary care neurotology private practice. RESULTS: EMS and ESD were equally effective in reducing the incidence and severity of vertigo attacks with significant improvement in 67 percent and 66 percent of patients, respectively. CONCLUSION: Both EMS and ESD are effective, nondestructive alternatives for patients who have failed medical management of Ménière's disease with similar long-term hearing outcomes. SIGNIFICANCE: This is the only study within the same institution using AAO-HNS guidelines comparing EMS versus ESD.

Hydroxyapatite cement cranioplasty in translabyrinthine acoustic neuroma surgery-update.

OBJECTIVE: To update the outcome of hydroxyapatite cement cranioplasty in translabyrinthine acoustic neuroma (TLAN) surgery. PATIENTS: One hundred eight previously reported patients undergoing abdominal fat graft reconstruction versus hydroxyapatite cement cranioplasty with additional 4-year follow up. Ninety additional patients undergoing a uniform technique of hydroxyapatite cement cranioplasty after TLAN. INTERVENTION(S): After TLAN, strips of abdominal fat are placed through the dural opening and medial to the level of the mastoid antrum, filling the lateral mastoid cavity. MAIN OUTCOME MEASURE(S): Cerebrospinal fluid (CSF) leaks and wound complications. RESULTS: No additional CSF leaks or wound complications were identified in the patients included in the previous report. In the new series of 90 consecutive patients, there was one CSF leak. CONCLUSION: Hydroxyapatite cranioplasty is a reliable method to avoid CSF leaks after TLAN surgery.

Hydroxyapatite cement cranioplasty following translabyrinthine approach: Long-term study of 369 cases.

OBJECTIVE: To report the authors' experience with hydroxyapatite cement (HAC) cranioplasty and analyze the material's long-term safety and efficacy in repairing translabyrinthine skull-base defects by examining adverse events, specifically cerebrospinal fluid (CSF) leaks and surgical site infections. STUDY DESIGN: Retrospective case-control study (primary study arm); prospective cross-sectional study of patients not examined within the last 5 years (secondary arm). SETTING: tertiary-care neurotology private practice and academic practice (two centers). METHODS: Hydroxyapatite cement implanted following translabyrinthine approach, with or without fat graft, was included. Combined approaches were excluded. Implant-associated adverse events were defined as 1) CSF leaks requiring reoperation or spinal drainage, and (2) infections requiring reoperation. Patients not examined within 5 years were interviewed by telephone to update their condition. Incidence of adverse events was compared to published data for translabyrinthine cranioplasty using fat graft alone. Implant survival analysis was performed. RESULTS: The study cohort included 369 HAC implants in the same number of patients. There were seven CSF leaks and seven infections. Combined (n = 14) incidence of adverse events was 3.8% (2.09%, 6.28%). Compared to fat graft alone, the adverse events associated with HAC were fewer (P < 0.001). Up to 15 years (5,475 days), HAC cement maintained 95% adverse event-free survival. There were no cases of meningitis. CONCLUSION: Cranioplasty using HAC with autologous fat following translabyrinthine skull-base surgery is safer and more effective than fat graft alone, up to 15 years after surgery. LEVEL OF EVIDENCE: 4. Laryngoscope, 127:2120-2125, 2017.

Visually enhanced vestibulo-ocular reflex: a diagnostic tool for migraine vestibulopathy.

OBJECTIVES: 1) To compare the incidence of elevated visually enhanced vestibular-ocular reflex (VVOR) rotational gain during rotational chair testing in a normal control group versus a group of patients diagnosed with migraine vestibulopathy; 2) to discuss the possible application of VVOR gain during rotational chair testing for diagnosing migraine vestibulopathy. STUDY DESIGN: Prospective normal control group and retrospective cohort comparison. METHODS: 1) Prospective rotational chair studies including VVOR in 20 normal control patients; 2) retrospective review of vestibular studies including VVOR in 100 consecutive patients with migraine vestibulopathy. RESULTS: Twenty of the normal controls and 69 of the migraine vestibulopathy patients met all inclusion criteria. One of 20 (5%) normal control patients had elevated VVOR gain, whereas 49 of 69 (71%) of migraine vestibulopathy patients had elevated VVOR gain. CONCLUSIONS: VVOR gain normal criteria were appropriate in 95% of our normal control test group. VVOR gain was more frequently elevated in migraine vestibulopathy patients than in the normal controls, and the difference was significant (P < .001). VVOR gain elevation was the most common vestibular test abnormality in this cohort of patients with migraine vestibulopathy. Because VVOR measures visual-vestibular interaction and its central connections, this parameter may be a useful diagnostic tool for migraine vestibulopathy in patients manifesting disequilibrium and motion sensitivity.

Rotational chair (ROTO) instead of electronystagmography (ENG) as the primary vestibular test.

OBJECTIVES: To compare the sensitivity of rotational chair (ROTO) versus electronystagmography (ENG) in peripheral vestibular pathology. METHODS: Retrospective chart review. RESULTS: One thousand consecutive patients undergoing evaluation for dizziness and imbalance at a tertiary care referral balance center were reviewed. ROTO was the primary vestibular study used in all patients with ENG used as a confirmatory test at the discretion of the treating physician. A subgroup of 478 patients underwent both ROTO and ENG. Among the patients diagnosed with peripheral vestibulopathy, sensitivity for peripheral vestibulopathy was 71% for ROTO and 31% for ENG. However, specificity was 54% for ROTO and 86% for ENG. CONCLUSIONS: We conclude that in this retrospective cohort with the authors' clinical diagnoses, ROTO is a more sensitive diagnostic study of peripheral vestibular pathology. The higher sensitivity of ROTO and the higher specificity of ENG may support the use of ROTO as the primary vestibular study and ENG as a supplemental vestibular study. Prospective analysis with distinct diagnostic criteria and defined inclusion criteria are necessary before these results can be widely extrapolated.

Role of squamosal suture as a consistent landmark for middle fossa approach craniotomy: an anatomical study.

Objective To establish a consistent surface bony landmark for a middle fossa approach (MFA) lateral craniotomy represented by the squamosal suture (SS). Methods In 60 dried skulls, we assessed the relation between the SS and the external auditory canal (EAC). The lateral portion of the middle cranial fossa floor was also assessed for a possible relation with the anteroposterior diameter (APD) of the squama temporalis (ST). Clinically, we applied our findings on the SS in MFA for different lesions. Results A vertical line at the EAC divided the ST into the anterior part constituting 61% of the APD (i.e., two thirds) and the posterior part forming 39% (i.e., one third). The average ST height was 35.92 mm. The SS posterior limit at the supramastoid crest was located just anterior to the external projection of the petrous ridge in 35 skulls (58%) and exactly corresponded to it in 25 skulls (42%). The APD of the ST equals on average 97% of the APD of the lateral middle cranial fossa. Optimum exposure of the middle fossa was obtained without any further craniotomy extension. Conclusion The SS serves as a consistent natural surface bony landmark for MFA. Optimum craniotomy, two thirds anterior to the EAC and one third posterior, is obtained following SS as a landmark.

Translabyrinthine approach for acoustic neuroma.

The translabyrinthine approach has been popularized during the past 30 years for the surgical treatment of acoustic neuromas. It serves as an alternative to the retrosigmoid approach in patients when hearing preservation is not a primary consideration. Patients with a tumor of any size may be treated by the translabyrinthine approach. The corridor of access to the cerebellopontine angle is shifted anteriorly in contrast to the retrosigmoid approach, resulting in minimized retraction of the cerebellum. Successful use of the approach relies on a number of technical nuances that are outlined in this article.

Technical refinements and precautions during ionomeric cement reconstruction of incus erosion during revision stapedectomy.

OBJECTIVE: The study describes the technical precautions and short-term hearing results of fast-setting ionomeric cement (SerenoCem) for managing incus erosion in revision stapedectomy. STUDY DESIGN: Observational and retrospective chart review. METHODS: Consecutive patients undergoing ionomeric cement incus reconstruction during revision stapedectomy had surgery on an ambulatory basis in a tertiary care referral center. Main outcome measures included technical details, precautions, and recommendations for handling this new material and 6-week hearing outcomes comparing preoperative and postoperative air-conduction and bone-conduction thresholds. RESULTS: A small amount of ionomeric cement on the tip of otological picks applied to the incus remnant successfully reconstitutes the original length of the long process of the incus. In revision stapedectomy, a crimp-on prosthesis may be placed on the cement-lengthened incus. Six-week postoperative audiograms demonstrated significant closure of the air-bone gap in operated cases. Our experience in a failed case leads us to recommend that the setting time for the cement be increased to no less than 20 minutes as opposed to the manufacturer's recommendation of 10 minutes. Also, revision stapedectomy was more likely to be successful when the prosthesis was placed to the incus remnant and stabilized with cement, rather than placing the prosthesis on the cement itself. CONCLUSIONS: Ionomeric cement permits direct reconstruction of a pathologically shortened incus in revision stapedectomy. Surgeons must be aware of precaution and limitations of this new material. Preliminary results indicate significant hearing improvement with this technique when appropriate precautions are taken.

Vestibular nerve section versus intratympanic gentamicin for Meniere's disease.

OBJECTIVES/HYPOTHESIS: Vestibular nerve section and transtympanic gentamicin administration are procedures with proven efficacy in the treatment of vertigo associated with Meniere's disease refractory to medical management. Hearing loss is a known complication of each of these procedures; however, there has not been a report of hearing results of both treatments from a single institution. STUDY DESIGN: Retrospective review. METHODS: Review was made of 25 patients undergoing gentamicin injection and 39 patients undergoing vestibular nerve section for Meniere's disease. Rate of vertigo control and pretreatment and post-treatment pure-tone average values and speech discrimination scores were reported. RESULTS: The mean preoperative pure-tone average for patients having vestibular nerve section was 47.2 dB, with a speech discrimination score of 75.4%. In these patients, the postoperative pure-tone average was 49.1 dB and the speech discrimination score was 75%. Patients undergoing gentamicin injection had a mean pretreatment pure-tone average of 55.9 dB and a speech discrimination score of 62%. The post-treatment pure-tone average and speech discrimination score for the gentamicin group were 68.8 dB and 49.3%, respectively. Five of 25 patients (20%) in the gentamicin treatment group and 1 of 39 (3%) in the vestibular nerve section treatment group had an increase in bone-conduction threshold greater than 30 dB. The amount of postprocedure hearing loss was significantly greater in the gentamicin treatment group (P =.006). Control of vertigo was good to excellent in 95% of the patients treated with vestibular nerve section and in 80% of the patients treated with gentamicin. CONCLUSION: Although vestibular nerve section and transtympanic gentamicin are both acceptable treatment options for vertigo associated with Meniere's disease, gentamicin causes a higher level of hearing loss related to treatment and vestibular nerve section has higher vertigo control rates.

Intratympanic steroids: do they acutely improve hearing in cases of cochlear hydrops?

OBJECTIVE: To study the acute effects on hearing of intratympanic dexamethasone in patients with cochlear hydrops. STUDY DESIGN: Retrospective review. METHODS: Patients who met established criteria for the diagnosis of Ménière's disease or had a history of fluctuating hearing loss and met hearing loss criteria for Ménière's disease, indicating cochlear hydrops, underwent a series of one to three intratympanic injections of dexamethasone in the affected ear. Follow-up audiograms were obtained 1 week after each injection and, in many patients, several months after injection. RESULTS: Fifty patients met inclusion criteria and were studied. Using the American Academy of Otolaryngology-Head and Neck Surgery reporting guidelines, hearing improved acutely in 20 of the 50 patients (40%), was worse in 2 (4%), and did not change in 28 (56%). For those who improved, the average decrease in threshold was 14.2 dB. Whether the patient had typical Ménière's disease or cochlear hydrops did not affect the response to therapy. There were no significant complications from the injections. CONCLUSIONS: Intratympanic administration of dexamethasone may acutely affect sensorineural hearing loss associated with endolymphatic hydrops. A prospective, controlled study is required.

Hydroxyapatite cement cranioplasty in translabyrinthine acoustic neuroma surgery.

OBJECTIVES: Hydroxyapatite cement cranioplasty (HAC) after translabyrinthine resection of acoustic neuroma is a promising new technique for wound reconstruction. This study reviews the efficacy of HAC for the prevention of cerebrospinal fluid (CSF) leakage and the long-term wound outcomes of HAC versus abdominal fat graft (AFG) reconstruction. METHODS: This retrospective study of l08 consecutive acoustic neuromas operated on by Pittsburgh Ear Associates uses chart review, telephone interview, and mail questionnaire data. Fifty-four patients received AFG dural repair, and 54 patients received HAC. RESULTS: Seven AFG patients (12.5%) had CSF leaks versus 2 (3.7%) of the overall group of 54 HAC patients. However, none (0%) of the 47 HAC patients had CSF leakage with current HAC techniques. HAC also produced significantly less postauricular wound depression and superior cosmetic results in comparison with AFG. Although HAC patients experienced less postoperative discomfort, wound complications requiring medical or surgical intervention were extremely uncommon in both groups. CONCLUSION: HAC offers significant CSF leakage control and long-term cosmetic and comfort advantages over AFG alone. We recommend HAC as the standard closure technique for translabyrinthine acoustic neuroma surgery.

Phase 1 clinical trial results of the Envoy System: a totally implantable middle ear device for sensorineural hearing loss.

OBJECTIVES: This report will present the results of the USA Phase 1 clinical trials for the Envoy System (St. Croix Medical): A totally implantable middle ear hearing system for sensorineural loss. STUDY DESIGN: A prospective, single-subject, repeated-measures, multicenter study was performed to evaluate safety and functionality of the Envoy System. Data collected included Abbreviated Profile of Hearing Aid Benefit, bone conduction threshold, speech reception threshold, functional gain, word recognition, and adverse events. Testing was performed unaided, with the patient's best-fit hearing aid, and post device activation at 2 (trial endpoint) and 4 months. RESULTS: Five of 7 patients at the 2-month postactivation period had working systems. All 5 patients perceived benefit increases with the Envoy System over their best-fit hearing aid, including communication in high background noise levels. Word recognition was improved over hearing aids. Functional gain and speech reception thresholds were similar for the Envoy device and hearing aids. CONCLUSIONS: The feasibility trial has shown the Envoy device, a totally implantable middle ear device, can safely sense and drive the ossicular chain. EBM RATING: B-2.

MRI information for commonly used otologic implants: review and update.

OBJECTIVE: To review information on magnetic resonance imaging (MRI) issues for commonly used otologic implants. DATA SOURCES: Manufacturing companies, National Library of Medicine's online database, and an additional online database (www.MRIsafety.com). REVIEW METHODS: A literature review of the National Library of Medicine's online database with focus on MRI issues for otologic implants was performed. The MRI information on implants provided by manufacturers was reviewed. RESULTS: Baha and Ponto Pro osseointegrated implants' abutment and fixture and the implanted magnet of the Sophono Alpha 1 and 2 abutment-free systems are approved for 3-Tesla magnetic resonance (MR) systems. The external processors of these devices are MR Unsafe. Of the implants tested, middle ear ossicular prostheses, including stapes prostheses, except for the 1987 McGee prosthesis, are MR Conditional for 1.5-Tesla (and many are approved for 3-Tesla) MR systems. Cochlear implants with removable magnets are approved for patients undergoing MRI at 1.5 Tesla after magnet removal. The MED-EL PULSAR, SONATA, CONCERT, and CONCERT PIN cochlear implants can be used in patients undergoing MRI at 1.5 Tesla with application of a protective bandage. The MED-EL COMBI 40+ can be used in 0.2-Tesla MR systems. Implants made from nonmagnetic and nonconducting materials are MR Safe. CONCLUSION: Knowledge of MRI guidelines for commonly used otologic implants is important. Guidelines on MRI issues approved by the US Food and Drug Administration are not always the same compared with other parts of the world. IMPLICATIONS FOR PRACTICE: This monograph provides a current reference for physicians on MRI issues for commonly used otologic implants.