FDA MAUDE database analysis of titanium middle ear prosthesis.

PURPOSE: Partial ossicular replacement (PORP) and total ossicular replacement prostheses (TORP) are used to restore ossicular chain function. Despite favorable auditory outcomes, these interventions have associated risks and complications. This study examines the FDA MAUDE database for ossicular chain prosthesis adverse events to highlight complications, interventions, and root cause analysis (RCA) findings. MATERIALS AND METHODS: The MAUDE database was searched for Medical Device Reports (MDRs) relating to PORPs and TORPs from 2010 to 2020. MDR event descriptions were reviewed, and adverse events were identified as a device issue, patient issue, and/or packaging issue that occurred intraoperatively or postoperatively. RESULTS: Our search identified 70 MDRs which included 110 reported adverse events. Events consisted of 63 device issues, often due to device breaks and displacements, 39 patient issues, including common complaints of hearing loss and erosion, and 8 packaging issues. When comparing PORPs and TORPs, TORPs had more reported device issues whereas PORPs had more packaging issues. Intraoperative device issues were commonly resolved by completing the procedure with a backup device and most postoperative device issues required additional surgery. For devices returned to the manufacturer, RCA determined that most breaks were caused by modification and/or mishandling or that the product met specifications with an undetermined cause for the break. CONCLUSION: Device issues were the most common adverse events and frequently required subsequent intervention. Displacement occurred more often with TORPs and was associated with changes in hearing or erosion. The findings of this study are purely descriptive and may not have direct clinical relevance.

Clinical trials in otology: Examining trends and framework for prioritization.

OBJECTIVE: To characterize otologic clinical trials and examine otologic clinical trial trends from 2008 to 2018 using the clinicaltrials.gov database. METHODS: Data was collected from clinicaltrials.gov and included all clinical trials that focused on otology from 2008 to 2018. Outcome measures include status of trials, funding sources, details regarding otologic conditions studied, and trends in clinical trials. RESULTS: There were 992 otology clinical trials from 2008 to 2018.457 (46.1%) were completed and 94 (9.5%) were discontinued. Industry remained the highest (76.5%) contributor to otology clinical trials. The otologic conditions studied, from most common to least common, include hearing loss (40.6%), vestibulopathy (18.8%), tinnitus (18.8%), and otitis media (15.1%). The number of otology clinical trials increased by an average of 12.0 trials per year from 2008 to 2018 (p < 0.001). The number of otology clinical trials focusing on hearing loss and vestibulopathy significantly increased over the studied period (p < 0.001), while those focusing on tinnitus and otitis media did not (p = 0.09 and p = 0.20, respectively). The majority of clinical trials on each of these four conditions focused on treatment options. CONCLUSION: Our study describes trends in otology clinical trials registered on clinicaltrials.gov from 2008 through 2018. The total number of clinical trials over this time period increased significantly, driven by trials investigating hearing loss and vestibulopathy. Furthermore, most clinical trials were industry-sponsored and focused on treatment modalities. Our study provides an outline of otology clinical trials registered in a US web-based database, which may be of use for the development of future clinical trials.

Impact and Cost Effectiveness of Videonystagmography.

OBJECTIVE: Videonystagmography (VNG) is a commonly ordered test to evaluate patients with vestibular complaints. To date, there are no evidence-based guidelines for evaluating patients presenting with vestibular symptoms. This study evaluates the cost effectiveness of VNG and the impact of VNG findings on patient management. METHODS: Patient charts were reviewed from 3 institutions to collect the pre- and post-VNG ICD-9/10 diagnosis and treatment plan. VNG findings were recorded to calculate the incidence of abnormal findings and the incidence of change in diagnosis and/or treatment plan. The cost effectiveness of VNG was estimated based on these calculations. RESULTS: A total of 120 patient charts were reviewed. 69/120 (57.5%; 95% CI: 48.2%-66.5%) patients had abnormal findings on their VNG. A change in diagnosis was noted in 24/120 (20.0%; 95% CI: 13.3%-28.3%) patients. A change in treatment plan was noted in 62/120 (51.7%; 95% CI: 42.4%-60.9%) patients, and 11/120 (9.2%; 95% CI: 4.7%-15.8%) had a change in diagnosis that led to change in treatment plan. Using the average Medicare reimbursement for VNG, the cost effectiveness analysis showed a cost of $869.57 per VNG with abnormal findings and a cost of $5454.55 per VNG that lead to a change in diagnosis and treatment plan. CONCLUSIONS: VNG findings may not result in changes in clinical diagnosis. However, VNG is impactful at influencing treatment plan changes. VNG results are beneficial for counseling patients, guiding treatment plans, and managing patient expectations. When there is a clear indication, VNG testing can be cost effective in managing patients presenting with vestibular symptoms.

Absence of contrast enhancement in a petroclival meningioma: Case report and systematic literature review.

BACKGROUND: Meningioma is one of the most common intracranial tumors with well-established radiologic features such as contrast enhancement, dural tail, and hyperostosis on computed tomography and magnetic resonance imaging. Contrast enhancement is usually homogeneous or heterogeneous based on tumor vascularity and underlying histopathology. Even in this context, faint or nonenhancing meningioma is exceedingly rare. CASE DESCRIPTION: A 57-year-old male presented with progressive right hearing loss, disequilibrium, occasional difficulty swallowing, and facial numbness. Imaging demonstrated an extensive hypodense, nonenhancing right cerebellopontine angle mass extending from the interpeduncular, and ambient cisterns to the foramen magnum. The pathological analysis demonstrated a microcystic meningioma WHO Grade I. There are few reported case reports or series of minimal or nonenhancing meningiomas, and a systematic review was performed for these cases. Seven peer-reviewed articles with 14 verifiable cases were identified and reviewed for radiologic features, tumor location, and tumor classification. The majority of minimal or nonenhancing meningiomas were microcystic, and most of them located at the convexity. This is the second case reported of a nonenhancing meningioma at the cerebellopontine angle and petroclival region. CONCLUSION: Meningioma should be considered a differential diagnosis for nonenhancing lesion at the cerebellopontine and petroclival regions.

Utility of intraoperative computed tomography for cochlear implantation in patients with difficult anatomy.

OBJECTIVE AND IMPORTANCE: To describe cases that illustrate the utility of intraoperative computed tomography (CT) in cochlear implantation of patients with difficult temporal bone anatomy. CLINICAL PRESENTATION: A 2-year-old male with congenital X-linked stapes gusher syndrome and a 2-year-old female with enlarged vestibular aqueduct underwent successful cochlear implantation with the help of intraoperative CT. In the latter case, the initial intraoperative C-arm fluoroscopy suggested malposition of the electrode, however, was not able to provide details for adjustments. In both cases, intraoperative CT changed the insertion technique of the operating surgeon and allowed for improved electrode positioning. A 47-year-old female with polyostotic fibrous dysplasia and a 55-year-old male with post-meningitis near-total cochlear obliteration underwent successful cochlear implantation with confirmation of electrode position with intraoperative CT. In the former case, the image-guided navigation system was also implemented. Finally, a 72-year-old female underwent cochlear implantation during which intraoperative C-arm fluoroscopy suggested intra-cochlear insertion. However, postoperative CT showed the electrode extending into the internal auditory canal (IAC), illustrating the limitations of C-arm fluoroscopy. INTERVENTION: Intraoperative CT imaging and image-guided navigation system. CONCLUSION: When faced with challenging temporal bone anatomy, intraoperative CT can provide critical details of the patient's microanatomy that allows for improved localization of the electrode and adjustments in operative techniques for successful cochlear implantation.

Epidural hematoma after tympanomastoidectomy and bone-anchored hearing aid (BAHA) placement: case report.

BACKGROUND AND IMPORTANCE: Epidural hematoma (EDH) has never been reported as a complication after placement of a bone-anchored hearing aid (BAHA). To our knowledge, this is the first case report of an EDH after placement of a BAHA. CLINICAL PRESENTATION: We report the case of a 15-year-old girl with an EDH after placement of a BAHA. Initially, she presented with a history of right ear conductive hearing loss and had a tympanomastoidectomy and placement of a BAHA at an outpatient surgical facility. Postoperatively, the patient was transferred to the postoperative care unit in stable neurological condition but was subsequently noted to be lethargic with dilated, nonreactive pupils and extensor posturing. A computed tomography scan revealed a large right temporal EDH with midline shift. She was then taken to the operating room emergently for craniotomy and evacuation of the EDH. After evacuation, she was admitted to the pediatric intensive care unit and slowly emerged from her coma with supportive care. She was discharged to inpatient rehabilitation and has made a good recovery. CONCLUSION: This report emphasizes the need for a high index of suspicion of this rare, but life-threatening complication of an EDH after the placement of a BAHA.

Intact meatal skin, canal wall down approach for difficult cochlear implantation.

INTRODUCTION: The intact posterior meatal skin, canal wall down technique for difficult cochlear implantation provides expanded access to the middle ear for cochleostomy in cases of obscured middle-ear landmarks, limited facial recess access and limited mastoid cavity dimensions. Careful preservation of the posterior canal wall skin in this procedure obviates the need for obliteration of the middle-ear mucosa and closure of the external auditory canal. OBJECTIVES: To present a canal wall down technique for cochlear implantation, which preserves the intact posterior external auditory canal wall skin. This approach is employed when a standard facial recess cochleostomy is not possible. METHODS: Three cases of intact posterior meatal skin, canal wall down cochlear implantation are presented together with long-term follow-up results. In all three cases, implantation via a facial recess approach was not possible. One patient suffered from severe cochlear otosclerosis with obliteration of the round window niche. The second patient had severe middle-ear fibrosis with encasement of all middle-ear structures and obliteration of routine landmarks. The third patient had an anterior sigmoid sinus obscuring access to the facial recess. Cochlear implantation via the canal wall down, intact posterior canal wall skin technique was successfully performed in each of these patients. RESULTS: All three patients were successfully implanted, with full electrode insertion achieved. All patients subsequently became active implant users. One patient did suffer from a minor wound complication post-operatively, unrelated to the approach. Patient follow up ranged from four to six years.

Auricular ossification resulting in external auditory canal stenosis.

We report the case of a 49-year-old man who presented with left aural fullness, hearing loss, and a stenotic left external auditory meatus. Physical examination and computed tomography revealed the presence of an idiopathic ossification of the cartilaginous auricle and external auditory canal. The patient was successfully treated with meatoplasty. Pathologic examination of the removed specimen revealed osseous metaplasia.

Underlay tympanoplasty with laser tissue welding.

We investigated the feasibility of using laser tissue welding techniques to perform transcanal underlay tympanoplasty. We used 10 temporal bones obtained from human cadavers. After creating a subtotal tympanic membrane perforation, we introduced harvested periosteum through the perforation and used laser tissue welding to secure the periosteum graft in place in an underlay fashion. The procedure was performed via a transcanal approach and did not require middle ear packing. Immediately after the graft had been placed, we qualitatively tested its integrity with a blunt probe. The graft was as strong as the native cadaver tympanic membrane in all 10 cases. We conclude that laser transcanal underlay tympanoplasty is a feasible and effective method of repairing a tympanic membrane. The ultimate goal is to develop a technique that will allow physicians to routinely perform underlay tympanoplasty on moderately sized perforations in an office setting.

Minimal access surgery for the Symphonix/Med-El Vibrant Soundbridge middle ear hearing implant.

OBJECTIVE: To develop a minimal access approach for implantation of the Vibrant Soundbridge middle ear hearing implant. This approach ideally uses the smallest skin incision possible, minimal or no hair shave, and the least possible amount of tissue and bone manipulation. This will facilitate the acceptability of the procedure to the general community and reduce the flap-related complication rate. The procedure is similar to the minimal access approach described for cochlear implantation. STUDY DESIGN: Eight patients with various degrees of sensorineural hearing loss and one with a mixed hearing loss who met implant criteria for the Vibrant Soundbridge middle ear hearing implant received the device over a 42-month period. The first two patients underwent the traditional implant procedure with postauricular hair shave, postauricular S-shaped incision, and implant receiver suture fixation to the temporal bone. The following seven consecutive patients received a progressively smaller C-shaped postauricular skin incision, no hair shave, retrograde skull drilling for the implant seat, and no implant suture fixation until the technique closely approximated the minimal access cochlear implant procedure. Postoperative performance of the Soundbridge/Vibrant Med-El was evaluated through audiology testing and subjective patient reports. SETTING: Private neurotology clinic and tertiary care teaching hospital. RESULTS: The technique was feasible in all patients. Follow-up for the minimal access group ranged from 3 years to 5 months. There were no complications related to the approach, and all patients were satisfied users of the implant. The lack of hair shave and small incision size was greatly appreciated and warmly endorsed by the patients. CONCLUSION: The Vibrant Soundbridge/Vibrant Med-El can be safely implanted using the minimal access method that has been popularized for cochlear implant surgery. A large incision, extensive hair shave, risk of flap necrosis, and possibility of unsightly scar may deter patients from pursuing the potential benefits of implanted hearing technology. The technique may make the device more accessible to individuals who have concerns regarding cosmetics and potential flap complications.