New Medical Device and Therapeutic Approvals in Otolaryngology: State of the Art Review of 2022.

Objective: To review new drugs and devices relevant to otolaryngology approved by the Food and Drug Administration (FDA) in 2022. Data Sources: Publicly available FDA data on drugs and devices approved in 2022. Review Methods: A preliminary screen was conducted to identify drugs and devices relevant to otolaryngology. A secondary screen by members of the American Academy of Otolaryngology-Head and Neck Surgery's (AAO-HNS) Medical Devices and Drugs Committee differentiated between minor updates and new approvals. The final list of drugs and devices was sent to members of each subspecialty for review and analysis. Conclusion: A total of 1251 devices and 37 drugs were identified on preliminary screening. Of these, 329 devices and 5 drugs were sent to subspecialists for further review, from which 37 devices and 2 novel drugs were selected for further analysis. The newly approved devices spanned all subspecialties within otolaryngology. Many of the newly approved devices aimed to enhance patient experience, including over-the-counter hearing aids, sleep monitoring devices, and refined CPAP devices. Other advances aimed to improve surgical access, convenience, or comfort in the operating room and clinic. Implications for Practice: Many new devices and drugs are approved each year to improve patient care and care delivery. By staying up to date with these advances, otolaryngologists can leverage new innovations to improve the safety and quality of care. Given the recent approval of these devices, further studies are needed to assess long-term impact within the field of otolaryngology.

Quantifying the effect of shoulder size on operation duration: an analysis of stapes surgery outcomes.

OBJECTIVE: To investigate the effect of body mass index on hearing outcomes, operative time and complication rates following stapes surgery. METHOD: This is a five-year retrospective review of 402 charts from a single tertiary otology referral centre from 2015 to 2020. RESULTS: When the patient's shoulder was adjacent to the surgeon's dominant hand, the average operative time of 40 minutes increased to 70 minutes because of a significant positive association between higher body mass index and longer operative times (normal body mass index group (<25 kg/m2) r = 0.273, p = 0.032; overweight body mass index group (25-30 kg/m2) r = 0.265, p = 0.019). Operative times were not significantly longer upon comparison of low and high body mass index groups without stratification by laterality (54.9 ± 19.6 minutes vs 57.8 ± 19.2 minutes, p = 0.127). CONCLUSION: There is a clinically significant relationship between body mass index and operating times. This may be due to access limitations imposed by shoulder size.

Recent surgical advances and continued controversies in medically refractory Meniere's disease.

PURPOSE OF REVIEW: Meniere's disease is caused by hydropic changes in the endolymphatic system, and manifests as a collection of vertigo, hearing loss, tinnitus, and aural fullness. Although high-quality clinical practice guidelines exist for the diagnosis and initial management of Meniere's disease, there is no strong consensus for treatment of medically refractory Meniere's disease. This review summarizes treatment options and highlights controversies surrounding surgical treatment of Meniere's disease. RECENT FINDINGS: Intratympanic steroid and intratympanic gentamicin injections continue to be widely used as in-office therapies in medically refractory Meniere's disease. Despite historical controversy surrounding the use of endolymphatic sac (ELS) surgery, the use of ELS decompression has been widely adopted by the international neurotologic community due to high vertigo control rate, coupled with low risk of audiovestibular loss. Wider decompression of the sac and surgical manipulation of the endolymphatic duct may impact outcome and are the subject of discussion. An emerging surgical technique called Triple Semicircular Canal Occlusion (TSCO) holds promise as a partially ablative procedure with high vertigo control rate in Meniere's disease. Cochlear implants may be placed in active Meniere's disease patients, or during an ablative surgery such as labyrinthectomy. SUMMARY: For the medically refractory Meniere's disease patient, treatment options include intratympanic steroid injection, endolymphatic sac decompression, medical or surgical labyrinthectomy, and vestibular nerve section. TSCO holds promise as an emerging partially ablative procedure. Cochlear implants maintain an important role in the rehabilitation of hearing loss associated with Meniere's disease.

Twelve-Month Outcomes of Simultaneous Translabyrinthine Resection and Cochlear Implantation.

OBJECTIVE: Audiometric outcomes at 12 months following simultaneous translabyrinthine (TL) resection of vestibular schwannoma (VS) and cochlear implantation (CI). STUDY DESIGN: Prospective cohort study. SETTING: Tertiary referral center. METHODS: Adult patients undergoing TL resection of sporadic, unilateral VS ≤ 2 cm were prospectively enrolled. Preoperative testing included binaural AZBio in noise and quiet and unilateral Consonant-Nucleus-Consonant (CNC). Tinnitus Handicap Index (THI) and Speech, Spatial, and Qualities of Hearing (SSQ) questionnaires were also completed. Patients underwent TL resection with simultaneous CI. The preoperative test battery was repeated at 1, 3, 6, and 12 months after activation. Statistical analysis was performed to characterize short-term outcomes (preoperative to 3 months), longer-term outcomes (3-12 months), and overall changes during the preoperative to 12-month period. RESULTS: AZBio, CNC, and THI improved at 3 months with no significant changes thereafter and showed durable improvement at 12 months compared to preoperative testing. While SSQ did not improve at 12 months, a subset of patients showed either recovery or improvement of SSQ-spatial subscores. Patients with cerebellopontine angle tumors had poorer performance, although the impact of tumor size and location could not be deduced based on the small sample size. CONCLUSION: Patients undergoing simultaneous CI and TL resection of VS had durable improvements in speech perception and tinnitus severity 12 months following surgery. Subjective improvements in localization were not observed. Additional studies are needed to determine which VS patients are optimal candidates for CI.

Effects of an evidence-based model for cochlear implant aftercare delivery on clinical efficiency and patient outcomes.

OBJECTIVES: To assess an evidence-based model (EBM) approach to cochlear implant (CI) aftercare that includes a modified, reduced treatment schedule for newly-implanted adult CI recipients consisting of four appointments (initial activation, 1-, 3- and 6- months postactivation) in the first year post-surgery. METHOD: This prospective multicenter proof-of-concept study was conducted across three clinics in the United States by five experienced CI clinicians. Seventeen newly-implanted adult patients with postlingual hearing loss enrolled in the study. Hearing outcomes were measured using objective speech testing and subjective self-report measures. RESULTS: Most recipients (14/17; 82%) were able to follow the four-appointment EBM schedule. The reduced number of visits translated into an average time savings of 3 hours per patient. Significant improvements in speech perception were observed at both 3- and 6-months postactivation, as measured by CNC words in quiet and AzBio sentences at +10 dB SNR, consistent with published results achieved by traditional practices. Recipients were significantly satisfied with telephone, music, small group conversation, and television listening at 6 months postactivation. Recipient satisfaction with overall service was rated as "excellent" by 14/14 (100%) respondents. CONCLUSION: The four-appointment EBM approach delivered efficient and effective audiological aftercare to CI recipients in the first year following CI implantation.

New Medical Device and Therapeutic Approvals in Otolaryngology: State of the Art Review of 2021.

Objective: To evaluate new medical devices and drugs pertinent to otolaryngology-head and neck surgery that were approved by the Food and Drug Administration (FDA) in 2021. Data Sources: Publicly available FDA device and drug approvals from ENT (ear, nose, and throat), anesthesia, neurosurgery, plastic surgery, and general surgery FDA committees. Review Methods: FDA device and therapeutic approvals were identified and reviewed by members of the American Academy of Otolaryngology-Head and Neck Surgery's Medical Devices and Drugs Committee. Two independent reviewers assessed the relevance of devices and drugs to otolaryngologists. Medical devices and drugs were then allocated to their respective subspecialty fields for critical review based on available scientific literature. Conclusions: The Medical Devices and Drugs Committee reviewed 1153 devices and 52 novel drugs that received FDA approval in 2021 (67 ENT, 106 anesthesia, 618 general surgery and plastic surgery, 362 neurosurgery). Twenty-three devices and 1 therapeutic agent relevant to otolaryngology were included in the state of the art review. Advances spanned all subspecialties, including over-the-counter hearing aid options in otology, expanding treatment options for rhinitis in rhinology, innovative laser-safe endotracheal tubes in laryngology, novel facial rejuvenation and implant technology in facial plastic surgery, and advances in noninvasive and surgical treatment options for obstructive sleep apnea. Implications for Practice: FDA approvals for new technology and pharmaceuticals present new opportunities across subspecialties in otolaryngology. Clinicians' nuanced understanding of the safety, advantages, and limitations of these innovations ensures ongoing progress in patient care.

Patient Sentiments Influencing Management Strategy for Single-sided Deafness.

OBJECTIVE: Assess opinions that influence treatment choice for single sided deafness (SSD). STUDY DESIGN: Retrospective chart review. SETTING: Tertiary neurotology referral center. PATIENTS: Patients with SSD were recruited between December 2020 and February 2021. Included patients were self-selected by voluntary completion of the study questionnaire. MAIN OUTCOME MEASURES: Tinnitus Handicap Inventory (THI), Hearing Handicap Inventory for Adults (HHIA), and a questionnaire containing 25 areas of inquiry relevant to management strategy decision making. RESULTS: In comparison to the surgical management group, patients opting for nonsurgical amplification were significantly more concerned about device visibility (p = 0.005, 1.32 ±â€Š0.22 versus 2.67 ±â€Š0.37), undergoing surgery (p = 0.017, 1.64 ±â€Š0.23 versus 2.89 ±â€Š0.51), and the thought of harboring an implanted device (p = 0.003, 1.46 ±â€Š0.22 versus 2.82 ±â€Š0.35). Patients with a major hearing handicap (grade 2-4) placed significantly less emphasis on out-of-pocket costs (p = 0.049, 2.38 ±â€Š0.17 versus 2.94 ±â€Š0.21) and were less concerned about experiencing discomfort from the device (p = 0.033, 3.13 ±â€Š0.11 versus 3.56 ±â€Š0.16) or ease of device use (p = 0.040, 3.20 ±â€Š0.13 versus 3.63 ±â€Š0.13) when compared with the minor handicap group. CONCLUSIONS: Lingering concerns about device visibility, undergoing surgery, and harboring an implanted device underscore the need for thorough patient counseling during SSD device selection consultations. These efforts should aim to address esthetic and surgical risk concerns while emphasizing the potential for improvements in quality of life.

Rate of Development of Venous Thromboembolism in Lateral Skull Base Surgery.

OBJECTIVES: Venous thromboembolism (VTE) is a major cause of morbidity and mortality for surgical patients. This article aims to determine factors that may have contributed to the development of VTE in patients undergoing lateral skull base surgery, to assess the validity of the Caprini Risk Assessment Model (RAM) score in this subset of patients, and to determine the efficacy of mechanical DVT prophylaxis alone in preventing VTE. STUDY DESIGN: Retrospective chart review. METHODS: A retrospective chart review was conducted of patients who underwent skull base surgery for vestibular schwannoma, and the rate of VTE was assessed. Patient demographics, comorbidities, and treatment factors were examined to determine risk factors associated with the development of a postoperative thrombotic event. Caprini RAM scores were compared for patients who developed a VTE. RESULTS: Among 197 patients, the rate of VTE formation was 3.5%. No individual risk factor independently contributed to the development of a thrombotic event. The mean Caprini RAM score was 4.06 in patients who did not develop a VTE and 5.14 in the patients that did develop a VTE (P = .005). The Caprini score was significant for the risk of VTE formation, with an odds ratio of 2.8 (P = .009, 95% CI = 1.3-6.2). CONCLUSION: Venous thromboembolism rates are relatively low following lateral skull base surgery. While there is no individual risk factor associated with increased VTE risk, the Caprini RAM score appears to be a useful predictor of risk. The Caprini score may be useful in identifying high-risk patients who may benefit from chemoprophylaxis for VTE prevention. LEVEL OF EVIDENCE: 3 Laryngoscope, 132:662-667, 2022.

Otologic Manifestations of Langerhans Cell Histiocytosis: A Systematic Review.

OBJECTIVE: To perform a systematic review to investigate common otologic manifestations of Langerhans cell histiocytosis, the incidence of these findings, methods for diagnosis, as well as medical and surgical management. DATA SOURCES: PubMed/MEDLINE, Embase, and Cochrane Library. REVIEW METHODS: A search of PubMed/MEDLINE, Embase, and Cochrane Library for all articles published between 1963 to 2020 was performed with variations and combinations of the following search terms: Langerhans cell histiocytosis, eosinophilic granuloma, Letterer-Siwe, Hand-Schüller-Christian, otitis, otologic, ear. A review of the references of all included articles was also conducted. RESULTS: Sixty-two articles encompassing 631 patients met inclusion criteria. Otologic symptoms at presentation were found in 246 (39%) patients in the reported studies with 48% reporting bilaterality. The mean age was 14.8 years with a male predominance (64%). The most common otologic presenting symptom was otorrhea (46%). A majority had the multisystem variant (52%). The most common treatment modalities were chemotherapy (52%), followed by surgery (50%), systemic steroids (45%), and radiotherapy (31%). Surgery was performed in 75.8% with unisystem involvement and in 50.6% with multisystem involvement. The most effective treatments included radiotherapy (56% success rate, 17% of treated patients), systemic steroids (44% success, 20% treated), chemotherapy (41% success, 21% treated), and surgical modalities (36% success, 19% treated). CONCLUSIONS: Otologic manifestations that occur with the multisystem variant or are at high risk for central nervous system involvement necessitate systemic treatment. For unifocal lesions, surgery is recommended. Lastly, radiotherapy should be reserved for extensive lesions involving vital structures or presenting in older patients.

New Medical Device and Therapeutic Approvals in Otolaryngology: State of the Art Review 2020.

OBJECTIVES: To evaluate new drugs and devices relevant to otolaryngology-head and neck surgery that were approved by the US Food and Drug Administration (FDA) in 2020. DATA SOURCES: Publicly available device and therapeutic approvals from ENT (ear, nose, and throat), anesthesia, neurology (neurosurgery), and plastic and general surgery FDA committees. REVIEW METHODS: Members of the American Academy of Otolaryngology-Head and Neck Surgery's Medical Devices and Drugs Committee reviewed new therapeutics and medical devices from a query of the FDA's device and therapeutic approvals. Two independent reviewers assessed the drug's or device's relevance to otolaryngology, classified to subspecialty field, with a critical review of available scientific literature. CONCLUSIONS: The Medical Devices and Drugs Committee reviewed 53 new therapeutics and 1094 devices (89 ENT, 140 anesthesia, 511 plastic and general surgery, and 354 neurology) approved in 2020. Ten drugs and 17 devices were considered relevant to the otolaryngology community. Rhinology saw significant improvements around image guidance systems; indications for cochlear implantation expanded; several new monoclonal therapeutics were added to head and neck oncology's armamentarium; and several new approvals appeared for facial plastics surgery, pediatric otolaryngology, and comprehensive otolaryngology. IMPLICATIONS FOR PRACTICE: New technologies and pharmaceuticals offer the promise of improving how we care for otolaryngology patients. However, judicious introduction of innovations into practice requires a nuanced understanding of safety, advantages, and limitations. Working knowledge of new drugs and medical devices approved for the market helps clinicians tailor patient care accordingly.

Risk Factors for Complications Following Lateral Skull Base Surgery and the Utility of ICU Monitoring.

OBJECTIVE: To examine the role of intensive care unit (ICU) management following lateral skull base surgery for vestibular schwannoma and identify risk factors for complications warranting admission to the ICU. STUDY DESIGN: Retrospective review. SETTING: Tertiary referral center. PATIENTS: Two hundred consecutive patients undergoing lateral skull base surgery for vestibular schwannomas. INTERVENTION: Lateral skull base approach for resection of vestibular schwannoma and postoperative monitoring. MAIN OUTCOME MEASURES: Patients were grouped if they sustained an ICU complication, a non-ICU complication, or no complication. Analysis was performed to determine patient or treatment factors that may be associated with ICU complications. Multivariate and three-way analysis of variance compared groups, and multivariate logistic regression determined adjusted odds ratios (aOR) for analyzed factors. RESULTS: Seventeen of 200 patients sustained ICU complications (8.5%), most commonly hypertensive urgency (n = 15). Forty-six (23%) sustained non-ICU complications, and 137 (68.5%) had no complications. When controlling for age, sex, obesity, and other comorbidities, only hypertension (aOR 5.43, 95% confidence interval (CI) 1.35-21.73, p = 0.017) and tumor volume (aOR 3.29, 95% CI 1.09-9.96, p = 0.035) were independently associated with increased risk of ICU complications. CONCLUSIONS: The necessity of intensive care following lateral skull base surgery is rare, with the primary ICU complication being hypertensive urgency. Preoperative hypertension and large tumor volume (>4500 mm3) were independently associated with increased risk for ICU complications. These findings may allow for risk stratification of patients appropriate for admission to stepdown units following resection of vestibular schwannomas. Further prospective, multi-center, randomized studies are necessary to validate these findings before systematic changes to current postoperative care practices.

Diagnosis and management of eosinophilic otitis media: a systematic review.

BACKGROUND: Eosinophilic Otitis Media (EOM) is a relatively newly defined entity of recurrent and resistant otitis media. OBJECTIVE: To perform a systematic review of otologic manifestations, diagnosis and management of eosinophilic otitis media (EOM). METHODS: 393 patients diagnosed with EOM of 26 studies met inclusion criteria and were assessed for demographics, otologic manifestations, diagnostic criteria fulfilled, and medical and surgical treatments. RESULTS: Most common otologic manifestations were hearing loss (65%), otitis media with effusion (16%), tympanic membrane perforation (13%), and otorrhea (13%). 93% had a predominantly eosinophilic middle ear effusion, 95% had asthma, 85% had a highly viscous middle ear effusion, 71% had nasal polyposis, and 58% had resistance to conventional treatment. For treatment, 39% received intratympanic steroid injections, 33% received systemic steroids, 17% received steroid ear drops and 13% received a biological agent. 39% of patients underwent a surgical intervention with 26% receiving functional endoscopic sinus surgery and 18% receiving myringotomy with tube insertion. Success rates were highest with use of intratympanic steroids (45%), systemic steroids (26%), and biological agents (58%). CONCLUSION: Intratympanic steroids show the most efficacy in treating EOM, and aggressive optimization of asthma may be beneficial in resolving otologic symptoms. Surgery should be reserved for refractory cases and complications.

Early Outcomes of Simultaneous Translabyrinthine Resection and Cochlear Implantation.

OBJECTIVES/HYPOTHESIS: Hearing rehabilitation after translabyrinthine resection of a vestibular schwannoma (VS) has largely been based on the transfer of acoustic stimulus to the contralateral ear, typically through a contralateral routing of signal hearing aid or bone-anchored hearing aid (BAHA). Cochlear implant, either as a subsequent surgery or simultaneously, has become a more common treatment option; however, there is still relatively limited data available on its success. The purpose of this study is to evaluate the early outcomes of simultaneous cochlear implantation in patients with sporadic VS undergoing translabyrinthine resection. STUDY DESIGN: Prospective, nonrandomized study. METHODS: A prospective study of nonrandomized patients was completed at a tertiary care neurotology center. Audiologic outcomes, primarily based on AzBIO in quiet and background noise, as well as consonant-nucleus-consonant (CNC) testing of the affected ears were utilized. Tinnitus, dizziness, and spatial hearing questionnaries were also completed. Audiologic outcomes and questionnaires were compared between the pre- and postoperative groups. RESULTS: Ten patients were included in the study with 3 month follow-up data. There was statistically significant improvement in AzBO with +10 and +5 signal to noise ratio and in quiet, as well as in CNC testing (P < .05). There was a significant improvement in Tinnitus Handicap Inventory between the two groups. CONCLUSIONS: Simultaneous cochlear implantation is a viable treatment for hearing loss after translabyrinthine approach to VS. These patients have improved hearing in background noise and tinnitus compared to their preoperative state. Further prognostic data are required to determine which patients are the best candidates. LEVEL OF EVIDENCE: 4 Laryngoscope, 131:E2312-E2317, 2021.

Audiologic Outcomes After Oval and Round Window Reinforcement Surgery.

INTRODUCTION: Oval window (OW) and round window (RW) reinforcement surgery has been used for symptomatic treatment of multiple clinical entities, most commonly perilymphatic fistula and superior semicircular canal dehiscence. Owing to the theoretical acoustically negative effect of stiffening the windows, there has been concern of an unfavorable effect on audiologic outcomes due to the procedure. The purpose of this study is to specifically evaluate audiologic outcomes after OW and RW reinforcement. METHODS: A retrospective review of patients undergoing transcanal OW or RW reinforcement was completed. Patients were evaluated both as a total group and as two groups separated into "third window" and "two-window" groups based on their specific diagnosis. Primary outcomes included changes in individual pure-tone thresholds, pure-tone average (PTA), air-bone gap, speech reception threshold (SRT), and word recognition scores (WRS) between the preoperative and postoperative groups. RESULTS: Seventy-one patients were included in the study. The combined cohort demonstrated a significant postoperative 2.75 dB increase in the air conduction hearing level at 4000 Hz (p < 0.05). This was almost entirely accounted for by a 2.18 dB increase in the air-bone gap at this frequency (p < 0.05). There were no significant changes in PTA, SRT, or WRS between in the combined group or in the subgroup analysis. CONCLUSION: OW and RW tissue reinforcement resulted in a statistically significant but likely clinically insignificant decrease in hearing at the 4000 Hz frequency. There was no worsening of PTA, WRS, or SRT.

Post-stapedotomy reparative granuloma following use of acellular porcine small intestinal submucosa.

PURPOSE: There have been multiple proposed etiologies of reparative granuloma following stapes surgery. In this report, we present the first case of post-stapedectomy reparative granuloma following the use of Biodesign (Cook Medical, Bloomington, IN) otologic graft material, an acellular matrix derived from porcine small intestinal submucosa, and review the literature of post-stapes surgery reparative granuloma. PATIENT: 50-year-old woman who developed a reparative granuloma following stapedotomy with acellular porcine intestinal submucosa presenting with profound hearing loss and vertigo. INTERVENTION: Middle ear exploration with excision of granuloma and revision stapedotomy. MAIN OUTCOME MEASURES: Audiologic outcomes as measured by pure-tone air and bone conduction thresholds and word recognition scores. Improvement in vertigo. MAIN FINDINGS: Surgical excision of the reparative granuloma with revision stapedotomy resolved vertigo. Hearing has improved progressively postoperatively. CONCLUSIONS: We report the first case of post-stapedotomy reparative granuloma following the use of acellular porcine intestinal submucosa. Although exact etiology cannot be determined from a single case report, this illustrates the need for careful use of novel foreign graft material. This case additionally confirms that removal of granuloma and inciting materials can salvage serviceable hearing.

Hearing Outcomes With a Novel Total Ossicular Replacement Prosthesis.

INTRODUCTION: A total ossicular replacement prosthesis (TORP) is used to reconstruct the ossicular chain in the absence of the stapes suprastructure. The Wildcat prosthesis is a novel TORP that eliminates the need for a separate footplate shoe prosthesis and aims to improve ease-of-use and stability. This study evaluates hearing outcomes using the Wildcat prosthesis. STUDY DESIGN: Case series with chart review. SETTING: Tertiary neurotology referral center. METHODS: Retrospective chart review of 64 patients undergoing ossicular chain reconstruction using the Wildcat TORP. Hearing outcomes after surgery were assessed with air conduction pure-tone average, bone conduction pure-tone average, air-bone gap (ABG), speech recognition threshold , and word recognition score as primary outcome measures. The stability of hearing outcomes was evaluated on subsequent long-term follow-up. RESULTS: At mean short-term follow-up of 4.4 ±â€Š2.7 months, ABG improved from 31.0 ±â€Š13.0 dB preoperatively to 22.5 ±â€Š10.0 dB (p < 0.001) with 51.6% achieving ABG less than 20 dB. No significant difference in any primary outcome measures was found when analyzing outcomes by initial versus revision surgery, use of cartilage graft, or type of mastoidectomy. The only exception was a smaller reduction in ABG of 4.2 dB for patients with canal wall down mastoidectomy compared with a 13.7 dB ABG closure in patients with canal wall up mastoidectomy (p = 0.039). CONCLUSION: Total ossicular chain reconstruction using the Wildcat demonstrates versatility in challenging cases to provide hearing outcomes that are comparable to published data using TORPs.

Pre-existing Vestibular Symptoms Are Associated With Acute Vestibular Symptoms After Gamma Knife Therapy for Vestibular Schwannoma.

OBJECTIVE: To identify pretreatment variables associated with the development of acute vestibular symptoms after Gamma Knife (GK) treatment for Vestibular Schwannoma (VS). STUDY DESIGN: Retrospective case series. SETTING: Tertiary neurotology referral center. PATIENTS: Patients treated with GK radiosurgery for VS between March 2007 and March 2017 were considered for this study. Patients with neurofibromatosis type II, previous VS surgery, follow-up less than 6 months, or the lack of T2 magnetic resonance imaging (MRI) sequences from the day of treatment were excluded. MAIN OUTCOME MEASURES: The presence of acute vestibular symptoms arising within 6 months after GK was the main outcome variable. Tumor, patient, and treatment characteristics were gathered from the medical record. RESULTS: In total, 98 patients met inclusion criteria. The incidence of acute vestibular symptoms occurring within 6 months after GK treatment was 46.9%. Post-GK vestibular symptoms were reported at a significantly higher frequency among subjects who had reported vestibular symptoms before their treatment (p = 0.001). Tumor size was not associated with a propensity to develop acute vestibular symptoms (p = 0.397). The likelihood of receiving a referral to vestibular rehabilitation services was not significantly different among patients with larger versus smaller tumor size, as defined by 1.6 cm and 1.4 cm thresholds (p = 0.896, p = 0.654). CONCLUSIONS: Inquiries aimed at revealing a history of vestibular complaints may prove useful in counseling patients on the likelihood of experiencing acute vestibular symptoms after treatment of Vestibular Schwannoma with Gamma Knife therapy.

A Protective Cap: Fundal Fluid Cap Facilitates a Reduction in Inner Ear Radiation Dose in the Radiosurgical Treatment of Vestibular Schwannoma.

OBJECTIVE: Assess inner ear radiation dose magnitude as it relates to fundal cap length and hearing outcomes in the radiosurgical treatment of vestibular schwannoma. STUDY DESIGN: Retrospective case series. SETTING: Tertiary neurotology referral center. PATIENTS: Patients treated with Gamma Knife radiosurgery for vestibular schwannoma between March 2007 and March 2017 were considered for this study. Exclusion criteria included pretreatment pure-tone average (PTA) >90 dB, neurofibromatosis type II, history of previous surgical resection, and follow-up less than 1 year. MAIN OUTCOME MEASURE: (s): Hearing function was assessed by maintenance of class A/B hearing level and maintenance of baseline hearing (≤20 dB change in PTA following Gamma Knife radiosurgery). RESULTS: Lower radiation doses delivered to the inner ear were associated with longer fundal cap lengths: mean cochlear dose (r = -0.130; p = 0.184), mean labyrinth dose (r = -0.406; p < 0.001), max cochlear dose (r = -0.326; p = 0.001), and max labyrinth dose (r = -0.360; p < 0.001). Kaplan-Meier analysis with log-rank testing revealed that patients with a mean labyrinth dose < 3 Gy achieved higher rates of preserving baseline hearing (≤20 dB change in PTA) following radiosurgery, compared to patients with a mean labyrinth dose ≥3 Gy (p < 0.001). A fundal fluid cap length of 2.5 mm was associated with the 3 Gy mean labyrinth dose threshold. CONCLUSIONS: We report that fundal cap presence facilitated the creation of treatment plans with a lower dose delivered to the labyrinth. By affording this dose reduction, a fundal cap may be associated with a slight improvement in hearing outcomes.