Efficacy of the Bonebridge BCI602 for Adult Patients with Single-sided Deafness: A Prospective Multicenter Study.

OBJECTIVE: To investigate the safety and efficacy of a novel active transcutaneous bone conduction implant (BCI) device for patients with single-sided deafness (SSD). STUDY DESIGN: Prospective cohort study. SETTING: Tertiary referral hospitals. METHODS: This prospective multicenter study was conducted at 15 institutions nationwide. Thirty adult (aged ≥19 years) SSD patients were recruited. They underwent implantation of an active transcutaneous BCI device (Bonebridge BCI602). Objective outcomes included aided pure-tone thresholds, aided speech discrimination scores (SDSs), and the Hearing in Noise Test (HINT) and sound localization test results. The Bern Benefit in Single-Sided Deafness (BBSS) questionnaire, the Abbreviated Profile of Hearing Aid Benefit (APHAB) questionnaire, and the Tinnitus Handicap Inventory (THI) were used to measure subjective benefits. RESULTS: The mean aided pure-tone threshold was 34.2 (11.3), mean (SD), dB HL at 500 to 4000 Hz. The mean total BBSS score was 27.5 (13.8). All APHAB questionnaire domain scores showed significant improvements: ease of communication, 33.6 (23.2) versus 22.6 (21.3), P = .025; reverberation, 44.8 (16.6) versus 32.8 (15.9), P = .002; background noise, 55.5 (23.6) versus 35.2 (18.1), P < .001; and aversiveness, 36.7 (22.8) versus 25.8 (21.4), P = .028. Moreover, the THI scores were significantly reduced [47.4 (30.1) versus 31.1 (27.0), P = .003]. Congenital SSD was a significant factor of subjective benefit (-11.643; 95% confidence interval: -21.946 to -1.340). CONCLUSION: The BCI602 active transcutaneous BCI device can provide functional hearing gain without any adverse effects and is a feasible option for acquired SSD patients with long-term deafness.

A multicenter, randomized, active-controlled, clinical trial study to evaluate the efficacy and safety of navigation guided balloon Eustachian tuboplasty.

To assess the safety and efficacy of navigation-guided balloon Eustachian tuboplasty (BET) compared to medical management (MM) alone in patients with chronic Eustachian tube dilatory dysfunction (ETD). This is a prospective, multicenter, 1:1 parallel-group, randomized controlled trial (RCT). It aims to assess the efficacy of navigation-guided BET compared to MM alone in patients with chronic ETD. The primary outcome measure was an improvement in the Eustachian tube dysfunction questionnaire (ETDQ)-7 score at the 6-week follow-up compared with baseline. Secondary outcome measures included changes in the signs and symptoms during the follow-up, changes in the score for each subcategory of ETDQ-7, type of tympanometry, pure tone audiometry, and the availability of a positive modified Valsalva maneuver. Navigation-guided BET was safely performed in all patients. A total of 38 ears of 31 patients (19 ears of 16 patients in the BET group and 19 ears of 15 patients in the control group) completed the planned treatment and 6 weeks of follow-up. More patients in the BET group (1.99 ± 0.85) had less symptomatic dysfunction than in the control group (3.40 ± 1.29) at 6 weeks post-procedure (P = 0.001). More patients experienced tympanogram improvement in the BET group at 6 weeks compared to the control group (36.5% vs. 15.8%) with a positive modified Valsalva maneuver (36.6% vs. 15.8%, P = 0.014). Additionally, air-bone gap change was significantly decreased in the BET group compared to the control group at the 6-week follow-up visit (P = 0.037). This prospective, multicenter, RCT study suggests that navigation-guided BET is a safe and superior treatment option compared to MM alone in patients with chronic ETD.

High Blood Glucose Levels Affect Auditory Brainstem Responses after Acoustic Overexposure in Rats.

INTRODUCTION: Diabetes mellitus (DM) is a systemic disease characterized by hyperglycemia and several pathological changes. DM-related hearing dysfunctions are associated with histological changes. Here, we explore hearing function and synaptic changes in the inner hair cells (IHCs) of rats with streptozotocin (STZ)-induced diabetes. METHODS: STZ was injected to trigger diabetes. Rats with DM were exposed to narrow-band noise (105 dB SPL) for 2 h, and hearing function was analyzed 1, 3, 7, and 14 days later. Both the hearing threshold and the peak 1 amplitude of the tone auditory brainstem response were assessed. After the last functional test, animals were sacrificed for histological evaluation. RESULTS: We found no changes in the baseline hearing threshold; however, the peak 1 amplitude at the low frequency (4 kHz) was significantly higher in both DM groups than in the control groups. The hearing threshold had not fully recovered at 14 days after diabetic rats were exposed to noise. The peak 1 amplitude at the higher frequencies (16 and 32 kHz) was significantly larger in both DM groups than in the control groups. The histological analysis revealed that the long-term DM group had significantly more synapses in the 16 kHz region than the other groups. CONCLUSIONS: We found that high blood glucose levels increased peak 1 amplitudes without changing the hearing threshold. Diabetic rats were less resilient in threshold changes and were less vulnerable to peak 1 amplitude and synaptic damage than control animals.

Nimodipine and Steroid Combination Therapy for Idiopathic Sudden Sensorineural Hearing Loss.

OBJECTIVE: To evaluate the treatment outcomes of nimodipine and steroid combination therapy for idiopathic sudden sensorineural hearing loss (ISSNHL). STUDY DESIGN: Retrospective case review. SETTING: Tertiary referral center. PATIENTS: Seventy-eight patients who were diagnosed with ISSNHL were divided into two group based on the treatment strategies used: steroid+nimodipine (SN, n = 36) and steroid only (SO, n = 42) groups. Based on the level of hearing loss before treatment, subgroup analysis (<90 dB HL, SN-S versus SO-S groups; ≥90 dB HL, SN-P versus SO-P groups) was performed. INTERVENTIONS: Nimodipine+dexamethasone versus dexamethasone alone. MAIN OUTCOME MEASURES: Hearing thresholds and complete/partial recovery rate after treatment. RESULTS: Hearing thresholds after treatment were not significantly different between the SN and SO groups (46.8 ±â€Š29.4 versus 54.8 ±â€Š27.6 dB HL, p = 0.218). However, the complete recovery rate was significantly higher in the SN group than in the SO group (41.7% versus 16.8%, p = 0.014). In subgroup analysis, the complete recovery rate was significantly higher in the SN-S group than in the SO-S group (60.9% versus 19.2%, p = 0.003), whereas the difference between the SN-P and SO-P groups was not significant (7.7% versus 12.5%, p = 0.672). The cumulative incidence of complete recovery was significantly higher in SN-S group than in the SO-S group (p = 0.005); the mean recovery time was 4.4 weeks (95% confidence interval [CI], 2.8-6.1) in the SN-S group and 8.8 weeks (95% CI, 7.0-10.5) in the SO-S group. CONCLUSIONS: The results of this study suggest that nimodipine and steroid combination therapy for ISSNHL results in a higher complete recovery rate than steroid alone in patients with moderate to severe hearing loss.

Potential benefits of salvage intratympanic dexamethasone injection in profound idiopathic sudden sensorineural hearing loss.

PURPOSES: To compare hearing recovery levels after initial treatment or salvage intratympanic dexamethasone injection (ITDI), and to find the prognostic factor on salvage ITDI therapy in profound ISSNHL. METHODS: We retrospectively reviewed 115 patients with profound ISSNHL. All patients were treated with combination or systemic steroid therapy as the initial treatment. Next, we used salvage ITDI therapy on patients who showed slight or no improvement according to Siegel's criteria. To find the prognostic factors for the effectiveness of salvage ITDI therapy, we analyzed clinical data, such as, age, sex, vertigo, symptom duration, diabetes, hypertension, initial PTA, pre-salvage PTA, and treatment methods, using multiple regression analyses. RESULTS: The rate of serviceable hearing recovery were 10.4% (12/115) in the initial-treatment group and 20.4% (21/103) in the salvage group. The difference was statistically significant (p = 0.041). Pre-salvage PTA, diabetes mellitus, and symptom duration were affective factors for the effectiveness of salvage ITDI therapy in profound ISSNHL refractory to initial treatment, with odds ratios of 1.169 (95% confidence interval, 1.088-1.256), 0.069 (95% confidence interval, 0.005-0.889), and 9.242 (95% confidence interval, 1.079-79.146). CONCLUSIONS: Salvage therapy should be considered for profound ISSNHL, which is expected to result in poor prognosis or hearing recovery: ITSI therapy might be an effective treatment as salvage therapy.

Impaired Glycolysis Promotes AlcoholExposure-Induced Apoptosis in HEI-OC1 Cells via Inhibition of EGFR Signaling.

Glucose metabolism is an important metabolic pathway in the auditory system. Chronic alcohol exposure can cause metabolic dysfunction in auditory cells during hearing loss. While alcohol exposure has been linked to hearing loss, the mechanism by which impaired glycolysis promotes cytotoxicity and cell death in auditory cells remains unclear. Here, we show that the inhibition of epidermal growth factor receptor (EGFR)-induced glycolysis is a critical mechanism for alcohol exposure-induced apoptosis in HEI-OC1 cells. The cytotoxicity via apoptosis was significantly increased by alcohol exposure in HEI-OC1 cells. The glycolytic activity and the levels of hexokinase 1 (HK1) were significantly suppressed by alcohol exposure in HEI-OC1 cells. Mechanistic studies showed that the levels of EGFR and AKT phosphorylation were reduced by alcohol exposure in HEI-OC1 cells. Notably, HK1 expression and glycolytic activity was suppressed by EGFR inhibition in HEI-OC1 cells. These results suggest that impaired glycolysis promotes alcohol exposure-induced apoptosis in HEI-OC1 cells via the inhibition of EGFR signaling.

A 3D-printed polycaprolactone/ß-tricalcium phosphate mandibular prosthesis: A pilot animal study.

OBJECTIVE: In this study, we assessed the effectiveness of a tonsil-derived mesenchymal stem cell (TMSC)-transplanted polycaprolactone/beta-tricalcium phosphate prosthesis (specifically designed for easier fixing and grafting with a single scaffold) on rabbit mandible osteogenesis. METHODS: The mandibles of 18 rabbits were exposed, and 10 × 8-mm bone defects were made. Two rabbits did not receive implants; four were reconstructed with the scaffold control (SC) (SC group); four were reconstructed with scaffolds soaked in peripheral blood (PB) (PB group); four were reconstructed with TMSC-transplanted scaffolds (TMSC group); and four were reconstructed with differentiated osteocyte-transplanted scaffolds (DOC) (DOC group). Each rabbit was sacrificed 12 weeks after surgery, and the area of new bone formation was investigated by mechanical testing, histology, and micro-computed tomography. RESULTS: More extended and denser new bone masses were observed in the TMSC and DOC groups, although fibrosis and vascular formation levels were similar in all groups, suggesting that the dual-structured scaffold alone provides a good environment for bone attachment and regeneration. The bone volumes of representative scaffolds from the SC, PB, TMSC, and DOC groups were 43.12, 48.35, 53.10, and 57.44% of the total volumes, respectively. CONCLUSION: The design of the scaffold resulted in effective osteogenesis, and TMSCs showed osteogenic potency, indicating that their combination could enable effective bone regeneration. LEVEL OF EVIDENCE: NA Laryngoscope, 130:358-366, 2020.

Significance of 1 kHz Pure-tone Threshold in Acute Low-frequency Sensorineural Hearing Loss.

OBJECTIVES: To analyze risk factors for acute low-frequency hearing loss (ALFHL), and compare treatment outcomes in the presence or absence of such risk factors. STUDY DESIGN: A case series featuring retrospective chart review. SETTING: An academic university hospital. PATIENTS: We included 170 ALFHL patients without vertigo. All of the patients received one of four treatments: low-dose steroid (LD-steroid), high-dose steroid (HD-steroid), LD-steroid and diuretics (LD-combination therapy), and ITDI (intratympanic dexamethasone injection) and diuretics (ITDI-combination therapy). To identify risk factors, we reviewed the clinical features of patients such as age, sex, chief complaint, accompanying symptoms, diabetes, hypertension, time from disease onset, the extent of hearing loss, treatment methods, and 1 kHz involvement. INTERVENTIONS: ALFHL was diagnosed based on the average hearing loss >30 dB at 250 and 500 Hz. RESULTS: The overall rates of hearing recovery were 70-80% in the four treatment groups. In terms of the prognosis of ALFHL patients, we found that a longer time from disease onset and 1 kHz involvement were independent risk factors for poor prognosis. In addition, we compared treatment outcomes of four treatment methods in the presence or absence of risk factors. In ALFHL patients with risk factors, we found statistically significant differences (p = 0.042) among treatment methods; effectiveness ranged in the order if ITDI-combination therapy, LD-combination therapy, HD-steroid, and LD-steroid. CONCLUSIONS: Risk factors for poor hearing recovery in ALFHL included longer symptom duration and 1 kHz involvement. In ALFHL with such risk factors, combination therapy was more effective than oral steroid therapy.

Potential Risk Factors Affecting Repeated Canalith Repositioning Procedures in Benign Paroxysmal Positional Vertigo.

OBJECTIVE: To define the risk factors and adverse effects associated with repeated canalith repositioning procedures (CRPs). STUDY DESIGN: A case series featuring chart review. SETTING: An academic university hospital. PATIENTS: We retrospectively reviewed 1900 patients (average age, 54.9 years; range, 11-88 years) diagnosed with benign paroxysmal positional vertigo (BPPV). All underwent repeated CRPs. We recorded clinical features including age, gender, BPPV cause (idiopathic or secondary), symptom duration, the canal involved, the number of sessions of CRP, recurrence, follow-up duration, and complications. We compared these factors using Pearson's chi-squared test and multiple linear regression analysis with dummy variables. INTERVENTIONS: BPPV was diagnosed based on the results of the head roll and Dix-Hallpike tests. RESULTS: The overall BPPV resolution rate for patients treated with repeated CRPs was 96.4%. The risk factors for the need for multiple CRPs in BPPV were the duration of vertigo before treatment (ß = 0.326, p < 0.001), the type of canal involved (ß = 0.130, p < 0.001), and age (ß = 0.040, p = 0.040). The explanatory power of the regression model attained 46.0% (F = 172.510, p < 0.001). The failure rate of repeated CRPs was 3.6% and complications included canal conversion (3.1%), nausea (46.4%), vomiting (4.9%), head heaviness (50.8%), imbalance (31.9%), and hypotension or palpitations (8.6%). However, almost all patients recovered. CONCLUSION: The risk factors associated with the need for Multiple CRPs were as follows: longer duration of vertigo before treatment, bilateral or multiple canal involved, and age >50 years.

Is a Solitary Fibrous Tumor in the External Auditory Canal Benign?

A solitary fibrous tumor (SFT) is an extremely rare, distinct otological soft-tissue tumor. Only two such tumors in the external auditory canal have been reported. A SFT related to hemangiopericytomas (HPC), which commonly arise in the central nervous system. HPCs act malignant in many cases, while SFTs at other sites are mainly benign. A 25-year-old female presented with highly vascular tumor at the right external auditory meatus and bleeding from the mass when a crust was removed from its surface. After excisional biopsy followed by pre-operative embolization, this tumor confirmed with SFT. The recurrence rate of SFT is very low after complete resection, with a slightly increased risk of recurrence with extrathoracic tumors. We describe the third case of SFT in the external auditory canal and review the literature.

Volumetric Changes in the Bony External Auditory Canal in Unilateral Chronic Otitis Media.

BACKGROUND AND OBJECTIVES: Pneumatization of air cells in the mastoid bone is decreased in chronic otitis media (COM). A decrease in the size of the external auditory canal (EAC) is also found frequently in patients with COM, but this has been little studied. We compared the size of affected bony EACs and the contralateral side in patients with single-side COM using high-resolution computed tomography. SUBJECTS AND METHODS: In total, 99 patients with single-side COM were included. Four indicators related to the size of the bony EAC and IAC were measured using high-resolution computed tomography: the axial and coronal lengths of the tympanic membrane, the length of the isthmus, and the area of the bony ear canal. We also compared both internal auditory canals as negative controls. These assessments were made by radiologists who were blinded to the objective of this study. RESULTS: In patients with single-side COM, the axial length of the tympanic membrane was significantly shorter than normal, and the volume of the EAC was also significantly smaller. The length of the isthmus of the EAC was shorter on the affected side, but the difference was not significant. The IAC volume showed no difference between the two sides. CONCLUSIONS: COM affects general temporal bony development, including the bony EAC and mastoid bone. Therefore, whether to correct this should be considered when preparing for COM surgery.

Q787Q EGFR Polymorphism as a Prognostic Factor for Lung Squamous Cell Carcinoma.

OBJECTIVE: EGFR genetic polymorphisms have been investigated for carcinogenesis in various tumors including lung cancer. We evaluated EGFR mutations in four exons, with an emphasis on the Q787Q EGFR polymorphism in non-small-cell lung cancer. METHODS: To determine the presence of the Q787Q polymorphism in patients with lung cancer, we performed direct sequencing analyses of four exons for 83 squamous cell carcinomas and 80 adenocarcinomas untreated with EGFR tyrosine kinase inhibitors. RESULTS: The Q787Q EGFR polymorphism was more frequently detected in squamous cell carcinoma patients than in adenocarcinoma patients (24 vs. 15.9%). The group of patients with the Q787Q EGFR polymorphism included more males and heavy smokers compared with other patient groups. The presence of the Q787Q EGFR polymorphism significantly and negatively affected the overall survival rate among patients with non-small-cell carcinoma (p = 0.011), particularly those with squamous cell carcinoma (p = 0.037). Among stage I and II squamous cell carcinoma patients, those with the Q787Q EGFR polymorphism had a poor prognosis (p = 0.032). CONCLUSIONS: The Q787Q EGFR polymorphism allows stratifying lung squamous cell carcinoma patients and could be an independent prognostic marker, particularly among those in stages I and II.

Spiral ganglion degeneration and hearing loss as a consequence of satellite cell death in saposin B-deficient mice.

Saposin B (Sap B) is an essential activator protein for arylsulfatase A in the hydrolysis of sulfatide, a lipid component of myelin. To study Sap B's role in hearing and balance, a Sap B-deficient (B(-/-)) mouse was evaluated. At both light and electron microscopy (EM) levels, inclusion body accumulation was seen in satellite cells surrounding spiral ganglion (SG) neurons from postnatal month 1 onward, progressing into large vacuoles preceding satellite cell degeneration, and followed by SG degeneration. EM also revealed reduced or absent myelin sheaths in SG neurons from postnatal month 8 onwards. Hearing loss was initially seen at postnatal month 6 and progressed thereafter for frequency-specific stimuli, whereas click responses became abnormal from postnatal month 13 onward. The progressive hearing loss correlated with the accumulation of inclusion bodies in the satellite cells and their subsequent degeneration. Outer hair cell numbers and efferent function measures (distortion product otoacoustic emissions and contralateral suppression) were normal in the B(-/-) mice throughout this period. Alcian blue staining of SGs demonstrated that these inclusion bodies corresponded to sulfatide accumulation. In contrast, changes in the vestibular system were much milder, but caused severe physiologic deficits. These results demonstrate that loss of Sap B function leads to progressive sulfatide accumulation in satellite cells surrounding the SG neurons, leading to satellite cell degeneration and subsequent SG degeneration with a resultant loss of hearing. Relative sparing of the efferent auditory and vestibular neurons suggests that alternate glycosphingolipid metabolic pathways predominate in these other systems.

Atypical primary meningioma in the nasal septum with malignant transformation and distant metastasis.

BACKGROUND: Primary extracranial meningiomas (PEMs) originating from the nasal septum are extremely rare, as are extracranial metastases of meningiomas. CASE PRESENTATION: A 44-year-old male presented with a 2-month history of left-side nasal obstruction and frequent episodes of epistaxis. A friable mass originating from the nasal septum was resected completely via an endoscopic endonasal approach. According to WHO criteria, the tumor was diagnosed as an atypical meningioma radiologically and histopathologically. Two years later, a tumor recurred at the primary site with the same histopathological findings, and the patient was given local external radiotherapy (6840 cGy in 38 fractions). Two months after this local recurrence, a left anterior chest wall mass and a left parietal area scalp mass were observed. The subcutaneous mass was resected and showed histological evidence of malignant transformation. Several months after the last operation, the patient died. CONCLUSIONS: We describe the clinical, radiological, and bio-pathological features of this unique case and review the literature on atypical PEMs originating in the nasal septum. To our knowledge, this is the first reported case of an atypical PEM originating from the nasal septum that recurred with malignant transformation and extracranial metastasis.

Combination therapy with systemic steroids, an antiviral agent, anticoagulants, and stellate ganglion block for treatment of sudden sensorineural hearing loss.

BACKGROUND AND OBJECTIVES: Sudden sensorineural hearing loss (SSNHL) is commonly defined as a loss of at least 30 dB in three contiguous frequencies occurring within 3 days. Systemic steroid administration has become the most widely accepted treatment option for SSNHL. Since viral infection and vascular compromise are considered specific causes of SSNHL, antiviral agents, anticoagulants, and stellate ganglion block have been used for its treatment, although the evidence of their effectiveness is weak. The present study evaluated the hearing recovery rate in the combination therapy group (systemic steroids, antiviral agent, anticoagulants, and stellate ganglion block) in comparison with patients treated with systemic steroids alone. SUBJECTS AND METHODS: A total of 85 patients diagnosed with SSNHL were treated with combination therapy (group A, 46 patients) or systemic steroids only (group B, 39 patients). Hearing improvement was defined as a hearing gain of more than slight improvement using Siegel's criteria. All patients were treated with a 10-day course of systemic steroids (10-mg dexamethasone for 5 days, followed by tapering for 5 days). Acyclovir, heparin, and stellate ganglion block were included in the group A treatment regimen. RESULTS: The overall rate of hearing improvement was 60.9% (28/46 patients) in group A, which was significantly higher than that (38.5%, 15/39 patients) in group B. The distribution of prognostic factors was not significantly different between the two groups with the exception of the degree of initial hearing loss, which was more severe in group A. Upon analysis according to prognostic factors, group A showed a better hearing improvement recovery rate than group B in patients with hearing loss >70 dB, age >41 years, dizziness, and early treatment (<1 week). CONCLUSIONS: Thus SSNHL patients treated with combination therapy have a higher likelihood of hearing improvement than those treated with systemic steroids alone.

Mupirocin ointment prevents early post-tympanostomy tube otorrhea: a preliminary study.

BACKGROUND AND OBJECTIVES: The most common complication of tympanostomy tube (T-tube) insertion is the development of postoperative otorrhea. Post-tympanostomy tube otorrhea (PTTO) is defined as active drainage through an existing T-tube. Many surgeons routinely use topical antibiotics as prophylaxis against early PTTO. Mupirocin calcium ointment is a topical antimicrobial agent with broad-spectrum antimicrobial activity against many Gram-positive organisms. This study evaluated the clinical effectiveness of topical mupirocin ointment in reducing early PTTO. SUBJECTS AND METHODS: The study included 98 ears (67 patients, mean age 32.9 years) that had a T-tube inserted because of chronic middle ear effusion or atelectatic otitis media. A Paparella type-I polyethylene-tube coated with mupirocin was inserted through the tympanostomy. Patients were instructed not to use otic drops or any other medications. All patients were seen by day 14 postoperatively. RESULTS: Early PTTO occurred in one case (1.5%). No early PTTO was seen with a middle ear effusion. Nineteen children were treated under general anesthesia; none developed early PTTO. CONCLUSIONS: Insertion of a T-tube coated with mupirocin ointment could be effective at preventing early PTTO.