Otolaryngology ·
FDA approves IDE for U.S. pivotal venous sinus stent trial in pulsatile tinnitus; LLM-scored hearing test compares with standard tests
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The Food and Drug Administration (FDA) approved an investigational device exemption (IDE) for B-SILENT 2, which Sonorous Neurovascular described as the first U.S. FDA-approved IDE trial of a venous sinus stent for pulsatile tinnitus. New studies tested a speech-in-noise test scored by a large language model, confocal microscopy for laser cordectomy margins and deep learning body composition analysis in head and neck cancer radiotherapy.
THE DETAILS
- FDA Oct 9, 2026Sonorous Neurovascular received Food and Drug Administration (FDA) investigational device exemption (IDE) approval to begin B-SILENT 2, which the company described as the first U.S. FDA-approved IDE trial of a venous sinus stent for pulsatile tinnitus, according to NeuroNews International. The BosSTENT is a braided, self-expanding stent engineered for the cerebral venous sinuses and received Breakthrough Device designation in February 2026. The company expects U.S. enrollment to begin in the fourth quarter of 2026, while its B-SILENT study enrolls at six sites in France and Canada.Sources: NeuroNews International, Endovascular Today
- AI Oct 10, 2026Researchers built CHAT, a question-and-answer speech-in-noise test using text-to-speech, automatic speech recognition and a large language model to evaluate responses, and measured speech reception thresholds in 20 participants with normal hearing and 20 with mild to moderate hearing loss, according to a study published Oct. 10 in Trends in Hearing. The area under the receiver operating characteristic curve was 0.97 for CHAT, 0.95 for the Adaptive Sentence List and 0.89 for the Four Alternative Auditory Feature Test. The authors said AI tools can help create and administer conversational speech-in-noise tests.Sources: Trends in Hearing, PubMed
- Research Oct 8, 2026In a prospective pilot study published online Oct. 8 in The Laryngoscope, the Histolog Scanner, an ultra-fast ex vivo confocal microscopy system, was evaluated for intraoperative margin assessment in 19 patients undergoing transoral laser cordectomy for glottic squamous cell carcinoma, yielding 95 margins. Concordance with histopathology was 92.6%, with sensitivity of 85.7%, specificity of 93.8% and negative predictive value of 97.4%; mean acquisition time was 13 minutes per specimen. The authors described it as an intraoperative adjunct rather than a replacement for definitive histopathology.Sources: The Laryngoscope, PubMed
- AI Oct 8, 2026A retrospective single-center cohort study of 1,187 patients receiving definitive-intent radiotherapy for head and neck cancer, published online Oct. 8 in JAMA Otolaryngology-Head & Neck Surgery, used an open-source deep learning segmentation pipeline to extract body composition from pretreatment CT simulation scans. In the 659-patient imaging subcohort, elevated skeletal muscle was associated with improved overall survival (hazard ratio 0.67; 95% CI 0.50 to 0.89), and elevated intermuscular adiposity with increased mortality risk (hazard ratio 1.28; 95% CI 1.03 to 1.58).
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