FDA grants accelerated approval to amivantamab for head and neck cancer; fee schedule trims same-day visit pay; reports flag Lenire tinnitus worsening

• FDA Nov 5, 2026
  FDA grants accelerated approval to Rybrevant Faspro for head and neck cancer after platinum and immunotherapy, 42% response rate
  The Food and Drug Administration (FDA) granted accelerated approval on Nov. 5 to Rybrevant Faspro (amivantamab and hyaluronidase-lpuj) for recurrent or metastatic head and neck squamous cell carcinoma that progressed on or after platinum-based chemotherapy and immunotherapy. In an open-label trial of 102 patients, the overall response rate was 42%, and 56% of responders had responses lasting six months or longer. The FDA said it is the first drug approval in 10 years for recurrent or metastatic disease after prior platinum-based chemotherapy. It is not indicated for HPV-associated oropharyngeal cancer, and confirmatory studies are required.
  Source: FDA
• Payment Nov 4, 2026
  Final 2027 fee schedule pays the lesser service at 80% on same-day visits with 0-day procedures; otolaryngology among hardest hit
  The Centers for Medicare & Medicaid Services (CMS) said that when an office or outpatient visit is billed the same day as a 0-day global procedure, the most expensive service will be paid at 100% and the others at 80%, rather than 50% as proposed. Dermatology, otolaryngology and podiatry still take the largest hits from the policy, according to the rule's impact analysis as reported by Medical Economics. The nonqualifying alternative payment model conversion factor is $32.63, down 2.31%. The rule takes effect Jan. 1, 2027.
  Sources: CMS, Medical Economics
• Technology Nov 6, 2026
  FDA adverse event reports on Lenire bimodal tinnitus device include sustained tinnitus worsening after use stops
  A review of the Food and Drug Administration's MAUDE database, published online Nov. 6 in Otolaryngology-Head and Neck Surgery, found nine unique reports on the Lenire bimodal neuromodulation device. The most common events were tinnitus exacerbation, and one death by suicide was temporally associated with device use, with causality not established. The authors said the findings, limited by reporting bias and lack of validation, identify users who may have adverse effects that continue after the device is stopped.
  Sources: Otolaryngology-Head and Neck Surgery, PubMed
• Research Nov 6, 2026
  High-dose sodium fluoride tied to hearing stabilization in otosclerosis in meta-analysis of 10 studies and 2,352 patients
  A systematic review and meta-analysis of 10 randomized and observational studies with 2,352 patients, published online Nov. 6 in Otolaryngology-Head and Neck Surgery, found hearing improvement or stabilization in 96.4% of patients on high-dose fluoride, 83.8% on low-dose fluoride and 57.2% of untreated controls. The authors said high-dose fluoride was associated with a protective effect against hearing loss in otosclerosis, citing modest evidence quality and variable audiologic definitions.
  Sources: Otolaryngology-Head and Neck Surgery, PubMed
• Payment Nov 2, 2026
  UnitedHealthcare drops prior authorization Dec. 1 for more than 2,000 pediatric codes, including ear tube and tonsil procedures
  UnitedHealthcare said Nov. 2 that beginning Dec. 1, patients under age 18 will no longer need prior authorization for more than 2,000 pediatric care codes, part of the company's May commitment to eliminate nearly two-thirds of pediatric prior authorization requirements. Examples include ear tube and tonsil procedures, sleep studies and MRI and CT scans, the company said. The change applies to UnitedHealthcare commercial plans, Individual Exchange Plans and Community Plans where permissible by state law, the company said. "Every child deserves a healthcare experience centered on their needs," said Tim Noel, CEO of UnitedHealthcare.
  Source: UnitedHealthcare
• FDA Nov 3, 2026
  Cochlear recalls four Nucleus Nexa cochlear implants in U.S. over incomplete electrode welds
  The Food and Drug Administration posted a Class 2 recall on Nov. 3 of Cochlear Nucleus Nexa cochlear implants with the Contour Advance electrode, model CI1000, because of a manufacturing deviation that left electrode welds incomplete. Four devices were affected in the U.S., distributed in New Jersey, New York and Pennsylvania. Customers were told not to implant the affected devices and to return them to Cochlear, which began the recall on Sept. 30.
  Source: FDA recall database

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