Ear, Nose, Throat— FDA advisory panel EN

The ENT panel runs from the audiology clinic to the operating room: hearing aids and their fitting systems, audiometers and tympanometers, tympanostomy tubes, ENT endoscopes, sinus surgery instruments including balloon sinuplasty systems, nasal splints, and voice prostheses. Hearing technology dominates the panel's public profile.

The panel's defining recent event is regulatory rather than technological: the creation of the over-the-counter hearing aid category in 2022 restructured how hearing devices reach market, opening the register to consumer-electronics entrants alongside the traditional hearing-aid manufacturers. Filings under the hearing-aid product codes since then track that market opening directly. Cochlear implants, by contrast, are PMA devices — like every panel with a Class III flagship, ENT's most invasive technology is absent from its 510(k) listings.