(72 days)
Indications for insertion of a tympanostomy tube into an incision in the tympanic membrane include any of the following:
- . Chronic otitis media with effusion characterized as either serous, mucoid, or purulent
- . Recurrent acute otitis media which fails to respond satisfactorily to alternative therapies
- . A patient with a history of persistent high negative middle ear pressure which may be associated with conductive hearing loss that is symptomatic, persistant or recurrent otalgia, persistent or recurrent vertigo and/or tinnitus
- . Atelectasis resultant from retraction pocket of the tympanic membrane or eustachian tube dysfunction
Tympanostomy Tube
The provided text describes a 510(k) premarket notification for a Tympanostomy Tube. However, the document is a regulatory approval letter and an enclosure listing different tympanostomy tube models with their inner diameters. It does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.
Therefore, I cannot provide the requested information based on the given input.
§ 874.3880 Tympanostomy tube.
(a)
Identification. A tympanostomy tube is a device that is intended to be implanted for ventilation or drainage of the middle ear. The device is inserted through the tympanic membrane to permit a free exchange of air between the outer ear and middle ear. A type of tympanostomy tube known as the malleous clip tube attaches to the malleous to provide middle ear ventilation. The device is made of materials such as polytetrafluoroethylene, polyethylene, silicon elastomer, or porous polyethylene.(b)
Classification. Class II.