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At least 1,477 records · Page 82Linked to original sources
PubMed2002

Medical devices; ear, nose and throat devices; reclassification of the endolymphatic shunt tube with valve. Final rule.

The Food and Drug Administration (FDA) is reclassifying the endolymphatic shunt tube with valve from class III (premarket approval) into class II (special controls). The device is intended to be implanted in the inner ear to relieve the symptoms of vertigo and hearing loss due to endolymphatic hydrops (increase in endolymphatic fluid) of Meniere's disease. FDA is also identifying the guidance document entitled "Class II Special Controls Guidance Document: Endolymphatic Shunt Tube With Valve; Guidance for Industry and FDA" (the guidance) as the special control that the agency believes will reasonably ensure the safety and effectiveness of the device. This reclassification is based on new information submitted in are classification petition by E. Benson Hood Laboratories, Inc. (Hood Laboratories). FDA is taking this action under the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Medical Device Amendments of 1976, the Safe Medical Devices Act of 1990, and the Food and Drug Administration Modernization Act of 1997. Elsewhere in this issue of the Federal Register, FDA is publishing a notice announcing the guidance.

Device Approval↗
PubMed2001

A prospective evaluation of foreign bodies presenting to the Ear, Nose and Throat Clinic, Hospital Kuala Lumpur.

The results of a prospective study of 94 patients with history of ear, nose or aerodigestive tract foreign bodies were analysed. Sixty six to 94% of patients presented within 24 hours to a primary care doctor, 80 to 94% was referred to the ENT Department within 24 hours and 89 to 93% of patients had their foreign bodies removed within 24 hours. Overall, 58% of aural foreign bodies, 67% nasal foreign bodies and 94% of aerodigestive tract foreign bodies were removed within 48 hours of insertion. As a result of the prompt removal of foreign bodies in the majority of patients, no significant complications occurred. Foreign bodies in the aerodigestive tract tend to present earlier and more promptly removed compared with ear and nose foreign bodies. There was a significantly higher proportion of foreign body in the right ear and nostril compared to the left.

Adolescent↗
PubMed1975

[New aspects in the treatment of malignancy of the ear, nose, and throat (author's transl)].

The management of malignancy continues to change, and the basis of this change is improvement in diagnostic and therapeutic tech techniques and the search for new therapeutic principles. Examples of each group are given although their practical value is uncertain. They are important because they attempt to make methods of basic research in tumour biology applicable to clinical medicine.

Antineoplastic Agents↗