U.S. FDA advisory meetings through March 25

EAR, NOSE AND THROAT DEVICES PANEL OF THE MEDICAL DEVICES ADVISORY COMMITTEE

DATE: Dec 18, 0800/1300

LOCATION: Holiday Inn, 2 Montgomery Village Ave., Gaithersburg, Md.

CONTACT: James Kane, 301-796-6477

The committee will discuss, make recommendations and vote on a premarket approval application, sponsored by privately held Envoy Medical Corporation, for the Esteem Totally Implantable Hearing System. The Esteem is a totally implantable hearing device that is implanted in the middle ear to help hearing in patients suffering from mild to severe hearing loss that is sensorineural in origin. The Esteem System consists of three implantable components (sound processor, sensor and driver), two external programmers (Esteem Programmer and Personal Programmer), an external Intraoperative System Analyzer and accessories. The intended use of the Esteem is to alleviate hearing loss in adults by replicating the ossicular chain and providing additional gain.

NATIONAL MAMMOGRAPHY QUALITY ASSURANCE ADVISORY COMMITTEE

DATE: Jan 25, 0900/1400

LOCATION: Hilton, 2 Montgomery Village Ave., Gaithersburg, Md.

CONTACT: Normica Facey, 301-796-5914

The committee will discuss guidance documents issued since the last meeting. The committee also will receive updates on interventional mammography accreditation programs, recently approved alternative standards, facility inspection findings, the status of current inspection followup actions, and the radiological health program.

GENERAL AND PLASTIC SURGERY DEVICES PANEL OF THE MEDICAL DEVICES ADVISORY COMMITTEE

DATE: March 25, 0800/1300

LOCATION: Hilton, 620 Perry Parkway, Gaithersburg, Md.

The committee will review and discuss recent information, including recent literature regarding the possible risks to the general public from intentional exposure to ultraviolet radiation (UV) from use of tanning lamps. There continues to be a growing body of literature showing association of skin cancer with use of tanning lamps and the committee will discuss this information and other information related to the association of UV and skin cancer (both melanoma and non-melanoma). The committee will be asked to recommend whether changes to current classification or current regulatory controls of UV emitting devices (lamps) used for tanning are needed. (Reporting by Lisa Richwine and Susan Heavey; Editing by Tim Dobbyn)