James K. Kane

Reviewer

• [email protected]

Ear, Nose, and Throat Devices Branch, Division of Ophthalmic and ENT Devices, Office of Device Evaluation, Center for Devices and Radiological Health, Food and Drug Administration, 9200 Corporate Blvd, HFZ-460, Rockville, MD 20850, USA

Eric A. Mann MD

Branch Chief

• [email protected]

Ear, Nose, and Throat Devices Branch, Division of Ophthalmic and ENT Devices, Office of Device Evaluation, Center for Devices and Radiological Health, Food and Drug Administration, 9200 Corporate Blvd, HFZ-460, Rockville, MD 20850, USA

S. Lori Brown PhD, MPH

Epidemiologist

Investigations Branch, Seattle District Office, Food and Drug Administration, 22201 23 ^rd Drive SE, Bothell, WA 98021, USA

Epidemiology Branch, Division of Postmarket Surveillance, Office of Surveillance and Biometrics, Center for Devices and Radiological Health, Food and Drug Administration, 1350 Piccard Drive, HFZ-541, Rockville, MD 20850, USA

Roselie A. Bright ScD

Epidemiologist

Epidemiology Branch, Division of Postmarket Surveillance, Office of Surveillance and Biometrics, Center for Devices and Radiological Health, Food and Drug Administration, 1350 Piccard Drive, HFZ-541, Rockville, MD 20850, USA

Dale R. Tavris MD, MPH

Epidemiologist

Epidemiology Branch, Division of Postmarket Surveillance, Office of Surveillance and Biometrics, Center for Devices and Radiological Health, Food and Drug Administration, 1350 Piccard Drive, HFZ-541, Rockville, MD 20850, USA