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Otology / Assistive technology / Food law / Hearing / Hearing aid / Federal Food /  Drug /  and Cosmetic Act / Bone conduction / Premarket approval / Center for Devices and Radiological Health / Medicine / Health / Food and Drug Administration


Guidance for Industry and FDA Staff
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City

Rockville / /

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Event

Product Issues / /

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IndustryTerm

bone conduction devices / implantable middle ear hearing devices / wearable sound-amplifying device / wearable soundamplifying device / aid devices / electronic product / wearable electronic product / fundamental technology / personal sound amplification products / chemical action / aid device / electronic products / sound amplification equipment / marketed device / /

Organization

U.S. Department of Health and Human Services / Food and Drug Administration / Division of Dockets Management / Food and Drug Administration Center for Devices and Radiological Health Ear / FDA / Ear / Nose / and Throat Devices office of Device Evaluation Contains Nonbinding Recommendations Preface Public Comment Written / Nose / and Throat Devices Branch Division of Ophthalmic / Neurological and Ear / /

Person

Eric A. Mann / /

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Position

Governor / Branch Chief / distant speaker / licensed physician / /

Product

consumers / hearing / /

ProvinceOrState

Maryland / /

Technology

radiation / /

URL

http /

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