Two Citizen's Petitions requesting the Food and Drug Administration (FDA) "Create a New Over-the-Counter (OTC) Hearing Aid Classification That Grants OTC Sales, Distribution, and Use Status to One-Size-Fits-Most Hearing Aid Devices," were filed by Mead Killion, Ph.D., and ""Professional and Patient Labeling For Hearing Aid Devices," Gail Gudmundsen, Au.D., on August 11, 2003. The petitions have been assigned docket numbers 2003P-0362/CP 1 and 2003P-0363/CP 1, respectively. For the full docket text link to the Killion petition, CLICK HERE, for the full docket text link to the Gudmundsen petition CLICK HERE.
ADA Summary: The requested revisions to the Federal Rules and Regulations Regarding Hearing Aid Sales would eliminate the need for an adult to have a medical evaluation or sign a waiver. The petition states, "it is arguably unnecessary to require a hearing aid purchaser to take a [hearing] test or see a physician."..."The operative principle that separates over-the-counter devices from those that require prescription by a physician is whether misuse of that drug or device can cause harm to the user...The potential harm from an OTC hearing aid is negligible."
Comments can be made directly to the FDA via e-mail fdadockets@oc.fda.gov until February 7, 2004. The Docket numbers should be put in the "subject" line (2003P-0362 and 2003P-0363, Killion and Gudmundsen, respectively). Written comments should be sent to:
Dockets Management Branch
Food and Drug Administration
5630 Fishers Lane
Room 1061, HRA-305
Rockville, MD 20852
FDA Seeks Comment RE: Citizens Petitions for New Over The Counter (OTC) Class of Hearing Aids.
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