Over-The-Counter (OTC) Hearing Aids – FDA Proposed Guidelines Full Review | DrCliffAuD VLOG 092

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Over-The-Counter Hearing Aids – FDA Proposed Guidelines Full Review. Over the Counter Hearing Aids will be available in 2022! Doctor Cliff Olson, Audiologist and founder of Applied Hearing Solutions in Phoenix Arizona, discusses his thoughts and opinions on the Proposed Guidelines for OTC hearing aids issued by the FDA.

Link to the Full Proposed Guidelines Document: https://public-inspection.federalregister.gov/2021-22473.pdf (Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the-Counter Hearing Aids)

Instructions for Submitting Comments:

Submit Comments Online: Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your
comment will be made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party may not wish to be
posted, such as medical information, your or anyone else’s Social Security number, or
confidential business information, such as a manufacturing process. Please note that if
you include your name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on
https://www.regulations.gov.

Submit Written Comments: Mail/Hand delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852. For written/paper comments submitted to the Dockets Management Staff, FDA will post
your comment, as well as any attachments, except for information submitted, marked and
identified, as confidential, if submitted as detailed in “Instructions.”
Instructions: All submissions received must include the Docket No. FDA-2021-N-0555

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