Hearing Aids

… /medical-devices/consumer-products/hearing-aids … UPDATE - November 10, 2022: The FDA’s final rule: Establishing Over-the-Counter Hearing Aids , issued on August 17, 2022, to improve access to safe, effective, and affordable hearing aids for millions of Americans is now in effect. This …

Detention & Hearing

… /industry/fda-import-process/detention-hearing … Overview When products in your shipment violate or … This notice is considered the Notice of Detention and Hearing.  Why was my product detained? What can I do if my … I notified that my product has been detained? What is a “hearing”? What is Testimony? What is the “respond by” date on …

How to Get Hearing Aids

… /medical-devices/hearing-aids/how-get-hearing-aids … Where do I get hearing aids? Do I need a medical examination before buying hearing aids? What information should I consider before …

Hearing Aids and Cell Phones

… /radiation-emitting-products/cell-phones/hearing-aids-and-cell-phones … Before you buy a cell phone, … to see which phone works best for you. People who wear hearing aids or have implanted hearing devices may experience some difficulties when trying …

Other Hearing Devices and Products

… /medical-devices/hearing-aids/other-hearing-devices-and-products … Assistive Listening Devices Cochlear Implants Implantable Middle Ear Hearing Devices Bone-Anchored Hearing Aids Personal Sound …

Hearing Aids and Cellphones

… /medical-devices/hearing-aids/hearing-aids-and-cellphones … What is the buzzing noise in my … What is the buzzing noise in my cellphone? People who wear hearing aids or have implanted hearing devices may hear a …

Types of Hearing Aids

… /medical-devices/hearing-aids/types-hearing-aids … What are hearing aids? What are the styles of hearing aids? What is …

Webinar on Proposed Rule for Establishing Over-the-Counter Hearing Aids and Draft Guidance for Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products - 12/07/2021

… cal-devices/webinar-proposed-rule-establishing-over-counter-hearing-aids-and-draft-guidance-regulatory … Summary On … about the proposed rule, Establishing Over-the-Counter Hearing Aids and the updated draft guidance, Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification …

Hearing Loss

… /medical-devices/hearing-aids/hearing-loss … What are the signs of hearing loss? What are the types of hearing loss? What are the signs of hearing loss? You may …

Hearing Aids and Personal Sound Amplification Products: What to Know

… …   Español 简体中文 Are you or a loved one having a hard time hearing? Perhaps you considered getting a hearing aid in the past? Hearing aid technology keeps evolving, which means there’s a …

FDA allows marketing of first self-fitting hearing aid controlled by the user

… press-announcements/fda-allows-marketing-first-self-fitting-hearing-aid-controlled-user … The U.S. Food and Drug … today allowed marketing of a new device, the Bose Hearing Aid, intended to amplify sounds for individuals 18 years or older with perceived mild to moderate hearing impairment (hearing loss). This is the first hearing …

Hearing Aid Benefits and Limitations

… /medical-devices/hearing-aids/hearing-aid-benefits-and-limitations … What are the benefits of hearing aids? Do hearing aids have limitations? When should I see a doctor? …

FDA Finalizes Historic Rule Enabling Access to Over-the-Counter Hearing Aids for Millions of Americans

… ts/fda-finalizes-historic-rule-enabling-access-over-counter-hearing-aids-millions-americans … Español Today, the U.S. … Administration issued a final rule to improve access to hearing aids which may in turn lower costs for millions of … establishes a new category of over-the-counter (OTC) hearing aids, enabling consumers with perceived mild to …

OTC Hearing Aids (Proposed Rule) Preliminary Regulatory Impact Analysis (PRIA)

… establish a regulatory category for over-the-counter (OTC) hearing aids and make related amendments to update the regulatory framework for hearing aids. The primary social benefits would be the availability of less costly hearing aids in states that currently disallow or restrict …

FDA takes steps to improve hearing aid accessibility

… /news-events/press-announcements/fda-takes-steps-improve-hearing-aid-accessibility … Español The U.S. Food and Drug … important steps to better support consumer access to hearing aids. The agency issued a guidance document … evaluation or sign a waiver prior to purchasing most hearing aids. This guidance is effective immediately. Today, …

FDA Issues Landmark Proposal to Improve Access to Hearing Aid Technology for Millions of Americans

… s-announcements/fda-issues-landmark-proposal-improve-access-hearing-aid-technology-millions-americans … Español   简体中文 … intended to improve access to and reduce the cost of hearing aid technology for millions of Americans. The agency … rule to establish a new category of over-the-counter (OTC) hearing aids. When finalized, the rule would allow hearing …

Notice of Opportunity for Hearing (NOOH) Akhigbe, Ehigiator O. 9/13/10

… tory-information/electronic-reading-room/notice-opportunity-hearing-nooh-akhigbe-ehigiator-o-91310 …     Department of … WV 26507     PROPOSAL TO DEBAR NOTICE OF OPPORTUNITY FOR HEARING DOCKET No. FDA-2010-N-0235    Dear Dr. Akhigbe:   … This letter also offers you an opportunity to request a hearing on this proposal.   Conduct Related to Conviction   …

DHHS-FDA Notice of Opportunity for Hearing; Leon C. LaHaye, M.D.

… rmation/electronic-reading-room/dhhs-fda-notice-opportunity-hearing-leon-c-lahaye-md …       Department of Health and … Rockville, MD 20857 NOTICE OF OPPORTUNITY FOR HEARING (NOOH)   CERTIFIED MAIL RETURN RECEIPT REQUESTED Leon … you are being offered an opportunity for a regulatory hearing pursuant to 21 CFR part 16 and 812.119, on the …

DHHS-FDA Notice of Opportunity for Hearing; Arthur Riba, M.D.

… rmation/electronic-reading-room/dhhs-fda-notice-opportunity-hearing-arthur-riba-md …       Department of Health and Human … Rockville, MD 20857 NOTICE OF OPPORTUNITY FOR HEARING (NOOH)   February 17, 1999 Certified Mail-Restricted … Dr. Riba is being offered an opportunity for a regulatory hearing pursuant to 21 CFR Parts 16 and 312, to determine …

DHHS-FDA Notice of Opportunity for Hearing; Chavaramplakil P. Mathew, M.D.

… rmation/electronic-reading-room/dhhs-fda-notice-opportunity-hearing-chavaramplakil-p-mathew-md …       Department of … Rockville, MD 20857 NOTICE OF OPPORTUNITY FOR HEARING (NOOH)   JUN 3, 2002 CERTIFIED MAIL-RESTRICTED … you are being offered an opportunity for a regulatory hearing pursuant to 21 CFR parts 16 and 312, on the question …

DHHS-FDA Notice of Opportunity for Hearing; Carl A. DeAbate, M.D.

… rmation/electronic-reading-room/dhhs-fda-notice-opportunity-hearing-carl-deabate-md …       Department of Health and … Rockville, MD 20857 NOTICE OF OPPORTUNITY FOR HEARING (NOOH)   Nov 28, 2003 MAIL-RESTRICTED DELIVERY RETURN … DeAbate is being offered an opportunity for a regulatory hearing pursuant to 21 CFR parts 16 and 312, on the question …

Devices Referencing Drugs; Public Hearing; Request for Comments

… -conferences-and-workshops/devices-referencing-drugs-public-hearing-request-comments … Alert: Change to comment period … The Food and Drug Administration is holding a public hearing on a potential approach for certain device sponsors … and legal issues that these products may raise. Hearing Date and Time November 16, 2017 9 a.m. to 5 p.m. …

DHHS-FDA Notice of Opportunity for Hearing; Layne O. Gentry, M.D.

… rmation/electronic-reading-room/dhhs-fda-notice-opportunity-hearing-layne-o-gentry-md …       Department of Health and … Rockville, MD 20857 NOTICE OF OPPORTUNITY FOR HEARING (NOOH)   April 15, 1999 CERTIFIED MAIL RETURN RECEIPT … Gentry is being offered an opportunity for a regulatory hearing pursuant to 21 CFR Parts 16 and 312, to determine …

DHHS-FDA Notice of Opportunity for Hearing; William H. Ziering, M.D.

… rmation/electronic-reading-room/dhhs-fda-notice-opportunity-hearing-william-h-ziering-md …       Department of Health and … Rockville, MD 20857 NOTICE OF OPPORTUNITY FOR HEARING (NOOH)   August 16, 1999 CERTIFIED MAIL - RESTRICTED … conference. Instead, you and your client requested a hearing pursuant to 21 CFR 16. Accordingly, Dr. Ziering is …

DHHS-FDA Notice of Opportunity for Hearing; Frederick Coulston, Ph.D.

… rmation/electronic-reading-room/dhhs-fda-notice-opportunity-hearing-frederick-coulston-phd …       Department of Health … Rockville, MD 20857 NOTICE OF OPPORTUNITY FOR HEARING (NOOH)   March 18, 2003 VIA OVERNIGHT MAIL Frederick … letter offers you an opportunity to request a regulatory hearing to determine whether Coulston Foundation (CF) should …