Hearing Aids

… a new web page with details about over-the-counter (OTC) Hearing Aids: What You Should Know before and after buying an OTC hearing aid. Having trouble hearing? Close to 30 million adults in the United States have …

Detention & Hearing

… 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 the Notice of Detention and Hearing? What if I need more time to respond to the …

How to Get Hearing Aids

… On this page: Where do I get hearing aids? Do I need a medical examination before buying hearing aids? What information should I consider before buying hearing aids? Should I consult a hearing health care …

Hearing Aids and Cell Phones

… to see which phone works best for you. People who wear hearing aids or have implanted hearing devices may experience some difficulties when trying … cell phones can cause radiofrequency interference with hearing aids, so the user hears high-pitched whistling …

Types of Hearing Aids

… On this page: What are hearing aids? What are the styles of hearing aids? What is the difference between analog and digital hearing aids? What are some hearing aid features? What are …

Other Hearing Devices and Products

… Listening Devices Cochlear Implants Implantable Middle Ear Hearing Devices Bone-Anchored Hearing Aids Personal Sound Amplification Products Related … theaters, houses of worship, and meeting rooms. Normal hearing and hearing-impaired people may use ALDs to improve …

Hearing Loss

… On this page: What are the signs of hearing loss? What are the types of hearing loss? What are the signs of hearing loss? You may have a hearing loss if: People say you …

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

… 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 aid authorized for …

Hearing Aids and Cellphones

… What is the buzzing noise in my cellphone? People who wear hearing aids or have implanted hearing devices may hear a buzzing noise while using a … occur for all combinations of digital wireless phones and hearing aids. However, when interference occurs, the buzzing …

Hearing Aid Benefits and Limitations

… On this page: What are the benefits of hearing aids? Do hearing aids have limitations? When should I see a doctor? … device problems to the FDA? What are the benefits of hearing aids? You may hear sounds that you have not …

FDA Authorizes First Over-the-Counter Hearing Aid Software

… Administration authorized the first over-the-counter (OTC) hearing aid software device, Hearing Aid Feature, intended to be used with compatible … headphones. Once installed and customized to the user’s hearing needs, the Hearing Aid Feature enables compatible …

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

… 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, … to consider creating a category of over-the-counter (OTC) hearing aids that could deliver new, innovative and …

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

… 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 aids within this category to be sold directly to …

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

… 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   …   Proposed Action and Notice of Opportunity for Hearing   Based on the findings discussed above, FDA proposes …

OTC Hearing Aids: What You Should Know

… 30 million adults living in the U.S. have some degree of hearing loss . Despite the high number of people affected by hearing loss, only about one-fifth of those who could benefit from a hearing aid seek intervention. Using hearing aids may reduce …

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

… 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 … and represented by counsel at all times. Any regulatory hearing on this matter will be governed, by the regulations …

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

… 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 … are matters that will be considered at the regulatory hearing. Applicable provisions of the CFR are cited for each …

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

… 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 … and represented by counsel at all times. Any regulatory hearing on this matter will be governed by the regulations in …

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

… 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 … and represented by counsel at all times. Any regulatory hearing on this matter will be governed by the regulations in …

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

… 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 … and represented by counsel at all times. Any regulatory hearing on this matter will be governed by the regulations in …

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

… 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 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; Frederick Coulston, Ph.D.

… 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 … will be deemed to have waived any right to a regulatory hearing; and a decision in this matter will be made based on …

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

… Rockville, MD 20857 NOTICE OF OPPORTUNITY FOR HEARING (NOOH)   Hand delivered by Andrea Branch on March 4, … you are being offered an opportunity for a regulatory hearing pursuant to 21 CFR parts 16 and 312, to determine … and represented by counsel at all times. Any regulatory hearing on this matter will be governed by the regulations in …