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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 …
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 …
The FDA engages stakeholders on opportunities to improve hearing aid usage and innovation
… nnouncements/fda-engages-stakeholders-opportunities-improve-hearing-aid-usage-and-innovation … The U.S. Food and Drug … balance patient safety while encouraging advancements in hearing aid technology and access to these devices in the … related to the agency’s premarket requirements for hearing aids and personal sound amplification products …
Remarks from FDA Commissioner Scott Gottlieb, M.D., as prepared for oral testimony before the U.S. House Committee on Energy and Commerce Subcommittee on Oversight and Investigations hearing “Examining U.S. Public Health Preparedness for and Response Efforts to Seasonal Influenza.”
… … Commissioner remarks as prepared for testimony at the hearing “Examining U.S. Public Health Preparedness for and … and Commerce Subcommittee on Oversight and Investigations hearing “Examining U.S. Public Health Preparedness for and …
Remarks from FDA Commissioner Scott Gottlieb, M.D., as prepared for oral testimony before the House Committee on Energy and Commerce Hearing, “Federal Efforts to Combat the Opioid Crisis: A Status Update on CARA and Other Initiatives
… before the House Committee on Energy and Commerce Hearing, “Federal Efforts to Combat the Opioid Crisis: A … before the House Committee on Energy and Commerce Hearing, “Federal Efforts to Combat the Opioid Crisis: A …
Statement from FDA Commissioner Scott Gottlieb, M.D., on the agency’s continued efforts to bring competition to the insulin market to lower prices and expand access
… products. That’s why today we’re announcing a public hearing to discuss access to affordable insulin products, as … and interchangeable insulin products. At the public hearing, we want to hear from stakeholders about what factors … market. Ultimately the input we receive at the public hearing will help to inform steps the FDA can take to advance …
Remarks from FDA Commissioner Scott Gottlieb, M.D., as prepared for oral testimony before the U.S. Senate Committee on Health, Education, Labor & Pensions Hearing, “Implementation of the 21st Century Cures Act: Progress and the Path Forward for Medical Innovation
… committee, thank you for the invitation to testify at this hearing to discuss the implementation of the 21st Century … Senate Committee on Health, Education, Labor & Pensions Hearing, “Implementation of the 21st Century Cures Act: …
Remarks from FDA Commissioner Scott Gottlieb, M.D., as prepared for oral testimony before the House Committee on Energy and Commerce Hearing, “Implementing the 21st Century Cures Act: An Update from FDA and NIH"
… before the House Committee on Energy and Commerce Hearing, “Implementing the 21st Century Cures Act: An Update …
Statement from FDA Commissioner Robert Califf, M.D. announcing new draft guidances on medical product communications
… or cleared medical products. The FDA held a Part 15 hearing in November 2016 to hear from a broad range of … for the docket opened in connection with that public hearing for an additional 90 days (until April 19, 2017) to … We have also added a document to the docket for the public hearing titled “ Memorandum: Public Health Interests and …
Statement from FDA Commissioner Scott Gottlieb, M.D., on the agency’s continued efforts to address growing epidemic of youth e-cigarette use, including potential new therapies to support cessation
… to these products. Today, we’re announcing a public hearing , to be held Dec. 5, to discuss our efforts to … the development of such therapies for children. This hearing will also give us an opportunity to discuss the need … health. That the FDA finds that we need to hold such a hearing ‒ to discuss ways to use drug therapies to treat teen …
FDA takes steps to withdraw approval of the swine drug carbadox due to safety concerns
… approval, CVM must first file a Notice of Opportunity for Hearing, which it issued today. The notice provides the … manufacturer of carbadox with an opportunity to request a hearing on whether the approval should be withdrawn. The company has 30 days to request a hearing. If the company does not request a hearing, the …
FDA approves first telehealth option to program cochlear implants remotely
… Health. A cochlear implant is an implanted electronic hearing device, designed to produce useful hearing sensations to a person with severe to profound hearing loss, by electrically stimulating nerves inside the …
Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps to advance agency’s continued evaluation of potential regulatory pathways for cannabis-containing and cannabis-derived products
… existing authorities. These new steps include: A public hearing on May 31, as well as a broader opportunity for … claims that are aimed at vulnerable populations. Public Hearing The public hearing will give stakeholders an opportunity to provide the …
FDA Commissioner and Chief Scientist Announce Decision to Withdraw Approval of Makena
… the drug’s approval in 2020. The sponsor requested a hearing, which was held in October 2022. Following the hearing, the FDA Commissioner and Chief Scientist reviewed … public comments to the docket , the transcript of the hearing and the Presiding Officer’s report. Based on that …
FDA warns JUUL Labs for marketing unauthorized modified risk tobacco products, including in outreach to youth
… about several issues raised in a recent Congressional hearing regarding JUUL’s outreach and marketing practices, … practices that came to light in a recent Congressional hearing. We will continue to scrutinize tobacco product … discussed in testimony from a July 2019 Congressional hearing on JUUL. According to that testimony, a JUUL …
Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps to help prevent new addiction, curb abuse and overdose related to opioid products
… steps today toward these goals. Today, at a Part 15 hearing on this issue, we’re gathering a broad group of … on the delivery system – which brings me back to today’s hearing and why stakeholder feedback is so important. … is critical to our success. That’s why, following the hearing and discussion today, we welcome and strongly …
Statement from FDA Commissioner Scott Gottlieb, M.D., on new efforts to advance treatment strategies for helping youth addicted to nicotine as a result of the epidemic rise in teen use of e-cigarettes
… related to youth tobacco cessation, we held a public hearing in January on this topic that was invaluable in … of the scientific issues raised during the January public hearing. As part of our efforts to address this issue, we determined that holding both a public hearing and a scientific workshop would provide forums for …
FDA Roundup: May 09, 2023
… 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. COVID-19 testing updates: As of today, 449 …
FDA permits marketing of balloon device to treat persistent Eustachian tube dysfunction
… is the case with ETD, it results in discomfort, impaired hearing, persistent ear infections, ringing in the ears … or other symptoms. “The Eustachian tube supports hearing by maintaining pressure inside the ear,” said Malvina …
FDA Roundup: August 1, 2023
… violated the 2010 injunction and scheduled an evidentiary hearing regarding whether their noncompliance was justified. Prior to the hearing, the parties negotiated the consent decree, which, …
FDA Roundup: January 13, 2023
… video about the new category of over-the-counter (OTC) hearing aids, prescription hearing aids, and how they are different from personal sound …
FDA orders Puerto Rico fertility clinic to cease manufacturing immediately for significant violations that pose a danger to health
… has offered the clinic the opportunity for a regulatory hearing. The clinic has five days to request the hearing. Health care professionals and consumers should …
Coronavirus (COVID-19) Update: Federal judge enters temporary injunction against Genesis II Church of Health and Healing, preventing sale of Chlorine Dioxide Products Equivalent to Industrial Bleach to Treat COVID-19
… injunction was not entered and to provide the date for the hearing on the preliminary injunction request. Español A … and Jonathan Grenon until May 1st, 2020. There will be a hearing on the government’s request to extend the injunction …
Statement from FDA Commissioner Scott Gottlieb, M.D., on additional steps by the agency to support the development of safe and effective novel nicotine replacement therapies to help smokers quit cigarettes
… and improve their health. This included holding a public hearing in January 2018 examining the types of safety and … takes into consideration the input received at the public hearing in January 2018 and is intended to serve as a focus …