Over-the-Counter Hearing Aid Act Of 2017
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Over-the-Counter Hearing Aid Act Of 2017
The ''Over-the-Counter Hearing Aid Act of 2017'' (OTC Hearing Aid Act) was a law passed by the 115th United States Congress as a rider on the FDA Reauthorization Act of 2017. It created a class of hearing aids regulated by the Food and Drug Administration (FDA) available directly to consumers without involvement from a licensed professional (like an audiologist, otolaryngologist, or audiometrist). Regulations for this new class of hearing aid are expected to be released by the end of 2020. History Hearing loss affects approximately 466 million individuals worldwide and is most concentrated among older adults. Approximately half of adults in the US age 60+ have some degree of hearing loss. Despite hearing loss' impact on communication, social functioning, and economic productivity across the life course, hearing aid uptake is no higher than 50% - even in settings where costs are covered by insurance. Barriers to addressing hearing loss in the U.S. include stigma, financial cost ...
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Federal Food, Drug And Cosmetic Act
The United States Federal Food, Drug, and Cosmetic Act (abbreviated as FFDCA, FDCA, or FD&C) is a set of laws passed by the United States Congress in 1938 giving authority to the U.S. Food and Drug Administration (FDA) to oversee the safety of food, drugs, medical devices, and cosmetics. A principal author of this law was Royal S. Copeland, a three-term U.S. senator from New York. In 1968, the Electronic Product Radiation Control provisions were added to the FD&C. Also in that year the FDA formed the Drug Efficacy Study Implementation (DESI) to incorporate into FD&C regulations the recommendations from a National Academy of Sciences investigation of effectiveness of previously marketed drugs. The act has been amended many times, most recently to add requirements about bioterrorism preparations. The introduction of this act was influenced by the death of more than 100 patients due to elixir sulfanilamide, a sulfanilamide medication where the toxic solvent diethylene glycol was us ...
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Audiometrist
An Audiometrist (from Latin , "to hear"; and from Italian '' -metria'', “to measure” ) or Audiometric Officer, is a health-care professional technician who has received special training in the use of Pure tone audiometry equipment. An audiometrist conducts hearing tests, or "audiometric screening", with an Audiometer to establish hearing levels. The results are represented by an audiogram, and are usually interpreted by an audiologist, or a registered Medical Officer, unless the audiometrist is also an audiologist, with the aim of diagnosing hearing loss. There are currently some misconceptions regarding the definition of Audiometrist and Audiologist, which vary from country to country. These misconceptions continue to grow, in Australia in particular, which leads to the need for greater communication, less segregation of each other's role within the community and a broader understanding of each other's qualifications. Audiometrist vs. Audiologist The word "Audiometrist" is d ...
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General Controls And Special Controls
A general officer is an officer of high rank in the armies, and in some nations' air forces, space forces, and marines or naval infantry. In some usages the term "general officer" refers to a rank above colonel."general, adj. and n.". OED Online. March 2021. Oxford University Press. https://www.oed.com/view/Entry/77489?rskey=dCKrg4&result=1 (accessed May 11, 2021) The term ''general'' is used in two ways: as the generic title for all grades of general officer and as a specific rank. It originates in the 16th century, as a shortening of ''captain general'', which rank was taken from Middle French ''capitaine général''. The adjective ''general'' had been affixed to officer designations since the late medieval period to indicate relative superiority or an extended jurisdiction. Today, the title of ''general'' is known in some countries as a four-star rank. However, different countries use different systems of stars or other insignia for senior ranks. It has a NATO rank scal ...
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General Controls
A general officer is an officer of high rank in the armies, and in some nations' air forces, space forces, and marines or naval infantry. In some usages the term "general officer" refers to a rank above colonel."general, adj. and n.". OED Online. March 2021. Oxford University Press. https://www.oed.com/view/Entry/77489?rskey=dCKrg4&result=1 (accessed May 11, 2021) The term ''general'' is used in two ways: as the generic title for all grades of general officer and as a specific rank. It originates in the Tudor period, 16th century, as a shortening of ''captain general'', which rank was taken from Middle French ''capitaine général''. The adjective ''general'' had been affixed to officer designations since the late Middle Ages, late medieval period to indicate relative superiority or an extended jurisdiction. Today, the title of ''general'' is known in some countries as a four-star rank. However, different countries use different systems of stars or other insignia for senior ...
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21st Century Cures Act
The 21st Century Cures Act is a United States law enacted by the 114th United States Congress in December 2016 and then signed into law on December 13, 2016. It authorized $6.3 billion in funding, mostly for the National Institutes of Health. The act was supported especially by large pharmaceutical manufacturers and was opposed especially by some consumer organizations. Proponents said that it would streamline the drug and device approval process and bring treatments to market faster. Opponents said that it would allow drugs and devices to be approved on weaker evidence, bypassing randomized, controlled trials, and bring more dangerous or ineffective treatments to market. The bill incorporated the Helping Families In Mental Health Crisis Act, first introduced by then-Congressman Tim Murphy, R-Pa., which increased the availability of psychiatric hospital beds and established a new assistant secretary for mental health and substance use disorders. Content Research and drug de ...
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Food And Drug Administration Modernization Act Of 1997
The United States Food and Drug Administration Modernization Act of 1997 (FDAMA) amended the Federal Food, Drug, and Cosmetic Act. This act is related to the regulation of food, drugs, devices, and biological products by the FDA. These changes were made in order to recognize the changes in the way the FDA would be operating in the 21st century. The main focus of this is the acknowledgment in the advancement of technological, trade, and public health complexities. History Congressman Richard Burr and Senator James M. Jeffords were the chairperson sponsors of the Food and Drug Administration Regulatory Modernization Act of 1997 or Food and Drug Administration Modernization Act of 1997. The U.S. legislation was signed by Bill Clinton on 21 November 1997, and was fully enacted by 1 April 1999, putting into law reforms begun under the National Partnership for Reinventing Government. One result of the passing of the act was a reduction in the time for the approval of new pharmaceutica ...
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Federal Food, Drug, And Cosmetic Act
The United States Federal Food, Drug, and Cosmetic Act (abbreviated as FFDCA, FDCA, or FD&C) is a set of laws passed by the United States Congress in 1938 giving authority to the U.S. Food and Drug Administration (FDA) to oversee the safety of food, drugs, medical devices, and cosmetics. A principal author of this law was Royal S. Copeland, a three-term U.S. senator from New York. In 1968, the Electronic Product Radiation Control provisions were added to the FD&C. Also in that year the FDA formed the Drug Efficacy Study Implementation (DESI) to incorporate into FD&C regulations the recommendations from a National Academy of Sciences investigation of effectiveness of previously marketed drugs. The act has been amended many times, most recently to add requirements about bioterrorism preparations. The introduction of this act was influenced by the death of more than 100 patients due to elixir sulfanilamide, a sulfanilamide medication where the toxic solvent diethylene glycol was us ...
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Bose Corporation
Bose Corporation () is an American manufacturing company that predominantly sells audio equipment. The company was established by Amar Bose in 1964 and is based in Framingham, Massachusetts. It is best known for its home audio systems and speakers, noise cancelling headphones, professional audio products and automobile sound systems. Bose has a reputation for being particularly protective of its patents, trademarks, and brands. The majority owner of Bose Corporation is the Massachusetts Institute of Technology. Non-voting shares were donated to MIT by founder Amar Bose, and receive cash dividends. According to the company annual report for the 2021 financial year, Bose Corporation's annual sales were $3.2 billion, and the company employed approximately 7,000 people. History The company was founded in Massachusetts in 1964 by Amar Bose with angel investor funding, including Amar's thesis advisor and professor, Y. W. Lee. Bose's interest in speaker systems had begun in 1956 wh ...
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United States Department Of Health And Human Services
The United States Department of Health and Human Services (HHS) is a cabinet-level executive branch department of the U.S. federal government created to protect the health of all Americans and providing essential human services. Its motto is "Improving the health, safety, and well-being of America". Before the separate federal Department of Education was created in 1979, it was called the Department of Health, Education, and Welfare (HEW). HHS is administered by the Secretary of Health and Human Services, who is appointed by the president with the advice and consent of the United States Senate. The position is currently held by Xavier Becerra. The United States Public Health Service Commissioned Corps, the uniformed service of the PHS, is led by the Surgeon General who is responsible for addressing matters concerning public health as authorized by the secretary or by the assistant secretary for Health in addition to his or her primary mission of administering the Commission ...
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United States Senate
The United States Senate is the upper chamber of the United States Congress, with the House of Representatives being the lower chamber. Together they compose the national bicameral legislature of the United States. The composition and powers of the Senate are established by Article One of the United States Constitution. The Senate is composed of senators, each of whom represents a single state in its entirety. Each of the 50 states is equally represented by two senators who serve staggered terms of six years, for a total of 100 senators. The vice president of the United States serves as presiding officer and president of the Senate by virtue of that office, despite not being a senator, and has a vote only if the Senate is equally divided. In the vice president's absence, the president pro tempore, who is traditionally the senior member of the party holding a majority of seats, presides over the Senate. As the upper chamber of Congress, the Senate has several powers o ...
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United States House Of Representatives
The United States House of Representatives, often referred to as the House of Representatives, the U.S. House, or simply the House, is the Lower house, lower chamber of the United States Congress, with the United States Senate, Senate being the Upper house, upper chamber. Together they comprise the national Bicameralism, bicameral legislature of the United States. The House's composition was established by Article One of the United States Constitution. The House is composed of representatives who, pursuant to the Uniform Congressional District Act, sit in single member List of United States congressional districts, congressional districts allocated to each U.S. state, state on a basis of population as measured by the United States Census, with each district having one representative, provided that each state is entitled to at least one. Since its inception in 1789, all representatives have been directly elected, although universal suffrage did not come to effect until after ...
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Federal Trade Commission
The Federal Trade Commission (FTC) is an independent agency of the United States government whose principal mission is the enforcement of civil (non-criminal) antitrust law and the promotion of consumer protection. The FTC shares jurisdiction over federal civil antitrust enforcement with the Department of Justice Antitrust Division. The agency is headquartered in the Federal Trade Commission Building in Washington, DC. The FTC was established in 1914 with the passage of the Federal Trade Commission Act, signed in response to the 19th-century monopolistic trust crisis. Since its inception, the FTC has enforced the provisions of the Clayton Act, a key antitrust statute, as well as the provisions of the FTC Act, et seq. Over time, the FTC has been delegated with the enforcement of additional business regulation statutes and has promulgated a number of regulations (codified in Title 16 of the Code of Federal Regulations). The broad statutory authority granted to the FTC provide ...
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