Personal sound amplification product: Difference between revisions
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| ⚫ | '''Personal Sound Amplification Products''', also known as "Personal Sound Amplification Devices," or by the acronym '''PSAP''', are defined by the U.S. [[Food and Drug Administration]] as wearable electronic products that are intended to amplify sounds for people who are not hearing impaired. They are not [[hearing aids]], which the FDA describes as intended to compensate for impaired hearing.<ref>Mann, Eric A., M.D., Ph.D., [http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm185459.htm “Hearing Aids and Personal Sound Amplifiers: Know the Difference”], U.S. Food and Drug Administration Consumer Updates website, Oct. 20, 2009. Retrieved 2013-05-23.</ref> However, PSAPs can be a useful alternative to a hearing aid.<ref name="newoldage.blogs.nytimes">Graham, Judith, [http://newoldage.blogs.nytimes.com/2013/06/12/when-hearing-aids-wont-do/ “When Hearing Aids Won’t Do”], ''The New York Times,'' June 12, 2013. Retrieved 2013-06-12.</ref> |
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'''Personal Sound Amplification Products''' |
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| ⚫ | Both PSAPs and hearing aids are small electronic devices that fit into the ear and amplify sound. While the technology and function of PSAPs and hearing aids are similar, PSAPs are not regulated under the [[Food, Drug and Cosmetic Act]] because they are not intended to treat, diagnose or cure hearing impairment and do not alter the structure or function of the body. As a result, there is no regulatory classification, product code or definition for these products. However, the FDA does regulate PSAPs under certain provisions of the Radiation Control for Health and Safety Act of 1968, covering electronic products such as sound amplification equipment that emits sonic vibrations.<ref name="fda">Mann, [http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm127086.htm “Guidance for Industry and FDA Staff: Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products”], U.S. Food and Drug Administration website, Feb. 25, 2009. Retrieved 2013-05-23.</ref> |
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| ⚫ | '''Personal Sound Amplification Products''', also known as "Personal Sound Amplification Devices," or by the acronym PSAP, are defined by the U.S. [[Food and Drug Administration]] as wearable electronic products that are intended to amplify sounds for people who are not hearing impaired. |
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| ⚫ | Because they do not require a medical prescription and professional fitting, PSAPs have been described as the audio version of reading [[glasses]].<ref name="online">Beck, Melinda, [http://online.wsj.com/article/SB10000872396390443921504577643451266751104.html “Testing, Testing...Can You Hear Better Now?”], ''The Wall Street Journal,'' Sept. 10. 2012. Retrieved 2013-05-23.</ref> As such, PSAPs are suggested for use by hunters listening for prey, for [[bird watching]], assistance hearing distant conversations or performances and amplifying the sound of a television in a quiet room, for example.<ref name="fda" /> |
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| ⚫ | Both PSAPs and hearing aids are small electronic devices that fit into the ear and amplify sound. |
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| ⚫ | Because they do not require a medical prescription and professional fitting, PSAPs have been described as the audio version of reading [[glasses]].<ref name="online">Beck, Melinda, [http://online.wsj.com/article/SB10000872396390443921504577643451266751104.html “Testing, Testing...Can You Hear Better Now?”], ''The Wall Street Journal,'' Sept. 10. 2012. Retrieved 2013-05-23.</ref> |
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Various models of PSAPs from a variety of manufacturers vary in price and performance. Simple models merely amplify sound while more sophisticated designs provide directional [[microphones]] and customizable [[equalization]] of the audio signal to clear up ambient or extraneous noise.<ref>Beck, Melinda, [http://online.wsj.com/article/SB120156046709123567.html “Getting an Earful: Testing A Tiny, Pricey Hearing Aid”], ''The Wall Street Journal,'' Jan. 29, 2008. Retrieved 2013-05-23.</ref> In this way, the more advanced PSAPs contain much of the same technology found in hearing aids.<ref name="newoldage.blogs.nytimes" /> |
Various models of PSAPs from a variety of manufacturers vary in price and performance. Simple models merely amplify sound while more sophisticated designs provide directional [[microphones]] and customizable [[equalization]] of the audio signal to clear up ambient or extraneous noise.<ref>Beck, Melinda, [http://online.wsj.com/article/SB120156046709123567.html “Getting an Earful: Testing A Tiny, Pricey Hearing Aid”], ''The Wall Street Journal,'' Jan. 29, 2008. Retrieved 2013-05-23.</ref> In this way, the more advanced PSAPs contain much of the same technology found in hearing aids.<ref name="newoldage.blogs.nytimes" /> |
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PSAPs have grown in popularity among people with hearing impairment, in part because they are less expensive than custom hearing aids,<ref>Strom, Karl, [http://www.hearingreview.com/all-news/16998-the-psap-dilemma “The PSAP Dilemma”], ''The Hearing Review,'' June 2010. Retrieved 2013-05-29.,</ref> although apathy, vanity and difficulty scheduling appointments with audiologists also have been cited as reasons for low hearing aid adoption.<ref>Ramachandran, Virginia, Stach, Brad, [http://www.hearingreview.com/all-news/20029-just-making-hearing-aid-less-expensive-doesnt-encourage-earlier-use “Just Making Hearing Aid Less Expensive Doesn't Encourage Earlier Use”], ''The Hearing Review,'' May 2011. Retrieved 2013-05-28.</ref> |
PSAPs have grown in popularity among people with hearing impairment, in part because they are less expensive than custom hearing aids,<ref>Strom, Karl, [http://www.hearingreview.com/all-news/16998-the-psap-dilemma “The PSAP Dilemma”], ''The Hearing Review,'' June 2010. Retrieved 2013-05-29.,</ref> although apathy, vanity and difficulty scheduling appointments with audiologists also have been cited as reasons for low hearing aid adoption.<ref>Ramachandran, Virginia, Stach, Brad, [http://www.hearingreview.com/all-news/20029-just-making-hearing-aid-less-expensive-doesnt-encourage-earlier-use “Just Making Hearing Aid Less Expensive Doesn't Encourage Earlier Use”], ''The Hearing Review,'' May 2011. Retrieved 2013-05-28.</ref> Because they do not require medical examination and fitting, PSAPs range from as little as 50 to several hundred dollars in price, while custom hearing aids cost about $1400 on average<ref name="betterhearing">Kochkin, Sergei, Ph.D., [http://www.betterhearing.org/pdfs/PSAP_study.pdf “MarkeTrak VIII: Utilization of PSAPs and Direct-Mail Hearing Aids by People with Hearing Impairment”], ''The Hearing Review,'' June 2010; Volume 17, Number 6. Retrieved 2013-05-23.</ref> and are not covered by [[Medicare]] and many insurance plans.<ref name="online" /> As much as 70 percent of the final price of a hearing aid can be accounted for by additional services from audiologists that are bundled in to the price.<ref>Romano, Tricia, [http://well.blogs.nytimes.com/2012/10/22/the-hunt-for-an-affordable-hearing-aid/ “The Hunt for an Affordable Hearing Aid”], ''The New York Times,'' Oct. 22, 2012. Retrieved 2013-06-12.</ref> |
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According to the National Institute of Deafness and Other Communication Diseases, of the 36 million Americans who might benefit from a hearing aid, only about 20 percent actually use one.<ref name="online" /> However, a 2010 survey indicates that fewer than 18 percent of PSAPs were used as a substitute for custom hearing aids and concludes that the majority of PSAP users would have lived with their hearing loss because of the higher price of hearing aids.<ref name="betterhearing" /> |
According to the National Institute of Deafness and Other Communication Diseases, of the 36 million Americans who might benefit from a hearing aid, only about 20 percent actually use one.<ref name="online" /> However, a 2010 survey indicates that fewer than 18 percent of PSAPs were used as a substitute for custom hearing aids and concludes that the majority of PSAP users would have lived with their hearing loss because of the higher price of hearing aids.<ref name="betterhearing" /> |
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== External links == |
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Revision as of 16:26, 20 June 2013
Personal Sound Amplification Products, also known as "Personal Sound Amplification Devices," or by the acronym PSAP, are defined by the U.S. Food and Drug Administration as wearable electronic products that are intended to amplify sounds for people who are not hearing impaired. They are not hearing aids, which the FDA describes as intended to compensate for impaired hearing.[1] However, PSAPs can be a useful alternative to a hearing aid.[2]
Both PSAPs and hearing aids are small electronic devices that fit into the ear and amplify sound. While the technology and function of PSAPs and hearing aids are similar, PSAPs are not regulated under the Food, Drug and Cosmetic Act because they are not intended to treat, diagnose or cure hearing impairment and do not alter the structure or function of the body. As a result, there is no regulatory classification, product code or definition for these products. However, the FDA does regulate PSAPs under certain provisions of the Radiation Control for Health and Safety Act of 1968, covering electronic products such as sound amplification equipment that emits sonic vibrations.[3]
Because they do not require a medical prescription and professional fitting, PSAPs have been described as the audio version of reading glasses.[4] As such, PSAPs are suggested for use by hunters listening for prey, for bird watching, assistance hearing distant conversations or performances and amplifying the sound of a television in a quiet room, for example.[3]
Various models of PSAPs from a variety of manufacturers vary in price and performance. Simple models merely amplify sound while more sophisticated designs provide directional microphones and customizable equalization of the audio signal to clear up ambient or extraneous noise.[5] In this way, the more advanced PSAPs contain much of the same technology found in hearing aids.[2]
PSAPs have grown in popularity among people with hearing impairment, in part because they are less expensive than custom hearing aids,[6] although apathy, vanity and difficulty scheduling appointments with audiologists also have been cited as reasons for low hearing aid adoption.[7] Because they do not require medical examination and fitting, PSAPs range from as little as 50 to several hundred dollars in price, while custom hearing aids cost about $1400 on average[8] and are not covered by Medicare and many insurance plans.[4] As much as 70 percent of the final price of a hearing aid can be accounted for by additional services from audiologists that are bundled in to the price.[9]
According to the National Institute of Deafness and Other Communication Diseases, of the 36 million Americans who might benefit from a hearing aid, only about 20 percent actually use one.[4] However, a 2010 survey indicates that fewer than 18 percent of PSAPs were used as a substitute for custom hearing aids and concludes that the majority of PSAP users would have lived with their hearing loss because of the higher price of hearing aids.[8]
Many PSAPs are sold direct to the consumer through online stores, at pharmacies and through many drugstore and retail store chains.
References
- ^ Mann, Eric A., M.D., Ph.D., “Hearing Aids and Personal Sound Amplifiers: Know the Difference”, U.S. Food and Drug Administration Consumer Updates website, Oct. 20, 2009. Retrieved 2013-05-23.
- ^ a b Graham, Judith, “When Hearing Aids Won’t Do”, The New York Times, June 12, 2013. Retrieved 2013-06-12.
- ^ a b Mann, “Guidance for Industry and FDA Staff: Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products”, U.S. Food and Drug Administration website, Feb. 25, 2009. Retrieved 2013-05-23.
- ^ a b c Beck, Melinda, “Testing, Testing...Can You Hear Better Now?”, The Wall Street Journal, Sept. 10. 2012. Retrieved 2013-05-23.
- ^ Beck, Melinda, “Getting an Earful: Testing A Tiny, Pricey Hearing Aid”, The Wall Street Journal, Jan. 29, 2008. Retrieved 2013-05-23.
- ^ Strom, Karl, “The PSAP Dilemma”, The Hearing Review, June 2010. Retrieved 2013-05-29.,
- ^ Ramachandran, Virginia, Stach, Brad, “Just Making Hearing Aid Less Expensive Doesn't Encourage Earlier Use”, The Hearing Review, May 2011. Retrieved 2013-05-28.
- ^ a b Kochkin, Sergei, Ph.D., “MarkeTrak VIII: Utilization of PSAPs and Direct-Mail Hearing Aids by People with Hearing Impairment”, The Hearing Review, June 2010; Volume 17, Number 6. Retrieved 2013-05-23.
- ^ Romano, Tricia, “The Hunt for an Affordable Hearing Aid”, The New York Times, Oct. 22, 2012. Retrieved 2013-06-12.