The History Of Hearing Aids PDF

Click to edit Master title style THE HISTORY OF HEARING AIDS, FDA, AND LEGISLATION SLH 394P AMPLIFYING SYSTEMS IN AURAL R E H A B I L I T AT I O N 1 Click to edit Master title style Food and Drug Administration (FDA)...

Click to edit Master title style THE HISTORY OF HEARING AIDS, FDA, AND LEGISLATION SLH 394P AMPLIFYING SYSTEMS IN AURAL R E H A B I L I T AT I O N 1 Click to edit Master title style Food and Drug Administration (FDA) The FDA is the federal agency that regulates food, drugs, medical devices, and other products in the U.S. 2 https://www.fda.gov/ Click to edit Master title style Code of Federal Regulations (CFR) The CFR is the codification of the general and permanent rules published in the Federal Register by the departments and agencies of the Federal Government. §: is a typographical character used for when citing sections of legal code and it can mean section symbol or section mark 3 https://www.ecfr.gov/ Click to Food andedit DrugMaster Administration, title style HHS (Health Human Services) Subpart D—Prosthetic Devices § 874.3300 Air-conduction hearing aid. (a) Identification. An air-conduction hearing aid is a wearable sound-amplifying device intended to compensate for impaired hearing that conducts sound to the ear through the air. An air-conduction hearing aid is subject to the requirements in §800.30 or §801.422 of this chapter, as applicable. [87 FR 50762, Aug. 17, 2022] § 874.3302 Bone-conduction hearing aid. (a) Identification. A bone-conduction hearing aid is a wearable sound-amplifying device intended to compensate for impaired hearing and that conducts sound to the inner ear through the skull. The non-implantable components of a bone-conduction hearing aid, such as the external sound processor, are subject to the requirements in §801.422 of this chapter. 4 https://www.ecfr.gov/ Click to Food andedit DrugMaster Administration, title style HHS (Health Human Services) § 874.3305 Wireless air-conduction hearing aid. (a) Identification. A wireless air-conduction hearing aid is a wearable sound- amplifying device, intended to compensate for impaired hearing that incorporates wireless technology in its programming or use. A wireless air conduction hearing aid is subject to the requirements in §800.30 or §801.422 of this chapter, as applicable. (b) Classification. Class II (special controls). The special controls for this device are: (1) Performance data must demonstrate the electromagnetic compatibility (EMC), electrical safety, and thermal safety of the device; (2) Performance testing must validate safety of exposure to non-ionizing radiation; and (3) Performance data must validate wireless technology functions. (c) Premarket notification. The wireless air-conduction hearing aid is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to §874.9. [76 FR 34846, June 15, 2011, as amended at 87 FR 50762, Aug. 17, 2022] https://www.ecfr.gov/ 5 Food andedit Click to Drug Administration, Master title style HHS (Health Human Services) § 874.3330 Master hearing aid. (a) Identification. A master hearing aid is an electronic device intended to simulate a hearing aid during audiometric testing. It has adjustable acoustic output levels, such as those for gain, output, and frequency response. The device is used to select and adjust a person’s wearable hearing aid. (b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in §874.9. [51 FR 40389, Nov. 6, 1986, as amended at 84 FR 71813, Dec. 30, 2019] § 874.3340 Active implantable bone conduction hearing system. (a) Identification. An active implantable bone conduction hearing system is a prescription device consisting of an implanted transducer, implanted electronics components, and an audio processor. The active implantable bone conduction hearing system is intended to compensate for conductive or mixed hearing losses by conveying amplified acoustic signals to the cochlea via mechanical vibrations on the skull bone. 6 https://www.ecfr.gov/ Guidance forMaster Click to edit Industry and title FDA Staff Regulatory style Requirements for Hearing Aid Devices and Personal Sound Amplification Products Document issued on: February 25, 2009 Personal Sound Amplification Products (PSAPs) PSAPs are intended to amplify environmental sound for non-hearing impaired consumers. They are not intended to compensate for hearing impairment. Examples of situations in which PSAPs typically are used include hunting (listening for prey), bird watching, listening to lectures with a distant speaker, and listening to soft sounds that would be difficult for normal hearing individuals to hear (e.g., distant conversations, performances). Because PSAPs are not intended to diagnose, treat, cure or mitigate disease and do not alter the structure or function of the body, they are not devices as defined in the Food, Drug and Cosmetic Act. As such, there is no regulatory classification, product code, or definition for these products. Furthermore, there are no requirements for registration of manufacturers and listing of these products with FDA. 7 https://www.ecfr.gov/  Click to Food andedit DrugMaster Administration, title style HHS (Health Human Services) § 874.3320 Group hearing aid or group auditory trainer. (a) Identification. A group hearing aid or group auditory trainer is a hearing aid that is intended for use in communicating simultaneously with one or more listeners having hearing impairment. The device is used with an associated transmitter microphone. It may be either monaural or binaural, and it provides coupling to the ear through either earphones or earmolds… [51 FR 40389, Nov. 6, 1986, as amended at 84 FR 71813, Dec. 30, 2019] § 874.3325 Self-fitting air-conduction hearing aid. (a) Identification. A self-fitting air conduction hearing aid is a wearable sound amplifying device that is intended to compensate for impaired hearing and incorporates technology, including software, that allows users to program their hearing aids. This technology integrates user input with a self-fitting strategy and enables users to independently derive and customize 8 https://www.ecfr.gov/  Click to Food andedit DrugMaster Administration, title style HHS (Health Human Services) § 874.3310 Hearing aid calibrator and analysis system. (a) Identification. A hearing aid calibrator and analysis system is an electronic reference device intended to calibrate and assess the electroacoustic frequency and sound intensity characteristics emanating from a hearing aid, master hearing aid, group hearing aid or group auditory trainer. The device consists of an acoustic complex of known cavity volume, a sound level meter, a microphone, oscillators, frequency counters, microphone amplifiers, a distortion analyzer, a chart recorder, and a hearing aid test box. (b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in §874.9. [51 FR 40389, Nov. 6, 1986, as amended at 84 FR 71813, Dec. 30, 2019} What do you think this is? 9 https://www.ecfr.gov/  Click to Food andedit DrugMaster Administration, title style HHS (Health Human Services) § 801.420 Hearing aid devices; professional and patient labeling. (a) Definitions for the purposes of this section and §801.421. (1) Hearing aid means any wearable instrument or device designed for, offered for the purpose of, or represented as aiding persons with or compensating for, impaired hearing. (2) Ear specialist … physicians are also known as otolaryngologists, otologists, and otorhinolaryngologists. (3) Dispenser means any person…engaged in the sale, lease, or rental of hearing aids to any member of the consuming public (4) Audiologist means any person qualified by training and experience to specialize in the evaluation and rehabilitation of individuals whose communication disorders center in whole or in part in the hearing function. In some states audiologists must satisfy specific requirements for licensure 10 https://www.ecfr.gov/  Click to Food andedit DrugMaster Administration, title style HHS (Health Human Services) § 801.420 Hearing aid devices; professional and patient labeling. (continued) ( 5) Sale or purchase includes any lease or rental of a hearing aid to a member of the consuming public who is a user or prospective user of a hearing aid. (6) Used hearing aid means any hearing aid that has been worn for any period of time by a user. However, a hearing aid shall not be considered ‘‘used’’ merely because it has been worn by a prospective user …. (b) Label requirements for hearing aids. Hearing aids shall be clearly and permanently marked with: (1) The name of the manufacturer or distributor, the model name or number, the serial number, and the year of manufacture. (2) A ‘‘ + ’’ symbol to indicate the positive connection for battery insertion, unless it is physically impossible to insert the battery in the reversed position. (c) Labeling requirements for hearing aids—(1) General. All labeling information required by this paragraph shall be included in a User Instructional Brochure that shall be developed by the manufacturer or distributor, shall accompany the hearing aid, and shall be provided to the prospective user by the dispenser of the hearing aid in accordance with §801.421(c). 11 https://www.ecfr.gov/  Click to Food andedit DrugMaster Administration, title style HHS (Health Human Services) § 801.420 Hearing aid devices; professional and patient labeling. (continued) The User Instructional Brochure accompanying each hearing aid shall contain the following information and instructions for use, to the extent applicable to the particular requirements and characteristics of the hearing aid: … (c) Replacing or recharging the batteries, including a generic designation of replacement batteries…( Viii) A statement that a hearing aid will not restore normal hearing and will not prevent or improve a hearing impairment resulting from organic conditions. (ix) A statement that in most cases infrequent use of a hearing aid does not permit a user to attain full benefit from it. (x) A statement that the use of a hearing aid is only part of hearing habilitation and may need to be supplemented by auditory training and instruction in lipreading. 12 https://www.ecfr.gov/  Click to Food andedit DrugMaster Administration, title style HHS (Health Human Services) § 801.420 Hearing aid devices; professional and patient labeling. (continued) WARNING TO HEARING AID DISPENSERS … should advise a prospective hearing aid user to consult promptly with a licensed physician (preferably an ear specialist) before dispensing hearing aid if the hearing aid dispenser determines through inquiry, actual observation, or review of any other available information concerning the prospective user, that the prospective user has any of the following conditions: (i) Visible congenital or traumatic deformity of the ear. (ii) History of active drainage from the ear within the previous 90 days. (iii) History of sudden or rapidly progressive hearing loss within the previous 90 days. (iv) Acute or chronic dizziness. (v) Unilateral hearing loss of sudden or recent onset within the previous 90 days. (vi) Audiometric air-bone gap equal to or greater than 15 decibels at 500 hertz (Hz), 1,000 Hz, and 2,000 Hz. (vii) Visible evidence of significant cerumen accumulation or a foreign body in the ear canal. (viii) Pain or discomfort in the ear. Special care should be exercised in selecting and fitting a hearing aid whose maximum sound pressure level exceeds 132 decibels because there may be risk of impairing the remaining hearing of the hearing aid user. 13 https://www.ecfr.gov/  Food and Drug Administration, Click to edit Master title style HHS (Health Human Services) § 801.420 Hearing aid devices; professional and patient labeling. (continued) IMPORTANT NOTICE FOR PROSPECTIVE HEARING AID USERS Good health practice requires that a person with a hearing loss have a medical evaluation by a licensed physician (preferably a physician who specializes in diseases of the ear) before purchasing a hearing aid. Licensed physicians who specialize in diseases of the ear are often referred to as otolaryngologists, otologists or otorhinolaryngologists. The purpose of medical evaluation is to assure that all medically treatable conditions that may affect hearing are identified and treated before the hearing aid is purchased. Following the medical evaluation, the physician will give you a written statement that states that your hearing loss has been medically evaluated and that you may be considered a candidate for a hearing aid. The physician will refer you to an audiologist or a hearing aid dispenser, as appropriate, for a hearing aid evaluation. … Federal law restricts the sale of hearing aids to those individuals who have obtained a medical evaluation from a licensed physician. Federal law permits a fully informed adult to sign a waiver statement declining the medical evaluation for religious or personal beliefs that preclude consultation with a physician. The exercise of such a waiver is not in your best health interest and its use is strongly discouraged 14 https://www.ecfr.gov/  Click Foodtoand editDrug Master title style HHS (Health Human Services) Administration, § 801.420 Hearing aid devices; professional and patient labeling. (continued) CHILDREN WITH HEARING LOSS In addition to seeing a physician for a medical evaluation, a child with a hearing loss should be directed to an audiologist for evaluation and rehabilitation since hearing loss may cause problems in language development and the educational and social growth of a child. An audiologist is qualified by training and experience to assist in the evaluation and rehabilitation of a child with a hearing loss. (4) Technical data. Technical data useful in selecting, fitting, and checking the performance of a hearing aid shall be provided in the User Instructional Brochure or in separate labeling that accompanies the device. The determination of technical data values for the hearing aid labeling shall be conducted in accordance with the test procedures of the American National Standard ‘‘Specification of Hearing Aid Characteristics,’’ ANSI S3.22– 2003 (Revision of ANSI S3.22–1996) (Includes April 2007 Erratum). 15 https://www.ecfr.gov/  50568 Federal Register / Vol. 87, No. 158 / Click to edit Wednesday, Master August 17,title 2022style / Rules and Regulations DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 800, 801, 808, and 874 [Docket No. FDA–2020–D–1380] SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled ‘‘Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products.’’ This guidance document is intended to describe hearing aids, personal sound amplification products (PSAPs), their respective intended uses, and the regulatory requirements that apply to these products. The FDA Reauthorization Act of 2017 (FDARA) directed FDA to update and finalize the draft guidance entitled ‘‘Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products,’’ issued on November 7, 2013. This final guidance fulfills this FDARA requirement and supersedes ‘‘Guidance for Industry and FDA Staff: Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products,’’ dated February 25, 2009. DATES: The announcement of the guidance is published in the Federal Register on August 17, 2022. See Also: 58192 16 https://www.ecfr.gov/ Click to edit Master title style LEGISLATION 117TH CONGRESS 1ST SESSION S. 1731 To provide certain coverage of audiologist services under the Medicare program, and for other purposes. Supposed to give audiologist direct access. https://www.congress.gov/bill/117th-congress/senate-bill/1731 Audiology Services UPDATE – November 14, 2022 In the CY 2023 Physician Fee Schedule Final Rule, CMS finalized an exception to the physician order requirement for certain diagnostic testing services to broaden patient access to services furnished by audiologists. The finalized policy will allow beneficiaries direct access (without an order from a physician or NPP) to an audiologist, but only for non-acute hearing conditions…July 2023. Until such time, however, for dates of service on or after January 1, 2023, audiologists may elect to use modifier AB 17 https://www.cms.gov/medicare/payment/fee-schedules/physician/audiology-services  HISTORY OF HEARING AIDS Click to edit Master title style 1650-1890 Ear trumpet (~ 1650)- acoustic type hearing aid that collected sound waves from the pinna and funneled the sound waved into the ear canal Ear trumpet in a hat (1890) 18 Hearing Tests and Hearing Aids by Watson and Tolan  HISTORY OF HEARING AIDS Click to edit Master1900-1902 title style Which invention that was patented in 1869 led to the invention of the electrical hearing aid? 1900 Dr. Ferdinand Alt- The hearing aid had a carbon granule transmitter that was operated by a battery and magnetic telephone type receiver. U.S.- 1902 “Akouphone” by Miller Reese Hutchinson from Mobile, Alabama and “Oriphone” by C.W. Harper from Boston, Massachusetts 19 Hearing Tests and Hearing Aids by Watson and Tolan  HISTORY OF HEARING AIDS Click to edit Master title style FLAWS OF CARBON TYPE HEARING AIDS Had 50%-75% harmonic distortion Only provided 10-15 decibels of gain Limited to frequency range of 1000 cycles to 1800 cycles This led to the invention of the carbon amplifier to help boost the electrical signal, but it only worked in vertical plane. 20 Hearing Tests and Hearing Aids by Watson and Tolan  HISTORY OF HEARING AIDS Click to edit Master title style 1920-1932 BONE CONDUCTION HEARING AIDS First bone conduction receiver was developed in early 1920s for use with audiometers German Physicist Hugo Lieber developed small wearable bone conduction hearing aid Were popular between 1931 and 1932. A FLAW OF BONE CONDUCTION HEARING AIDS Inefficient due to the amount of electrical power they needed to work 21 Hearing Tests and Hearing Aids by Watson and Tolan  HISTORY OF HEARING AIDS: Click to edit Master VACUUM title style TUBE LEAD TO ALL IN ONE HEARING AIDS 1943 Due to use of vacuum tube available in radios and televisions Wider high frequency response Improved gain FLAWS High levels of internal noise from the tube, battery “Invisible” tube style earmolds were made for the device but they suppressed certain frequencies and the smaller the tubing the more sound was attenuated. Produced by product tones 22 Hearing Tests and Hearing Aids by Watson and Tolan Mills, M. “Hearing Aids and the History of Electronics Miniaturization.” IEEE annals of the history of computing 33.2 (2011): 24–45. Web.  Click to edit HISTORY OF HEARING Master title AIDS: style WWII TECHNOLOGIES Technologies Developed During WWII Button battery- invented by Samuel Ruben 1942 Printed circuit -invented by Paul Eisler Circuit was smaller, it could be stacked , double sided, sturdier, interconnected layers, and led to more moisture resistance Mills, M. “Hearing Aids and the History of Electronics Miniaturization.” IEEE annals of the history of computing 33.2 (2011): 24–45. Web. 2323  Click to edit HISTORY OF HEARING Master title AIDS: style WWII TECHNOLOGIES Solo-pak hearing aid by Allen-Howe firm Had 48 possible settings: Three different types of receiver Controls for volume and frequency, and different ‘‘strengths’’ of vacuum tubes. Advertised as ‘‘easy to repair’’ by simply replacing the circuit wafer Users could no longer reconfigure hardware Mills, M. “Hearing Aids and the History of Electronics Miniaturization.” IEEE annals of the history of computing 33.2 (2011): 24–45. Web. 2424 Click to edit HISTORY OF HEARING Master title AIDS: style TRANSISTOR 1948 Transist-Ear by Bell Laboratories Transistor invented by Invented by John Bardeen, Walter Brattain, and William Shockley Innovative way to provide amplification Could switching signals Lasted longer than vacuum tubes Required less battery power FLAWS Had many defects Could not withstand small electrical shock 95% of the transistors were returned Led to the 1951 invention of the junction transistor by Raytheon. In 1953 200,000 transistorized hearing aids were purchased 2525 Mills, M. “Hearing Aids and the History of Electronics Miniaturization.” IEEE annals of the history of computing 33.2 (2011): 24–45. Web. Click to edit HISTORY OF HEARING Master title AIDS: style INTERGRATED CIRCUIT 1959 Integrated Circuit- a small electronic device made up of multiple interconnected electronic components such as transistors, resistors, and capacitors. microchip What do you know this to be today? 2626 Mills, M. “Hearing Aids and the History of Electronics Miniaturization.” IEEE annals of the history of computing 33.2 (2011): 24–45. Web. Click to edit HISTORY OF HEARING Master title AIDS: style MICROPROCESSORS Early 1970s microprocessors -is a computer processor for which the data processing logic and control is included on a single integrated circuit By end of 1970s, there chips ‘‘capable of processing audio signals in real time.” Analog hearing aid adjusted using screwdriver potentiometer for gain adjustment Usually 5-10 dB Single channel with no compression Minor changes in frequency response Took another decade to have a computer programmable hearing aid. 2727 Mills, M. “Hearing Aids and the History of Electronics Miniaturization.” IEEE annals of the history of computing 33.2 (2011): 24–45. Web. Click to edit Master title style 2828  Click to edit Master title style 2929 https://hearingreview.com/hearing-products/hearing-aids/a-brief-history-of-modern-hearing-aid-technology-types  Click to edit Master title style FOR NEXT CLASS 1. Read Chapter 14 Rickets et al. prior to next class. (It will be posted on Canvas) 2. Next class will be via Zoom 30 Hearing Tests and Hearing Aids by Watson and Tolan