Hearing Health Care for Adults Priorities for Improving Access and Affordability (2016) / Chapter Skim
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4 Hearing Technologies: Expanding Options
4 Hearing Technologies: Expanding Options
Pages 149-204
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regulatory structure for hearing aids and other products that address hearing loss. The chapter closes with the committee's recommendations on next steps for improving the accessibility and availability of hearing health care technology.
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Clayton Christensen used the term "disruptive innovation" to describe "a technology that brings a much more affordable product or service that is much simpler to use into a market. And so it allows a whole new population of consumers to afford to own and have the skill to use a product or service, whereas historically, Box 4-1 TYPES OF HEARING-RELATED TECHNOLOGIES Medical Devices for Hearing Loss • Hearing aids • Over-the-counter wearable hearing devices (proposed)
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as "any wearable instrument or device designed for, offered for the purpose of, or represented as aiding persons with or compensating for, impaired hearing."1 As detailed below, FDA regulates hearing aids as Class I or Class II medical devices. Hearing aids generally have a number of components including a microphone, analog-to-digital converter, digital sound processor, output transducer, and battery.
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However, under certain conditions, even well-fit hearing aids may not necessarily improve the signal-to-noise ratio to result in improved speech recognition in noise. For these individuals with mild to moderate hearing loss, hearing assistive technologies and/or auditory rehabilitation may provide additional benefit.
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An estimated 360 million individuals in developing countries live with disabling hearing loss, and in 2004 the World Health Organization set out guidelines for hearing aids and services in an effort to support efforts to meet this demand (Olusanya et al., 2014; WHO, 2004)
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. An earlier report that was focused on NHANES participants ages 70 and older found a strong gradient of hearing aid use based on the severity of hearing loss, with 3 percent of those with a mild loss, 40 percent of those with a moderate loss, and 77 percent of those with a severe loss regularly wearing hearing aids (Lin et al., 2011)
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(18.5–25.8) Estimated total number of individuals with hearing aids and with hearing loss, in millions 3.8d 26.7 aHearing loss was defined as a speech-frequency pure tone average of hearing thresholds at 0.5-, 1-, 2-, and 4-kHz tones presented by air conduction in the better hearing ear of 25 dB or greater.
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Factors associated with hearing aid use were older age, a greater severity of hearing loss, having a college education, poorer performance on word recognition tests, and self-reported hearing handicap and loss. Similar results of low hearing aid use were seen in a study of the adult children of participants in the Epidemiology of Hearing Loss Study, with only 4 percent of people with mild loss and 23 percent of participants with moderate-to-severe loss using hearing aids (Nash et al., 2013)
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. In a 2004 M arkeTrak survey, two-thirds of respondents who acknowledged that they had a hearing loss but said that they had not adopted the use of hearing aids reported that their barriers to hearing aid adoption included perceptions of or experiences with problems in hearing aid performance (e.g., whistling, background noise)
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Great strides have been made in hearing aids in the past 50 to 60 years, but issues regarding background noise and clarity of sound, among others, can limit benefits, particularly in certain situations and locations. Individuals who have hearing loss and use hearing aids can frequently benefit from hearing assistive technologies and from using strategies such as consideration of the location and proximity to (or away from)
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5) Some of these products have technical and performance characteristics quite similar to the hearing aids that FDA regulates.
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Hearing Assistive Technologies Individuals with hearing loss, particularly those with moderate to s evere hearing loss, may use a variety of hearing assistive technologies in addition to hearing aids to connect to or receive information from other communication avenues (such as the phone or television) or from sound systems in classrooms, theaters, places of worship, or other public spaces or for emergency alerts (see Box 4-3)
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-- Captioning for teleconferences • Alerts ○ Auditory ○ Visual (flashing lights, text) ○ Vibrotactile A public accommodation shall take those steps that may be necessary to ensure that no individual with a disability is excluded, denied services, segregated or otherwise treated differently than other individuals because of the absence of auxiliary aids and services, unless the public accom modation can demonstrate that taking those steps would fundamentally alter the nature of the goods, services, facilities, privileges, advantages, or accommodations being offered or would result in an undue burden, i.e., significant difficulty or expense.5 These types of products have also been termed "hearing assistance technologies." Improving the availability and effectiveness of hearing assistive technologies is a priority for achieving better hearing and communication for individuals with hearing loss.
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Some states have recognized the value of the telecoil to couple with an induction loop by mandating that consumers be informed about the telecoil when they purchase their hearing aids. Hearing induction loops have been installed in some public spaces, such as movie theaters, places of worship, and other large venues, but they can also be installed in private homes (Shaw, 2012)
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Some types of hearing aids can process the wireless FM transmissions. In other cases, a body-worn receiver is used that is connected to earphones or a neckloop is used that converts the transmission to an electromagnetic signal that can be picked up by the telecoil in the hearing aid (ASHA, 2016; Chisolm et al., 2007b; Kim and Kim, 2014)
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Hearing Aid Compatibility Act of 1988b requires that the Federal Communications Commission ensure that new telephones be compatible with hearing aids. Wireless phones were exempt from the requirements, but subsequent changes to the law have extended its provisions to cellular phones.
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Additionally, telephones are available that provide greater amplification, and other assistive technologies can also be used in conjunction with phone Telecommunications Act of 1996h added Section 713 to the Communications Act, which requires the Federal Communications Commission to develop rules and imple entation schedules for the closed captioning of television video programs, m and Section 255, which requires telecommunications equipment manufacturers to strengthen efforts to improve accessibility. Twenty-First Century Communications and Video Accessibility Act of 2010i provides protections to enable people with hearing loss and others with disabilities to access broadband, digital, and mobile innovations and includes a focus on emergency information technologies.
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. A recent FCC report to Congress highlighted several consumer-related issues including ensuring seamless connections between smartphones and hearing aids and providing more extensive consumer information online and in retail settings to help customers compare features of phones and other technologies (FCC, 2014)
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Additionally, efforts are ongoing to update and expand the methods of emergency communications to include text-to-911 capabilities for individuals with hearing loss or other disabilities (FCC, 2015c)
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EFFECTIVENESS OF HEARING AIDS AND OTHER ASSISTIVE PRODUCTS Recent research on the effectiveness of hearing aid use (and the use of other technologies, such as cochlear implants) has largely focused on the impact of that use on speech development and learning in children with hearing loss.
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reviewed one randomized controlled trial and seven randomized crossover trials and found no significant differences in user function and quality of life assessments between analog and digital devices when pooling the data. Assessing the impact of hearing aids on quality of life is a challenge because of the multiple comorbidities in many participants and the gradual onset of hearing loss in many adults.
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examined the results of laboratory tests and journal entries of speech understanding for 25 participants with bilateral mild to moderate sensorineural hearing loss who used four types of hearing aids (two basic and two premium level) in a randomized crossover trial.
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The study found that most of these products performed within the ANSI standards for hearing aids, with several being outside of the equivalent input noise and total harmonic distortion levels, and that most were more appropriate for helping people with lowfrequency hearing loss than the high-frequency loss often experienced by older adults (Cheng and McPherson, 2000)
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Research and standards needs identified by the committee relevant to this chapter include • Effectiveness and comparative-effectiveness studies of hearing tech nologies using consumer-relevant parameters across the varying levels of severity of hearing loss; • Continued innovative research and design of hearing aids and hear ing assistive technologies with a focus on improving hearing clarity, facilitating ease of use (particularly for older adults) , and compat ibility with the other assistive and communications technologies; • The development of minimum performance standards for examin ing the effectiveness of hearing devices in real-world situations; • Consensus criteria for defining an individual with hearing loss as a candidate for a hearing aid or other hearing device; and • Product labeling comprehension studies.
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This section provides an overview of these regulatory laws and describes their impacts on accessibility to hearing health care for adults. Food and Drug Administration FDA regulates hearing aids as medical devices under the FDCA.
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review.14 FDA is authorized to regulate the advertising of restricted medical devices.15 Current FDA Regulation of Hearing Aids as Medical Devices FDA has classified hearing aids under several different classification regulations, based on the intended use and risk of the different technologies. As defined in FDA regulations, a hearing aid is a "wearable sound 10 FDCA § 513(a)
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. amplifying device that is intended to compensate for impaired hearing."16 Air conduction hearing aids amplify and deliver sounds to the external ear canal via air conduction.
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A transcutaneous air conduction hearing aid system is a "wearable sound-amplifying device intended to compensate for hearing loss without occluding the ear canal."19 The system involves of an air-conduction hearing aid attached to tube system that is surgically fitted between the back of the outer ear and outer ear canal. It is Class II, requires a 510(k)
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A hearing aid dispenser cannot sell a hearing aid unless the prospective user provides a written statement signed by a licensed physician stating that the hearing loss has been evaluated and the person is a candidate for a hearing aid or, alternatively, the prospective user signs and presents a waiver of the medical evaluation. The prospective user must be given the opportunity to review the user instructional brochure for the hearing aid prior to signing the waiver of medical examination (see Chapter 3)
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. FDA denied the petitions requesting an OTC hearing aid classification, citing concerns that a medical evaluation is necessary to ensure that the "red flag" ear conditions would not be "undiagnosed and unevaluated" and to avoid delays in diagnosis and management of medically treatable conditions that cause hearing loss (FDA, 2004a,b)
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. This draft guidance document retains the same description of uses that would be considered appropriate for a PSAP, but it also includes lists of uses that FDA considers "listening situations that are typically associated with and indicative of hearing loss" and thus within the "hearing aid" device classification.
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.24 Moreover, the FDA regulations imposing the restrictions on sale, distribution, and use -- ncluding i requirements pertaining to medical evaluations, hearing aid dispensing, and the user instructional brochure -- would not apply to PSAPs. FDA did advise, in both the 2009 guidance and the 2013 draft guidance documents, that PSAPs are electronic products that emit sonic vibrations and thus are subject to the electronic product provisions of the FDCA that apply to both nondevice products and medical devices.25 Manufacturers of PSAPs are required to report defects (including product failure to perform to design specifications and causing certain types of injury)
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Whether the benefits of OTC hearing aids would outweigh the risks of foregoing the requirement of medical evaluation. Concurrently with reopening the comment period on the PSAP draft guidance, FDA also announced a public workshop (held in April 2016)
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The committee provides details later in this chapter on its recommendation to FDA to establish a new category of OTC wearable hearing devices. State Laws Relating to Hearing Aids and Hearing Aid Dispensing Types of State Laws Affecting Hearing Aids and Dispensing Numerous states have enacted laws that affect sales of "hearing aids" as defined in the state law.
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Other state laws of general applicability might also be relevant, but they are beyond the scope of this review. Relationship Between FDA and State Regulatory Requirements There is a complicated relationship between FDA regulations and state laws as they apply to medical devices, and this relationship is particularly relevant to the regulation of hearing aids.
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. Nevertheless, FDA has decided affirmatively to exempt these laws from federal preemption through the rule-making exemption procedure.30 A manufacturer seeking to market an OTC hearing aid or other innovative hearing assistive technology product thus faces at least four principal hurdles: 1.
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These state law requirements impose barriers to improving the accessibility and affordability of hearing aids and hearing technologies, in addition to any FDA-related barriers. Federal Trade Commission The FTC enforces laws that prohibit fraudulent, unfair, and deceptive trade practices.35 FTC regulations prohibit the use of misleading sales and advertising practices, including giving inaccurate information about hearing loss, hearing aid performance, refund policies, or warranty coverage.
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FCC rules require that phones subject to the Hearing Aid Compatibility Act produce a magnetic field of sufficient strength and quality to permit coupling with hearing aids that contain telecoils. The telecoil picks up the voice signal from an electromagnetic signal from the telephone, enabling users of telecoil-equipped hearing aids to communicate over the telephone without feedback and without the amplification of unwanted background noise.
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The FCC accessibility rules require noninterference with hearing technologies -- defined to include hearing aids, cochlear implants, and hearing assistive technologies -- to the lowest possible level that allows 41 Notice of Proposed Rulemaking, FCC 15-144, adopted October 23, 2015. 42 Fourth Report and Order, and Notice of Proposed Rulemaking, FCC 15-155, adopted November 19, 2015.
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Litigation under the ADA has been used to try to expand accessibility to communications technology. For example, there are court decisions with inconsistent outcomes as to whether a website for an entity that does not have a physical location open to the public is subject to ADA requirements relating to public accommodations.46 The Department of Justice has not issued regulations regarding applicability to websites, but it has suggested that the ADA would obligate public accommodations to make the websites that they use to provide their goods and services accessible to and usable by individuals with disabilities.47 These statutes, enforced by private litigants as well as the Department of Justice, might also encourage the development of advanced communications technologies that are accessible and usable by individuals with hearing loss.
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Develop and Clarify Hearing Device Options FDA's hearing aid regulations along with state laws relating to hearing aid sales and dispensing place obstacles in the way of new technologies that could make hearing assistance more easily available and accessible for adults who could benefit from such assistance in connection with mild to moderate hearing loss. As noted throughout this report, innovation in technologies relevant to hearing loss are occurring that can provide affordable, effective, safe, and usable technologies to address the unmet need for hearing health care.
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An approach that could better protect consumers and offer options for more informed consumer decision making would be for FDA to create a category of "OTC wearable hearing devices" intended for mild to moderate hearing loss. In order to ensure their safety and effectiveness, these devices could be subject to ANSI and other technical standards applicable to hearing aid performance.
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In essence, age-related hearing loss would not be considered a "disease," and thus the products would not be considered as within the statutory definition of "device." To keep PSAPs outside the device definition, FDA would also have to conclude that PSAPs are not intended to affect a structure or function of the body. This approach would not preempt state laws, however, and many state laws define "hearing aids" as instruments compensating for hearing loss and subject them to dispensing requirements.
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These devices would • Explicitly be defined by FDA as intended for OTC sale; • able to be marketed as devices that may assist with hearing loss Be and be sold as OTC, by mail, or online; and would include mobile apps and associated wearable technologies intended to function as an OTC wearable hearing device for mild to moderate hearing loss; • subject to regulatory requirements that would explicitly preempt Be current state laws and regulations for hearing aids and dispensing and preempt potential future state laws and regulations seeking to limit OTC access; • exempt from 510(k) premarket review to the extent that the Be technology is not fundamentally different from air conduction hearing aids; • Include thorough consumer labeling, including information on o frequency gain characteristics, o adequate directions for use, o communication challenges for which it may be helpful to seek professional consultation, and
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cases) 801.420 & 801.421 • State law licensing • Relevant ANSI standards requirements for and others hearing aids and • FCC oversight as relevant dispensing regarding compatibility • Remove and interoperability regulatory • FTC oversight as requirement for relevant regarding medical evaluation advertising or waiver OTC Medical devices • FDA Class 1 or Class II • OTC "wearable available OTC that devices • Online hearing focus on addressing • Exempt from premarket • State laws devices" mild to moderate review (unless applicable to (proposed hearing loss in adults fundamentally new "hearing aids" new and meet FDA technology)
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requirements, but Be be considered for exemption from certain QSR requirements as determined by FDA to be appropriate for this category; and • Have the option to include accessory tests for self-assessment of mild to moderate hearing loss for purposes of selecting and fitting an OTC hearing device. To further clarify the types of hearing technologies and their oversight and regulation: • FDA should retain a guidance document on personal sound ampli fication products (PSAPs)
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• The Consumer Product Safety Commission and the Federal Trade Commission should exercise their respective authorities in the regu lation of consumer products marketed as PSAPs. Improve Transparency, Compatibility, and Interoperability of Hearing Technologies and Telecommunications Systems Individuals with hearing loss frequently use hearing aids with telecoils or other hearing assistive technologies to couple with many other electronic communications products.
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Goal 8: Improve the Compatibility and Interoperability of Hearing Technologies with Communications Systems and the Transparency of Hearing Aid Programming Recommendation 8: The Federal Communications Commission, the Federal Trade Commission, the Food and Drug Administration, the National Instiutes of Health, and other relevant federal agencies; the t American National Standards Institute and other standards-setting or ganizations; manufacturers; and industry, professional, and consumer advocacy organizations should • develop standards that ensure that hearing aids and over-the- counter (OTC) wearable hearing devices are compatible and inter operable with other technologies and communications systems; • increase public awareness and consumer-friendly information on the availability, connectivity, and use of hearing aids and hearing assistive technologies; and • develop and implement standards for an open platform approach for hearing aid programming that allows any hearing health care professional (or, as evolving technology allows, the device owner)
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2011. Hearing aids in the real world: Use of multimemory and volume controls.
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2014. Impact of advanced hearing aid technology on speech understanding for older listeners with mild to moderate, adult-onset, sensorineural hearing loss.
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2009b. Regulatory requirements for hearing aid devices and personal sound amplification products.
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2016. Hearing aid benefit in p atients with mild sensorineural hearing loss: A systematic review.
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1991. Hearing loss and hearing aid use in Hispanic adults: Results from the Hispanic Health and Nutrition Ex amination Survey.
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2002. Speech recognition perfor mance of patients with sensorineural hearing loss under unaided and aided conditions using linear and compression hearing aids.
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2011. Evidence on self-fitting hearing aids.
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