NCSB Comments to the FDA on the Proposed Rule regarding OTC Hearing Aids
The National Council of State Boards of Examiners for Speech-Language Pathology and Audiology (NCSB) is a non-profit membership organization of boards that license and regulate the practice of speech-language pathology and audiology. Consumer protection is core to our mission.
Labeling Outside the Package and Condition for Sale
NCSB recommends the FDA consider using the following clarifying warning statement:
Labeling Inside the Package
NCSB recommends the following important notice be included as part of inside labeling:
NCSB recommends user-adjustable device volume control with maximum acoustic output limit of 110 dB output be required as a design feature for OTC hearing aids to minimize harmful high output levels.
NCSB recommends output levels include examples of the type of noise a consumer would be experiencing, e.g. noise at 110 dB would be equivalent to the maximum volume level for personal listening devices, a very loud radio or television, and loud entertainment venues. NCSB recommends the information indicate that as loudness increases, the amount of time you can hear the sound before damage occurs decreases.
Clarification of mild to moderate hearing loss
Submitted via regulations.gov on January 16, 2022. Thanks to Gregg Thornton, Tammy Brown, and Glenn Waguespack drafting and reviewing these comments.
May 12, 2021
The National Council of State Boards of Examiners for Speech-Language Pathology and Audiology (NCSB), consistent with its mission to promote consumer protection by supporting regulatory boards in speech-language pathology and audiology in fulfilling statutory, professional and ethical obligations adopts the following position regarding the proposed Audiology and Speech-Language Pathology Interstate Compact (ASLP-IC).
NCSB supports the proposed ASLP-IC. Since 2016 NCSB has worked closely with the Council of State Governments and their Interstate Compact Advisory Workgroup to develop a proposed interstate compact for speech-language pathology and audiology. The ASLP-IC is an occupational licensure compact that addresses the increased demand for practitioners to provide, and for consumers to receive appropriate speech-language pathology and audiology services in concert with prevailing standards. It authorizes both telehealth and in-person practice across state lines without having to become licensed in additional ASLP-IC states. The compact permits audiologists and speech-language pathologists to provide services to populations currently underserved or geographically isolated. The compact also allows military personnel and spouses to more easily maintain their professional license when relocating.
Additionally, the ASLP-IC improves consumer protection across state lines. The compact increases access to care when patients, clients, and/or students relocate or travel to another compact member state. The compact also promotes cooperation between ASLP-IC member states on interstate licensure and regulation requirements such as continuing education. The compact ensures that audiologists and speech-language pathologists from other ASLP-IC member states who practice in another compact state, under the privilege granted by the compact, have met acceptable standards of practice. In summary, the ASLP-IC reduces regulatory barriers that negatively impact both consumers and practitioners. The compact does not change a state’s scope of practice for audiology or speech-language pathology. The ASLP-IC ensures the ethical and legal provision of services and reduces regulatory barriers while still protecting the public.
The Board of Directors support passage of the ASLP-IC in states and commits to supporting legislative efforts to that end.
As an organization that supports licensure of audiologists and speech-language pathologists (SLPs), the National Council of State Boards of Examiners for SLP and Audiology (NCSB) wishes to express its concern about the recently introduced S.670/H.R.1652, the Over-the-Counter Hearing Aid Act of 2017. This bill will limit state authority to regulate “the servicing, marketing, sale, dispensing, use, customer support, or distribution of over-the-counter-hearing aids.” As we are sure you are aware, state licensing boards are given the authority within each respective state to ensure consumer protection, and it is our belief that this bill, as written, will curtail the authority of state boards.
We are requesting that you make changes to this bill that will ensure appropriate state oversight either through the state SLP and audiology licensure boards, or other state regulatory agencies. It is important that states have the ability to protect consumers who purchase over-the-counter hearing devices.
S. 670/H.R. 1652 will have serious unintended health and safety consequences. The bill supports OTC sales of hearing devices that are not appropriate for people with greater than mild degrees of hearing loss, and will allow sale of such devices for children who rely on hearing for critical language and cognitive development. Consumers will self-diagnose, but will not be able to accurately assess the degree of hearing loss, thereby selecting a hearing device that is not fitted properly or may even cause harm. There are medical conditions that require referral to a physician that may be missed. States may currently have laws in place that require medical/audiological evaluation before the sale of an aid because of health and safety concerns, so allowing state licensure boards to develop oversight that is congruent with current laws is a sensible approach.
Thank-you for your consideration of this serious matter. Members of the Board of Directors of NCSB would be happy to discuss our concerns with you and provide additional information.
May 15, 2017
Dear State Licensure Board Members:
The National Council of State Boards of Examiners for Speech-Language Pathology and Audiology (NCSB), consistent with its mission to facilitate communication among licensure boards, is writing to you to express concerns over the issues related to the sale of Over-the-Counter (OTC) hearing aids, as it relates to consumer safety. While OTC hearing aids may be appropriate for consumers with mild hearing losses, the devices are not necessarily appropriate for those with greater degrees of hearing loss and definitely not for children. Information regarding frequency response and maximum power output is not made available, and either of these measures, especially when utilized with pediatric population, can be a detriment to hearing.
As you are aware, the purpose of licensure is protection of the public, and the sale of OTC hearing aids does not ensure that consumers will be protected. Consumers do not have the skills or equipment necessary to conduct their own hearing evaluations, and the “phone tests” are not sophisticated enough to measure uncomfortable loudness, word recognition, or other measures essential to an appropriate hearing aid fitting. Audiologists are frequently not a part of the process, and it is audiologists, who by virtue of academic and clinical training, are uniquely qualified to assess the gains a patient might receive from amplification. There are often medical conditions; e.g. acoustic neuromas or conductive hearing loss that contraindicate the use of amplification, and in these cases, audiologists administer a battery of tests that leads to an appropriate medical referral. None of these safeguards exist if the public is allowed to purchase OTC hearing aids without intervention from an audiologist. The aforementioned examples might result in a patient unnecessarily obtaining a hearing aid, or in a more extreme situation, purchasing a hearing aid when immediate medical intervention for another medical condition is needed.
NCSB supports licensure as an important means of consumer protection, and encourages you to discuss this matter with your state licensure board so that members are fully informed about the issue of OTC hearing aids. If you have questions or comments concerning this matter, please do not hesitate to contact us.
Alison Lemke, M.A., M.P.A., CCC-SLP, CBIS
November 23, 2009
Michael D. Maves, M.D. MBA
Re: RESPONSE TO AMA SCOPE OF PRACTICE SERIES
Dear Dr. Maves:
The Scope of Practice Partnership, formed in 2006 by the American Medical Association (AMA) to aid state medical societies in opposing scope of practice expansions by non-physician providers, has drafted a practice data module for the profession of audiology. It has been brought to the attention of the National Council of State Boards of Examiners for Speech-Language Pathology and Audiology (NCSB) that information included in this document not only fails to accurately reflect the scope of practice for the profession of audiology, but may in fact, contain information that may be misleading to the public. Of particular concern to NCSB, an organization whose mission is to facilitate communication among licensure boards, are the descriptions included in the scope of practice document for audiology, the references to the education and training of audiologists, and the lack of information regarding direct access to audiological services.
As with many other professions, scope of practice statements began as an outgrowth of the needs of a professional association to define the practice. On a national level, scope of practice definitions, as well as preferred practice patterns for audiology, were initially developed by the American Speech-Language-Hearing Association (ASHA) and later by the American Academy of Audiology (AAA). Since the advent of the first audiology licensure act in 1969, states have been given the statutory authority to develop and promulgate laws, rules and regulations. Licensure for the practice of audiology is now required in all fifty states and in the District of Columbia. Inherent in all of these enabling statutes are scope of practice statements that specifically define the practice of audiology. Many of these statements were adapted from those of the professional associations, but the primary authority for defining the practice of audiology lies with the legislative powers given to states in formulating the laws, rules and regulations that govern audiology and the licensed audiologists within that state. As the profession of audiology has changed, so has its expanded scope of practice. These changes are reflected in the ever-changing scopes of practice by the national organizations that represent audiologists, and ultimately in the changes made in the enabling statutes for individual states.
Having phased out its Master’s level training programs in 2006, the profession of audiology has undergone a transition to the doctoral level, as evidenced by the sixty-nine accredited universities that provide educational and clinical training leading to a clinical doctorate in audiology. Utilizing scope of practice guidelines developed by professional associations and state licensing boards, universities now provide a curriculum of academic and clinical training ensuring that students have opportunities to acquire the knowledge and skills necessary for entry into independent professional practice across the range of practice settings with all age groups. Additionally, licensure boards across the country have recognized the need to modify their entry-level requirements to continue with their mission of public protection. To date twenty-two states have promulgated revised laws and/or rules that mandate a doctoral degree in audiology as the minimum standard to engage in the practice of audiology in that particular state. A number of other states have passed legislation with date-certain mandates for change.
The issue of direct access to audiologists and the services they provide is particularly troublesome to NCSB as it continues its efforts to share information with licensure boards and to advocate for the protection of the consumers of our services. Audiologists, by virtue of academic training and clinical experiences, are qualified to engage in the autonomous practice of audiology, and are recognized as independent providers of services by state licensing laws and regulations in fifty states. Additionally, audiologists are recognized as essential health care providers in the performance of their duties and are eligible for reimbursement for their services. The expanding needs of the American health care system will be compromised if patients are denied access to the health care providers of their choice. Legislation across the country to mandate newborn hearing screening has heightened the awareness of the profession of audiology and has increased the demand for audiologists. The demand from this population, coupled with the ever-increasing needs of the geriatric population, highlights the importance of direct access to audiologists.
The continuously expanding scope of practice in audiology should not be construed as an encroachment on other professions. Rather, it should be viewed as a means of expanding services to a population that might not otherwise be served. The scope of practice in audiology should remain within the purview of its stakeholders—the universities providing the training, the professional associations representing audiologists, and most importantly, the individual licensure boards that possess the statutory authority to protect the consumers of audiological services.
The National Council of State Boards of Examiners for Speech-Language Pathology and Audiology (NCSB), in recognition of the fact that audiologists are regulated by statute to provide direct services to consumers in all fifty states, understands and promotes public protection. Existing state licensure laws ensure such protection, and regulation and/or restriction beyond what has been established by statute in all fifty states, is not only unwarranted but may indeed be harmful to consumers by restricting their ability to access care from qualified providers. NCSB respectfully requests that members of allied health professions assist the organization and the profession of audiology in their mission to hold paramount the welfare of the public by recognizing audiologists as independent providers and by removing any barriers that might restrict access to the provision of health care by audiologists.
Thank you for your consideration in this matter.
Lisa C. O’Connor, President
State licensure boards have a legal, moral and ethical responsibility to protect consumers from unscrupulous and unqualified practitioners through regulation of standards of practice. It is incumbent upon regulatory boards to address the provision of services including those that transcend traditional service delivery models. Designed initially to deliver health care at a distance, the use of telepractice has evolved not only as an alternative method, but in many cases, as the primary mode of service delivery. Given that speech-language pathology and audiology regulatory boards have had a long-standing commitment to public protection, there is a renewed responsibility to ensure that enabling statutes and rules and regulations encompass the current practice of the professions, including the utilization of telepractice (telehealth) as an appropriate, contemporary service delivery model.
The U. S. Department of Health and Human Services Health Resources and Services Administration (HRSA) defines telehealth as the use of electronic information and telecommunications technologies to support long-distance clinical health care, patient and professional health-related education, public health and health administration (retrieved September 27, 2014 from http://www.hrsa.gov/ruralhealth/about/telehealth/). Each state agency or occupational licensing board that regulates the practice of speech-language pathology and/or audiology should develop policies necessary to provide for, promote, and regulate the use of telepractice in the delivery of services within the scope of practice regulated by the licensing entity.
It is the position of the National Council of State Boards of Examiners for Speech-Language Pathology and Audiology (NCSB) that telepractice constitutes the practice of speech-language pathology and audiology in both the patient site and the provider site. Further, state licensure boards should address protection of the consumer by requiring out-of-state practitioners to notify the board of their intent to engage in the practice of speech-language pathology and/or audiology in the state where the patient resides. The provision of services by telepractice shall encompass the following essential standards:
Although there is not a uniform practice act, and standards do vary to some extent from state to state, licensure boards nevertheless share the responsibility to protect consumers regardless of the mode of service delivery. The establishment of a mechanism for telepractice services, whereby licensure boards can expand services to individuals with speech, language, or hearing problems, can remove barriers to care while also ensuring that protection of the public’s health, safety and welfare is maintained. It shall be the responsibility of each state licensing board to develop rules, policies, and procedures consistent with the laws of that state for the regulation and enforcement of services provided by telepractice.
Revised March 2015
July 28, 2003
Susan Pilch, Director
May 15, 2003
May 1, 2003
Glenda Ochsner, Ph.D., President