In August, 2018, a Consensus Paper from hearing care associations was published relative to “Regulatory Recommendations for OTC Hearing Aids: Safety & Effectiveness.”1 The organizations involved in writing this Consensus Paper consisted of the AAA (American Academy of Audiology), ASHA (American Speech, Language, Hearing Association), HIS (International Hearing Society), and ADA (Academy of Doctors of Audiology), groups that could be financially negatively impacted by OTC hearing aid sales, depending on how extensively the FDA defines safety and efficacy of such devices. This Paper also appears to be endorsed by the HIA (Hearing Industries Association), a trade association representing the major hearing aid manufacturers, who sell their products to hearing aid sellers of these organizations.
The Consensus Paper is intended to influence the FDA in its description of safety and efficacy of the 2017 OTC Hearing Aid Act.2 In what appears to be more than tacit support, the HIA trade association believes that it is “heartening to have the dispensing community finally coalesce around the key issues for consumers relative to OTC”, and that this “unity will positively impact FDA actions on this new category, here’s hoping!”3
To an outsider, this Consensus Paper appears to be a well-thought-out document related to the safety and efficacy of hearing aids, something that the FDA is bound to as a part of the 2017 OTC Hearing Aid Act. The Consensus Paper states in its Forward that “while the goal of making hearing health care solutions more accessible (they somehow left out “affordable”) is agreeable, the FDA needs to provide reasonable reassurance that safety and efficacy will be maintained.” An interesting omission in this statement is that the OTC Hearing Aid Act of 2017 has as two of its primary goals the accessibility and affordability issues. The Consensus Paper has hyped the safety and efficacy while totally ignoring accessibility and affordability. As such, its subtitle: “How to Regulate OTC Hearing Aids for Safety and Effectiveness” describes the primary purpose of the Paper (emphasis added).
Accessibility and affordability were the two goals and the primary impetus for the 2017 OTC Hearing Aid Act. It is interesting that in the Consensus Paper neither of these two issues, upon which the basis of the OTC Hearing Aid Act of 2017 was based, is NEVER addressed, even though legislatively mandated. Instead, the Consensus Paper focuses on presumed safety and effectiveness issues in a way that is intended to distract individuals who are not knowledgeable of hearing loss, hearing aids and their fitting from the primary goals set out by the Act. This distraction, by its plethora of intended justifications for safety, serves to disguise the two drivers of the 2017 OTC Hearing Aid Act, accessibility and affordability.
Safety is important – but important for what, and for whom? Is it to serve the self-interest of the organizations involved, or to sincerely meet the mandate as to why the OTC Hearing Aid Act was introduced and passed to begin with? The primary purpose was not to develop a set of “Regulations” that are written in such a way to actually hinder the OTC, and written to limit distribution, accessibility, and most likely cost. This intent is not in the Act, and the Act suggests other. Unfortunately, this is what the Consensus Paper does.
This “feel good” and seemingly deceptive Consensus Paper pretends to have the consumer interest in mind. But, wouldn’t it then be fitting also that current hearing aids be made to conform with these same “regulations” proposed, which are actually more restrictive in many ways than for conventional hearing aids? One has to wonder why this is so? In fact, it has been shown that current hearing aids do not even conform to the ANSI standards to which they are required to meet.4
How Will the Congressional Mandate Be Implemented?
The Consensus Paper states that the OTC Act does not provide information as to how the mandate could be implemented. True. But, then, neither does this Consensus Paper provide any suggestions as to how the mandate of accessibility and affordability can be implemented. One might at least hope that those involved with the manufacturing, sales, and distribution of hearing aids would at least offer ways in which hearing aids could be made more accessible and affordable, the primary purposes associated with the OTC Bill. However, the organizations putting forth this Consensus Paper do not even attempt to address these two critical issues. The organizations writing the Consensus Paper may imply that they are specifically interested in the safety and efficacy of OTC hearing aids, and that explanation can be accepted. But, that is only one part of the trilogy.
Will these organizations be just as energetic to address the issues of accessibility and affordability as they are to defining “regulations”?
If increasing hearing aid usage to the massive unserved market is really the goal, then why not concentrate on this issue rather than spending a massive effort on generating regulations/specifications for a product that will tend to lessen the opportunity to meet the congressional mandates?
If the real concern is to radically expand the use of hearing aids to meet the massive unmet need, then it should be reasonable to assume that these organizations will soon offer a plan to increase accessibility and affordability. Or, is that expecting too much from organizations who seem to be more concerned with self-protection/interest and market control (regulations) as evidenced from this Consensus Paper?
Consensus Paper Recommendations
An evaluation of the full Consensus Paper is too extensive for this post. Therefore, the following discussion is limited to two issues in Recommendation 1, Hearing Threshold Measurements, and Gain. The reason for concentrating on these two is because if Recommendation 1 could be approached with reasonable FDA “Regulations” re the OTC hearing aid, Recommendations 2, 3, and 4 could be managed more easily.
Recommendation 1: Establish product requirements appropriate for OTC hearing devices targeting mild-to-moderate hearing impairment.
Hearing Threshold Measurements
The Consensus Paper goes into great detail in attempting to define mild and moderate hearing impairments. The Paper states that even though the definition of the degree of hearing loss is based upon potential users’ subjective perception of his/her hearing difficulty, that they have determined that is not good enough (forget what the potential user thinks), and instead force potential users to adhere to an audiometric description of hearing levels in order to define the desired hearing aid specifications.
Do they really believe that an audiogram defines the desired hearing aid specifications for a potential hearing aid user? If that were the case, there would be one hearing aid fitting formula, and not the different (often substantially different) proprietary formulas provided by each manufacturer.
To the best of knowledge, hearing aids are not fitted and actually worn based on the degree of hearing levels as measured audiometrically. Some individuals have no measurable hearing loss and still wear hearing aids. Hearing aids are worn based on the degree of hurt (physically, emotionally, psychologically, economically, or socially) as perceived by the individual, not by some outside arbitrary (unscientific) definition based on unacceptable threshold measurement procedures. What is ignored is that the use of audiometric thresholds has been shown to be of limited use in predicting hearing aid satisfaction.5,6,7,8,9,10,11,12,13
Any “Guideline” suggesting the ranges of hearing loss are just that – guidelines, and perhaps poor at that. It is unrealistic that a hearing level of 40 dB is a mild loss, but one of 41 is a moderate loss, but that is essentially what the Consensus Paper describes. Knowing that hearing levels are measured in 5-dB increments suggests that any of the measured responses could be either 5 dB greater, or 5 dB poorer.12,13
Interestingly, hearing test thresholds are accepted if there is 10 dB difference between results, and are not considered a real difference until there is a variation of 15 dB or more from one test to another at a given frequency. Is it with this “exactness” that hearing levels and recommendations are being determined as suggested? Further, would a hearing loss fitted with an OTC hearing aid later to be found that their hearing level is 56 dB HL (1-dB above the guideline level) possibly result in legal action or condemnation by these organizations? When self-serving is involved, it is not impractical to ignore this possibility.
The Consensus Paper “Guidelines” provide for no exceptions to realistic potential variations. Perhaps the concept of accepting hearing levels as a litmus test for hearing aid use should be applied with substantially greater reservations than suggested by the Consensus Paper. How critical is the audiogram to a successful hearing aid fitting? Research does not appear to suggest that it is mandatory, nor particularly helpful for this purpose.7,8,13,14,15,16,17,18,19,20,21
However, if a hearing diagnosis is the intent, then perhaps this should be left to those audiologists who are directly involved in differential diagnosis of hearing problems rather than those who sell hearing aids as their primary revenue stream.
With respect to the audiogram and audiometric thresholds, reports have described not only the variability of audiometric threshold measurements6 but also the questionability of these measurements being used for suprathreshold hearing aid fittings.7,8
First Rule of Thumb: A patient will prefer a hearing aid that has amplification to the level they desire, not based on an outsider’s subjective impression. This is axiomatic regardless of any acoustic frequency response modifications that might be available. Staab, 2015
Comments in the Consensus Paper relative to gain might be better described as questionable Gain Estimates. The Paper states that “The National Acoustics Laboratories NAL-NL2 is the most widely-used formula world-wide for the calculation of gain for adults.” Is that really true? The hearing aid industry has essentially six manufacturers providing 95% of the world’s hearing aids. It is interesting that each of these offers their own proprietary fitting formula, with the NAL-NL2 as an option. Because most dispensers use the “quick fit” provided by the manufacturer, which is based on the manufacturers’ proprietary fitting formulas, it may or may not be true that the NAL-NL2 is the most used fitting formula by manufacturers.
The fact that recommended gains by frequency vary dramatically by manufacturers based on their proprietary fitting formulas, confirms that there is no “optimal” hearing aid fitting formula.
In reality, gain issues can be managed best by the user having self-control of volume, and is something that many individuals prefer, including existing wearers of hearing aids. Each of the results in the Consensus Paper Tables 1 and 2 that highlight the key variables influencing the desired gain can be managed with a user-controlled volume adjustment. All the superfluous documentation provided has little to do with the practicality of what an OTC user purchased product requires. Should not the offering of an OTC product also consider the KISS principle?
And certainly, the belief that hearing aids are fitted optimally based on pure-tone audiometric thresholds is belied when reviewing the substantial differences between hearing aid manufacturers’ recommended gain by frequency suggested target gains.21
Treat Hearing Aids Like Some Other Medical Products
Now that the medical evaluation has been eliminated (having acknowledged that a medical evaluation was not mandatory because of low risk in wearing hearing aids, with the organizations involved in preparing the Consensus Paper supporting its removal), perhaps the FDA should consider treating OTC hearing aids as they do to some other medical devices where little or no risk to consumers is involved?
For some unexplained reason, the Consensus Paper has suddenly determined that hearing aids currently being fitted were safe and effective, that now with OTC hearing aids, that safety arises as a primary concern and they devote an inordinate amount of ink to this subject. Consider that removal of the waiver was predicated on convincing the FDA that millions of hearing aids have been sold and fitted with few complaints of safety, and that hearing aids did not deleteriously exacerbate other existing hearing issues.
In a move that would make sense (but, unfortunately, common sense seems to be something missing in the discussion of OTC hearing aids), the FDA could resolve much of this “regulatory” complexity by adopting a de-regulatory approach as suggested by the TIA (Telecommunications Industry Association) to the FDA relative to the PSAP Guidance of 2013:
“FDA could resolve much of this uncertainty by adopting a de-regulatory approach and using its enforcement discretion. Such an approach would be consistent with the FDA’s mobile medical applications guidance, which made clear that certain mobile applications subject to FDA enforcement which posed little or no risk to consumers would qualify for this discretion, because the resources spent on regulating them outweighs the degree of their risk to consumers.”22
The FDA, through that referenced guidance, proactively chose to express its intention to exercise “enforcement discretion” on several types of mobile medical apps posing low risk to patients. This, even though they might meet the statutory definition of a medical device, FDA stated that it does not intend to enforce requirements under the Food Drug and Cosmetic Act.23,24
In a similar way, although some PSAP/OTC hearing aids and apps might quality as medical devices because of their inherent functionality, the FDA could easily exercise enforcement discretion because they pose such a low risk of harm to consumers and their availability to the general population far outweighs burdensome requirements which make little sense to enforce, including the 510k application. Additionally, discussion continues as to whether hearing aids/OTCs are medical devices or consumer products.
This Consensus Paper is written in a way to control the hearing aid distribution system by those who have the current, greatest interest against an easily accessible and affordable hearing aid. To that effect, it offers a bloviated presentation that is a self-serving recommendation designed for these “professional” organizations to retain their control of the market. In no place does the Consensus Paper recommend steps intended to expand the market outside or inside of their control and self-interest. There is nothing in the Consensus Paper that addresses the two primary purposes of the 2017 OTC Hearing Aid Act – Accessibility and Affordability.
- Not enough! Hearing Health and Technology Matters. January 10, 2017. https://hearinghealthmatters.org/waynesworld/2017/all-ears-are-real-ears-but-thats- not-enough/
- Bentler RA. (2006). Audiometric considerations for hearing aid fitting (and success). Hearing Care for Adults, Phonak International Conference, Chicago, 2006, pp 89-95.
- Walden T, Walden B, Cord T. (2002) Performance of custom-fit versus fixed-format hearing aids for precipitously sloping high-frequency hearing loss. J Am Acad Audiol 13:356-366.
- Sereda, M, Hoare D, Nicholson R, Smith S, Hall D. (2015). Consensus on Hearing aid candidature and fitting for mild hearing loss, with and without tinnitus: Delphi Review. Ear & Hearing, July/Aug. Vol 36, issue 4, pp 417-429.
- Chasin, M. Strengths and weaknesses of the pure-tone audiogram. Rants! Some things we would change – if we could. Hearing Review, March, p. 16.
- Staab WJ. (2016). Program the aid…and whatever you hit is the target. Hearing Review, March, p. 17.
- Dirks D. (1982). Comments regarding “speech discrimination abiity in the hearing-impaired,” The Vanderbilt Hearing Aid Report, Studebaker G. and Bess F (eds), Monographs in Contemporary Audiology, pages 44-50.
- Humes L. (1986) An evaluation of several rationales for selecting hearing aid gain. J Speech Hear Disord 51:272-281.
- Sullivan JA, Levitt H, Hwang J-Y,Hennessey A-M.(1988) An experimental comparison of four hearing aid prescription methods. Ear Hear 9:22-32.
- Humes L, Hackett T. (1990). Comparison of frequency response and aided speech-recognition performance for hearing aids selected by three different prescriptive methods. JAm Acad Audiol1:101-108.
- Walden T, Walden B, Cord T. (2002) Performance of custom-fit versus fixed-format hearing aids for precipitously sloping high-frequency hearing loss. J Am Acad Audiol 13:356-366.
- ,Davis H, Stevens SS, Nichols RH, Hudgins CV, Peterson GE, Marquis RJ, Ross DA. (1947). Hearing aids: An experimental study of design objectives. Cambridge, MA: Harvard University Press.
- Azah H, Moore BC, & Prasher D. (2012). The accuracy of matching target insertion gains with open-fit hearing aids. American Journal of Audiology, 21:175-180.
- Cox RM. (1995). Using loudness data for hearing aid selection: the IHAFF approach. Hear Jour 48(2)10:39-44.
- Staab, W.J. (2015). Program the aid…and whatever you hit is “the target.” Rants! Some things we would change – if we could Chasin (Ed). Hearing Review, 2015, p. 17.
- Telecommunications Industry Association. (2014). Comments of the Telecommunications Industry Association to the Food and Drug Administration’s Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products – Draft Guidance for Industry and Food and Drug Administration Staff (Docket No. FDA-2013-D-1295). Comments of the Telecommunications Industry Association to the Food and Drug Administration’s Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products – Draft Guidance for Industry and Food and Drug Administration.
- See Food and Drug Administration, mobile medical applications: guidance for industry and Food and Drug Administration staff (2013) at 8 (“MMA Guidance”), available at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM 263366.pdf.
Wayne Staab, PhD, is an internationally recognized authority on hearing aids. His professional career has included University teaching, hearing clinic work, hearing aid company management and sales, and extensive work with engineering in developing and bringing new technology and products to the discipline of hearing. Dr. Staab is the Founding Editor of Wayne’s World and served as the Editor-In-Chief of HHTM from 2015 to 2017.