Legislation recently passed in the U.S. House of Representatives1 and expected to be passed soon in the U.S. Senate2, requires the FDA to establish an OTC (over-the-counter) hearing aid category for adults with perceived mild-to-moderate hearing impairment, within three years. This category is estimated to overlap the hearing levels of approximately 60-80% of all hearing aids sold in the U.S. market today. Related to the legislation, a proposal has been made for a measurement procedure, identified as a PSAP Standard, but that is where the confusion starts.

These bills would leave it up to the FDA to determine what form the regulation will take.  This uncertainty will have the different factions (few restrictions vs. maximum restrictions) jockeying for position.

The major change relating to OTC hearing aid sales is likely to be that a licensed person would not be required to make a sale.  What other types of “regulations” related to products to be sold still awaits to be seen, but it appears that at least one attempt that primarily looks at measurement of OTC hearing aids has been proposed – in the form of a PSAP Standard. How minimal or extensive the oversight will be by the FDA is not known at this time.  It is suspected that this will all depend on how serious the FDA will be to provide the charge given to them for accessibility and affordability of hearing amplification help.


Enter the CTA (Consumer Technology Association)

January 2017, the CTA proposed a “standard” to determine PSAP performance.  The document was titled “ANSI/CTA Standard – Personal Sound Amplification Performance Criteria, ANSI/CTA-2051.3   This was stated, as designed, to serve the public interest through eliminating misunderstandings between manufacturers and purchasers, facilitating interchangeability and improvement of products, and assisting the purchaser in selecting and obtaining with minimum delay the proper product for the hearing-impaired consumer’s particular need.  Any “Standard” with such lofty and variable goals is subject to serious analysis.

The remainder of this post, and the series that follows, will comment on different sections of the CTA-1051 proposal. 

Relative to stated purposes, the “Standard” seems to initially have missed its mark.

  1. The “Standard” is written for PSAPs. Will there actually be a PSAP category with new OTC legislation?
  2. Regulations to meet a “Standard” necessarily involve additional costs to produce and market the product.  How is this going to help the consumer when these “Standards” realistically lead to increased costs, which will be passed on to the consumer?
  3. If the intent of all of the IOM (Institute of Medicine), PCAST (President’s Council of Advisors on Science and Technology, NAS (National Academies of Science, NASEM (National Academy of Science, Engineering and Medicine, MDIFA (FDA Medical Device User Fee Amendments Act of 2017), meetings and discussion was to get more amplification products to an untapped consumer market requiring accessibility and affordability, this “Standard” works against those goals.
  4. The proposed “Standard” states a concern for consumer safety. However, safety features are AWOL in this “Standard,” other than the single one found that limits the output level.


Change Name of “Standard” from PSAP to GSAP (general sound amplification products)

It seems that the name of this proposed “Standard” should change from PSAP (personal sound amplification products) to GSAP (general sound amplification products). As a consumer product, OTC amplification products should be viewed the same way as are earbuds, smart phones, iPods, etc.  These products are designed for general use, not personal (suggests prescription) use.  While these products are not intended to be personalized, as are hearing aids, people that use these products have the same general hearing levels as the general population. Are smart phones, earbuds, iPods, radios, etc. therefore personalized as are hearing aids?  In reality, these products are used also to provide personal sound amplification and/or enhancement to a user. So, in this sense, they are personalized, even though the personalization is performed by the consumer.  How well would a “Standard” be accepted that would impose the same measurement requirements on these products as are being proposed for PSAPs?

 

If for PSAPs, Then Why Referencing Hearing Aid Standards?

The ANSI/CTA “Standard” reads just like an ANSI hearing aid test Standard.  This “Standard” puts PSAPs and hearing aids in the same category, except that requirements for PSAPs are much higher than for hearing aids.  That being the case, should all such products in this “Standard” be identified as PSAPs or hearing aids?


Is This a Hearing Aid Standard or a PSAP “Standard?” 

The way this is written, it would seem reasonable to replace the current ANSI HA Standards with this proposed “Standard.”  This statement means that although this is presented as a PSAP standard, it is essentially a hearing aid standard, using the same measurement features and references, but actually even more stringent than current hearing aid measurement standards in many ways.  Why not just call it what it is: A hearing aid standard that is somewhat different than the current ANSI HA Standard, but in most ways, for a PSAP, more stringent than the current hearing aid measurements.

 

Scope

As written, this document applies to hearing aids as well: “..products that provide personal sound amplification and/or enhancement to a user.”  That is exactly what hearing aids do.  There is no differentiation in the Scope, so this proposed “Standard” should apply to hearing aids as well.

 

Safety

The “Standard” states that it does not purport to address all safety problems associated with the product’s use.  It was right on the mark with this one.  In fact, the only safety measure addressed is that of the SSPL90 maximum. This could be done with a simple statement, not requiring a “Standard.” This is also the only, and same, safety measure addressed for hearing aids.

 

Definitions

The purpose of these for PSAPs is definitely not clear. How will definitions of electroacoustical performance assist the general consumer – definitions that most hearing professionals may not fully understand?  Perhaps a few additional definitions should be thrown in to make this seem more impressive, and more confusing. It is difficult to see how this section helps consumers or expands the market.  Why is there a concern about such definitions?  Are these to be posted in materials for the consumer?  These appear to be more important for hearing aid designers than for PSAP designers.  This is more complicated than it needs to be.

 

Symbols and Abbreviations

It is not clear who these symbols and abbreviations are for.  If for the designer, they should already be known and understood.  If for the consumer, how do they use/compare terms like CORFIG, RECD, SNR, SPL, dBA, etc.?   How do these help the consumer compare PSAPs?  If not, why are they included?  The information that follows relates to specific sections of the proposed ANSI/CTA-2051 “Standard.”

And, these comments are only the start.  More will be made in following posts, with the next post looking at the “Categorization” of hearing products.

 

 References

  1. S. House of Representatives. H.R. 2430 – FDA Reauthorization Act of 2017.  July 13, 2017.
  2. S. Senate. S9 – Over-the-Counter Hearing Aid Act of 2017.  https://www.warren.senate.gov/files/documents/3_21_17_Hearing_Aids_Bill_Text.pdf.
  3. Consumer Technology Association (CTA). (2017). ANSI/CTA Standard.  Personal Sound Amplification Performance Criteria. ANSI/CTA-2051.  https://standards.cta.tech/kwspub/published_docs/ANSI-CTA-2051-2017_Preview.pdf.

2 Responses to PSAP Standard Review

  1. Max Stanley Chartrand, Ph.D. says:

    Forgive typos on tiny IPhone screens

  2. Max Stanley Chartrand, Ph.D. says:

    Really, all we are taking about is how much control FDA has over product. What about the more important topic of how much regulatory control over seller? Under the current scenario, no one will be regulating standards of advertising, seller promises, training of seller in Médicolegal structures of informed consent, required disclosures, consumer warnings and protections, and all the other considerations that required more than five decades to establish and refine. It’s like an alternate universe is being created: one fraught with dangers, omissions, booby traps, and land mines–chaos is a better word; the other the established regulatory mechanism that brought the highest consumer satisfaction rate in the world, complete with the best trained and educated hearing healthcare teams in history. Of course, the promitive, DIY of OTC sans FDA regs and state licenuxing laws will significantly downsize the lawless OTC crew and consumers with myriad liethreatening oto conditions will have few left to watch their backs. China’s and Japan’s terrible OTC experience is about to become ours. It’s amazing how much one can buy by bribing compliant consumer groups with “donations” and politicians who listen only to one-sided arguments with “campaign contributions”.

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