By David H. Kirkwood
SILVER SPRING, MD–The U.S. Food and Drug Administration (FDA) has more than 100, highly diverse, public comments to consider in deciding if it should implement or rethink a proposed new guidance document that it issued on November 7.
The document, drafted by the Ear, Nose, and Throat Devices Branch of FDA’s Center for Devices and Radiological Health, calls for tightening restrictions on the marketing of non-hearing aid, personal amplifying devices, which the agency categorizes as “personal sound amplification products,” or PSAPs.
As reported here previously, FDA’s intention is to draw a clearer line between hearing aids and PSAPs and, in doing so, prevent PSAPs from being marketed to people to address their hearing loss. That, says the agency, is the domain of hearing aids, which it regulates as medical devices.
During the 90-day period for comments which ended February 5, FDA’s proposed revision of the existing 2009 guidance on PSAPs garnered strong support from the major professional associations of practitioners licensed to fit hearing aids (the Academy of Doctors of Audiology, the International Hearing Society, the American Academy of Audiology, and the American Speech-Language-Hearing Association), as well as from the Hearing Industries Association, which represents hearing aid manufacturers and related companies.
These organizations, some of whose comments were reported here earlier, commended FDA for trying to provide increased protection to hearing-impaired consumers by steering them toward getting professional help for their condition.
Meanwhile, advocates for PSAPs, including RightToHear.Org, the Consumer Electronics Association (CEA), and the Telecommunications Industry Association, as well as executives from numerous companies that make such devices, criticized FDA’s proposal as unduly restricting consumer access to products that could help them hear better.
For example, the Consumer Electronics Association said that approving FDA’s proposal would prevent PSAP manufacturers from effectively marketing their products. As a result, CEA said, “The millions of Americans who could benefit from affordable and readily accessible hearing solutions will remain unaware of the valuable assistance that PSAPs can provide.”
MORE NAYS THAN AYES
While the comments from the four professional associations represented the largest total number of people, FDA’s invitation for public input drew significantly more comments opposing its proposed guidance than favoring it.
As noted here February 5, the Hearing Loss Association of America (HLAA) asked the FDA to craft clearer guidance. In her letter, Anna Gilmore Hall, HLAA’s executive director, wrote, “Many people with hearing loss do not obtain hearing aids for reasons of cost or fear of being stigmatized. While HLAA is working to overcome these barriers, we believe that, under current circumstances, some of these individuals could benefit from PSAPs, and there is no reason to erect a barrier to preclude this from happening.”
Richard Goode
Some of the strongest criticisms of the guidance came from individuals prominent in hearing healthcare. Richard Goode, MD, an otolaryngologist at Stanford Medical Center who was formerly president of the American Academy of Otolaryngology/Head and Neck Surgery and chair of the ENT Advisory Committee to the FDA, wrote that “from my background, it would be suspected I would be strongly in favor of FDA regulation of PSAPs, considering them to be hearing aids.”
However, Goode, who was a founder of GN ReSound, a major hearing aid manufacturer, recommended that FDA withdraw its proposed action. He explained, “I feel it essential that our citizens have choices in devices to help hearing in difficult situations. Hearing aids are now very expensive and many patients cannot afford them. The likelihood that we will miss an undiagnosed tumor or infection is very low. We need to have PSAPs outside of the FDA regulatory mechanism.”
COMPLETE REVIEW URGED
In a comment submitted jointly, Brenda Battat, former executive director of the Hearing Loss Association of America (and a cochlear implant wearer), and Cynthia Compton-Conley, PhD, an audiologist who is a leading expert on assistive hearing technology, said that the language in FDA’s proposal is “confusing, overly prescriptive, contradictory, and inconsistent.” They stated, “There should be no restriction on the description of situations in which a PSAP can be helpful, as long as it does not state that the product is intended for hearing-impaired persons or to correct hearing loss… The draft guidance fails to accept that listening ability in all situations can be improved with the use of a PSAP because the product improves audibility.”
Instead of FDA’s proposed document, Battat and Compton-Conley said, “Attention must be given to a complete review of FDA hearing aid regulations… This action is necessary to reflect the current status of technology, the health care climate, and the need to dramatically improve access to hearing help for the millions of people in this country with hearing loss.”
KOCHKIN: “TIME TO DEREGULATE HEARING AIDS”
One of the harshest criticisms of the FDA document came from Sergei Kochkin, PhD. Kochkin, who was executive director of the Better Hearing Institute (BHI) for eight years until his departure in October 2012, is perhaps the most prominent analyst of the hearing healthcare market.
Kochkin described FDA’s proposed guidance as “so misguided that it should be withdrawn.” He explained, “The majority of people with hearing loss are not candidates for the current medical model form of hearing help intervention. Many have mild or even moderate losses which require situational help at best. They will need consumer electronics and assistive listening devices or smart phones to help them where they have difficulty.”
Sergei Kochkin
Kochkin, who was director of market development and market research at Knowles Electronics for 15 years, asserted, “One of the greatest barriers to hearing healthcare is cost. Some people can only afford a $300 solution. Consumer electronics can provide improved audibility to some people at a high value. Forcing them into a medical model will result in them getting no help or sneaking around to get a consumer electronic devices that they desperately need.”
He added, “It is time to deregulate hearing aids and allow the consumer to choose the solution they can afford. Give them the choice of seeking a hearing healthcare or consumer electronics solution.”
PRACTITIONERS EXPRESS MIXED VIEWS
Several individuals who dispense hearing aids in their practice submitted comments, some endorsing the measure, some not.
Michael Brown, AuD, told FDA, “I support your proposal to more carefully define the distinguishing characteristics of PSAPs and hearing aids. Manufacturers cleverly craft the language of their advertisements to imply that hearing-impaired patients can use PSAPs as inexpensive substitutes for properly fitted hearing aids. Bad experiences with such devices lead patients to conclude that ‘hearing aids’ don’t work.”
Kim Cavitt
On the other hand, Kim Cavitt, AuD, an audiologist in Chicago, wrote, “While I am an advocate of hearing aids as the best form of treatment for the hearing impaired, the fact is that 80% of those currently in need are not being helped. Some of the reasons for failure to pursue amplification are cost, accessibility of services, and stigma.
Cavitt said, “I fear that this current draft policy, to marginalize personal sound amplification products away from the management and treatment of hearing loss, will have a detrimental effect on those who we, in the audiology community, are trying to assist.”
She added, “The optometric community has been able to integrate over-the-counter, non-prescription reading glasses into their patient care process. I would like to see the audiologic, hearing aid, and medical communities reconcile the need for access and cost containment with the need for patient safety as the vision community has been able to accomplish.”
SOME COUNSEL A DIFFERENT APPROACH
Several of the comments submitted agreed with FDA on the need to protect consumers with hearing loss from the potential hazards of PSAPs, but suggested a different way to do this.
Richard Usifer, a veteran hearing aid specialist in Connecticut, wrote that PSAPs “must not be sold to consumers in place of hearing aids,” but added, “objective criteria are needed to define what is a hearing aid and what is a PSAP so that companies trying to sell hearing aids masquerading as PSAPs can be held accountable and prevented from doing so.” He suggested setting a limit on the degree of amplification and type of frequency response that a device could provide without becoming subject to regulation as a hearing aid.
Similarly, Earl Johnson, PhD, a VA audiologist in Tennessee, recommended that FDA use the decibel sound pressure level (dB SPL) output capability of PSAPs and hearing aids as “a definitive measure for differentiation. The output capability can address safety concerns of potentially harmful sound exposure levels due to design and manufacturing as well as usage by wearers.”
IT’S IN FDA’S HANDS NOW
Faced with a wave of public comments in response to its invitation, the FDA now must consider what weight to give them in deciding what to do with its proposed revision of its PSAP policy. Assuming that the agency is genuinely open to heeding public opinion, it has plenty of ideas and suggestions to draw upon. It could finalize the draft document more or less unchanged; make substantive changes; or, as some have counseled, go back to the drawing board and take a new look at the whole issue of hearing aid regulation.
One who made that recommendation was Gail Gudmundsen, AuD, in a Citizen Petition sent to the FDA. She cited President Obama’s Executive Order 13563 — Improving Regulation and Regulatory Review, in calling upon FDA to undertake a retrospective analysis of its hearing aid regulations to determine if they are “… outmoded, ineffective, insufficient, or excessively burdensome, and to modify, streamline, expand, or repeal them in accordance with what has been learned.”
Is there a American Association for the Hearing Impaired? A friend told me another of her friends in Las Vegas is currently designing a national video campaign for them. I can’t find name like this linking it with a the Hearing Impaired. Are you aware of any such program being done? I think this guy is going to scam her out of money and I’d like to stop it before it happens. Thank you very much.
Dear Mr. Holler,
I have not heard of an association by that name. The leading organization for hard-of-hearing people is the Hearing Loss Association of America, whose web site is http://www.hearingloss.org.
This is a fantastic article. Thank you David.
Why does this have to be so complicated? The current model of the FDA is a PSAP is a device designed for amplification but not designed to compensate for hearing loss. Their restrictions are only in how the product is advertised, not in what the product can actually do.
SO, under these guidelines, if I take a name brand hearing aid and advertise it as a PSAP, “not meant to compensate for hearing loss”, I can sell it this way to my heart’s content, regardless of how much amplification it is capable of providing.
It could be much simpler, based on gain and output characteristics. Limit gain to 15dB, and output to no more that 80dB SPL. OSHA guidelines state that sounds 85dB over an 8-hour period have a significant potential for causing hearing loss. Since most PSAP users would be unlikely to use their device for more than 16 hours, and we know about the 5dB halving / doubling effect for noise exposure, then limiting the output of the PSAP to 80dB would likely prevent potential damage from loudness exposure.
So, have the FDA limit PSAP specifications to 15 / 80. Any instrument capable of producing more amplification than this would be considered a hearing aid. Before the instrument could be sold on the open market, it would need to be tested via ANSI to determine if it’s an aid or PSAP.
How simple would that be?
Scot – excellent point! The guidelines only cover “intended use”, which makes the FDA’s job easy but is essentially meaningless. In my comment I proposed something a lot like you stated, among other criteria. The guidelines as they stand are of little value for consumer protection. Nothing whatsoever would prevent a consumer from buying a worthless PSAP to use as an (ineffective) hearing aid, which makes the entire 1977 hearing aid rule null and void.
I also find it amazing that while at least 38 states have banned mail order hearing aids–enough to get an amendment to the Federal Constitution, but not enough to convince the FDA that mail order is a bad thing.