Hearing aid establishment and PSAP advocates clash over proposed FDA regulations

For an updated post on this subject, click here.

By David H. Kirkwood

ROCKVILLE, MD–A U.S. Food and Drug Administration (FDA) proposal to tighten existing restrictions on the marketing of personal sound amplification products (PSAPs) is arousing both a storm of criticism and strong support from various interested parties.

Although the February 5 deadline for submitting responses to FDA’s proposed new guidance document on PSAPs is still two weeks away, those responses that have been made public show a clear and unsurprising pattern: The hearing aid establishment—the organizations of hearing aid manufacturers and of professionals who dispense hearing aids–endorse the agency’s proposal to further limit the marketing of PSAPs.

Those involved in making and selling PSAPs—some of whom have banded together in a new coalition, RightToHear.Org¹ –would like FDA to loosen its restrictions, or better yet, quit regulating these non-medical products altogether.

While the two camps have reached opposite conclusions on FDA’s proposal, both cite the same motivation for their position: to promote and protect the best interests of consumers. They also share a strong suspicion that the other side’s true motivation is not the good of the consumer, but rather its own business interests.

A MATTER OF INTENT, SAYS FDA

As discussed previously on this blog, the proposed FDA guidance document issued on November 7 is not fundamentally different from its current guidance, which took effect in 2009.

In its 2009 discussion of the applicable requirements under the Food, Drug, and Cosmetic Act, the agency stated, “Hearing aids and PSAPs…have different intended uses, and are therefore subject to different regulatory controls. A hearing aid is a wearable sound-amplifying device intended to compensate for impaired hearing. A PSAP is a wearable electronic product that is not intended to compensate for impaired hearing, but rather is intended for non-hearing-impaired consumers to amplify sounds in the environment for a number of reasons, such as for recreational activities.”

Of course, anyone who has paid attention to how non-hearing aid personal amplifiers have been marketed knows that they are, for the most part, pitched to people with some hearing loss. (Indeed, there is very little other demand for personal amplifiers.)

For this reason, the Hearing industries Association (HIA), the trade association of hearing aid manufacturers and related companies, wrote to the FDA in May 2012 complaining that it was failing to enforce its own rules for PSAPs. HIA’s letter included copy from ads that clearly presented PSAPs as devices for people with hearing loss.

While FDA did not respond directly to HIA, it’s likely that its letter, along with similar communications from organizations of hearing care providers, influenced the agency’s decision to rewrite its rules to tighten restrictions on advertising of PSAPs.

In issuing its revised document, it said that since its 2009 guidance took effect, “FDA has become aware of a lack of clarity regarding how the Agency defines a hearing aid versus a personal sound amplification product (PSAP), which has also led, in some cases, to inappropriate application of regulatory requirements for such products. These inconsistent interpretations of the definitions may inadvertently result in hearing-impaired consumers bypassing safeguards that were implemented to promote the prompt diagnosis of treatable medical conditions causing hearing loss. To ensure consistent interpretation, consistent application of relevant regulatory requirements, and adequate protection of the public health, FDA seeks to further clarify the definitions of hearing aids and PSAPs.”

To this end, the revised document states that PSAPs “are intended to accentuate sounds in specific listening environments, rather than for everyday use in multiple listening situations.”

It also adds a list of “examples of listening situations that are typically associated with and indicative of hearing loss.” Among these situations, FDA says, are “difficulty understanding conversations in crowded rooms” and “difficulty in listening situations in which environmental noise might interfere with speech intelligibility.” Hearing aids, not PSAPs, are properly intended to address such situations, says the agency, and therefore any product purported to do so is, in effect even if not in name, a hearing aid and must comply with FDA’s regulations for hearing aids.

STRONG SUPPORT FROM HIA

Andy Bopp

Among the first organizations to respond to FDA was HIA. In a January 10 letter to the agency, Andy Bopp, the executive director, wrote, “HIA applauds FDA’s efforts to clarity the distinctions between PSAPs and hearing aids and strongly supports the position put forth by FDA.”

Bopp said, “Given HIA’s commitment to aiding individuals with hearing loss, we are keenly aware of the potential health and safety risks that may arise if an individual attempts to compensate for hearing loss with a PSAP rather than a hearing aid.” That was a reference to the FDA recommendation that patients be examined by a physician before getting a hearing aid and also to FDA’s list of “red flag ear conditions” that audiologists and hearing aid specialists are required to look for in their patients so that, if they detect one, they will immediately refer the patient to a physician.

HIA’s response also approved of FDA listing types of marketing claims that PSAP must not make. Doing this, Bopp said, would help prevent consumers from being misled into believing that a PSAP can provide them with the same assistance as a hearing aid can.

MORE RESPONSES TO COME

Three professional organizations—the American Speech-Language-Hearing association, the International Hearing Society, and the Academy of Doctors of Audiology—have told Hearing News Watch that they are preparing responses to FDA, and the American Academy of Audiology is expected to as well. It is virtually certain that all will have generally positive comments on the FDA proposal.]

THE PSAP COALITION’S REBUTTAL

RightToHear.Org, the recently assembled coalition of PSAP supporters, is mounting a spirited rebuttal to FDA’s proposal and to the arguments that it’s based on. Whether or not it will have any effect on the agency remains to be seen. One PSAP supporter said, not for attribution, that once FDA issues a proposed guidance document, it rarely amends it no matter how much public opposition there is. Nevertheless, backers of the PSAPs cause are giving it their best shot.

“IN DEFENSE OF PSAPs”

Chip Goldsmith

One of the most prominent of these is M. Miles “Chip” Goldsmith, MD, a practicing neurotologist at the Georgia Ear Institute in Savannah, and a co-founder with Malcolm Graham, MD, and William F. House, MD, of the International Center for Otologic Training. As he is quick to acknowledge, Goldsmith recently formed a company, ICOT Hearing Systems, whose “mission,” he says, “is to fund and develop high-quality, affordable hearing systems targeting the vast middle markets who cannot afford currently available technologies.”

In a 3500-word dissertation entitled, “In Defense of PSAPs” (which can be read in full on Wayne Staab’s blog starting this week), Goldsmith lays out in detail why he opposes FDA’s proposed revision of its PSAPs guidelines.

These guidelines, he contends, “have expanded the restrictive language for PSAP promotions in an overreaching way,” which, “clearly threatens a burgeoning industry which is providing a safe, effective, and affordable hearing benefit to those in need.”

Citing his professional experience, Goldsmith largely dismisses the safety issues raised by FDA, saying that the “red flag” medical conditions are rare, are more likely to be detected when a patient goes to a physician because of symptoms than during a hearing aid fitting, and are not exacerbated by the use of a PSAP.

He also rejects FDA’s contention that a device that helps people hear in noise or in multiple settings must be intended exclusively for people with hearing loss. He says, “It is well documented that normal-hearing people have trouble hearing in competitive noise.”

Contending that there is “no compelling safety and efficacy issue” to support the FDA’s proposal, Goldsmith says that the new guidelines  “beg the question as to whom FDA is protecting here. Is it the consumer? Or, is it the hearing aid industry?”

Goldsmith closes with a plea to FDA: “Particularly in these economic times where affordable access to health care is sharply in focus in our public arena, these new proposed guidelines warrant careful re-examination and revision. In their current form, they clearly threaten the viability of an industry that seeks to provide affordable hearing health care to a population that is clearly benefiting from this effort.  Please do not deny them their right to hear.”

CITIZEN PETITION FILED

Mead Killion

A leading couple in the hearing industry, Mead Killion, PhD, and Gail Gudmundsen, AuD, are also among the organizers of RightToHear.org In addition, their company, Etymotic Research, has introduced a personal sound amplifier, The Bean, that is worn completely in the ear.

Gudmundsen, managing director of the audiology division of Etymotic, filed a Citizen Petition on January 16 asking that the FDA commissioner instruct the Center for Devices and Radiological Health (CDRH) to withdraw its draft PSAP guidance document.

Gail Gudmundsen

Her petition charges, “FDA’s attempt to narrowly define and thus regulate a category of consumer products that provide personal sound amplification is a poor use of government resources. CDRH should cease the expenditure of all agency resources on activities related to products that are not under FDA jurisdiction (e.g., PSAPs) and focus its efforts on products that it does regulate (e.g., hearing aids).

RightToHear.org is recruiting others to support its cause. It has posted a “suggested text” on its site for people to send to the FDA, which includes the statement, “We object to any actions on the part of FDA to restrict access and make it difficult to purchase personal sound amplifiers.”

It also offers “talking points” that citizens may want to share with the FDA, including this one:

“The 2013 draft guidance is out of step with the current health care climate… Consumers want less regulation and more freedom to choose products that assist them in their daily lives and promote better quality of life.”

HLAA LEADER SAYS “CONFUSING” LANGUAGE MAKES FDA REVISIONS “UNHELPFUL”

So far, there have been no surprises in the positions taken by the various organizations that have responded to FDA’s proposal. However, one sector yet to be heard from is the hard-of-hearing population, many of whom belong to the Hearing Loss Association of America (HLAA).

While HLAA had not yet submitted its comments to the agency when this post was originally published on January 22, Anna Gilmore Hall, the executive director, sent the following reply on January 27 to a query from Hearing News Watch.

Anna Gilmore Hall

“HLAA appreciates the work the FDA has put into the Draft Guidance. However, too much of the new language is confusing, resulting in an overall unhelpful change to the 2009 Guidance. We respectfully request that the FDA seek input from a broad range of stakeholders to work together to craft a new document that is helpful to industry, providers, and consumers alike. We strongly support standards and labels for all products and believe there is a need for greater consumer education. “

HLAA has worked closely with HIA and with professional organizations in hearing care on a number of issues. However, on some issues it has staked out different positions from those groups. For example, in April 2012, its then-executive director, Brenda Battat, declined to join those organizations in opposing United HealthCare’s direct-to-consumer hearing aid distribution model. Battat explained that given how few consumers get the hearing help they need through the existing system, “Our stance is to give innovative programs such as this one a chance.”

Footnotes

¹Right to Hear and the positions it advocated can no longer be found on the Internet (called up 5/18/2016)