US Food & Drug Administration: The Need for Transparency in the Hearing Aid Market; April

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Hello, my name is Janice Schacter Lintz, I am the CEO of Hearing Access & Innovations and a mom of a 21 year old daughter with hearing loss.

The FDA should require generic names for hearing aid features with a rating system.

I. The consumer has no idea what they are purchasing unless there is greater transparency.

It’s easier to compare computer brands than hearing aids. Trademarked proprietary names are used for features which makes it impossible to compare them. Generic names should be required. Hearing aid buyers are dependent on the audiologist/dispenser to provide information, which may present a conflict of interest because the dispenser:

1. Represents a limited number of manufacturers and may not have knowledge of all hearing aids on the market.

Dispensers are presumed to know all the aids on the market, but the reality is that that they only dispense a few brands. The mix they offer is based on such concerns as percentage of earnings, incentive pricing, delivery schedule, quality, and customer support. Some of these concerns, such as percentage of earnings, are not in the best interest of the consumer.

2. May receive bonuses/equipment based on the volume of hearing
aids sold.

Many hearing aid companies provide free equipment or incentives or perks to dispensers based on their sales volume. This marketing program is now frowned on in the pharmaceutical business and should be eliminated in the hearing aid business as well.

3. Has a financial incentive to maximize the likelihood of making a sale.

Dispensers make a substantial profit when they sell hearing aids. Critical information that may obstruct the sale, such as the pros and cons of various features, may not be disclosed. Hearing aid manufacturers also heavily fund, either directly or indirectly through advertising, many of the hearing loss organizations, which can interfere with their advocacy on this issue as well.

Consumers can only educate themselves with information that is easily attainable and understandable, but there is no incentive for manufacturers or vendors to provide it unless they are required to do so. The FDA can bring greater transparency and accountability to the dispensing of hearing aids by developing a rating system for the various hearing aid features based on international ANSI standards and by standardizing the naming of these features. The availability of this information will enable consumers to become better informed and more satisfied with their purchase.

Standardizing terminology for hearing aid features will also help consumers to evaluate personal sound amplification products (PSAPs) which are not hearing aids and thus not regulated by the FDA. PSAPs are flooding the market, and consumers have no idea how effective these devices are for people with hearing loss—they only know that PSAPs are more affordable. If generic names for hearing aid features were used, then consumers could compare PSAPs to hearing aids and see what they are or are not receiving.

As Sy Syms said, “An educated consumer is our best customer.”

It is insincere for HIA to state that an audiologist would know which hearing aid works best since even they are unable to compare one hearing aid to another since the information doesn’t exist.

The CEA is an industry lobby group funded by membership companies. Having sat on the FCC’s Consumer Advisory Committee under Chairman Martin for two terms, the CEA is unlikely to do their part without regulation. The changes made by the CEA primarily occurred in my opinion when mandated by the FCC including adding a captioning chip to televisions. The same was true for adding an easy to find close captioning button on television remote controls. The FCC does not have this oversight on hearing aids. There will be no regulatory authority to ensure CEA acts in the best interest of people with hearing loss.

Another example was with hearing aid compatibility for cell phones required knowing the radio frequency immunity numbers or Hearing Aid Compatible (HAC) numbers for cell phones as well as for hearing aids. The FCC required the cell phone manufacturers to provide HAC ratings. Only the FDA could require the hearing aid manufacturers to provide its HAC ratings. While the FCC was willing to require the cell phone companies to provide the ratings, the FDA was unwilling to do so the same for hearing aid companies. Having one rating without the other was meaningless and infuriating.

Some of the cell phone companies grudgingly provided the information in tiny print that was hard to find, failed to properly train their employees and refused to provide a sufficient numbers of attractive and popular models with appropriate ratings. The information was available but good luck finding it.

The FDA meanwhile refused to mandate hearing aid manufacturers to provide HAC ratings. This made it impossible to purchase a cell phone for our daughter. At the time, no one at the FCC would contact the appropriate person at the FDA to set-up a meeting between the FCC and FDA Chairmen to resolve this issue. I was repeatedly told, only a Chairman could contact a Chairman. It became an issue of protocol.

But, as a mother, I could call anyone since government protocol did not apply to me… So, I did. I literally called the FDA Chairman almost every single day until a voluntary rating system was adopted.

The voluntary hearing aid rating availability meant our daughter could finally purchase a cell phone after we purchased new hearing aids. To close the remaining gaps that the cell phone manufacturers refused to provide, CTIA as a voluntary membership organization could not mandate but merrily suggest and the FCC refused to address, I published the article, “How to Buy a Cell Phone when You Have a Hearing Loss.” The article embarrassed the various cell phone companies to disclose the information needed by people with hearing loss.

This information would not have moved forward without this article. It was simply ridiculous. I was literally the only person in the country who could publish this information because of various regulations, protocols, company policies and lack of common sense.

I learned through this process and working with other membership organizations that certain large companies have tremendous clout and place unwieldy pressure on membership organizations. The membership organizations cannot mandate anything but can only recommend action. Placing people with hearing loss, who have no market force, dependent on these organizations is untenable. Success is only accomplished by people like me who have dedicated their life to work for free to achieve success for people with hearing loss. This is inappropriate. I am tired of working for free to do everyone’s job.

People with hearing loss have no market force as evidenced by the lack of significant change with hearing aids. People with hearing loss cannot be dependent on membership organizations or the generosity of people to receive the information that they so sorely need. Another example, is my 2009 petition before the FDA on these issues has gone unanswered. The hearing aid market needs a radical overhaul, clear regulation and oversight. The hearing aid industry and audiologist stranglehold must be broken.

II. HIA’s Report is Self-Serving

HIA’s report is self-serving to protect the organization’s funders which are upon information and belief, hearing aid manufacturers. The report discussed hearing aid alternatives. Other than a cochlear implant which would be prescribed by an otolaryngologist, there aren’t alternatives. The after-market accessories are after market add-ons that audiologists peddle to consumers similar to gum at the supermarket checkout stand. Most do not work and are relinquished to sitting in the drawer. The one product that is routinely not recommended is the telecoil. The feature adds only $50 to the sale of a hearing aid but tends to require a lengthy discussion. So, audiologists omit the discussion even when required by law in four states: Arizona, Florida, New York and Rhode Island.

HIA’s discussion of complex algorithms is insincere. Audiologists are not mathematicians. The hearing aid manufacturers have developed software to calculate the formulas. The audiogram numbers are inputed into the software to determine the hearing aid program. The hearing aids are adjusted based on consumer input after testing the aids. This statement is just utter nonsense.
Summary

Greater transparency of features whether they are hearing aids or PSAPs is needed. Consumers need to understand how the features serve their needs whether they are purchasing an PSAP or a hearing aid.

http://www.fda.gov/downloads/MedicalDevices/NewsEvents/WorkshopsConferences/UCM500626.pdf

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