Petitions for Pragmatism?

DtromFor at least 6 years, there have been valiant attempts at creating a “starter hearing aid” category that would have widespread appeal to consumers—particularly for those people who are in the early stages of sensorineural hearing loss, or for those who have limited time and money to spare. The fact is these products are fighting an uphill battle. The two Citizen’s Petitions filed by Mead Killion, PhD, and Gail Gudmundsen, MA, with the Food and Drug Administration in early August (see HR News, page 12) say there is a need for an over-the-counter (OTC) hearing aid category and, by extension, the elimination of the current medical waiver system. While not explicitly cited in the petitions, the following makes a case for OTC hearing aids:

1) Only about 1 in 5 people (22.2%) who could benefit from hearing aids have them. Further, about one-third of the hearing-impaired population is between ages 25-54, and market penetration for hearing aids in these age groups ranges from 7 to 9%.

2) Currently, the average hearing aid dispensed costs $1,730, with low-price linear hearing aids in most offices costing $700 to $900. About one-half to two-thirds of the price of a hearing aid is bundled into professional fees-for-services. It is possible that starter aids—without the substantial benefits of professional services and custom fitting—could be offered for $50 to $300.

3) About three-quarters (72%) of people purchasing a hearing aid need to visit the dispensing professional 3-5 times, which represents a large amount of time for the average person—especially one who has a “borderline hearing problem.”

It would be desirable to create a more flexible treatment pathway for those who have a hearing loss, providing options for younger “entry-level” users, as well as those who have limited time and financial resources. So, should hearing aids (with design safeguards that protect a person’s residual hearing) be allowed to be sold without the current medical waiver or the benefit of professional services, much like reading glasses are sold in grocery stores and pharmacies without the help of an optometrist or optician?

The medical waiver system, at face value, works. Many dispensing professionals have literally saved people’s lives by identifying a medical condition and referring them to a doctor, and far more have pointed out to a relieved visitor that it is not a hearing problem they have but, instead, an earwax problem. However, it should be remembered that the medical waiver system and the red-flag system are different things; even if the waiver system was eliminated, all dispensing professionals would still be obligated to evaluate patients for serious medical conditions, obstructions in the ear canal, etc, and refer them to a medical doctor in the event of a problem. According to the National Center on Hearing Assessment and Management, only 5% of hearing loss can be improved through medical or surgical treatment, while the overwhelming majority (95%) of losses are treatable with amplification devices.

So, the real questions are: How many fewer patients would receive professional hearing care through the creation of an OTC classification, and how would not sending the patient to a doctor before being professionally fitted affect hearing health in general? Your guess is as good as mine. Physicians currently screen only 14% of their patients anyway. Few would argue about a professionally fit hearing aid working better than a one-size-fits-most aid. But the truth is many people want to try hearing aids without the price and without the office visits. This has been demonstrated in the past with products like WhisperXL (and their ilk), and is demonstrated in the present by the number of Internet and mail-order aids being offered and purchased. We live in a time of abundant consumer options.

In my view, the devil is in the details of the packaging and accompanying product literature. There should be a way to offer OTC aids while protecting consumers’ best interests. But, in order to do so, there needs to be clear health warnings, and detailed education about the value of professionally fitted custom aids and the numerous options available for those who have hearing loss. Gudmundsen and Killion will probably have to weather a firestorm of criticism for the questions they pose, but the questions are as appropriate as their timing. As always, we look forward to your comments.

Karl Strom