The evolution of the hearing aid industry sketched out in parts 1-3 of this post series is that of a consumer product. From hand to horn to telephone-like device, the hearing aid was developed and thought of by manufacturers and consumers alike as an appliance that boosted sound. In that regard, hearing aids were a closer fit to the personal stereo niche than to a medical device category.
20th century technological advances focused on shaping and boosting the amplified sound in order to offer an improved product to more targeted markets – specifically, people with hearing loss. Product differentiation was a response to the market, which in turn became more clearly targeted as those with disability as the product evolved to meet their specific needs. Hearing aids became more expensive as they improved technologically and competed on claims of correcting disabilities. The stage was set for scrutiny, and possible regulation, of claims and pricing by the industry.
The curtain crashed down on the industry’s stage in 1977 when hearing aids became Class 3 devices (later relaxed to Class 1 and 2) within the FDA medical device taxonomy1 Suddenly, the rules changed: definitions, restrictions, standards and warnings abounded. Before these are described, it is worthwhile asking how a consumer product suddenly became a heavily policed medical device.
As usual, a number of factors contributed. Technological innovation continued down the path of miniaturization, thanks to the introduction of zinc-air batteries in 1977, the development of dental plastics that could be formed into custom-fit in the ear (ITE) instruments, and increasingly sophisticated, small integrated circuits, microphones, and receivers. ITE instruments meant that the fitter was “in” the consumer’s ear, especially when taking the impression from which the custom shell was fabricated. Frequently, the fitter used an otoscope to examine the ear canal and take the impression. On some occasions, the fitter even removed pesky ear wax! It is not surprising that consumers and ear doctors began to view these fitting activities and tools as an encroachment into territory previously considered medical, or at least private.
By 1977, the Audiology profession had accumulated about 25 years of experience, curriculum development, and equipment refinement. They had moved away from rehabilitating soldiers in hospitals and gravitated toward diagnosis of hearing loss by test procedures performed in clinics and physicians’ offices. Also in 1977, Audiologists managed to defy their membership organization and expand their scope of practice to include fitting (selling) of hearing aids. The connection between medical model and hearing aid was strengthened as Audiologists entered the fray.
Consumerism and protests came into their own in the 1970s, in good part thanks to Ralph Nader and consumer protection groups. In the case of hearing aids, these two forces came together in an interesting way. In 1973, Nader’s Retired Professional Action Group (RPAG) released a report called ‘’Paying Through the Ear,”2 which described hearing aid sales abuses. The RPAG was quickly joined by the Gray Panthers, an advocacy group for senior citizens, to monitor the hearing aid industry.3 Perhaps as a result of the pressure brought to bear by this coalition, the FDA did a survey (details unknown) that cited “many cases of hearing aids fitted badly for users” and “unethical sales tactics combined with no returns policy.” As a result, the FDA formed an Interdepartmental Task Force on Hearing Aids, which issued a report citing studies “indicating that patients bought hearing aids when their hearing loss required medical treatment.”
Please tune in again for Part 5 of this series, when we’ll look at the FDA Final Rule for Hearing Aids.
Footnotes and References
1As described in part 1 of this post series, Class 1 FDA device means that they are exempted from the premarket notification and FDA clearance requirement. Hearing aid manufacturers are required to register their establishments and bring their products into compliance with a number of “recognized consensus standards” developed and published by the American National Standards Institute (ANSI).
2 A reader sent a draft of parts 1-5 of this document which admonishes that it cannot be reproduced in whole or in part.
Feature image courtesy of zombietime.com