Over the past few days a video that has gone viral has caught the attention of those of the HHTM Blogs. You will recall that we had a story at Hearing International a couple of weeks ago about “Why does all the Good Stuff go to Europe First?”
This was a two-part series that discussed the reasons for good products ending up in Europe before they were offered in the USA. One of these products that has been in Europe for quite awhile is the Esteem by Envoy Medical. The video in question features a 29-year-old woman who was, in her own words, “cured of her deafness.” Her statement that accompanies the video is, “Hello, I was born deaf and 8 weeks ago I received a hearing implant. This is the video of them turning it on and me hearing myself for the first time :), For those of you who have asked, the implant I received was Esteem offered by Envoy Medical.” Check the video out to see what you think: http://www.youtube.com/watch?v=WlSOtH9BrRk
A Look at the Device
The Esteem, is an implantable middle ear hearing device from Envoy Medical, ( http://www.envoymedical.com) that has been in Europe for quite some time (since about 2006), but only available in the United States since its FDA approval in March of 2010 (Traynor, 2011). The implant is essentially a piezoelectric device that, according to Envoy Medical (2011), is FDA approved for hearing losses up to moderately severe (about 60 dB). Essentially, the instrument utilizes the patient’s own eardrum to send a signal to a transducer which, in turn, presents an electrical signal to the implant which is, in turn, amplified by the implanted hearing device. The amplified signal is then presented to a transducer directed to the head of the stapes completing the connection to the auditory system. Here’s how it works: http://www.youtube.com/watch?v=xdBzjR-i9E0.
Of course. we have no first hand clinical knowledge of the patient’s hearing impairment so our comments here are only speculation. As a group of seasoned audiologists, our HHTM group was able to detect a very slight component of “deaf speech” in the woman’s voice, As a group we agreed that her speech is exceptional for someone that has been a “deaf” person for all of her life. In fact, she must have utilized good amplification and obtained lots of speech therapy to gain speech skills of this caliber with a hearing loss that would be classified as “deaf”. After watching this video numerous times, the concern at HHTM was that if this patient was truly deaf, a hearing device with a documented useable fitting range up to 60 dB would not have had enough gain to be of that much benefit.
As a group of audiologists we felt that it was impossible for a “deaf” person and some with mto derive that much benefit from this device. Allowing for the “direct drive” effects of implantable middle ear devices, the benefits of a natural signal sent to the eardrum with appropriate resonance, and allowing for the possibility that the patient was inadequately aided prior to the implant; this patient still seems to have had an overreaction to the activation of the device. A “deaf” person would not be able to hear that well with this device, if she really had a 90 dB+ hearing loss prior to the implant. Although the video offers some hope to those with hearing losses that can be fit with implantable middle ear hearing devices, it also presents some implications that border on ethical advertising, especially to the US market. As this video went viral over the weekend the consumer blog at HHTM has had inquiries from totally deaf individuals as to how they can obtain the same device, hopefully to receive the same benefit as presented in the video (Hannan, 2011). When the truly deaf try this device and are unsuccessful it will add “fuel to the fire” for discussions regarding the under delivery of benefit from amplification and the arguments of further “medicalization” of the “deaf by the deaf community.
The discrepancy could be explained by the differences in the definition of “deaf” across various countries of the world. In the United States, a classically definition of deaf is defined a 90 dB hearing deficit at the frequencies of 500, 1000, 2000 and 4000 Hz. (Sanders, 1993). Staab (2011), however, indicates that a person with a hearing loss greater than 30 dB in Europe is also considered to be “deaf”. Reviewing the disparity in these definitions suggests that the frustration of audiologists in the review of this case may be simply due to the actual definition of “deaf”. On one hand, if the definition of deaf deals with a 90 dB+ hearing loss then the benefit offered by the device in the video is at best over stated while if the definition of deafness is 30 dB+ then it is possible that the Esteem hearing device was of great benefit to someone that posses a hearing impairment well within the fitting range.
At Hearing International we certainly understand the differences in definitions for various issues among audiologists from different parts of the world. It is, however, unfortunate that the specifics of this case is not presented as it would allow for objective assessment of the benefit.
For us…..we need to know more to determine if this is a miracle or if it is a significant exaggeration of benefit.
Envoy Medical (2011). Esteem Middle Ear Implant, Retrieved from the World Wide Web October 4, 2011: http://www.envoymedical.com/
Hannan, G., (2011). Personal communication, October 3, 2011.
Staab, W., (2011). Personal Communication. October 3, 2011.
Sanders, D., (1993). The Management of Hearing Handicap: Infants to Elderly. Englewood Cliffs, NJ: Prentice-Hall.
Traynor, R., (2011). Why does all the good stuff go to Europe? Hearing Health and TechnologyMatters. Retrieved from the World Wide
Web October 4, 2011: https://hearinghealthmatters.org/hearinginternational/2011/new-product-approvals-why-does-all-the-good-stuff-go-to-europe-first-part-i/