Growing Clamour Over Micro Suction
At Hearing Aid Know we get a lot of correspondence, one email caught my attention a while ago. It was from a chap and it was about damage or injury caused by micro-suction ear wax removal. He said that micro-suction ear wax removal was dangerous and there were many accounts on the web about people’s tinnitus being exacerbated and people losing their hearing. Since ear wax removal has become a major part of our practice, I thought I better take it seriously. When I began to research my answer, I thought that anyone who offers micro-suction ear wax removal needs to know a few things. If you offer micro-suction, you need to read this.
Two things struck me about his email, the first was that he had obviously spent time researching the subject and had handpicked two studies to back his claim. The first was about general loudness of suction devices in the ear canal and the second was about sound levels being reached during an explosive clearing of the canula. I will talk about them later in the article.
The CE Mark
The second thing was that he stated that micro suction machines being currently used for aural micro suction were not in fact CE marked for the purpose. He said that most of the devices were certified for the suction of liquids and not substances like ear wax. When I looked into that, it appeared that there is only one CE marked “aural” suction device available in the UK which is supplied by Guymark. It is the Otopront VAC system. I need to completely verify that and I will stand corrected if I am wrong.
Not a Huge Amount, But Significant
The email intrigued me so I decided to check out just how many instances I could find of people complaining about damage or injury caused by ear wax removal. I also decided to look at the studies that were out there in relation to micro suction ear wax removal.
It turned out that there weren’t very many people who had complained, at least online. I found some instances but they were relatively limited in number
Deafness or Tinnitus Caused By Micro-suction Ear Wax Removal
There are some studies out there in relation to micro-suction for ear wax removal but not a lot. First I will look at the issues at hand and then I will discuss the studies. We all know that if a patient has pre-existing tinnitus, micro-suction ear wax removal may exacerbate it. While I have always believed that the problem will be temporary, there are people who have reported ongoing problems with their tinnitus after micro-suction.
Onset of Chronic Tinnitus!
There are also people who have reported the onset of chronic tinnitus from micro-suction. There are little statistics to tell us how many and during my searches across the web, I only came across about ten. That is not to say that there are not others out there.
Just How Loud?
We all know that micro-suction is a noisy procedure, but are you aware of just how loud the noise in the ear canal can get? We know that any exposure to noise can cause a temporary threshold shift and normally, that is all it will be, a temporary problem.
Long Term Hearing Loss?
However, some people have reported that micro-suction has caused them a long-term hearing loss. Again, there are few if any statistics and I could only find about six during my searches. This is what I have found out about the studies that are out there and the noise levels of the machines.
In the study Noise levels generated within the external auditory canal during microsuction aural toilet and the effect on hearing: a prospective controlled series a test was undertaken with 14 patients. It was found that in 2 patients the peak noise level in the ear canal was 120 dB which is pretty damn noisy.
However, it was found that none of the patients suffered a temporary threshold shift. In the study Aural microsuction for wax impaction: survey of efficacy and patient perception a study that was undertaken with 159 patients. It was found that although a few people suffered from some pain and or vertigo, “Aural microsuction is well tolerated. Side effects are mild, and the prior use of cerumenolytics appears to further reduce their severity“.
In the study Suction-generated noise in an anatomic silicon ear model it was found that the noise which occurred during the procedure was “Average noise levels during normal suction in a distance of 1 cm in front of the eardrum ranged between 97 and 103.5 dB(A) (broadband noise). Peak noise levels reached 118 dB(A). During partial obstruction of the sucker by cerumen or dermal flakes, peak noise levels reached 146 dB(A).”
They and others refer to the partial obstruction phenomenon as either Clarinetting or the Clarinet Phenomena. There is another study called Suction-Generated Noise Levels During Aural Toilet which was undertaken in Germany. It is perhaps the most unrealistic of the studies, the study was undertaken using water and lard. It found “The suctioning of water generated a maximum noise level of more than 130 dB(LAmax), while the suctioning of lard reached nearly 150 dB(LAmax). The time lapse of both noise and frequency level for lard suctioning was characteristic of a bang”.
This study, in particular, has been quoted online several times to support people’s arguments that micro-suction is inherently unsafe. I think our argument with it is that ear wax is not the same consistency of either water or lard. Another argument I would have is that any professional who is stupid enough to leave the probe in the ear when it is blocked has not been trained to competent standards and needs a slap.
There are cannulas available that have a very small hole in them to control suction levels, not unlike the set up of a hoover. Cover the hole with your finger, maximum suction, uncover the hole the suction abates. This is really useful because as soon as you hear the cannula become blocked, you can uncover the hole and take it out of the person’s ear. In that way, you reduce the patient’s exposure to Clarinetting.
The reason I write this article is that there are people out there using forums to bring up the unrealistic lard study and making claims about hundreds of people who have been damaged by the process. Interestingly though, all of the people who claim to have been injured say it was done by an ENT, no one seems to mention Audiologists.
Considering everything I have found during my research, I think it is clear that you need to protect yourself now more than ever. While I will further research the CE marking of the Otopront device, I think if there is a CE marked suction device for aural suction, well then I would consider getting it. The MHRA says that you can use off label medical devices if there are no other options. If indeed the Otopront is CE marked for aural suction, well then that is no longer a defence.