[2784943]
My complaint is about the ear irrigation device, the elephant washer, a spray wash bottle. On (b)(6) 2007, i was a pt of an ear irrigation when this device was used, which caused permanent and severe damage to my left inner ear. Some time later i purchased this device and studied its characteristics and tested its performance. The force it injects the water through a tip only 1 mm i. D. , directly into the ear canal, is so powerful it can only be described as scary and frightening. I sent a letter to the mfr and a copy to the distributor describing my experience and how the characteristics of this device make it so unsafe. I never received a reply from either. There are facilities which could determine the actual pressure (p. S. I. ) of this device. I am trying to find where such a test could be conducted. My ear irrigation with the elephant ear washer took place during a routine physical exam by my primary care physician of internal medicine. After the irrigation i experienced profound hearing loss and chronic high-pitched tinnitus in my left ear. The medical assistant began with my left ear. Because of the apparent difficulty in removing wax from my left ear she had to refill the bottle three times. It was about halfway through the third bottle that the wax finally came loose and she stopped. No hydrogen peroxide or shampoo was added to the water as a ceruminolytic agent. The water forcefully injected into my left ear canal caused extreme discomfort, pain and loud noise from the constant pressure of the spray against my tympanic membrane (ear drum) during the entire irrigation. The irrigation for my right ear went easier and didn't take as long. Prior irrigations at this same medical facility: i had some prior irrigations at this same medical facility over the yrs. During those irrigations i experienced no discomfort, pain or loud noise. I later learned the reason for the difference: the devices used in the previous irrigations had been syringes which injected the water gently. At the time of the irrigation i am describing i didn't know the type of device which had been used. I didn't even pay attention to what it looked like. All i knew was that it must have been extremely powerful to inject water with such great force. Result of the irrigation: it was about the next day after the irrigation that i began to experience a dramatic difference in the tinnitus in my left ear. Ever since the irrigation the tinnitus in my left ear, though still intermittent, instead of being barely perceptible has been severe, chronic and high-pitched. I had a number of audiograms after the irrigation to test my hearing. The audiograms revealed a "profound" hearing loss in my left ear. On the first audiogram about one month after the irrigation my word recognition in my left ear had dropped to just 52%. I now practically can't hear anything in my left ear. The hearing in my right ear was not affected by the irrigation. Because the left ear canal irrigation resulted in both a dramatic increase in the severity of the tinnitus and a profound hearing loss, physicians of otology and neuro-otology recommended a hearing aid for the left ear. The improved hearing this would provide would help mask the tinnitus. Because of the severity of the damage to my left ear i have to wear a "premium" level hearing aid at a cost of (b)(4), not counting ear mold, and i have to carry extra batteries wherever i go. Before the irrigation the though of needing or having to wear a hearing aid had never entered my mind. At night the distress from the severe tinnitus in my left ear is noticeably much worse. The hearing aid is removed before sleep. Before the irrigation i never had trouble sleeping. After the irrigation, because of the severe tinnitus, sleep is now very difficult. When i can't sleep i am constantly aware of the tinnitus. The elephant ear washer: i didn't learn until much later after the irrigation that the device which had been used was the elephant ear washer. To better understand how any irrigation device could inject water with such great force, i purchased the elephant ear washer and tested its characteristics and performance. Summary of left ear canal irrigation with the elephant ear washer: the medical assistant injected approximately 1295 ml water over a period of approximately 8 minutes 20 seconds (not counting two times bottle refilled) with 400 strokes of trigger (no pauses between strokes) through a vinyl tip i mm i. D. Inserted 15/16" (length of tip) into my left ear canal directed straight back against my tympanic membrane, with a force great enough for the spray to travel, uninterrupted, approximately 24'. Damage to the left ear from the irrigation: after exams and consultations with ent physicians of otology, neuro-otology; audiologist; and tinnitus associations, a summary of the conclusions from these sources on the impact of the left ear canal irrigation using the elephant ear washer: the forceful injection of water into the left ear canal against the tympanic membrane produced excessive pressure and loud noise which caused mechanical/acoustic trauma to the cochlea (inner ear) permanently damaging the sensori hair cells. This damage resulted in severe, chronic high-pitched tinnitus and profound hearing loss. See scanned pages.
Patient Sequence No: 1, Text Type: D, B5