[92872664]
A company based in (b)(4) is actively marketing a "hearing-aid-device" which is very dangerous. To use the product, one must insert it into the ear and then turn it on to "see if adjustment is necessary". If the settings are not correct, which will almost always be the case for first use (and subsequently until optimum settings are achieved), the device has a high-pitch and very loud "whistle" which can permanently damage whatever degree of "hearing" exists. There is no warning or remedy for this and the product instruction notes are very confusing, incomplete, and poorly written. Further, on the devices i received, there was no possibility or means for adjustment. Finally, the company has no u. S service, support, or offices, so the purchaser is virtually left to fend for self with a very dangerous product. This product should be banned from the market! I will in the following list what contact information i have: company marketing the device: this can be accessed on the internet by entering the search term (which is the brand-name) - "wihear"; a contact with which i have corresponded: support. (b)(4); i finally, after much research, found an address for return of the dangerous product: (b)(4); this person seems to be with the manufacturer: (b)(4). Although the product came from the seller, noted in the two contacts above. Dates of use: 1 minute. Diagnosis or reason for use: to improve hearing. Is the product compounded: no. Is the product over-the-counter: yes. Event abated after use stopped or dose reduced: no.
Patient Sequence No: 1, Text Type: D, B5