Consumer Product Safety

Article Test Results of "Ears Care Goods" Product

February 24, 1998

Article Test Results of "Ears Care Goods" Product

To prevent the similar accident from reoccurring, the Ministry of International Trade and Industry performed a field survey of the damage report states and the article test of the quality and safety of the "Ears Care Goods" product, in February 20 (Friday), 1998, released the results as follows, and also instructed the importers and manufacturers.

1. Field Survey Results of Damage Reports

The field survey was conducted to 500 doctors of the otolaryngology in the whole country on the following items, 1. recognition of the products, 2. damage reports, and 3. cases, and, out of 207 doctors of the otolaryngology (percentage of reply 41.4%) who replied thereto, 161 doctors (82.6% of the respondents) answered to have actually examined such cases, and thereby we collected 847 cases who are supposed to have damage by using the products.

It was found that, 2 - 4 weeks after using the product, most cases complained of pruritus, hearing loss, and obstruction and were diagnosed as the otitis externa, the myringitis, and a foreign body in the eardrum.

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2. Product Test Result

Tested brands are as follows.

Product Test Result
Sample No. Name of Brand Name of Article Production Country Importer or Manufacturer Use of Gauze
1 OTOSAN Otosan cone Italy Hiro Denshi Co., Ltd.
Manufactured by; OTOSAN
No use
2 AURIPLUS Auriplus Italy Prima Della
Prima Co.ltd.
Manufactured by; OTOSAN
No use
3 AURISAN Aurisan Italy Seine Line Co., Inc.
Manufactured by; OTOSAN
No use
4 Ear MAGIC Ear Magic Italy Parex Japon Co., Ltd. No use
5 MiMi Can MiMi Can USA (JDI Corporation
Sanko Shokai Co., Inc.
No use
6 Ear Trim Ear Trim Japan M.A.P. Kyoto No use
7-1 OTTAMAGATION Ottamagation Taiwan Medic Far East Co., Ltd.
Manufactured by; Guankai Keji Gongsi
No use
7-2 Use
8 OTOCONE Otocone Italy FUJI.CO.,LTD. Use
9 OTOMIL OTOMIL Italy Emuz Co., Ltd. No gauze attached thereto as attachment, however there is description about the gauze in the instruction manual.
10 AURYS Ear Candle Canada Northern Light Trading Co., Ltd. No use

A test was performed about following 7 items.

1 Material Analysis

Qualitative analysis of components (wax part and fiber part)
No. 1 2 3 4 5 6 7-2 8 9 10
Wax part Paraffin
Beeswax
Paraffin
Beeswax
Paraffin
Beeswax
Paraffin
Beeswax
Paraffin Beeswax Paraffin
Beeswax
Paraffin Paraffin Beeswax
Fiber part Cotton Cotton Cotton Cotton Cotton Cotton Rayon Cotton Cotton Cotton

2 Analysis of Evolved Gas and Condensed Matter

Hydrocarbon gas, etc. were detected as components of the evolved gas, however, it was just contacted with the skin and not directly absorbed in the body so that we must not jump to conclusions that it is noxious for the human body. As for the condensed matter, though similar components as the wax part of the material analysis were detected, the beeswax which is brought in contact with the skin for a long time and from which, it was reported, a person with an allergic constitution gets a rash, may be the origin of itch or pain of some persons.

3 Temperature Measurement

The temperature rise in 5 points of the external auditory was examined by two methods, installing it at angles of 90℃(vertically) and 60℃to the ears. Generally, the temperature rise in using it at the angle of 60℃ was larger than that in using it at the angle of 90℃, the wax component of some of them flowed down when using it at the angle of 60℃, and the temperature in using the four specimens exceeded 40.0℃. The skin in the bone part of the external auditory meatus is thin and sensitive so that there is a fear to get burnt.

4 Measurement of Weight of Attachment

The maximum weight of the attachments of the external auditory meatus used at the installation angle of 90℃and 60℃ was 54.7mg and there was clear difference between a case of using a gauze and a case of not using the gauze.

5 Pressure Measurement

No negative pressure was generated in all the specimens and no earwax removing effect was found.

6 Observation of Combustion State

Without using the gauze, the flow of the evolved gas in using was instantaneously reaches the tympanic membrane irrelevant to the installation angles. After a while, the gas flow to the external auditory meatus almost stopped and the evolved gas condensed materials were accumulated in the lower part of the specimen.

7 Observation of Practical Utilization

A medical specialist introduced by the Oto-Rhino-Laryngological Society of Japan, Inc. observed the practical utilization of the appropriate product to the human body to find "adhesion of light yellowish white powered foreign body" and "some soft and light lump formed by accumulating the powers" in the external auditory meatus, where pollutant such as the foreign body does not originally exist. All the powders accumulated thereon could not be removed by the use of an aspirator and parts of the powders were left stuck to the wall of the external auditory meatus.

8 Instruction to Importer and Manufacturer

Based on the results of the article test and the field survey of the damage reports and, though there were individual difference of users, taking account of the report of the cases of the otitis externa and the myringitis, the competent Ministry considers it an urgent business that the industries concerned should take thorough safety actions such as improvement of the products, sufficient explanation for the use in the instruction manual, etc.

The Ministry of International Trade and Industry explained the industries concerned about the article test of the appropriate products and the field survey on the damage reports and persuaded them to take all possible and through actions to ensure the safety on the following three points.

  • 1 To improve the device so as not to let the flue gas flow into the external auditory meatus and the tympanic membrane.
  • 2 To thoroughly describe the use method and attentions in the instruction manual and the like.
  • 3 To delete the descriptions such as "remove the ear wax", which may be liable to cause misunderstanding of the users.

Contact us

 Risk Analysis and Public Relations Division  Product Safety Technology Center  National Institute of Technology and Evaluation
Phone number:+81-6-6612-2066
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