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Why are leak tests for customised hearing protection important?

Fitting otoplastics

Since October 2023, there has been a change in the law making it mandatory to carry out a leakage test when delivering custom-made hearing protection.

What is a leakage test, how is it performed and what does the amended law entail? You can read about it in this blog article.

 

What is a leakage test?

A leakage test or a seal test for custom-made hearing protection is a procedure performed to check whether the hearing protection seals effectively and adequately protects the ear from harmful noise.

The purpose of this test is to identify any leaks in the seals of the ear moulds and ensure that the hearing protection provides the intended noise reduction and fits the wearer properly.

 

How is a seal test performed?

Below are the steps involved in performing a seal test:

  1. Inspection of the ear: A specialist inspects the user's ear to ensure there are no obstructions that could affect the seal.
  2. Inspection of ear moulds: The ear moulds are checked to identify any cracks, dents or other visible damage.
  3. Instructions for correct use: The user is given detailed instructions on how to correctly wear the custom-made hearing protection. Accurate insertion of ear moulds is essential.
  4. Placement of ear moulds: The ear moulds are inserted by the user according to the instructions given.
  5. Leakage test or seal test: There are several methods that can be used to test the seal. At Vandeputte, we do a seal test by blowing air through the filter channel into the ear. Thus, the device measures whether the pressure built up in the ear behind the ear moulds is maintained.
  6. New impression if necessary: If it is found that the ear moulds leak during the test, a new impression is taken, and new ear moulds made. The new ear moulds undergo the same tests.

 

After a successful leakage test, as a wearer you can be confident that the custom-made hearing protection is performing optimally, and you can do your job in safety.

 

Why is it important to carry out a leakage test?

It is important to carry out a seal test because a good seal is essential for the effectiveness of hearing protection. In case of leaks, harmful noise can still reach the ear, increasing the risk of hearing damage. We recommend a leakage test every year. This will ensure that custom-made hearing protection performs optimally and maintains the safety of the wearer. Vandeputte's Total Care concept includes an annual seal test of your ear moulds.

 

Amended legislation

In October 2023, the law on leakage testing changed and it is now mandatory to carry out a seal test when delivering custom-made hearing protection. It is a European law, which makes it applicable in all countries within the EU.

This means that the manufacturer (or a person authorised by the manufacturer) takes individual impressions of the user's ear canal and auricle.  Based on this impression, the final personal protective equipment (PPE) is manufactured.

Because of the customised production method, where each item is adapted to the individual user, the manufacturer has to implement specific quality assurance measures.

To ensure the protective function, a final functionality check at the user's ear canal is essential, carried out by the manufacturer or a person authorised by the manufacturer. So before ear moulds reach the end user, they must first pass the leakage test.

The protective values, including SNR, HML, and Octave Band, should be clearly stated on the packaging and in the user information.

To ensure safety and prevent hearing damage, we at Vandeputte conduct these leakage tests before delivering to our customers.

 

Is a seal test only mandatory for ear moulds?

The obligation to carry out a seal test for custom-made hearing protection stems from the fact that the degree of protection depends heavily on a good seal. With standard hearing protection, this is less relevant as the design is less dependent on the specific shape of the user's ear.

Standard hearing protection, such as foam or silicone ear plugs, is based on average sizes and shapes. While they can certainly be useful, they may not fit each individual ear canal perfectly. Custom-made hearing protection aims to create an optimal seal as these ear moulds are specifically designed to fit perfectly in the individual user's ear canal.

Want to know more about the different types of hearing protection with their advantages and disadvantages? Then be sure to read: A complete guide to hearing protection: legislation, types and maintenance.

 

Is an annual leak test mandatory?

It is mentioned above that it is mandatory to carry out a leak test when the product is delivered. However, there remains ambiguity about the obligation of an annual leak test for users.

In the Netherlands, the annual leakage test is mandatory from the arbo, but in Belgium it is not explicitly mentioned. Nevertheless, the general rule applies that the product must be used according to the manufacturer's instructions, as stated in the Codex. If the manufacturer links correct use to an annual leak test in the manual, it is mandatory.

It is crucial that the manufacturer clearly communicates this advice through the manual. Only advice in the manual has legal force, as it is assessed by the notified body during type approval. Loose advice outside the manual has no legal force.