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UK alert: Zenipower mercury-free hearing aid batteries

Background

On 10 March 2016 the UK-based Medicines & Healthcare products Regulatory Agency (MHRA) issued a Medical Device Alert regarding the Zenipower mercury-free hearing aid batteries. Zenipower is the contracted supplier of hearing aid batteries to the UK National Health Service (NHS).

This alert has prompted a number of enquiries.

Hearing Aid Batteries Express (HABEX) has had an opportunity to clarify the issue with Zenipower.

 

Clarification #1

The public MHRA advice has omitted some key information which has triggered a response from concerned Zenipower users.

Following correspondence with Zenipower, we can confirm the issue relates only to Zenipower mercury-free hearing aid batteries with a date / production code on the back of the card of ‘08-2018 NHS’ and ‘09-2018 NHS’. These batteries were manufactured during August and September 2015 specifically for the UK NHS.

All other batches of ZeniPower mercury-free hearing aid batteries are not affected.

HABEX has not supplied any of the Zenipower mercury-free batteries in question.

HABEX did not commence stocking Zenipower mercury-free hearing aid batteries until January 2016. This means our current batch was manufactured well after the affected batteries and we have have not had any reports of serious issues.

 

Clarification #2

Several HABEX customers have reported they are getting less than normal battery life from their Zenipower hearing aid batteries. HABEX has clarified this issue with Zenipower.

HABEX has confirmed there was a metal conductivity issue affecting a small batch of Zenipower mercury-content batteries (not the mercury-free batteries). This issue is different from the MHRA issue.

The affected batch have a date of ’08-2018’ on the back of the card. The issue only affects the Zenipower A13 and A312 mercury-content batteries.

The A10, A675 and A675P batteries are not affected.

HABEX have replaced the affected batteries with a newer batch.

If you are a HABEX customer and have experienced performance issues with Zenipower A13 or A312 batteries with a ’08-2018’ on the back of the card, please email HABEX.

 

About mercury-free hearing aid batteries

The world is moving away from products containing mercury.

For many years mercury has been used in many products, including hearing aid batteries.

Mercury is a very dangerous and toxic substance to all living species and the environment. Steps have been taken by various governments around the world to ban the use of mercury in products.

From October 2015 new European legislation (Directive 2013/56/EU) means all button-cell batteries sold in Europe must be mercury-free (MF). Several states in the USA have similar laws.

All Rayovac, Power One and Zenipower hearing aid batteries are compliant with this directive. Hearing aid battery manufacturers are moving quickly to make their mercury-free batteries available globally and phase out mercury-content batteries.

HABEX has sold MF batteries for a number of years and have not experienced any issues with the forth generation of the Rayovac mercury-free batteries. The performance is as good as the mercury-content batteries, if not better!

From early 2016 HABEX will phase out stocks of Rayovac, Power One and Zenipower mercury-content batteries in favour of mercury-free batteries.

The manufacturing process of mercury-free hearing aid batteries is different to that of mercury-content hearing aid batteries. This is because a different stabilising ingredient is used and a different design / assembly process is used to achieve voltage stability.

There are usually teething issues with any emerging technology. The transition from mercury-content to mercury-free batteries is no exception.

There are many reasons why customers may get ‘less than usual’ performance from their hearing aids. Most of these are hearing device related or the way the batteries have been handled or stored. Fortunately, the number of production issues are small relative to the large volume of hearing aid batteries manufactured every day.

HABEX continues to work closely with customers and hearing aid battery manufacturers / suppliers to minimise the impact of a defective batch. Your feedback plays a crucial role in this process.

 

If you any any questions about this release, please email HABEX.

 

Hearing Aid Batteries Express
14 March 2016