The Medicines and Healthcare products Regulatory Agency (MHRA), the UK’s medical device regulator, has circulated a recall notice in relation to all ZeniPower mercury-free hearing aid batteries, warning that there is a low risk of the batteries exploding during use or if they become depleted.
The recall notice has revealed that the potential problem is caused by excessive gassing, as the zinc electrode reacts with the electrolyte to generate hydrogen. On rare occasions, the battery may expand and possibly explode. A number of ZeniPower products are affected which are listed on the MHRA website (click here for details). Only batteries with best before dates of ’08-2018’ and ‘09-2018’ are involved.
Charlene McAuliffe, an associate in the personal injury team at Penningtons Manches LLP, said: “It is unclear exactly how this problem has arisen and the manufacturers will now need to consider the effectiveness of their quality control process to prevent this from happening again. The trauma of such an explosion taking place within the ear would cause significant sensory damage, which at its worst, could be irreversible. Patient safety is absolutely paramount and we strongly recommend that users of the specified hearing aids, who have concerns about the notice, should contact the supplier.”