Rayovac is the first hearing aid battery manufacturer to obtain a medical device license (MDL) for zinc air hearing aid batteries from Health Canada. According to Health Canada, batteries are considered medical devices when they are designed, manufactured and labelled specifically for use with medical devices. Hearing aids and hearing aid batteries are Class II medical devices, which means special licensing is required.
To fulfill these requirements, hearing aid manufacturers must obtain an MDL from Health Canada. Before issuing a license, Health Canada assesses the output systems for safety, effectiveness, and compliance with labeling and other requirements. Since Rayovacs quality system has been ISO certified since the 1990s, the companys batteries already met most of the requirements for Health Canadas MDL. Any changes made were focused on labeling and enhanced documentation processes.