Rayovac, Madison, Wis, is reportedly the first hearing aid battery manufacturer to obtain a medical device license (MDL) for zinc air hearing aid batteries from Health Canada, Rayovac’s successor company, Spectrum Brands, announced on its website.
“Obtaining the license from Health Canada is an assurance to our professional and retail customers in Canada that Rayovac will be there to meet their hearing aid battery needs,” said Kevin Kouba, division vice president of hearing aid batteries at Spectrum Brands, Inc. “Since some manufacturers do not yet have the required MDL, we are seeing this as an important competitive advantage for our customers, as well as Rayovac.”
According to Health Canada, “batteries are considered medical devices when they are designed, manufactured, and labelled specifically for use with medical devices.” According to the press release, 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 labelling and other requirements. Since Rayovac’s quality system has reportedly been ISO certified since the 1990s, the company’s batteries already met most of the requirements for Health Canada’s MDL. Any changes made were focused on labeling and enhanced documentation processes, said Spectrum Brands.
“Complying with Health Canada’s standards has impact beyond just our Canadian customers,” said Ann Rule, senior director of marketing at Spectrum Brands, Inc. Rayovac. “All of our customers, regardless of market, will benefit from the processes we put into place to meet these requirements. This accomplishment is another indication that Rayovac hearing aid batteries are always at the forefront of quality and safety.”
Source: Rayovac, Spectrum Brands