As previously communicated on October 14, 2021, Oticon Medical, which constitutes the Hearing Implants business in the Demant Group, has initiated a voluntary field corrective action by recalling a number of non-implanted Neuro Zti cochlear implants and has temporarily halted sales of new implants.
Related article: Demant Recalls Non-implanted Neuro Zti Implants
While uncertainties still exist, the company announced that it believes it has now identified the root cause of the issue, which is related to the manufacturing process and not the design of the implants. The company is currently working on implementing and verifying a solution to the issue to ensure high and consistent process quality, according to its latest announcement. Based on its current assessment, Demant Group now expects sales activities to be resumed in Q3 2022 and ramped up in the subsequent months. This expected timeline is subject to final verification and validation, including approval by relevant external bodies, the company said.
Until implant sales are resumed, revenue generated by Hearing Implants will comprise sales of external cochlear implant sound processors to existing users as well as bone-anchored hearing systems, which are still expected to remain unaffected. As previously communicated, such continuous sales accounted for around 65% of total revenue for Hearing Implants prior to the voluntary field corrective action.
In mid October, investigations showed that up to 3,976 Neuro Zti implants were potentially affected and that a total of 28 implants had either been explanted or were at that time under surveillance to be explanted. As of December 19, 2021, the latter number had increased to 43 implants. So far, the number of reported incidents has thus remained low, and most users are unlikely to experience any issues. There have still not been any reported safety events in relation to the implants, and there are still no safety concerns for existing users, Demant said in its announcement.
There are no changes to the company’s previous assessment that the voluntary field corrective action will result in one-off costs of around DKK 70-100 million (USD $11-$15 million) in 2021, the company reported.
Unless the timeline for the resumption of implant sales mentioned above changes, or unless other developments require the company to give an update, Demant does not expect to provide further separate updates on the voluntary field corrective action.
As per the company’s financial calendar, its Annual Report is scheduled for release on February 8, 2022.
Source: Demant Group