Category: Cochlear Implants

Acclaim Cochlear Implant Begins Clinical Trial

Envoy Medical Corporation, a hearing health company focused on providing innovative technologies across the hearing loss spectrum, announced the US Food and Drug Administration (FDA) approved its Investigational Device Exemption (IDE) application to begin a clinical trial with its fully implanted Acclaim cochlear implant. 

Read More

Demant Issues Update on Neuro Zti Cochlear 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.

Read More

Demant Recalls Non-implanted Neuro Zti Implants

Oticon Medical, which constitutes the hearing implants business in the Demant Group, announced that it has decided to take voluntary field corrective action by recalling non-implanted Oticon Medical Neuro Zti implants and to temporarily halt sales of new implants. The recall is entirely related to the identification of performance issues in a small subset of implants, and there have been no reported safety events with the implants, according to the company’s announcement.

Read More