Malmö, Sweden — Duearity AB, a Swedish medical technology company, announced that it has received market approval from the Food & Drug Administration (FDA) in the United States for its tinnitus product, Tinearity G1. The FDA’s 510(k) clearance, paves the way for Duearity Americas Inc., a subsidiary of Duearity AB, to begin marketing and sales of Tinearity G1 in the USA.
The FDA’s approval follows a comprehensive evaluation of Tinearity G1 by the FDA, which encompassed various aspects such as electronics, clinical effectiveness, and a recent user study conducted by Duearity. The achievement of obtaining market approval within the first half of 2023 aligns with Duearity’s previously communicated objective.
Company Eyes Significant US Market Opportunity
This milestone represents a significant advancement for Duearity as it enables the company to introduce Tinearity G1 to what it believes to be the largest and most crucial market for medical devices. With an established team that has already identified several promising sales channels, Duearity plans to expand further by hiring key personnel in the US this year and next.
The company believes that Tinearity G1 holds great potential in the American market.
Over the past months, Duearity Americas Inc. has engaged in productive discussions with ear, nose, and throat doctors, as well as audiologists and specialists across the country, regarding the tinnitus relief needs of patients. The company notes the response has been positive, with Tinearity G1 regarded as having a crucial role in both masking tinnitus and facilitating Tinnitus Retraining Therapy.
Fredrik Westman, the CEO of Duearity AB, expressed his satisfaction with the market approval, emphasizing the company’s ambition to capitalize on this achievement. “The market approval means that Duearity has taken another significant step forward in that we can launch Tinearity G1 on the world’s most important market for medical devices,” he said. Westman also highlighted the company’s plans to leverage the product’s strong potential in the US and expand its presence by bringing onboard additional key personnel.
With FDA approval, the company plans to launch Tinearity G1 in the US
With FDA approval in hand, Duearity is poised to enter the US market and offer a solution for individuals seeking relief from tinnitus. Tinearity G1’s ability to address the masking of tinnitus and support Tinnitus Retraining Therapy positions it as a valuable asset in the pursuit of improved quality of life for those affected by this condition.
About Duearity
Duearity is a medtech company that develops and produces solutions aiming to relieve tinnitus symptoms and make everyday life easier for those who suffer from tinnitus. With a deep understanding of the people who have problems with tinnitus, the Company will with intelligent solutions give these people the opportunity to enjoy life. The company will offer the products Tinearity and Tinearity-AI. Tinearity transmits white noise using Bone Conduction Technology to the inner ear in order to relieve symptoms. Tinearity AI will use artificial intelligence to help people anticipate the symptoms and relieve their discomfort. The company’s headquarters are located in Malmö, Sweden.
Source: Duearity (translated from original Swedish language announcement)
