Malmö, Sweden — Duearity, a Swedish medical technology company, announced the recent completion of a user study to assess the impact of Tinearity G1 on tinnitus relief. The study involved 22 participants who reported being bothered by tinnitus, with one person being excluded from the study. Notably, all 22 individuals experienced relief from their tinnitus symptoms.
Conducted in April of this year, the user study aimed to evaluate the immediate relief provided by Tinearity G1 for tinnitus symptoms. Additionally, the study sought to examine potential side effects such as skin irritation, dizziness, or nausea resulting from the mechanical vibration of Tinearity G1.
The study findings will undergo review by both the US Food and Drug Administration (FDA) and Intertek, the European certification body for Duearity.
Not currently available in the US, the Tinearity G1 device is currently available in some European countries
Tinnitus Study with Tinearity G1
Participants included individuals aged 18 and above, possessing normal hearing in at least one ear, and experiencing tonal tinnitus. The study encompassed assessments of the participants’ hearing abilities, as well as measurements of tinnitus sounds, including frequency and amplitude. One participant was excluded from the statistical analysis due to mild hearing loss in both ears. Despite this hearing loss, the individual still reported relief from tinnitus symptoms.
During the study, participants used a five-point scale to indicate the degree of relief experienced, with scores ranging from 1 to 5. Scores of 3 to 5 denoted clear relief, partial masking, and complete masking of tinnitus symptoms, respectively. Conversely, scores of 1 and 2 represented no masking and noticeable masking, respectively.
Of the 21 individuals included in the study results, all reported scores between 3 and 5, indicating that they experienced relief from their tinnitus. However, one participant reported a side effect of dizziness, rating its severity as a 3 on the 1-5 scale, where 1 indicated no discomfort and 5 signified severe discomfort.
A particularly intriguing observation from the user study was that individuals with tinnitus frequencies surpassing the frequency range of white noise experienced relief from their symptoms. This phenomenon has captured Duearity’s interest, leading them to further investigate how Tinearity G1 masks tinnitus frequencies beyond its maximum frequency range.
Tinearity G1 is a CE-marked medical technology device specifically designed for tinnitus relief. It can be used either as a standalone solution or as a sound source in sound therapy, particularly when applied in conjunction with Tinnitus Retraining Therapy (TRT). Tinearity G1 is suitable for individuals with normal hearing or mild hearing loss and non-invasively delivers white noise to the inner ear. White noise encompasses sound frequencies across the spectrum, enabling individuals with both monotonous and polyphonic tinnitus tones to benefit from using Tinearity G1.
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
