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TENT-A1 Trial User Experience Data: Usability of Bimodal Neuromodulation to Treat Tinnitus

Lenire Tonguetip in patient's hand

In late 2020, the results of the first large scale clinical trial of Lenire to treat tinnitus, TENT-A1, were published in the scientific journal Science Translational Medicine. The paper focused primarily on the treatment outcomes for patients – did their tinnitus symptoms improve?

This is typical of research papers from clinical trials which are peer-reviewed before a scientific journal publishes them. It’s obviously important to focus on what the outcomes were for the patients’ symptoms, particularly if the research is into a promising treatment such as bimodal neuromodulation for tinnitus. However, during clinical trials like TENT-A1 there are many other data points gathered such as:

  • How comfortable was the device?
  • How easy was it to fit treatment with it into your daily schedule?
  • Did the patient understand how to use it?

These are important things to understand. If a treatment is shown to work in a trial, it’s even better if it’s easy-to-use and easily accessible for patients. That means it could be more likely to have success in the real-world in less controlled environments than clinical trials, especially in the medical device field where the characteristics of different devices and how they are used can vary greatly.

Sometimes these measures of accessibility are never published either because they are not included in the published research paper and never released by the organisations running or organising the trial.

Now, this additional information from Lenire’s clinical trials will be made available. We think it’s important to share more information about our research into treatments for tinnitus so The Hearing Review, a hearing healthcare trade publication, are publishing a series of articles about data collected during Lenire’s trials which were not yet published.

The first article, which discusses the patients’ experiences of using the device for treatment during the trial, is available here:

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