BC125 SENSE, version 1
Research type
Research Study
Full title
Sentio Systematic Evaluation (SENSE)
IRAS ID
355858
Contact name
Anirvan Banerjee
Contact email
Sponsor organisation
Oticon Medical AB
Clinicaltrials.gov Identifier
To be assigned, ClinicalTrials.gov Identifier (NCT number):
Duration of Study in the UK
10 years, 0 months, 1 days
Research summary
The Sentio system is a bone conduction hearing system that recieved CE-mark and FDA clearance in July 2024 and is available on the market (including the UK) for patients aged 12 and above.\n\nThe aim of the study is to collect real-world data on the use of the Sentio system in clinical practice. The study is of an observational nature, meaning that it aims to observe local clinical practice. Study participants will be recruited among patients who have already received a Sentio system or is planned to receive a Sentio system, thus the decision for the patient to be treated with the Sentio system is taken independently of the study.\nThe study is an international, multi-center investigations and it is expected to include 20 sites across the world, of which 4 are located in the UK. Each site is expected to include at least 5 patients, thus the expected number of included patients in the UK is minimum 20. However, as the study aims to observe clinical practice and use of the system, the final number of patients included will depend on the number of patients treated at each site and the number of those patients volunteering for the study. \nOutcome assessment and data collection in the study will consist of data routinely collected for patients treated with a bone conduction hearing aid and the patients are not expected to attend any additional study visits. Patients will be requested to complete voluntary questionnaires about their use of the hearing system, as well as validated questionnaires about treatment benefit and quality of life. \n\n
REC name
West of Scotland REC 4
REC reference
25/WS/0118
Date of REC Opinion
7 Aug 2025
REC opinion
Favourable Opinion