BC101 - Safety and performance of the Sentio system
Research type
Research Study
Full title
A prospective, multi-center, single-arm, clinical investigation of the safety and performance of the Sentio system in users with mixed/conductive hearing losses and single sided deafness
IRAS ID
297271
Contact name
Peter Monksfield
Contact email
Sponsor organisation
Oticon Medical AB
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 6 months, 0 days
Research summary
This prospective, multi-centre study funded by Oticon Medical AB will be conducted at six hospitals across Europe (UK, Germany and the Netherlands). In the UK, the study will be performed at two sites (Birmingham and Cambridge). This is a pre-market authorisation activity, a regulatory requirement before medical device manufacturers can put products on the market. Patients with a hearing loss already planned for treatment with a bone-anchored hearing system (BAHS) will be included in the study. 16 to 20 patients will be included in the UK and the total number of patients in the study will be 50. Participation is completely voluntary and the decision to participate must be well-founded and well-informed. The purposes of this study are to investigate the safety and performance of the Sentio system, which is a new transcutaneous bone conduction hearing system (an implant, an external sound processor and accessories) for people with certain types of hearing losses. The implant is implanted into the bone behind the ear (mastoid and temporal bone area). After a period of skin healing a sound processor which transmits sound waves to the implant can be magnetically attached. The implant transforms sound waves to vibrations which are then transmitted to the inner ear via the bone. The (combined) primary objectives are to demonstrate that this device improves the hearing on the implanted ear and makes it easier to recognize speech, compared to the unaided situation. The study includes ten visits to the clinic; one before surgery, the surgery visit, and eight follow-up visits (last visit 24 months after surgery). At the follow-up visits, the skin above the implant will be examined and hearing outcomes will be measured and assessed. Complications and adverse events will be collected. Subjective evaluation of quality of life will be performed via validated questionnaires.
REC name
North of Scotland Research Ethics Committee 1
REC reference
21/NS/0105
Date of REC Opinion
27 Aug 2021
REC opinion
Favourable Opinion