At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Active transcutaneous bone conduction system (device)
- How long the study runs
- Study runs about 27 months (dates as stated)
- About the drug or intervention
- Active transcutaneous bone conduction system — device: The Sentio system consists of the Sentio 1 Mini sound processor (SP) and Sentio Ti implant with fixation band and screws.
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 3 Years to 11 Years
- Who
- All
- Number of participants
- 50
- Started
- 2025-04-30
- Last checked
- 2026-08
Plain English Summary
What is this study?
- • Testing a new treatment for hearing loss, conductive
- • NA - 50 participants
- • This study is performed to collect safety and performance data supporting the use of the Sentio system in children below 12 years of age
Who can take part?
- • Ages 3 Years to 11 Years
- • Diagnosed with hearing loss, conductive
Where?
- • Birmingham - Birmingham Children's hospital, Birmingham Women's and Children's NHS Foundation Trust
- • London - The Evelina London Children's Hospital, Guy's and St Thomas' NHS Foundation Trust
- • London - Great Ormond Street Hospital, Great Ormond Street Hospital for Children NHS Foundation Trust
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
This study is performed to collect safety and performance data supporting the use of the Sentio system in children below 12 years of age. The system is currently available on the market for patients 12 years and above. It is a prospective study conducted at eight European hospitals, aiming to treat 50 patients with a hearing loss than would benefit from treatment with a bone-anchored hearing system (BAHS). The primary objective of the study is to demonstrate that the Sentio system improves the hearing on the implanted ear, compared with the unaided situation.
More detail
This study is performed to collect safety and performance data supporting the use of the Sentio system in children below 12 years of age. The system is currently available on the market for patients 12 years and above. It is a prospective, multicentre study sponsored by Oticon Medical AB, which will be conducted at eight hospitals across Europe (UK, Spain and the Netherlands). A total of 50 patients with a hearing loss than would benefit from treatment with a bone-anchored hearing system (BAHS) will be included. Participation is voluntary and the decision to participate must be well-founded and well informed. The Sentio system is a transcutaneous bone conduction hearing system (an implant and an external sound processor) for individuals 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 the sound waves to vibrations, which are then transmitted to the inner ear via the bone. The primary objective of the study is to demonstrate that the Sentio system improves the hearing on the implanted ear, compared with the unaided situation. The study includes eight study visits; one before surgery, the surgery visit, and six follow-up visits, with the last visit taking place 12 months after surgery.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 3 Years - 11 Years
- Who can join: All genders
Biomarkers mentioned
What the study is looking for
- ✓Signed agreement to take part Form (depending on age of child, signed by parent or legal guardian and child)
- ✓Subject aged 3 to 11 years
- ✓Subject with:
- ✓1 conductive or mixed hearing losses with pure tone average (PTA) bone conduction (BC) threshold (measured at 0.5,...
- ✓Subject and parent or legal guardian have the ability and willingness to comply with investigational procedures/...
Who cannot take part
- ✗Medical condition that contraindicates implant surgery or anesthesia as judged by the investigator.
- ✗Untreated ongoing middle ear infection at the time of surgery.
- ✗Known or suspected contact allergy to silicone or other material used in the Sentio system.
- ✗Known condition that could jeopardize wound healing and skin condition, e.g. uncontrolled diabetes over time, as...
- ✗Known skin or scalp conditions that may preclude attachment or interfere with the usage of the sound processor.
See the full criteria
Where Is This Study? (3 UK sites)
Birmingham Children's hospital, Birmingham Women's and Children's NHS Foundation Trust
Birmingham B4 6NH, United Kingdom
The Evelina London Children's Hospital, Guy's and St Thomas' NHS Foundation Trust
London SE1 7EH, United Kingdom
Great Ormond Street Hospital, Great Ormond Street Hospital for Children NHS Foundation Trust
London WC1N 3JH, United Kingdom
Main Email: Research.Governance@gosh.nhs.uk
Research.Governance@gosh.nhs.uk0207 905 2700