Hearing Loss, ConductiveBC119NCT06976086
Pediatric Expansion Study of the Sentio System
A study testing Active transcutaneous bone conduction system in people with Hearing Loss, Conductive and Hearing Loss, Mixed, run by Oticon Medical at 8 sites in 3 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 3 to 11 years
- Conditions the study is for
- Hearing Loss, Conductive, Hearing Loss, Mixed, Single Sided Deafness
- What is being tested?
- Active transcutaneous bone conduction system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 8 sitesin 3 countries
- Study dates
- 30 Apr 2025to 1 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Signed Informed Consent Form (depending on age of child, signed by parent or legal guardian and child)
- Subject aged 3 to 11 years
- Subject with:
- 3.1 conductive or mixed hearing losses with pure tone average (PTA) bone conduction (BC) threshold (measured at 0.5, 1, 2 and 3 kHz) of the indicated ear better than or equal to 45 dB HL.
- 3.2 OR subject who has a profound sensorineural hearing loss in one ear and normal hearing in the opposite ear (i.e. SSD). The pure tone average (PTA) air conduction (AC) threshold of the hearing ear should then be better than or equal to 20 dB HL (measured at 0.5, 1, 2 and 3 kHz) 3.3 OR subject indicated for an air-conduction contralateral routing of signals (AC CROS) hearing aid, but who for some reason cannot or will not use an AC CROS.
- Subject and parent or legal guardian have the ability and willingness to comply with investigational procedures/ requirements, as determined by the investigator.
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- Subject with prior experience of amplified sound through a properly fitted hearing aid, a CROS device, or a non-surgical bone anchored solution (e.g. softband).
- For subject with conductive or mixed hearing losses, ensure sufficient air bone gap (ABG) at the ear to be implanted.
- Sufficient bone quality/quantity/depth or skull size for implantation of a Sentio Ti implant as assessed according to clinical practice.
Who cannot join
- 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 judged by the investigator.
- Known skin or scalp conditions that may preclude attachment or interfere with the usage of the sound processor.
- Evidence of conditions that would prevent good speech recognition potential as determined by good clinical judgment.
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- Any other known condition that the investigator determines could interfere with compliance or investigation assessments.
- Use of ototoxic drugs that could be harmful to the hearing, as judged by the investigator.
- Subject that has received radiotherapy in the area of implantation or is planned for such radiotherapy or similar during the investigation period.
- For bilateral asymmetric candidates, subject already treated with a bone-anchored hearing solution on the side with the best bone conduction thresholds.
- Known chronic or non-revisable vestibular or balance disorder.
- Known abnormally progressive hearing loss.
- Currently participating, or participated within the last 30 days, in another clinical investigation involving an investigational drug or device that could impact the safety or effectiveness of the Sentio system as determined by the investigator.
- Use of active implantable or body worn device that for medical reasons cannot be removed or discontinued, such as CSF shunts, implantable cardiac pacemakers, defibrillators, or neurostimulators.
- Known need for frequent MRI investigations for follow-up of other diseases.
- Any subject that according to the Declaration of Helsinki is deemed unsuitable for investigation enrolment.
Trial locations and contacts
8 sites in 3 countries.
8 sites in 3 countries
Spain3 sites
Hospital Universitario de Donostia
San Sebastián, 20014
Hospital Universitario Virgen Macarena
Seville, 41009
Hospital Universitario y Politécnico La Fe
Valencia, 46026
United Kingdom3 sites
Birmingham Children's hospital, Birmingham Women's and Children's NHS Foundation Trust
Birmingham, B4 6NH
The Evelina London Children's Hospital, Guy's and St Thomas' NHS Foundation Trust
London, SE1 7EH
Great Ormond Street Hospital, Great Ormond Street Hospital for Children NHS Foundation Trust
London, WC1N 3JH
Netherlands2 sites
University Medical Center Groningen
Groningen, 9700 RB
Radboud University Medical Center
Nijmegen, 6525EX
About this study
Official title: A Prospective, Multicenter, Single-arm Clinical Investigation of the Safety and Performance of the Sentio System in a Pediatric Population
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.
Read the detailed description
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.
- Being tested
- Active transcutaneous bone conduction system
- Keywords
- Sentio system, Paediatric, Hearing loss, Children, Bone conduction, Transcutaneous
- Medical subject headings
- Hearing Loss, Conductive, Hearing Loss, Mixed Conductive-Sensorineural, Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active transcutaneous bone conduction systemDevice
Also called Sentio system
The Sentio system consists of the Sentio 1 Mini sound processor (SP) and Sentio Ti implant with fixation band and screws.
| Study group | Role | What they receive |
|---|---|---|
| Sentio system | Experimental | Prospective, open label, single-arm multicentre investigation designed to follow clinical practice for bone conduction devices. Receives: Device: Active transcutaneous bone conduction system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Demonstrate that the Sentio system improves hearing on the implanted ear.
Functional gain with the Sentio system, i.e. the difference between pre-operative unaided and post-operative aided sound field thresholds on the implanted ear. The functional gain is calculated as the average of frequencies 500, 1000, 2000 and 4000 Hz (PTA4).
Measured: 3 months post-surgery
Secondary outcomes (9)
Evaluation of the safety profile of the Sentio system in terms of the occurrence of adverse events and serious adverse events related to the device.
Tabulated adverse events and serious adverse events related to the device reported from surgery throughout the investigation reported at 3 months post-surgery.
Measured: 3 months post-surgery
Functional gain
Functional gain is used to assess the performance of the Sentio system. The functional gain is a calculation and is defined as the difference between unaided and aided sound field thresholds. The average functional gain is calculated as the average of frequencies 500, 1000, 2000 and 4000 Hz (PTA4).
Measured: 12 months post-surgery
Effective gain
Effective gain is used to assess the degree the Sentio system compensates for the hearing loss on the implanted ear in patients with mixed/conductive hearing losses. Effective gain is a calculation and is defined as the aided threshold relative to the BC (unmasked bone conduction) threshold and is calculated as the difference in dB between aided sound field thresholds and BC in situ hearing thresholds. The average effective gain (PTA4) is calculated as the average of frequencies 500, 1000, 2000 and 4000 Hz.
Measured: 12 months post-surgery
Assessment of speech recognition improvement
Difference in speech recognition score (%) between pre-operative unaided condition and Sentio-aided condition, measured in quiet on the implanted ear.
Measured: 3 months post-surgery
Assessment of listening-related fatigue
Change in Vanderbilt Fatigue Scale (VFS) questionnaire score between pre-operative unaided condition at baseline and aided condition post-surgery.
The Vandebilt Fatigue Score questionnaire as a valid measure of listening-related fatigue in children.
Measured: 6 months post-surgery
Assessment of quality of life
Glasgow Children Benefit Inventory (GCBI) questionnaire score addressing the consequences of a specific intervention on various aspects of the child's day-to-day life. The score goes from -100 (max negative effect) to +100 (max positive effect).
Measured: 12 months post-surgery
Usage hours
Sound processor usage hours per day.
Measured: 12 months post-surgery
Duration of surgery
Average length of surgery measured in minutes.
Measured: 3 months post-surgery
IPS (Inflammation, Pain, Skin numbness) scores
Distribution of IPS scores (Inflammation score 0-4; Pain score 0-2; Skin numbness score 0-2) assigned by investigator. The IPS score is presented as [Ix Px Sx] with x being the individual score for each parameter. A higher score corresponds to a poorer outcome.
Measured: 12 months post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2025
- Study start30 Apr 2025
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing Loss, ConductiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oticon Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Guy's and St Thomas' NHS Foundation Trust, Birmingham Women's and Children's NHS Foundation Trust, Great Ormond Street Hospital for Children NHS Foundation Trust, University Medical Center Groningen, Radboud University Medical Center, Hospital Universitario La Fe, Hospital Universitario Virgen Macarena, Hospital Donostia
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06976086
- Sponsor's protocol ID
- BC119
- Other IDs
- CIV-4-12-050315, CI/2024/0074/GB
- Acronym
- BC119
- Status last verified
- Aug 2026
- First submitted
- 25 Apr 2025
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Single-arm Clinical Investigation of the Safety and Performance of the Sentio System in a Pediatric Population
- ClinicalTrials.gov ID
- NCT06976086
- Acronym / sponsor ID
- BC119 / BC119
- Keywords
- Sentio system, Paediatric, Hearing loss, Children, Bone conduction, Transcutaneous
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Oticon MedicalIndustry (pharma, biotech, devices)
- Collaborators
- Guy's and St Thomas' NHS Foundation Trust, Birmingham Women's and Children's NHS Foundation Trust, Great Ormond Street Hospital for Children NHS Foundation Trust, University Medical Center Groningen, Radboud University Medical Center, Hospital Universitario La Fe, Hospital Universitario Virgen Macarena, Hospital Donostia
- Study start
- 30 Apr 2025 (actual)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 16 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sentio system | Experimental | Device: Active transcutaneous bone conduction systemProspective, open label, single-arm multicentre investigation designed to follow clinical practice for bone conduction devices. |
Who may qualify
- Ages
- 3 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Signed Informed Consent Form (depending on age of child, signed by parent or legal guardian and child)
- Subject aged 3 to 11 years
- Subject with:
- 3.1 conductive or mixed hearing losses with pure tone average (PTA) bone conduction (BC) threshold (measured at 0.5, 1, 2 and 3 kHz) of the indicated ear better than or equal to 45 dB HL.
- 3.2 OR subject who has a profound sensorineural hearing loss in one ear and normal hearing in the opposite ear (i.e. SSD). The pure tone average (PTA) air conduction (AC) threshold of the hearing ear should then be better than or equal to 20 dB HL (measured at 0.5, 1, 2 and 3 kHz) 3.3 OR subject indicated for an air-conduction contralateral routing of signals (AC CROS) hearing aid, but who for some reason cannot or will not use an AC CROS.
Key exclusion criteria (16 listed)
- 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 judged by the investigator.
- Known skin or scalp conditions that may preclude attachment or interfere with the usage of the sound processor.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active transcutaneous bone conduction systemAlso: Sentio systemThe Sentio system consists of the Sentio 1 Mini sound processor (SP) and Sentio Ti implant with fixation band and screws. | Device | Sentio system |
Primary outcome
Demonstrate that the Sentio system improves hearing on the implanted ear.
Time frame: 3 months post-surgery
Functional gain with the Sentio system, i.e. the difference between pre-operative unaided and post-operative aided sound field thresholds on the implanted ear. The functional gain is calculated as the average of frequencies 500, 1000, 2000 and 4000 Hz (PTA4).
9 secondary outcomes
Evaluation of the safety profile of the Sentio system in terms of the occurrence of adverse events and serious adverse events related to the device.
Time frame: 3 months post-surgery
Functional gain
Time frame: 12 months post-surgery
Effective gain
Time frame: 12 months post-surgery
Assessment of speech recognition improvement
Time frame: 3 months post-surgery
Assessment of listening-related fatigue
Time frame: 6 months post-surgery
Assessment of quality of life
Time frame: 12 months post-surgery
Usage hours
Time frame: 12 months post-surgery
Duration of surgery
Time frame: 3 months post-surgery
IPS (Inflammation, Pain, Skin numbness) scores
Time frame: 12 months post-surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active transcutaneous bone conduction system in people with Hearing Loss, Conductive and Hearing Loss, Mixed, run by Oticon Medical at 8 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Spain, United Kingdom, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Demonstrate that the Sentio system improves hearing on the implanted ear. (time frame: 3 months post-surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2026.