Hearing Loss, ConductiveNCT05166265
Clinical Investigation Study of Safety and Performance of the Sentio System.
A study testing Active transcutaneous bone conduction hearing system in people with Hearing Loss, Conductive and Hearing Loss, Mixed, run by Oticon Medical at 6 sites in 3 countries.
Trial summary
Prospective, open label, single-arm, multi-centre investigation, designed to follow clinical practice for Sentio bone conduction devices in 50 subjects, during 10 clinical visits, and 24 months follow-up. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hearing Loss, Conductive, Hearing Loss, Mixed, Hearing Loss, Unilateral
- What is being tested?
- Active transcutaneous bone conduction hearing system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 6 sitesin 3 countries
- Study dates
- 19 Jan 2022to Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed Informed Consent Form
- Adult subjects (18 years or older)
- Subjects 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 subjects who have 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 subjects who are indicated for an air-conduction contralateral routing of signals (ACCROS) hearing aid, but who for some reason cannot or will not use an AC CROS.
- Fluent in local language
- Subjects who have the ability and are willing to follow investigational procedures/requirements, e.g. to complete quality of life scales.
Who cannot join
- Inability to undergo general or local anesthesia
- Prior implantation with percutaneous device or middle ear implant on the side to be implanted
- Known medical conditions that contraindicate undergoing surgery as judged by the investigator
- Untreated ongoing middle ear infection at the time of surgery
- Known insufficient bone quality/quantity/depth or skull size (scull abnormalities) for implantation of a Sentio Ti Implant
- Known or suspected contact allergy to silicone or other material used in the Sentio system.
Show all 20Show fewer
- 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.
- Known retro cochlear pathology and auditory processing disorders that may have an impact on the outcome of the investigation
- 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
- For conductive and mixed losses: evidence that hearing loss is retro-cochlear or of central origin
- Participation in another clinical investigation with pharmaceuticals and/or devices which might cause interference with investigation participation.
- Use of active implantable or body worn device that for medical reasons cannot be removed or discontinued, such as 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
6 sites in 3 countries.
6 sites in 3 countries
Germany2 sites
Universitätsklinikum Freiburg Universitätsklinik für Hals,- Nasen und Ohrenheilkunde
Freiburg im Breisgau, 79106
HNO-Klinik Medizinische Hochschule Hanover
Hanover, 30625
Netherlands2 sites
ENT Department, University Medical Center Groningen
Groningen, 9700 RB
ENT department Radboud University Medical Center (Radboud UMC)
Nijmegen, 6500 HB
United Kingdom2 sites
ENT - University Hospitals Birmingham NHS Foundation Trust, Queen Elizabeth Hospital Birmingham
Birmingham, B15 2GW
Cambridge University Hospitals NHS Foundation Trust, Addenbrookes Hospital
Cambridge, CB2 0QQ
About this study
Official 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
Prospective, open label, single-arm, multi-centre investigation, designed to follow clinical practice for Sentio bone conduction devices in 50 subjects, during 10 clinical visits, and 24 months follow-up.
Read the detailed description
The investigation is a 24-months multinational, multicentre, prospective, open label, single arm investigation on the Sentio system. The purpose of this investigation is to evaluate safety and performance three months after implantation of the new Sentio system. In addition, safety will be analysed six months after implantation, and long-term safety and performance will be evaluated over a 24-month follow-up period. The endpoints chosen, together with applicable measurements, are commonly used, both in the clinical setting as well as in bone anchored hearing research as shown in the scientific literature covering this area. That is, the primary objectives of this study is to demonstrate that the Sentio system improves hearing and speech recognition on the implanted ear. Secondary objectives includes investigation of hearing improvement, speech intelligibility, patient satisfaction, and quality of life. The study also aims to evaluate the safety profile of the Sentio system in terms of the occurrence of adverse events and serious adverse events related to the device.
- Being tested
- Active transcutaneous bone conduction hearing system
- Keywords
- Hearing Loss, Conductive, Mixed, Single-sided, Deafness
- Medical subject headings
- Hearing Loss, Conductive, Hearing Loss, Mixed Conductive-Sensorineural, Hearing Loss, Unilateral, Hearing Loss, Deafness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active transcutaneous bone conduction hearing systemDevice
Also called Sentio system
The Sentio system consists of the Sentio 1 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 multi-centre investigation following clinical practice for bone conduction devices. Receives: Device: Active transcutaneous bone conduction hearing 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 Sentio, i.e. the difference between preoperative unaided and aided sound field thresholds on the implanted ear.
Measured: 3 months post-surgery
Demonstrate that the Sentio system provides patients with improved speech recognition on the implanted ear.
Difference in speech recognition score in percent between pre-operative unaided condition and aided with Sentio, measured in quiet on the implanted ear.
Measured: 3 months post-surgery
Secondary outcomes (1)
Thorough assessment of performance (functional gain, effective gain, speech recognition), satisfaction, usability, comfort and health-related quality of life.
Sound field audiometry, speech testing in quiet and noise and patient reported outcomes on listed topics.
Measured: 3-24 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 posted21 Dec 2021
- Study start19 Jan 2022
- Primary completion19 Feb 2024
- Study completionNov 2025 (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
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oticon Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Myrthe Hol, MD, PhD, Principal investigator, ENT Department, University Medical Center GroningenEmmanuel Mylanus, MD, PhD, Principal investigator, ENT Department, Radboud University Medical CenterPeter Monksfield, MD, PhD, Principal investigator, ENT - University Hospitals Birmingham NHS, Foundation TrustJames Tysome, MD, PhD, Principal investigator, Cambridge University Hospitals NHS Foundation Trust, Addenbrookes HospitalSusan Arndt, MD, PhD, Principal investigator, University Hospital FreiburgThomas Lenartz, MD, PhD, Study director, HNO-Klinik Medizinische Hochschule Hannover
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05166265
- Sponsor's protocol ID
- BC101
- Other IDs
- CIV-21-07-037287, CI/2021/0043/GB
- Status last verified
- Apr 2024
- First submitted
- 8 Dec 2021
- Last updated
- 3 Apr 2024
- 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 3 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT05166265
- Acronym / sponsor ID
- BC101
- Keywords
- Hearing Loss, Conductive, Mixed, Single-sided, Deafness
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Oticon MedicalIndustry (pharma, biotech, devices)
- Study start
- 19 Jan 2022 (actual)
- Primary completion
- 19 Feb 2024 (actual)
- Study completion
- Nov 2025 (estimated)
- First posted
- 21 Dec 2021 (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.
Prospective, open label, single-arm, multi-centre investigation, designed to follow clinical practice for Sentio bone conduction devices in 50 subjects, during 10 clinical visits, and 24 months follow-up.
Detailed description
The investigation is a 24-months multinational, multicentre, prospective, open label, single arm investigation on the Sentio system. The purpose of this investigation is to evaluate safety and performance three months after implantation of the new Sentio system. In addition, safety will be analysed six months after implantation, and long-term safety and performance will be evaluated over a 24-month follow-up period. The endpoints chosen, together with applicable measurements, are commonly used, both in the clinical setting as well as in bone anchored hearing research as shown in the scientific literature covering this area. That is, the primary objectives of this study is to demonstrate that the Sentio system improves hearing and speech recognition on the implanted ear. Secondary objectives includes investigation of hearing improvement, speech intelligibility, patient satisfaction, and quality of life. The study also aims to evaluate the safety profile of the Sentio system in terms of the occurrence of adverse events and serious adverse events related to the device.
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 hearing systemProspective, open label, single-arm multi-centre investigation following clinical practice for bone conduction devices. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Signed Informed Consent Form
- Adult subjects (18 years or older)
- Subjects 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 subjects who have 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 subjects who are indicated for an air-conduction contralateral routing of signals (ACCROS) hearing aid, but who for some reason cannot or will not use an AC CROS.
- Fluent in local language
Key exclusion criteria (20 listed)
- Inability to undergo general or local anesthesia
- Prior implantation with percutaneous device or middle ear implant on the side to be implanted
- Known medical conditions that contraindicate undergoing surgery as judged by the investigator
- Untreated ongoing middle ear infection at the time of surgery
- Known insufficient bone quality/quantity/depth or skull size (scull abnormalities) for implantation of a Sentio Ti Implant
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 hearing systemAlso: Sentio systemThe Sentio system consists of the Sentio 1 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 Sentio, i.e. the difference between preoperative unaided and aided sound field thresholds on the implanted ear.
Demonstrate that the Sentio system provides patients with improved speech recognition on the implanted ear.
Time frame: 3 months post-surgery
Difference in speech recognition score in percent between pre-operative unaided condition and aided with Sentio, measured in quiet on the implanted ear.
1 secondary outcome
Thorough assessment of performance (functional gain, effective gain, speech recognition), satisfaction, usability, comfort and health-related quality of life.
Time frame: 3-24 months post-surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2024.
- 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.
Myrthe Hol, MD, PhD principal investigator
ENT Department, University Medical Center Groningen
Emmanuel Mylanus, MD, PhD principal investigator
ENT Department, Radboud University Medical Center
Peter Monksfield, MD, PhD principal investigator
ENT - University Hospitals Birmingham NHS, Foundation Trust
6 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 hearing system in people with Hearing Loss, Conductive and Hearing Loss, Mixed, run by Oticon Medical at 6 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 6 inclusion and 20 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: status not confirmed, as of the sponsor's last update on 3 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Germany, Netherlands, United Kingdom. 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?
Results are not available in the source record.
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). The study lists 2 primary outcomes in all. 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 3 Apr 2024.