- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05166265
Clinical Investigation Study of Safety and Performance of the Sentio System.
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
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Dennis Lindholm, RN
- Phone Number: +46 701 499 080
- Email: dlin@oticonmedical.com
Study Contact Backup
- Name: Åsa Nilsson, PhD
- Phone Number: +46735374120
- Email: asnn@oticonmedical.com
Study Locations
-
-
-
Freiburg, Germany, 79106
- Universitätsklinikum Freiburg Universitätsklinik für Hals,- Nasen und Ohrenheilkunde
-
Hanover, Germany, 30625
- HNO-Klinik Medizinische Hochschule Hanover
-
-
-
-
-
Groningen, Netherlands, 9700 RB
- ENT Department, University Medical Center Groningen
-
Nijmegen, Netherlands, 6500 HB
- ENT department Radboud University Medical Center (Radboud UMC)
-
-
-
-
-
Birmingham, United Kingdom, B15 2GW
- ENT - University Hospitals Birmingham NHS Foundation Trust, Queen Elizabeth Hospital Birmingham
-
Cambridge, United Kingdom, CB2 0QQ
- Cambridge University Hospitals NHS Foundation Trust, Addenbrookes Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Sentio system
Prospective, open label, single-arm multi-centre investigation following clinical practice for bone conduction devices.
|
The Sentio system consists of the Sentio 1 sound processor (SP) and Sentio Ti implant with fixation band and screws.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
3 months post-surgery
|
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.
|
3 months post-surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Sound field audiometry, speech testing in quiet and noise and patient reported outcomes on listed topics.
|
3-24 months post-surgery
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluate 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
|
Tabulated adverse events and serious adverse events related to the device reported from surgery throughout the investigation reported at 3 months post-surgery
|
3 months post-surgery
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Myrthe Hol, MD, PhD, ENT Department, University Medical Center Groningen
- Principal Investigator: Emmanuel Mylanus, MD, PhD, ENT Department, Radboud University Medical Center
- Principal Investigator: Peter Monksfield, MD, PhD, ENT - University Hospitals Birmingham NHS, Foundation Trust
- Principal Investigator: James Tysome, MD, PhD, Cambridge University Hospitals NHS Foundation Trust, Addenbrookes Hospital
- Principal Investigator: Susan Arndt, MD, PhD, Universitätsklinikum Freiburg
- Study Director: Thomas Lenartz, MD, PhD, HNO-Klinik Medizinische Hochschule Hannover
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- BC101
- CIV-21-07-037287 (Other Identifier: EUDAMED)
- CI/2021/0043/GB (Other Identifier: MHRA)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hearing Loss, Conductive
-
Oticon MedicalRecruitingEar Diseases | Hearing Loss, Conductive | Hearing Loss Mixed | Hearing Disability | Conductive Hearing Loss | Conductive Hearing Loss, Bilateral | Conductive Hearing Loss, UnilateralUnited Kingdom
-
Oticon MedicalSahlgrenska University Hospital, SwedenCompletedConductive Hearing Loss | Mixed Hearing LossSweden
-
Audioptics Medical IncorporatedNot yet recruitingConductive Hearing Loss, Middle Ear
-
Oticon MedicalActive, not recruitingConductive Hearing Loss | Mixed Hearing LossSweden
-
Oticon MedicalCompletedConductive Hearing Loss | Mixed Hearing Loss | Unilateral Partial DeafnessSweden
-
Oticon MedicalCompletedConductive Hearing Loss | Unilateral Partial Deafness | Mixed Conductive-sensorineural Hearing LossNetherlands
-
Khon Kaen UniversityPrince of Songkla University; Chiang Mai UniversityNot yet recruitingNormal Hearing | Conductive Hearing Loss, Middle EarThailand
-
CochlearCompletedConductive Hearing Loss | Deafness; Sensoneural Single Sided | Mixed Hearing LossUnited States, Netherlands, Australia, Germany, Poland
-
CochlearCompletedConductive Hearing Loss | Deafness; Sensoneural Single Sided | Mixed Hearing LossAustralia
Clinical Trials on Active transcutaneous bone conduction hearing system
-
Sonitus Medical IncCompletedUnilateral Hearing LossUnited States
-
University Hospital Inselspital, BerneCompletedHearing Loss, ConductiveSwitzerland
-
University of MiamiMed-El CorporationTerminated
-
CochlearCompletedUnilateral Mixed Conductive and Sensorineural Hearing Loss (Diagnosis) | Sensorineural Hearing Loss, Unilateral With Normal Hearing on the Contralateral SideCanada
-
Dominik RissCompletedHearing Loss, Conductive | Bone Conduction DeafnessAustria
-
Sonitus Medical IncCompletedHearing Loss | Unilateral Hearing Loss | Total Unilateral DeafnessUnited States
-
Medtronic Surgical TechnologiesCompletedConductive Hearing Loss | Single-Sided Deafness | Mixed Hearing LossUnited States
-
Oticon MedicalCompletedHearing Impairment, Conductive | Deafness Unilateral | Hearing Impaired (Partially)Denmark
-
ONYAvaniaNot yet recruitingIntubation Complication | Death; Neonatal | Respiratory Distress Syndrome (Neonatal)United States
-
VA Office of Research and DevelopmentRecruiting