Clinical Investigation Study of Safety and Performance of the Sentio System.

NCT ID: NCT05166265

Last Updated: 2024-04-03

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-19
• Study Completion Date: 2025-11-30

Brief 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.

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.

Conditions

Hearing Loss, Conductive; Hearing Loss, Mixed; Hearing Loss, Unilateral

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Sentio system

Prospective, open label, single-arm multi-centre investigation following clinical practice for bone conduction devices.

Group Type: EXPERIMENTAL

Active transcutaneous bone conduction hearing system

Intervention Type: DEVICE

The Sentio system consists of the Sentio 1 sound processor (SP) and Sentio Ti implant with fixation band and screws.

Interventions

Active transcutaneous bone conduction hearing system

The Sentio system consists of the Sentio 1 sound processor (SP) and Sentio Ti implant with fixation band and screws.

Intervention Type: DEVICE

Other Intervention Names

Sentio system

Eligibility Criteria

Inclusion Criteria

1. Signed Informed Consent Form

2. Adult subjects (18 years or older)

3. 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.

4. Fluent in local language

5. Subjects who have the ability and are willing to follow investigational procedures/requirements, e.g. to complete quality of life scales.

Exclusion Criteria

1. Inability to undergo general or local anesthesia

2. Prior implantation with percutaneous device or middle ear implant on the side to be implanted

3. Known medical conditions that contraindicate undergoing surgery as judged by the investigator

4. Untreated ongoing middle ear infection at the time of surgery

5. Known insufficient bone quality/quantity/depth or skull size (scull abnormalities) for implantation of a Sentio Ti Implant

6. Known or suspected contact allergy to silicone or other material used in the Sentio system.

7. Known condition that could jeopardize wound healing and skin condition e.g. uncontrolled diabetes over time as judged by the investigator.

8. Known skin or scalp conditions that may preclude attachment or interfere with the usage of the sound processor.

9. Known retro cochlear pathology and auditory processing disorders that may have an impact on the outcome of the investigation

10. Any other known condition that the investigator determines could interfere with compliance or investigation assessments.

11. Use of ototoxic drugs that could be harmful to the hearing, as judged by the investigator.

12. Subject that has received radiotherapy in the area of implantation or is planned for such radiotherapy or similar during the investigation period.

13. For bilateral asymmetric candidates, subject already treated with a bone-anchored hearing solution on the side with the best bone conduction thresholds

14. Known chronic or non-revisable vestibular or balance disorder

15. Known abnormally progressive hearing loss

16. For conductive and mixed losses: evidence that hearing loss is retro-cochlear or of central origin

17. Participation in another clinical investigation with pharmaceuticals and/or devices which might cause interference with investigation participation.

18. 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.

19. Known need for frequent MRI investigations for follow-up of other diseases.

20. Any subject that according to the Declaration of Helsinki is deemed unsuitable for investigation enrolment.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Oticon Medical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Myrthe Hol, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

ENT Department, University Medical Center Groningen

Emmanuel Mylanus, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

ENT Department, Radboud University Medical Center

Peter Monksfield, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

ENT - University Hospitals Birmingham NHS, Foundation Trust

James Tysome, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Cambridge University Hospitals NHS Foundation Trust, Addenbrookes Hospital

Susan Arndt, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Universitätsklinikum Freiburg

Thomas Lenartz, MD, PhD

Role: STUDY_DIRECTOR

HNO-Klinik Medizinische Hochschule Hannover

Locations

Universitätsklinikum Freiburg Universitätsklinik für Hals,- Nasen und Ohrenheilkunde

Freiburg im Breisgau, , Germany

HNO-Klinik Medizinische Hochschule Hanover

Hanover, , Germany

ENT Department, University Medical Center Groningen

Groningen, , Netherlands

ENT department Radboud University Medical Center (Radboud UMC)

Nijmegen, , Netherlands

ENT - University Hospitals Birmingham NHS Foundation Trust, Queen Elizabeth Hospital Birmingham

Birmingham, , United Kingdom

Cambridge University Hospitals NHS Foundation Trust, Addenbrookes Hospital

Cambridge, , United Kingdom

Countries

Germany; Netherlands; United Kingdom

Other Identifiers

CIV-21-07-037287

Identifier Type: OTHER

Identifier Source: secondary_id

CI/2021/0043/GB

Identifier Type: OTHER

Identifier Source: secondary_id

BC101

Identifier Type: -

Identifier Source: org_study_id