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

NCT05166265 | Active Not Recruiting

• 3 other identifiers: BC101CIV-21-07-037287CI/2021/0043/GB
• Study Type: interventional
• Target: 51
• Locations: 3 countries
• Sites: 6

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.

Conditions

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

Keywords

Hearing Loss; Conductive; Mixed; Single-sided; Deafness

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  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.

  3-24 months post-surgery

Other Outcomes (1)

• Evaluate the safety profile of the Sentio system in terms of the occurrence of adverse events and serious adverse events related to the device.

  3 months post-surgery

Study Arms (1)

Sentio system

EXPERIMENTAL

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

Device: Active transcutaneous bone conduction hearing system

Interventions

Active transcutaneous bone conduction hearing system DEVICE

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

Also known as: Sentio system

Sentio system

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Oticon Medical: lead

Study Sites (6)

Universitätsklinikum Freiburg Universitätsklinik für Hals,- Nasen und Ohrenheilkunde

Freiburg im Breisgau, 79106, Germany

Location

HNO-Klinik Medizinische Hochschule Hanover

Hanover, 30625, Germany

Location

ENT Department, University Medical Center Groningen

Groningen, 9700 RB, Netherlands

Location

ENT department Radboud University Medical Center (Radboud UMC)

Nijmegen, 6500 HB, Netherlands

Location

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

Birmingham, B15 2GW, United Kingdom

Location

Cambridge University Hospitals NHS Foundation Trust, Addenbrookes Hospital

Cambridge, CB2 0QQ, United Kingdom

Location

MeSH Terms

Conditions

Hearing Loss, Conductive; Hearing Loss, Mixed Conductive-Sensorineural; Hearing Loss, Unilateral; Hearing Loss; Deafness

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

• Thomas Lenartz, MD, PhD

  HNO-Klinik Medizinische Hochschule Hannover

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2021
• First Posted: December 21, 2021
• Study Start: January 19, 2022
• Primary Completion: February 19, 2024
• Study Completion: November 1, 2025
• Last Updated: April 3, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2); DE (2); NL (2)