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

Primary Purpose

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

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Active transcutaneous bone conduction hearing system
Sponsored by
Oticon Medical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hearing Loss, Conductive focused on measuring Hearing Loss, Conductive, Mixed, Single-sided, Deafness

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Universitätsklinikum Freiburg Universitätsklinik für Hals,- Nasen und OhrenheilkundeRecruiting
  • HNO-Klinik Medizinische Hochschule HanoverRecruiting
  • ENT Department, University Medical Center GroningenRecruiting
  • ENT department Radboud University Medical Center (Radboud UMC)Recruiting
  • ENT - University Hospitals Birmingham NHS Foundation Trust, Queen Elizabeth Hospital BirminghamRecruiting
  • Cambridge University Hospitals NHS Foundation Trust, Addenbrookes HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Sentio system

Arm Description

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

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.

Full Information

First Posted
December 8, 2021
Last Updated
July 13, 2023
Sponsor
Oticon Medical
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1. Study Identification

Unique Protocol Identification Number
NCT05166265
Brief Title
Clinical Investigation Study of Safety and Performance of the Sentio System.
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 19, 2022 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
September 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Oticon Medical

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss, Conductive, Hearing Loss, Mixed, Hearing Loss, Unilateral
Keywords
Hearing Loss, Conductive, Mixed, Single-sided, Deafness

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sentio system
Arm Type
Experimental
Arm Description
Prospective, open label, single-arm multi-centre investigation following clinical practice for bone conduction devices.
Intervention Type
Device
Intervention Name(s)
Active transcutaneous bone conduction hearing system
Other Intervention Name(s)
Sentio system
Intervention Description
The Sentio system consists of the Sentio 1 sound processor (SP) and Sentio Ti implant with fixation band and screws.
Primary Outcome Measure Information:
Title
Demonstrate that the Sentio system improves hearing on the implanted ear.
Description
Functional gain with Sentio, i.e. the difference between preoperative unaided and aided sound field thresholds on the implanted ear.
Time Frame
3 months post-surgery
Title
Demonstrate that the Sentio system provides patients with improved speech recognition on the implanted ear.
Description
Difference in speech recognition score in percent between pre-operative unaided condition and aided with Sentio, measured in quiet on the implanted ear.
Time Frame
3 months post-surgery
Secondary Outcome Measure Information:
Title
Thorough assessment of performance (functional gain, effective gain, speech recognition), satisfaction, usability, comfort and health-related quality of life.
Description
Sound field audiometry, speech testing in quiet and noise and patient reported outcomes on listed topics.
Time Frame
3-24 months post-surgery
Other Pre-specified Outcome Measures:
Title
Evaluate the safety profile of the Sentio system in terms of the occurrence of adverse events and serious adverse events related to the device.
Description
Tabulated adverse events and serious adverse events related to the device reported from surgery throughout the investigation reported at 3 months post-surgery
Time Frame
3 months post-surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dennis Lindholm, RN
Phone
+46 701 499 080
Email
dlin@oticonmedical.com
First Name & Middle Initial & Last Name or Official Title & Degree
Åsa Nilsson, PhD
Phone
+46735374120
Email
asnn@oticonmedical.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Myrthe Hol, MD, PhD
Organizational Affiliation
ENT Department, University Medical Center Groningen
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Emmanuel Mylanus, MD, PhD
Organizational Affiliation
ENT Department, Radboud University Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Peter Monksfield, MD, PhD
Organizational Affiliation
ENT - University Hospitals Birmingham NHS, Foundation Trust
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
James Tysome, MD, PhD
Organizational Affiliation
Cambridge University Hospitals NHS Foundation Trust, Addenbrookes Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Susan Arndt, MD, PhD
Organizational Affiliation
Universitätsklinikum Freiburg
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Thomas Lenartz, MD, PhD
Organizational Affiliation
HNO-Klinik Medizinische Hochschule Hannover
Official's Role
Study Director
Facility Information:
Facility Name
Universitätsklinikum Freiburg Universitätsklinik für Hals,- Nasen und Ohrenheilkunde
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Susan Arndt, MD, PhD
Phone
+49 (0)761/270-42010
Email
susan.arndt@uniklinik-freiburg.de
First Name & Middle Initial & Last Name & Degree
Susan Arndt, MD, PhD
First Name & Middle Initial & Last Name & Degree
Benjamin Straub, MD, PhD
First Name & Middle Initial & Last Name & Degree
Rebecca C Schill, MD
Facility Name
HNO-Klinik Medizinische Hochschule Hanover
City
Hanover
ZIP/Postal Code
30625
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas Lenartz, Md, PhD
Phone
+49 (0) 511 532-6565
Email
lenarz.thomas@mh-hannover.de
First Name & Middle Initial & Last Name & Degree
Thomas Lenartz, MD, PhD
First Name & Middle Initial & Last Name & Degree
Nils Prentzler, MD
First Name & Middle Initial & Last Name & Degree
Magnus Teschner, MD, PhD
First Name & Middle Initial & Last Name & Degree
Kerstin Willenborg, MD, PhD
First Name & Middle Initial & Last Name & Degree
Rolf Salcher, MD
Facility Name
ENT Department, University Medical Center Groningen
City
Groningen
ZIP/Postal Code
9700 RB
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Myrthe Hol, MD, PhD
Phone
+31 50 361 2540
Email
m.k.s.hol@umcg.nl
First Name & Middle Initial & Last Name & Degree
Myrthe Hol, MD, PhD
First Name & Middle Initial & Last Name & Degree
Rutger Hofman, MD
First Name & Middle Initial & Last Name & Degree
Tjerk Aukema, Md
Facility Name
ENT department Radboud University Medical Center (Radboud UMC)
City
Nijmegen
ZIP/Postal Code
6500 HB
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emmanuel Mylanus, MD, PhD
Phone
+31 (024) 361 49 34
Email
Emmanuel.Mylanus@radboudumc.nl
First Name & Middle Initial & Last Name & Degree
Emmanuel Mylanus, MD, PhD
First Name & Middle Initial & Last Name & Degree
Emma Teunissen, MD
Facility Name
ENT - University Hospitals Birmingham NHS Foundation Trust, Queen Elizabeth Hospital Birmingham
City
Birmingham
ZIP/Postal Code
B15 2GW
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peter Monksfield, MD, PhD
Phone
+44 (0) 7887992906
Email
Peter.Monksfield@uhb.nhs.uk
First Name & Middle Initial & Last Name & Degree
Peter Monksfield, MD, PhD
First Name & Middle Initial & Last Name & Degree
Rupan Banga, MD
Facility Name
Cambridge University Hospitals NHS Foundation Trust, Addenbrookes Hospital
City
Cambridge
ZIP/Postal Code
CB2 0QQ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
James Tysome, MD, PhD
Phone
+44 1223 256051
Email
james.tysome@addenbrookes.nhs.uk
First Name & Middle Initial & Last Name & Degree
James Tysome, MD, PhD
First Name & Middle Initial & Last Name & Degree
Manohar Bance, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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